Takeda Pharmaceutical Co Ltd 6-K, filed Mar 30, 2026
Takeda Pharmaceutical Co Ltd (TAK)
6-K
2026-03-30
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About this 6-K
Takeda Pharmaceutical Co Ltd filed this 6-K on March 30, 2026.
FORM 6-K
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of March 2026
Commission File Number: 001-38757
TAKEDA PHARMACEUTICAL COMPANY LIMITED
(Translation of registrant’s name into English)
1-1, Nihonbashi-Honcho 2-Chome
Chuo-ku, Tokyo 103-8668
Japan
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
Information furnished on this form:
EXHIBIT
Exhibit Number | ||||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| TAKEDA PHARMACEUTICAL COMPANY LIMITED | |||||||||||
| Date: March 30, 2026 | By: | /s/ Norimasa Takeda | |||||||||
Norimasa Takeda Chief Accounting Officer and Corporate Controller | |||||||||||
News Release Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care - About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies - A significantly greater PASI 75 response rate versus placebo was observed as early as week 4 - Safety profile consistent with Phase 2b studies with no new safety signals identified OSAKA, Japan and CAMBRIDGE, Massachusetts, March 28, 2026 – Takeda (TSE:4502/NYSE:TAK) today announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham, MSc, MD, FRCPC, dermatologist, SKiN Centre for Dermatology, Peterborough, Ontario, Canada, principal investigator for the Latitude PsO studies and presenting author. “These efficacy and safety results show it’s possible for a once-daily pill to deliver rapid, lasting skin clearance, highlighting the potential of zasocitinib to become a leading oral treatment option for plaque psoriasis.” In the Phase 3 randomized, multicenter, double-blind, placebo- and active comparator- controlled Latitude PsO 3001 and 3002 studies, more than half of patients treated with zasocitinib achieved clear or almost clear skin at week 16, a key measure of treatment success: 1,2 • 71.4% and 69.2% of patients treated with zasocitinib achieved a static Physician Global Assessment (sPGA) score of 0/1 versus placebo (10.7% and 12.6%) and apremilast (32.1% and 29.7%) at week 16 (p<0.001).2 • 61.3% and 51.9% of patients treated with zasocitinib achieved Psoriasis Area and Severity Index (PASI) 90 versus placebo (5.0% and 4.0%) and apremilast (16.8% and 15.9%) at week 16 (p<0.001).2
Zasocitinib also demonstrated statistically significant improvements in complete skin clearance, an increasingly important treatment goal for patients with plaque psoriasis:1,2 • 39.9% and 33.7% of patients treated with zasocitinib achieved an sPGA score of 0 versus placebo (0.7% and 1.4%) and apremilast (8.0% and 6.5%) at week 16 (p<0.001).2 • 33.4% and 25.2% of patients treated with zasocitinib achieved a PASI 100 versus placebo (0.7% and 1.1%) and apremilast (2.9% and 4.3%) at week 16 (p<0.001).2 • Responses for co-primary and key secondary endpoints continued to increase through week 24 in both studies.2 In Latitude PsO 3002, rapidity of response was demonstrated as early as week 4 versus placebo (PASI 75: 16.8% for zasocitinib vs 4.3% for placebo, p<0.001).2 Among patients who achieved a PASI 75, PASI 90 or sPGA 0/1 response at week 40 and continued on zasocitinib throughout the study, over 90% maintained their response at week 60.2 Zasocitinib was generally well-tolerated.1,2 The safety and tolerability profile of zasocitinib in the Phase 3 studies remained consistent with prior studies. 1,2 Key findings across the two studies include: • Treatment-emergent adverse events (TEAEs) through week 16 were 62.1% for zasocitinib, 46.9% for placebo and 50.5% for apremilast.2 • The most common adverse events for zasocitinib treated patients through week 16 (≥5%) were upper respiratory tract infection (10.1%), nasopharyngitis (6.2%) and acne (6.5%), with no new safety signals identified.2 • Serious TEAEs through week 16 were 3.0% for zasocitinib, <1% for placebo and 1.5% for apremilast.2 “Our Phase 3 results demonstrate that highly selective TYK2 inhibition can offer many people with moderate-to-severe plaque psoriasis the potential for clear or nearly clear skin,” said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. “The positive data also underscore zasocitinib’s potential to deliver rapid and durable results with a favorable safety profile consistent with Phase 2b studies. We are working as quickly as possible with regulators to advance a potential new therapeutic option for patients seeking a safe, effective and convenient oral treatment.” Takeda is on track to submit a New Drug Application with the United States Food and Drug Administration and other regulatory authorities starting in fiscal year 2026. Results from the Phase 3 studies have no significant impact on the full-year consolidated forecast for the fiscal year ending March 31, 2026.
