What Adial Pharmaceuticals does

Adial Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company headquartered in Glen Allen, Virginia, founded in 2010 and listed on NASDAQ under ticker ADIL. The company develops genetically targeted therapeutics, with its lead candidate AD04 positioned as a precision-medicine treatment for Alcohol Use Disorder (AUD) and its secondary candidate AT177 targeting ulcerative colitis following the June 2026 acquisition of Azora Therapeutics. The intended patient population spans individuals with alcohol addiction and those suffering from inflammatory bowel disease, with therapeutic activity matched to genetically defined responder subgroups.

The company's core technology centers on biomarker-driven patient stratification. AD04 is paired with a companion diagnostic developed with Genomind that reportedly identifies patients with specific genetic profiles linked to serotonin signaling pathways, with stated 100% concordance in identifying suitable candidates for therapy. Adial is pursuing patent protection for AD04 through 2045 and filed an FDA Priority Voucher application in April 2026 to accelerate potential regulatory review. The organization employs 11-50 staff and is organized around clinical development rather than commercial operations.

The business model is currently pre-commercial: Adial does not generate product revenue and operates at an annual net loss of approximately $8.0 million (2025), funded through equity financings. Capital sources have included multiple small raises, a $5.9 million round into H2 2026, and a $32 million PIPE in June 2026 led by Coastlands Capital. Future revenue mechanics, contingent on regulatory approval, contemplate direct product sales in the US and partnership-driven commercialization in Europe via the Molteni Farmaceutici agreement signed March 2026 (potential deal value approximately $60 million). The company executed a 1-for-25 reverse stock split in February 2026 to maintain NASDAQ compliance.

Name

Adial Pharmaceuticals

Legal name

Adial Pharmaceuticals, Inc.

Website

https://adialpharma.com

Company type

Public

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company developing genetically targeted therapeutics, including AD04 for Alcohol Use Disorder and AT177 for ulcerative colitis, serving patients with addiction and inflammatory diseases through a precision-medicine approach with companion diagnostics.

Ownership category

akta.pro rank

Product category

Clinical-stage Biopharmaceuticals (Addiction Therapeutics)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Endocrinology & Metabolic Specialty Pharmaceuticals (HLAIACAD)

akta.pro secondary industry

Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)

Keywords

• Alcohol use disorder treatment
• Genetically targeted therapy
• Clinical-stage biopharmaceutical
• Ulcerative colitis drug development
• Addiction therapeutics pipeline

Headquarters

HQ city

Charlottesville

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Distribution channels2 records

Marketing channels6 records

Core offering

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company developing two prescription drug candidates: AD04, a genetically targeted serotonin-3 receptor antagonist advancing through a Phase 3 clinical trial program for the treatment of Alcohol Use Disorder in patients with specific target genotypes, and AT177, a novel colon-targeted aryl hydrocarbon receptor (AhR) agonist acquired from Azora Therapeutics in June 2026 for the treatment of ulcerative colitis. The company is pre-revenue and focuses on advancing these candidates through regulatory milestones toward commercial launch.

Product overview

Adial Pharmaceuticals is a biopharmaceutical company with a pipeline of two distinct drug candidates following its acquisition of Azora Therapeutics. The core product is AD04, a genetically targeted serotonin-3 receptor antagonist for Alcohol Use Disorder currently in Phase 3 clinical trials. The second product is AT177, a colon-targeted AhR agonist acquired from Azora Therapeutics for ulcerative colitis, expected to enter Phase 1 trials in mid-2027. The company operates as a clinical-stage developer without a unified platform architecture.

Differentiator

Problem solved

Functional benefit

Brands

• AD04: Genetically targeted serotonin-3 receptor antagonist being advanced through Phase 3 clinical trial program for treatment of Alcohol Use Disorder in patients with certain target genotypes
• AT177

Products and services

• AD04

Quantifiable outcome

• Net loss narrowed from $13.2M (2024) to $8.0M (2025)
• +3 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core.

