8-K

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

WASHINGTON,D.C. 20549

FORM8-K

CURRENTREPORT

Pursuantto Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): July 17, 2020

AdialPharmaceuticals, Inc.

(Exactname of registrant as specified in charter)

Delaware

(Stateor other jurisdiction of incorporation)

1180Seminole Trail, Suite 495

Charlottesville,Virginia 22901

(Addressof principal executive offices and zip code)

(434)422-9800

(Registrant’stelephone number including area code)

(FormerName and Former Address)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item8.01. Other Events.

On July 17, 2020, Adial Pharmaceuticals, Inc., a Delaware corporation (the “Company”), received notice that the European Medicines Agency (EMA) has accepted the Pediatric Investigation Plan (PIP) submitted by the Company for development of the Company’s lead drug candidate, AD04, for the treatment of alcohol use disorder in the pediatric population, ages 12 to 17. As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application (MAA) for a new medicinal product in the European Union.

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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 hereunto duly authorized.

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