Takeda Investor Conference Call and Webcast Details Takeda will host an investor call to discuss the Phase 3 data and market opportunity for zasocitinib on March 28 at 6:30 p.m. MDT / 8:30 p.m. EDT / March 29 at 9:30 a.m. JST. Presentation slides and a virtual meeting registration link will be available here. An on-demand replay of the webcast will be made available on Takeda’s website after the conclusion of the event. About Plaque Psoriasis Psoriasis is a chronic immune-mediated inflammatory disease in which the body’s immune system causes inflammation which results in skin cells that multiply too quickly.3 Plaque psoriasis, the most common form of psoriasis, is characterized by raised, red, gray or purple patches of skin that are itchy, painful and covered by scales.4-6 Psoriatic plaques can cover any part of the skin surface but are mostly found on the scalp, face, arms and elbows, legs, knees, torso, genitals, nails and in skin folds.3,7 Many people living with psoriasis experience intense itching and burning from their psoriasis plaques that disrupt their daily lives.5,6 Patients also report that their symptoms negatively impact their mental health and quality of life and can lead to social isolation.8 Globally, an estimated 64 million people are living with psoriasis and about 80-90% of those have plaque psoriasis.9,10 About Zasocitinib (TAK-279) Zasocitinib is an investigational, next-generation, highly selective oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways.11,12 It has the potential to be a leading oral treatment option for people living with immune- mediated inflammatory diseases. Zasocitinib has more than 1-million-fold greater selectivity for TYK2 compared to other JAK enzymes, which could maximize TYK2 inhibition without impacting JAK1, 2 and 3 signaling, based on in vitro data.11,13 Takeda is currently evaluating the safety and efficacy of zasocitinib in a head-to-head study against deucravacitinib in plaque psoriasis and in Phase 3 studies in psoriatic arthritis.14-16 In addition, Phase 2 studies are ongoing in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS).17-20 Zasocitinib is an investigational compound that has not been approved for use by any regulatory authority. About the LATITUDE Psoriasis Phase 3 Studies The Latitude Phase 3 psoriasis studies (NCT06088043 and NCT06108544) are global, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies to evaluate the efficacy, safety and tolerability of zasocitinib in adult patients with moderate-to- severe plaque psoriasis.21,22 The studies were conducted in 21 countries and enrolled 693 and 1,108 participants, respectively. The co-primary endpoints were the proportion of zasocitinib- treated patients achieving sPGA 0/1 and PASI 75 response compared to placebo at week
16.21,22 Ranked (key) secondary endpoints included comparisons versus placebo (week 16) and apremilast (week 16 and week 24).21,22 About Tyrosine Kinase 2 (TYK2) Inhibitors TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family.13,23,24 However, TYK2 is distinct from JAK1, 2 and 3 as it primarily regulates immune responses, whereas JAK1, 2 and 3 regulate broader biological processes. 13,23,24 TYK2 mediates IL-23 plus other immune and inflammatory signaling pathways that are fundamental to psoriasis, psoriatic arthritis and other immune-mediated inflammatory diseases.25 Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, 2 and 3, may be a promising therapeutic approach to target immune-mediated inflammation while potentially avoiding risks associated with inhibition of other members of the JAK family. 26 About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com. Media Contacts Japanese Media Tsuyoshi Tada tsuyoshi.tada@takeda.com U.S. and International Media Jennifer Henesey Jennifer.Henesey@takeda.com Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended
to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the
expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security- reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. References: 1. The topline results of these studies were disclosed on December 18, 2025 in, “Takeda’s Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment”. 2. Gooderham M, et al. Once-daily Oral Zasocitinib Demonstrates Rapid and Reproducible Skin Clearance with a Consistent Safety Profile in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials (LATITUDE-PsO-3001 and 3002). Presented at American Academy of Dermatology 2026. 2026 Mar 28; Denver, CO. 3. Dhabale A, Nagpure S. Types of psoriasis and their effects on the immune system. Cureus. 2022 Sep 24;14(9):e29536. doi: 10.7759/cureus.29536. 4. Gkini MA, Nakamura M, Alexis AF, et al. Psoriasis in People With Skin of Color: An Evidence-Based Update. Int J Dermatol. 2025;64(4):667-677. doi:10.1111/ijd.17651 5. Taliercio VL, Snyder AM, Webber LB, et al. The Disruptiveness of Itchiness from Psoriasis: A Qualitative Study of the Impact of a Single Symptom on Quality of Life. J Clin Aesthet Dermatol. 2021;14(6):42-48. 6. Snyder AM, Taliercio VL, Webber LB, et al. The Role of Pain in the Lives of Patients with Psoriasis: A Qualitative Study on an Inadequately Addressed Symptom. J Psoriasis Psoriatic Arthritis. 2022;7(1):29-34. doi:10.1177/24755303211066928 7. Dopytalska K, Sobolewski P, Błaszczak A, Szymańska E, Walecka I. Psoriasis in Special Localizations. Reumatologia. 2018;56(6):392-398. doi:10.5114/reum.2018.80718. 8. Blackstone B, Patel R, Bewley A. Assessing and Improving Psychological Well-Being in Psoriasis: Considerations for the Clinician. Psoriasis (Auckl). 2022;12:25- 33.doi:10.2147/PTT.S328447.
9. AIQassimi S, AIBrashdi S, Galadari H, Hashim MJ. Global Burden of Psoriasis - Comparison of Regional and Global Epidemiology, 1990 to 2017. Int J Dermatol. 2020;59(5):566-571. doi: 10.llll/ijd.14864. 10. Mehta S, Sathe NC. Plaque Psoriasis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; September 14, 2025. https://www.ncbi.nlm.nih.gov/books/NBK430879/. 11. Mehrotra S, Sano Y, Halkowycz P, et al. Pharmacological Characterization of Zasocitinib (TAK-279): An Oral, Highly Selective and Potent Allosteric TYK2 Inhibitor. May 26, 2025. J Invest Dermatol. 2025 May 27:S0022-202X(25)00531-7. doi:10.1016/j.jid.2025.05.014. 12. Shang L, et al. TYK2 in immune responses and treatment of psoriasis. J Inflamm Res. 2022;15:5373-5385. 2022 Sep 16. doi:10.2147/JIR.S380686 13. Leit S, Greenwood J, Carriero S, et al. Discovery of a Potent and Selective Tyrosine Kinase 2 Inhibitor: TAK-279. J Medicinal Chemistry.2023;66(15):10473- 10496.doi.org/10.1021/acs.jmedchem.3c00600. 14. A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis. ClinicalTrials.gov Identified: NCT06973291. Updated December 17, 2025. Accessed March 2026.https://clinicaltrials.gov/study/NCT06973291. 15. Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671483. Updated March 9, 2026. Accessed March 2026. https://clinicaltrials.gov/study/NCT06671483. 16. A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671496. Updated March 9, 2026. Accessed March 2026. https://clinicaltrials.gov/study/NCT06671496. 17. A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov Identifier: NCT06233461. Updated February 11, 2026. Accessed March 2026. https://clinicaltrials.gov/study/NCT06233461. 18. A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov Identifier: NCT06254950. Updated March 13, 2026. Accessed March 2026. https://www.clinicaltrials.gov/study/NCT06254950. 19. A Study of Zasocitinib in Adults With Nonsegmental Vitiligo. ClinicalTrials.gov Identifier: NCT07108283. Updated March 13, 2026. Accessed March 2026. https://clinicaltrials.gov/study/NCT07108283. 20. A Takeda Presentation. Quarterly Results - Quarter 1 FY2025. Available at: https://assets-dam.takeda.com/image/upload/v1753839858/Global/Investor/Financial- Results/FY2025/Q1/qr2025_q1_p01_en.pdf. Accessed March 2026. 21. A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate- to-Severe Plaque Psoriasis During 52 Weeks of Treatment. ClinicalTrials.gov Identifier: NCT06088043. Updated October 24, 2025. Accessed March 2026. https://clinicaltrials.gov/study/NCT06088043.
