Adial Pharmaceuticals (NASDAQ: ADIL)

What Adial Pharmaceuticals (NASDAQ: ADIL) does

Adial Pharmaceuticals (NASDAQ: ADIL) is a clinical-stage biopharmaceutical company headquartered in Glen Allen, Virginia, founded in 2010. Following its June 2026 acquisition of Azora Therapeutics, the company's pipeline is centered on two therapeutic candidates: AT177, a proprietary colon-targeted aryl hydrocarbon receptor (AhR) agonist in IND-enabling studies for ulcerative colitis; and AD04, a genetically targeted serotonin-3 receptor antagonist advancing through a new Phase 3 clinical trial program for the treatment of Alcohol Use Disorder in heavy drinking patients with certain target genotypes.

AT177 is a fully synthetic, patented oral prodrug of indirubin engineered for gut restriction, designed to deliver localized AhR activation in the colonic mucosa while minimizing systemic exposure that has been associated with adverse effects in other AhR agonists. Preclinical data cited by the company indicate robust local colonic AhR activation with markedly limited systemic exposure and superior colon-to-systemic selectivity. AD04 uses a precision-medicine approach, pairing ondansetron-class serotonin-3 receptor antagonism with genotype-based patient selection. In April 2026, Adial filed a new U.S. utility patent application covering AD04-responsive patient populations, with potential exclusivity targeted through 2045.

Adial is pre-revenue with no commercialized products and no product sales. