Adial Pharmaceuticals has announced the submission of the AD04 product application for consideration of the US Food & Drug Administration (FDA) Commissioner’s National Priority Voucher Pilot Program (CNPV).1
The CNPV program was announced in June 2025 and is designed to speed up the FDA review process for drugs that address 1 of 5 key US national health priorities (Sidebar). The program also utilizes a collaborative review approach, where experts meet to discuss cases and help evaluate applications more efficiently.2
Sidebar. The 5 Critical US National Health Priorities
- Public health crisis response: Products addressing urgent/emerging threats or significant population impact.
- Innovative breakthrough therapies: Transformative treatments with novel mechanisms that fundamentally change disease management.
- Large unmet medical needs: Therapies for conditions where existing treatments inadequately address patient outcomes.
- Onshoring and supply chain resilience: Onshoring drug development/manufacturing to strengthen US domestic capacity, reduce foreign dependencies, and improve national security.
- Affordability: Approaches that improve overall value through reduced costs to the health care system or that enhance access to important products.
According to the World Health Organization, harmful alcohol consumption causes 2.6 million deaths—or 4.7% of all deaths—globally every year,3 thus meeting the national health priority 3, large unmet medical needs.
AD04 is an investigational selective serotonin-3 receptor (5-HT3) antagonist being developed for the treatment of alcohol use disorder (AUD) in patients who engage in heavy drinking (defined as < 8 drinks/drinking day) with a 5-HT3 genomic biomarker. Patients who are biomarker positive for AG+ can be identified through Adial's proprietary genetic test; According to research, the AG+ biomarker is present in roughly 14% of the general population.4
If the FDA grants them a voucher, Adial can use it to receive faster review of AD04’s drug application. The benefits include increased direct communication with the FDA, a rolling review process, and notably, a faster review timeline. Compared with other FDA priority review programs, the CNPV program is much faster, with a review time of about 1 to 2 months rather than the standard 10 to 12 months once complete materials are submitted for FDA review. The program also allows for earlier engagement with the FDA before submission and includes in-depth discussions between the FDA review team and senior agency leadership to help speed decision-making.
“As we continue to advance the AD04 program and actively plan for the next phase of our clinical development efforts, we believe the Commissioner’s National Priority Voucher Pilot Program is an excellent strategic fit for AD04 and aligns well with our ongoing collaboration with the FDA. Participation in this program, if granted, would provide the opportunity for an accelerated FDA review timeline,” said Cary Claiborne, the president and chief executive officer of Adial. “We believe this shortened review period could meaningfully reduce the overall time to potential approval and, ultimately, expedite market availability of AD04 for patients who may benefit from this important therapeutic option.”
Back in September 2025, Adial shared they had received positive feedback from their end of phase 2 meeting with the FDA held on July 29, 2025. The minutes provided the FDA's formal input and positive feedback on the AD04 phase 3 adaptive clinical trial design and broader clinical development strategy.4
“With disciplined execution, we believe AD04 is positioned to become the first genetically targeted therapy for AUD—addressing a large, underserved patient population and unlocking a highly attractive commercial opportunity,” Clairborne shared.4
References
1. Adial Pharmaceuticals submits application to FDA Commissioner’s National Priority Voucher (CNPV) pilot program for AD04 clinical development program. News release. April 27, 2026. Accessed April 27, 2026. https://www.adial.com/adial-pharmaceuticals-submits-application-to-fda-commissioners-national-priority-voucher-cnpv-pilot-program-for-ad04-clinical-development-program/
2. Commissioner's National Priority Voucher (CNPV) Pilot Program. FDA. Accessed April 27, 2026. https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program
3. Alcohol. World Health Organization. May 9, 2022. Accessed April 27, 2026. https://www.who.int/news-room/fact-sheets/detail/alcohol
4. Adial Pharmaceuticals provides business update following favorable comments from FDA end-of-phase 2 (EOP2) meeting for AD04. News release. September 16, 2025. Accessed September 16, 2025. https://www.globenewswire.com/news-release/2025/09/16/3150713/26135/en/Adial-Pharmaceuticals-Provides-Business-Update-Following-Favorable-Comments-from-FDA-End-of-Phase-2-EOP2-Meeting-for-AD04.html