22. A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate- to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period. ClinicalTrials.gov Identifier: NCT06108544. Updated November 11, 2025. Accessed March 2026. https://clinicaltrials.gov/study/NCT06108544. 23. Muromoto R, Oritani K, Matsuda T. Current Understanding of the Role of Tyrosine Kinase 2 Signaling in Immune Responses. World J Biol Chem. 2022;13(1):1–14. doi:10.4331/wjbc.v13.i1.1. 24. Danese S, Peyrin-Biroulet L. Selective Tyrosine Kinase 2 Inhibition for Treatment of Inflammatory Bowel Disease: New Hope on the Rise. Inflamm Bowel Dis. 2021;27(12):2023-2030. doi: 10.1093/ibd/izab135. 25. Rusiñol L, Puig L. Tyk2 Targeting in Immune-Mediated Inflammatory Diseases. Int J Mol Sci. 2023;24(4):3391. Published 2023 Feb 8. doi:10.3390/ijms24043391. 26. Krueger JG, McInnes IB, Blauvelt A. Tyrosine Kinase 2 and Janus Kinase‒Signal Transducer and Activator of Transcription Signaling and Inhibition in Plaque Psoriasis. J Am Acad Dermatol. 2022;86(1):148-157. doi:10.1016/j.jaad.2021.06.869.
Zasocitinib IR Event Phase 3 Psoriasis Data Presented at AAD March 28th, 2026 ET / March 29th, 2026 JST This material is prepared and distributed solely for the purpose of providing information about Takeda's management or business to shareholders, investors, and analysts, and is not intended to induce purchase or prescription of any specific drugs and other products. This material is not intended for healthcare professionals, patients, or other persons other than those mentioned above. This material is prohibited from being used by persons other than those mentioned above and for the purpose other than one mentioned above. Photo: IFPA | All the Colors We Are
For the purposes of this notice, “presentation” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this presentation. This presentation (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this presentation. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This presentation is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this presentation, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners. Forward-Looking Statements This presentation and any materials distributed in connection with this presentation may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this presentation or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this presentation may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Peak Revenue Potential References in this presentation to peak revenue ranges are estimates that have not been adjusted for probability of technical and regulatory success (PTRS) and should not be considered a forecast or target. These peak revenue ranges represent Takeda’s assessments of various possible future commercial scenarios that may or may not occur. Medical information This presentation contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Important Notice 2
Opening Remarks Julie Kim, CEO-Elect Phase 3 Psoriasis Results Chinwe Ukomadu, Head of GI&I Therapeutic Area Market Opportunity Rhonda Pacheco, President, U.S. Business Unit; U.S. Country Head Question & Answer Session AGENDA 1. 2. 3. 4.
Preparing to launch 3 transformative medicines in the next 15 months setting Takeda on a new growth trajectory 4 Oveporexton Narcolepsy Type 1 Rusfertide Polycythemia Vera Zasocitinib Psoriasis Expected launch 2026 (H2) Expected launch 2026 (H2) Expected launch 2027 (H1) First orexin agonist to NDA submission with compelling efficacy across the broad spectrum of NT1 symptoms Primed to trigger a paradigm shift in the treatment of NT1 Hepcidin mimetic delivering durable & sustained hematocrit control addressing major unmet need Set to revolutionize outcomes at each step in the treatment landscape Next-generation, highly selective oral TYK2 inhibitor delivering rapid and durable skin clearance in a convenient once-daily pill Poised to be a leading oral option in an expanding oral market Estimated launch timings are all pending regulatory approval. Breakthrough Designation Fast Track Designation Orphan Drug Designation
Zasocitinib: Poised to be a leading oral treatment option for patients with psoriasis – significantly expanding the oral market 1 32 Convenient once-daily pill without fasting restrictions Rapid and durable skin clearance, with no new safety signals Next-generation, highly selective oral TYK2 inhibitor Zasocitinib U.S. and global filings on track to start in FY26 5
Zasocitinib Phase 3 Psoriasis Results
Zasocitinib: Next-generation, highly selective oral TYK2 inhibitor1,2 7 • More than 1 millionfold greater binding selectivity for TYK2 versus JAK1, JAK2 and JAK31,2 • Maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways without any inhibition of JAK1, JAK2 and JAK3 pathways.2,3 • Well tolerated and efficacious in a phase 2b trial in patients with moderate-to-severe plaque psoriasis4 Objective: To evaluate the efficacy and safety of zasocitinib in adults with moderate-to-severe plaque psoriasis in two pivotal phase 3 studies: LATITUDE-PsO-3001 (NCT06088043) and LATITUDE-PsO-3002 (NCT06108544) IFN, interferon; IL, interleukin; JAK, Janus kinase; TYK, tyrosine kinase 1. Leit S et al. J Med Chem 2023;66:10473–96; 2. Mehrotra S et al. J Invest Dermatol 2025;146:214–22; 3. Rusiñol L and Puig L. Int J Mol Sci 2023;24:3391. 4. Armstrong A et al. JAMA Dermatol 2024;160:1066–74.
LATITUDE-PsO-3001 and 3002 were randomized, multicenter, double-blind, placebo- and apremilast-controlled phase 3 trials 8 Endpoints Co-primary endpoints at Week 16 (versus placebo): • sPGA 0/1a • PASI 75 Key secondary endpoints (versus placebo or apremilast) included: • PASI 75 at Week 4 • sPGA 0, PASI 75/90/100 or DLQI 0/1b at Week 16/24 • sPGA 0/1 or PASI 75 maintenance at Week 60 Safety endpoints included: • TEAEs; laboratory parameters Eligibility • Adults (≥ 18 years) • Plaque psoriasis diagnosis for ≥ 6 months prior to screening • PASI ≥ 12, sPGA ≥ 3, ≥ 10% BSA • Candidate for phototherapy or systemic therapy aWith a ≥ 2-point decrease from baseline. bWith a baseline DLQI score ≥2. BSA, body surface area; DLQI, Dermatology Life Quality Index; F/U, follow-up; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment; TEAE, treatment-emergent adverse events.