• Azora TherapeuticscoreStrategic or Co-development Partner · 11 June 2026Adial Pharmaceuticals acquired Azora Therapeutics for $32 million, bringing AT177—a proprietary colon-targeted aryl hydrocarbon receptor agonist for ulcerative colitis—into its pipeline. Following the transaction, Azora equity holders own approximately 51% of the combined company on a fully-diluted basis. Phase 1 clinical trials for AT177 are planned for mid-2027.
• Molteni FarmaceuticicoreChannel Partner/ Reseller/ Distributor · 3 March 2026Collaboration framework agreement for exclusive European partnership to commercialize AD04, a serotonin-3 receptor antagonist treatment for Alcohol Use Disorder. Deal includes upfront payment, milestone payments, and tiered royalties ranging from high single digits to low double digits, with total potential value estimated at nearly $60 million contingent on successful development and market introduction. Partnership requires execution of final definitive agreement.
• GenomindcoreTechnology or Integration · 10 October 2025Collaboration with Genomind enabled successful validation of cheek swab collection method for genetic testing related to AD04 program. Testing of specific SNPs achieved 100% concordance, supporting regulatory progress towards Phase 3 trials and commercial deployment of companion diagnostic.

Scale indicators18 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• Alkermes: Alkermes markets Vivitrol (naltrexone), an approved therapy for Alcohol Use Disorder, making it the most directly comparable commercial-stage peer to Adial's AD04 AUD asset. Both companies target CNS/addiction therapeutics with similar specialty-pharma positioning.
• Indivior: Indivior is a global leader in addiction therapeutics (Suboxone, Sublocade for opioid use disorder) and is expanding into AUD. Direct overlap with Adial's addiction-treatment focus and similar specialty pharma commercial model.

Emerging players

• Camurus: Swedish specialty pharma developing long-acting injectable therapies for opioid use disorder and chronic pain using FluidCrystal technology. Comparable as an emerging CNS/addiction therapeutics developer with similar pipeline-stage profile.
• Axsome Therapeutics: Axsome is a clinical-stage and commercial CNS specialty pharma (Auvelity for depression, Sunosi for narcolepsy). Similar small-cap, CNS-focused, specialty-pharma profile with pipeline-stage parallels to Adial.
• Sage Therapeutics: Sage is a CNS-focused specialty biopharma (Zurzuvae for postpartum depression, collaborations with Biogen). Comparable as a small/mid-cap CNS specialty developer with similar regulatory-pathway and approval-cycle dynamics.
• BioXcel Therapeutics: BioXcel is a clinical-stage biopharma developing neuroscience and immuno-oncology therapies (Igalmi for agitation in schizophrenia/bipolar). Comparable as an emerging CNS-focused specialty pharma with similar capital-raise and regulatory-milestone profile.
• Tonix Pharmaceuticals: Tonix is a clinical-stage CNS specialty pharma developing therapies for migraine, fibromyalgia, and PTSD. Comparable as a small-cap CNS pipeline developer with similar financial profile and reliance on capital markets.

Broad incumbents

• AbbVie: AbbVie markets Skyrizi and Rinvoq, both approved for ulcerative colitis, and is the dominant incumbent in inflammatory bowel disease. Directly comparable to the AT177 ulcerative colitis opportunity in terms of competitive landscape and market dynamics.
• Pfizer: Pfizer markets etrasimod (Velsipity) for ulcerative colitis (acquired via Arena Pharmaceuticals) and is a broad incumbent in GI/inflammation. Comparable on the AT177 competitive landscape and as a large biopharma with strategic interest in IBD.
• Bristol Myers Squibb: BMS markets Zeposia (ozanimod) for ulcerative colitis and is a broad incumbent in inflammatory/autoimmune disease. Comparable on AT177's competitive context and as a major biopharma with established IBD commercial infrastructure.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/AdialPharma
• Facebookfacebook.com/adialpharma
• LinkedInlinkedin.com/company/adial-pharmaceuticals

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries1 record

Funding overview

Funding rounds14 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Adial Pharmaceuticals