Baseline demographics and characteristics were generally similar across treatment arms in each study 9 LATITUDE-PsO-3001 LATITUDE-PsO-3002 Zasocitinib (n = 416) Apremilast (n = 137) Placebo (n = 140) Zasocitinib (n = 555) Apremilast (n = 276) Placebo (n = 277) Age, years 43.8 (13.26) 46.0 (14.10) 45.3 (13.54) 45.8 (13.33) 46.1 (13.37) 46.5 (13.19) Sex, male, n (%) 295 (70.9) 95 (69.3) 93 (66.4) 367 (66.1) 187 (67.8) 188 (67.9) Race, White, n (%) 255 (61.3) 88 (64.2) 87 (62.1) 472 (85.0) 233 (84.4) 240 (86.6) BMI, kg/m2 29.7 (6.8) 28.5 (6.3) 28.2 (6.5) 30.2 (6.8) 30.1 (6.5) 30.4 (7.2) Psoriasis duration, median (range) yearsa 13.6 (0.6–62.4) 14.0 (0.6–71.3) 12.5 (0.6–59.3) 15.1 (0.5–69.2) 16.5 (0.6–60.5) 15.1 (0.6–65.9) PASI score 19.7 (7.5) 20.5 (9.0) 20.3 (7.4) 21.3 (9.3) 21.4 (8.6) 21.1 (8.5) sPGA score 3 (moderate), n (%) 329 (79.1) 116 (84.7) 112 (80.0) 473 (85.2) 237 (85.9) 228 (82.3) 4 (severe), n (%) 85 (20.4) 21 (15.3) 28 (20.0) 80 (14.4) 39 (14.1) 48 (17.3) BSA, % 24.0 (14.0) 25.8 (15.9) 24.2 (14.4) 27.9 (17.9) 27.8 (16.5) 27.0 (16.3) DLQI scoreb 12.7 (7.2) 11.1 (6.5) 12.2 (7.3) 11.6 (7.2) 11.5 (6.7) 12.2 (7.4) Bio-experienced, n (%) 141 (33.9) 40 (29.2) 45 (32.1) 155 (27.9) 80 (29.0) 83 (30.0) Data are mean (SD) unless otherwise stated. aData missing for one patient receiving zasocitinib (LATITUDE-PsO-3002). bData missing for three patients receiving zasocitinib and one receiving apremilast (LATITUDE-PsO-3001), and for three patients receiving zasocitinib, one patient receiving apremilast, and four patients receiving placebo (LATITUDE-PsO-3002). BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; SD, standard deviation; sPGA, static Physician’s Global Assessment.
LATITUDE-PsO-3002 Zasocitinib met the co-primary endpoints in both studies (sPGA 0/1 and PASI 75 versus placebo at Week 16) 10 PASI 75sPGA 0/1a PASI 75sPGA 0/1a aWith a ≥ 2-point decrease from baseline. Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. LATITUDE-PsO-3001
LATITUDE-PsO-3002 LATITUDE-PsO-3001 Rapid skin clearance as early as week 4 with zasocitinib 11 PASI 75 PASI 75sPGA 0/1a aWith a ≥ 2-point decrease from baseline. Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001, ̂ ^ nominal p<0.01 CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. *** 17% 6% 4% ^^ 23% 16% 5% ^^ 21% 12% 9% ^^^^ sPGA 0/1a 31% 18% 9% ^^^^
Zasocitinib led to greater proportions of patients achieving PASI 90 than apremilast or placebo as early as Week 4 12 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CfB, change from baseline; CI, confidence interval; PASI, Psoriasis Area and Severity Index; BSA, body surface area. Baseline Week 16 PASI: 15.8 PASI: 0.7 (CfB 95.6%) PASI 90 Responder: Baseline BSA 25% LATITUDE-PsO-3001 LATITUDE-PsO-3002 PASI 90 PASI 90
Zasocitinib led to greater proportions of patients achieving clear skin versus apremilast or placebo as early as Week 8 13 sPGA 0 sPGA 0 PASI 100 PASI 100 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. LATITUDE-PsO-3002 LATITUDE-PsO-3001
LATITUDE-PsO-3001 Zasocitinib led to greater proportions of patients achieving clear skin versus apremilast or placebo as early as Week 8 14 Baseline PASI: 31.3 PASI: 0 Week 16 PASI 100 Responder: Baseline BSA 62% PASI 100 PASI 100 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: Zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: Zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; BSA, body surface area. LATITUDE-PsO-3002
Zasocitinib demonstrated superior improvement in DLQI versus apremilast or placebo as early as Week 4 15 LATITUDE-PsO-3002LATITUDE-PsO-3001 DLQI 0/1a DLQI 0/1a aBased on evaluable patients defined as a subset of full analysis set with a baseline DLQI score ≥2 (with nonresponder imputation). Number of evaluable patients for LATITUDE-PsO-3001: zasocitinib (n = 406), apremilast (n = 133), placebo (n = 133). Number of evaluable patients for LATITUDE-PsO-3002: zasocitinib (n = 525), apremilast (n = 263), placebo (n = 260). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval, DLQI, Dermatology Life Quality Index.
Zasocitinib was well tolerated with no new safety signals identified through Week 16 16 Day 0 to Week 16 TEAEs from LATITUDE-PsO-3001 and 3002a Zasocitinib (n = 970) Apremilast (n = 412) Placebo (n = 417) n %b, (95% CI)c n %b, (95% CI)c n %b, (95% CI)c Any TEAE 605 62.1 (59.0–65.1) 207 50.5 (45.7–55.4) 196 46.9 (42.0–51.7) Leading to discontinuation 31 3.2 (2.1–4.3) 11 2.6 (1.1–4.2) 3 < 1 (0.0–1.6) SAE 29 3.0 (1.9–4.1) 6 1.5 (0.3–2.7) 2 < 1 (0.1–1.7) Death 1d < 1 (0.0–0.6)d 0 0 (0.0–0.9) 0 0 (0.0–0.9) Most frequent TEAE (≥ 5%)e URTI 100 10.1 (8.2–12.0) 24 6.0 (3.7–8.3) 13 3.2 (1.5–4.8) Acne 62 6.5 (5.0–8.1) 3 < 1 (0.0–1.7) 1 < 1 (0.0–1.3) Nasopharyngitis 60 6.2 (4.7–7.7) 23 5.4 (3.2–7.5) 20 4.7 (2.7–6.6) Diarrhea 30 3.1 (2.0–4.2) 33 8.2 (5.5–10.9) 8 1.8 (0.6–3.1) Headache 27 2.8 (1.8–3.9) 26 6.3 (4.0–8.7) 8 1.9 (0.6–3.2) Nausea 20 2.1 (1.2–3.0) 23 5.5 (3.3–7.8) 5 1.2 (0.1–2.2) • No new safety signals observed through week 24 • Most TEAEs were mild or moderate • Laboratory parameters (e.g. lymphocytes, liver enzymes, lipids) demonstrated no clinically meaningful trends over time in both studies TEAEs were coded using MedDRA v28.1. aEvents starting while on initial treatment are included. bSample size adjusted incidence rate x 100. c95% Wald CI unless 0 events occur in either trial, in which case a 95% exact binomial CI is used. dDeath occurred 1 day after first dose date (unrelated to treatment). eMost frequently reported adverse events occurring in ≥ 5% of patients in any treatment group. CI, confidence interval; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event; SAE, serious adverse event; URTI, upper respiratory tract infection.
LATITUDE-PsO-3001 and 3002 were randomized, multicenter, double-blind, placebo- and apremilast-controlled phase 3 trials 17 Endpoints Co-primary endpoints at Week 16 (versus placebo): • sPGA 0/1a • PASI 75 Key secondary endpoints (versus placebo or apremilast) included: • PASI 75 at Week 4 • sPGA 0, PASI 75/90/100 or DLQI 0/1b at Week 16/24 • sPGA 0/1 or PASI 75 maintenance at Week 60 Safety endpoints included: • TEAEs; laboratory parameters Eligibility • Adults (≥ 18 years) • Plaque psoriasis diagnosis for ≥ 6 months prior to screening • PASI ≥ 12, sPGA ≥ 3, ≥ 10% BSA • Candidate for phototherapy or systemic therapy Randomized withdrawal 40 aWith a ≥ 2-point decrease from baseline. bWith a baseline DLQI score ≥2. BSA, body surface area; DLQI, Dermatology Life Quality Index; F/U, follow-up; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment; TEAE, treatment-emergent adverse events.
More than 90% of patients continuing zasocitinib at Week 40 maintained sPGA 0/1, PASI 75 and PASI 90 through Week 60 18 sPGA 0/1 PASI 75 LATITUDE-PsO-3002 randomized withdrawal Most (59%, 69% and 52%) patients re-randomized from zasocitinib to placebo at Week 40 maintained sPGA 0/1, PASI 75, and PASI 90, respectively, for an additional ~5 months PASI 90 91% Evaluable patients based on the full analysis set for randomized withdrawal with nonresponder imputation. Number of patients for sPGA 0/1: zasocitinib–zasocitinib (n = 255), zasocitinib–placebo (n = 126). Number of patients for PASI 75: zasocitinib–zasocitinib (n = 273), zasocitinib–placebo (n = 134). Number of patients for PASI 90: zasocitinib–zasocitinib (n = 238), zasocitinib–placebo (n = 122) . P values for comparison versus zasocitinib–placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001; ***† nominal p <0.001. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. †
Zasocitinib: Enabling expansion with focused LCM programs 19 PHASE 2 START PHASE 2b READOUT PHASE 3 START PHASE 3 READOUT FILING Psoriasis March 2023 Nov 2023 Dec 2025 Target FY2026 Psoriasis H2H vs deucravacitinib July 2025 Target FY2026 Psoriasis Pediatric Dec 2025 Psoriatic Arthritis Sept 2023 March 2024 Target FY2027 Crohn’s Disease March 2024 (Ph2b) Target FY2026 Ulcerative Colitis June 2024 (Ph2b) Target FY2026 Vitiligo Dec 2025 (Ph2b) Hidradenitis Suppurativa Feb 2026 (Ph2a) Milestone achieved All timelines are approximate estimates as of March 28, 2026 are subject to change and are subject to clinical and regulatory success. Table is not comprehensive. For full glossary of abbreviations please refer to appendix.
Zasocitinib was generally well-tolerated • The safety profile of zasocitinib was consistent with that previously reported1 • No observed trends in labs over time such as cholesterol or lipids increases2 20 Week 24 3001 Study 3002 Study sPGA 0/1 74% 71% PASI 90 69% 63% sPGA 0 49% 41% PASI 100 42% 32% 1. Armstrong AW, Gooderham M, Lynde C, et al. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024;160(10):1066-1074. doi:10.1001/jamadermatol.2024.2701 2. Increases in lipids such as cholesterol and triglycerides are known to be associated with JAK inhibition Zasocitinib: Rapid and durable skin clearance in a convenient once-daily pill Zasocitinib demonstrated rapid and durable skin clearance • 49% of patients achieved clear skin, sPGA 0, by week 24 • Rapid response, demonstrated by early separation for PASI 75 and sPGA 0/1 at week 4 • Durable response, >90% of patients continuing zasocitinib at week 40 maintained sPGA 0/1 and PASI 90 through week 60 • Improved quality of life was observed by week 4, with responses continuing to increase over time, reaching up to 60% of patients reporting no impact of psoriasis on daily life (DLQI 0/1) at week 24
Zasocitinib Market Opportunity & Commercialization 21
22 Conventional Therapies Biologics Orals ~1M ~1.3M 27% 40% 51% 10% 22% 1. Conventional therapies include Oral + Topical Steroid, DMARD, & Retinoid 2. US Claim Data (IQVIA SOB Report) and Takeda Forecasting Insights Ad va nc ed T he ra py Ad va nc ed T he ra py 50% FY24 FY34 ~3x the number of patients treated with an oral therapy over the next decade (~100K to ~300K)2 Transformational efficacy with next-generation orals can give patients an opportunity to achieve clear skin without proceeding to biologics Today many moderate-to-severe psoriasis patients are sub-optimally treated with only ~50% on advanced therapies Patients often delay initiating biologic therapy due to concerns about injections, safety, and lifestyle impact, resulting in prolonged use of ineffective conventional treatments1 Next-generation orals can provide efficacious options positioned to drive significant growth of the oral segment US Psoriasis Market Growth Moderate-to-Severe (M2S) Treated Patients 1
Zasocitinib: Meeting patient needs with a treatment that fits effortlessly into daily life 2. Profile based on Ph3 data Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, No Fasting Restrictions2 Zasocitinib delivered clear to almost clear skin for ~70% of patients by week 16 • Rapid onset • Durable skin clearance • No new safety signals Fits effortlessly into daily life • Once daily oral dosing • Can be taken any time; no fasting restrictions 23 Photos: IFPA | All the Colors We Are It's very exciting for our community to have a potential new oral systemic option to treat their psoriasis. People living with psoriasis deserve treatment options that help them manage this disease so that they can maintain a high quality of life. It's great for them and their health care provider to have another option to turn to. Leah M. Howard, J.D. President and CEO of the National Psoriasis Foundation ” 1. Yilmaz O, Pinto JP, Torres T. New and emerging oral therapies for psoriasis. Drugs Context. 2024;13:2024-5-6. This transition towards oral therapies could lead to more convenient treatment regimens for patients, enhancing adherence and improving their quality of life.1 Orhan Yilmaz College of Medicine, University of Saskatchewan ”
24 Continued investment to maximize zasocitinib’s commercial impact and market potential Demonstrated success in an adjacent, highly competitive autoimmune market with Entyvio – #1 prescribed IBD treatment (UC and Crohn’s combined)1 In-depth knowledge and experience of payer dynamics to drive effective market access strategies and pull-through Early external engagement with KOLs & patient advocacy as well as continuing to build awareness of the strong safety profile consistent with selective TYK2 inhibition 1. Source: US IBD Patient Share – IQVIA Takeda’s proven immunology leadership positions it to execute a successful zasocitinib launch
Zasocitinib is positioned to transform and expand the oral advanced therapy market in psoriatic disease Enabling Expansion with Focused LCM Programs that Unlock Significant Future Upside Hidradenitis Suppurativa Ph2 started FY25Dermatology → Vitiligo Ph2 started FY25 Ulcerative Colitis Ph2 data expected FY26 Gastroenterology → Crohn’s Disease Ph2 data expected FY26 + 1.0M → 1.3M Moderate to Severe Psoriasis treated patients growing at low single digits 10% → 22% Significant expansion of the oral market driven by next-gen oral entrants Poised to Lead Among Oral Options in the Growing Psoriasis Market US Pso Market Evolution Over the Next Decade PsO Rapidly Expanding Within Psoriatic Disease PsA Ph3 Psoriatic Arthritis (PsA) data expected in FY27 Global Peak Revenue Potential For PsO + PsA PsO PsA $3-6B1 + = 25 1. Please refer to the Important Notice at the start of this presentation for more information about peak revenue estimates. ~3x more patients treated with an oral therapy
Zasocitinib: Poised to be a leading oral treatment option for patients with psoriasis – significantly expanding the oral market 1 32 Convenient once-daily pill without fasting restrictions Rapid and durable skin clearance, with no new safety signals Next-generation, highly selective oral TYK2 inhibitor Zasocitinib U.S. and global filings on track to start in FY26 26
Q&A Session JULIE KIM CEO Elect RHONDA PACHECO President, U.S. Business Unit; U.S. Country Head CHINWE UKOMADU Head of GI&I Therapeutic Area Unit
Appendix
29 Once-daily Oral Zasocitinib Demonstrates Rapid and Reproducible Skin Clearance with a Consistent Safety Profile in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials (LATITUDE-PsO-3001 and 3002) Melinda Gooderham, Vivian Laquer, Jianzhong Zhang, Joanna Narbutt, Akimichi Morita, Paula Luna, Wenwen Zhang, Warren Winkelman, Edith Angellotti, Kim Papp, April Armstrong Presenting author: Dr Melinda Gooderham SKiN Centre for Dermatology, Queen’s University and Probity Medical Research, Peterborough, Ontario, Canada Presented at the 2026 AAD Annual Meeting, 27–31 March 2026, Denver, Colorado, USA Presentation #79730
30 Disclosures Dr Melinda Gooderham has been an investigator, speaker and/or advisor for: AbbVie, Acelyrin, Akros, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Aristea, Bausch Health, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Inmagene, JAMP Pharma, Janssen, L’Oreal, LEO Pharma, MedImmune, Meiji, Moonlake, Nektar, Nimbus, Novartis, Organon, Oruka, Pfizer, Q32 Bio, Regeneron, Sanofi Genzyme, Sun Pharma, Takeda, Tarsus, UCB, Union, Ventyx and Vyne
31 Zasocitinib is an investigational, oral, allosteric, highly selective and potent TYK2 inhibitor1,2 ATP, adenosine triphosphate; IFN, interferon; IL, interleukin; JAK, Janus kinase; TYK, tyrosine kinase. 1. Leit S et al. J Med Chem 2023;66:10473–96; 2. Mehrotra S et al. J Invest Dermatol 2025;146:214–22; 3. Rusiñol L and Puig L. Int J Mol Sci 2023;24:3391. 4. Armstrong A et al. JAMA Dermatol 2024;160:1066–74. • More than 1 millionfold greater binding selectivity for TYK2 versus JAK1, JAK2 and JAK31,2 • Maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways2,3 • Well tolerated and efficacious in a phase 2b trial in patients with moderate-to-severe plaque psoriasis4 Objective: To evaluate the efficacy and safety of zasocitinib in adults with moderate-to-severe plaque psoriasis in two pivotal phase 3 studies: LATITUDE-PsO-3001 (NCT06088043) and LATITUDE-PsO-3002 (NCT06108544)
32 LATITUDE-PsO-3001 and 3002 were randomized, multicenter, double-blind, placebo- and apremilast-controlled phase 3 trials Eligibility • Adults (≥ 18 years) • Plaque psoriasis diagnosis for ≥ 6 months prior to screening • PASI ≥ 12, sPGA ≥ 3, ≥ 10% BSA • Candidate for phototherapy or systemic therapy aWith a ≥ 2-point decrease from baseline. bWith a baseline DLQI score ≥2. BSA, body surface area; DLQI, Dermatology Life Quality Index; F/U, follow-up; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment; TEAE, treatment-emergent adverse events. Endpoints Co-primary endpoints at Week 16 (versus placebo): • sPGA 0/1a • PASI 75 Key secondary endpoints (versus placebo or apremilast) included: • PASI 75 at Week 4 • sPGA 0, PASI 75/90/100 or DLQI 0/1b at Week 16 or 24 • sPGA 0/1 or PASI 75 maintenance at Week 60 Safety endpoints included: • TEAEs; laboratory parameters
33aWith a ≥ 2-point decrease from baseline. bWith a baseline DLQI score ≥2. BSA, body surface area; DLQI, Dermatology Life Quality Index; F/U, follow-up; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment; TEAE, treatment-emergent adverse events. Eligibility • Adults (≥ 18 years) • Plaque psoriasis diagnosis for ≥ 6 months prior to screening • PASI ≥ 12, sPGA ≥ 3, ≥ 10% BSA • Candidate for phototherapy or systemic therapy Endpoints Co-primary endpoints at Week 16 (versus placebo): • sPGA 0/1a • PASI 75 Key secondary endpoints (versus placebo or apremilast) included: • PASI 75 at Week 4 • sPGA 0, PASI 75/90/100 or DLQI 0/1b at Week 16 or 24 • sPGA 0/1 or PASI 75 maintenance at Week 60 Safety endpoints included: • TEAEs; laboratory parameters LATITUDE-PsO-3001 and 3002 were randomized, multicenter, double-blind, placebo- and apremilast-controlled phase 3 trials
34 LATITUDE-PsO-3001 LATITUDE-PsO-3002 Baseline demographics and characteristics were generally similar across treatment arms in each study Data are mean (SD) unless otherwise stated. aData missing for one patient receiving zasocitinib (LATITUDE-PsO-3002). bData missing for three patients receiving zasocitinib and one receiving apremilast (LATITUDE-PsO-3001), and for three patients receiving zasocitinib, one patient receiving apremilast, and four patients receiving placebo (LATITUDE-PsO-3002). BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; SD, standard deviation; sPGA, static Physician’s Global Assessment. Zasocitinib (n = 416) Apremilast (n = 137) Placebo (n = 140) Zasocitinib (n = 555) Apremilast (n = 276) Placebo (n = 277) Age, years 43.8 (13.26) 46.0 (14.10) 45.3 (13.54) 45.8 (13.33) 46.1 (13.37) 46.5 (13.19) Sex, male, n (%) 295 (70.9) 95 (69.3) 93 (66.4) 367 (66.1) 187 (67.8) 188 (67.9) Race, White, n (%) 255 (61.3) 88 (64.2) 87 (62.1) 472 (85.0) 233 (84.4) 240 (86.6) BMI, kg/m2 29.7 (6.8) 28.5 (6.3) 28.2 (6.5) 30.2 (6.8) 30.1 (6.5) 30.4 (7.2) Psoriasis duration, median (range) yearsa 13.6 (0.6–62.4) 14.0 (0.6–71.3) 12.5 (0.6–59.3) 15.1 (0.5–69.2) 16.5 (0.6–60.5) 15.1 (0.6–65.9) PASI score 19.7 (7.5) 20.5 (9.0) 20.3 (7.4) 21.3 (9.3) 21.4 (8.6) 21.1 (8.5) sPGA score 3 (moderate), n (%) 329 (79.1) 116 (84.7) 112 (80.0) 473 (85.2) 237 (85.9) 228 (82.3) 4 (severe), n (%) 85 (20.4) 21 (15.3) 28 (20.0) 80 (14.4) 39 (14.1) 48 (17.3) BSA, % 24.0 (14.0) 25.8 (15.9) 24.2 (14.4) 27.9 (17.8) 27.8 (16.5) 27.0 (16.3) DLQI scoreb 12.7 (7.2) 11.1 (6.5) 12.2 (7.3) 11.6 (7.2) 11.5 (6.7) 12.2 (7.4) Bio-experienced, n (%) 141 (33.9) 40 (29.2) 45 (32.1) 155 (27.9) 80 (29.0) 83 (30.0)
35 Zasocitinib met the co-primary endpoints in both studies (sPGA 0/1 and PASI 75 versus placebo at Week 16) aWith a ≥ 2-point decrease from baseline. Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. sPGA 0/1a LATITUDE-PsO-3001 sPGA 0/1a LATITUDE-PsO-3002
36 Zasocitinib met the co-primary endpoints in both studies (sPGA 0/1 and PASI 75 versus placebo at Week 16) aWith a ≥ 2-point decrease from baseline. Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. PASI 75 LATITUDE-PsO-3001 PASI 75 LATITUDE-PsO-3002 sPGA 0/1a LATITUDE-PsO-3001 sPGA 0/1a LATITUDE-PsO-3002
37 Zasocitinib led to greater proportions of patients achieving PASI 90 than apremilast or placebo as early as Week 4 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CfB, change from baseline; CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. PASI 90 LATITUDE-PsO-3001 PASI 90 LATITUDE-PsO-3002
38 Zasocitinib led to greater proportions of patients achieving PASI 90 than apremilast or placebo as early as Week 4 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CfB, change from baseline; CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. Baseline Week 16 PASI: 15.8 sPGA: 3 PASI: 0.7 (CfB 95.6%) sPGA: 0 PASI 90 LATITUDE-PsO-3001 PASI 90 LATITUDE-PsO-3002
39 Zasocitinib led to greater proportions of patients achieving clear skin versus apremilast or placebo as early as Week 8 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. sPGA 0 LATITUDE-PsO-3001 sPGA 0 LATITUDE-PsO-3002 PASI 100 LATITUDE-PsO-3001 PASI 100 LATITUDE-PsO-3002
40 Zasocitinib led to greater proportions of patients achieving clear skin versus apremilast or placebo as early as Week 8 Number of patients based on the full analysis set with non-responder imputation. LATITUDE-PsO-3001: zasocitinib (n = 416), apremilast (n = 137), placebo (n = 140). LATITUDE-PsO-3002: zasocitinib (n = 555), apremilast (n = 276), placebo (n = 277). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. Baseline PASI: 31.3 sPGA: 3 PASI: 0 sPGA: 0 Week 16 PASI 100 LATITUDE-PsO-3001 PASI 100 LATITUDE-PsO-3002
41 Zasocitinib demonstrated superior improvement in DLQI versus apremilast or placebo as early as Week 4 aBased on evaluable patients defined as a subset of full analysis set with a baseline DLQI score ≥2 (with nonresponder imputation). Number of evaluable patients for LATITUDE-PsO-3001:zasocitinib (n = 406), apremilast (n = 133), placebo (n = 133). Number of evaluable patients for LATITUDE-PsO-3002: zasocitinib (n = 525), apremilast (n = 263), placebo (n = 260). P values for comparison versus apremilast (in blue) and versus placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001. CI, confidence interval; DLQI, Dermatology Life Quality Index. DLQI 0/1a LATITUDE-PsO-3001 DLQI 0/1a LATITUDE-PsO-3002
42 Zasocitinib was well tolerated with no new safety signals identified through Week 24 TEAEs were coded using MedDRA v28.1. bSample size adjusted incidence proportion x 100. c95% Wald CI unless 0 events occur in either trial, in which case a 95% exact binomial CI is used. Most frequently reported adverse events occurring in ≥ 5% of patients in any treatment group, based on individual preferred term. CI, confidence interval; MedDRA, Medical Dictionary for Regulatory Activities; aEvents starting while on initial treatment are included. dDeath occurred 1 day after first dose date (unrelated to treatment). e SAE, serious adverse event; TEAE, treatment-emergent adverse event; URTI, upper respiratory tract infection. • Most TEAEs were mild or moderate • Laboratory parameters (e.g. lymphocytes, liver enzymes, lipids) demonstrated no clinically meaningful trends over time in both studies TEAEs from LATITUDE-PsO-3001 and 3002a Zasocitinib (n = 970) Apremilast (n = 412) Placebo (n = 417) Zasocitinib (n = 970) Apremilast (n = 412) n %b (95% CI)c n %b (95% CI)c n %b (95% CI)c n %b (95% CI)c n %b (95% CI)c Any TEAE 605 62.1 (59.0–65.1) 207 50.5 (45.7–55.4) 196 46.9 (42.0–51.7) 674 69.3 (66.4–72.2) 232 56.5 (51.7–61.4) Leading to discontinuation 31 3.2 (2.1–4.3) 11 2.6 (1.1–4.2) 3 < 1 (0.0–1.6) 36 3.7 (2.5–4.9) 13 1.3 (1.4–4.7) SAE 29 3.0 (1.9–4.1) 6 1.5 (0.3–2.7) 2 < 1 (0.1–1.7) 35 3.6 (2.4–4.8) 7 1.7 (0.5–3.0) Death 1d < 1 (0.0–0.6)d 0 0 (0.0–0.9) 0 0 (0.0–0.9) 1d < 1 (0.0–0.6)d 0 0 (0.0–0.9) Most frequent TEAE (≥ 5%)e URTI 100 10.1 (8.2–12.0) 24 6.0 (3.7–8.3) 13 3.2 (1.5–4.8) 123 12.5 (10.4–14.6) 29 7.4 (4.8–10.0) Acne 62 6.5 (5.0–8.1) 3 < 1 (0.0–1.7) 1 < 1 (0.0–1.3) 70 7.3 (5.6–8.9) 3 < 1 (0.0–1.7) Nasopharyngitis 60 6.2 (4.7–7.7) 23 5.4 (3.2–7.5) 20 4.7 (2.7–6.6) 80 8.3 (6.5–10.0) 34 7.9 (5.4–10.5) Diarrhea 30 3.1 (2.0–4.2) 33 8.2 (5.5–10.9) 8 1.8 (0.6–3.1) 36 3.7 (2.5–4.9) 33 8.2 (5.5–10.9) Headache 27 2.8 (1.8–3.9) 26 6.3 (4.0–8.7) 8 1.9 (0.6–3.2) 32 3.3 (2.2–4.5) 28 6.8 (4.4–9.3) Nausea 20 2.1 (1.2–3.0) 23 5.5 (3.3–7.8) 5 1.2 (0.1–2.2) 23 2.4 (1.4–3.4) 24 5.8 (3.5–8.1) Day 0 to Week 24Day 0 to Week 16
43 More than 90% of patients continuing zasocitinib at Week 40 maintained sPGA 0/1, PASI 75 and PASI 90 through Week 60 sPGA 0/1 PASI 75 Evaluable patients based on the full analysis set for randomized withdrawal with nonresponder imputation. Number of patients for sPGA 0/1: zasocitinib–zasocitinib (n = 255), zasocitinib–placebo (n = 126). Number of patients for PASI 75: zasocitinib–zasocitinib (n = 273), zasocitinib–placebo (n = 134). Number of patients for PASI 90: zasocitinib–zasocitinib (n = 238), zasocitinib–placebo (n = 122) . P values for comparison versus zasocitinib–placebo (in gray) based on a stratified Cochran–Mantel–Haenszel test: ***p < 0.001; ***† nominal p <0.001. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment. LATITUDE-PsO-3002 randomized withdrawal Most (59%, 69% and 52%) patients re-randomized from zasocitinib to placebo at Week 40 maintained sPGA 0/1, PASI 75, and PASI 90, respectively, for an additional ~5 months PASI 90
44 Conclusions Once-daily oral zasocitinib demonstrated rapid reproducible and durable skin clearance, and a consistent safety and laboratory parameter profile, across two pivotal phase 3 trials • Clear skin was achieved by ~one-third of zasocitinib-treated patients by Week 16 • More than 90% of patients continuing zasocitinib at Week 40 maintained sPGA 0/1, PASI 75 and PASI 90 through Week 60 • Zasocitinib demonstrated superior improvement in QoL versus placebo or apremilast • Zasocitinib was generally well tolerated with no new safety signals identified Zasocitinib efficacy and safety will be further evaluated in patients with moderate- to-severe plaque psoriasis in a 3-year long-term extension study (NCT06550076) and an ongoing head-to-head trial versus deucravacitinib (NCT06973291) PASI, Psoriasis Area and Severity Index; QoL, quality of life; sPGA, static Physician’s Global Assessment.
45 Acknowledgments We would like to acknowledge and thank all study sites and patients for their participation in this study This study was funded by Takeda Development Center Americas, Inc. Medical writing assistance was provided by Tina Borg, PhD, of Oxford PharmaGenesis, UK, under the direction of the authors, and was funded by Takeda Development Center Americas, Inc. Zasocitinib-related presentations at AAD 2026 Oral presentation slides: LATITUDE-PsO-3001 and 3002 phase 3 topline results ePoster: Phase 2b study early onset of response correlated to biomarkers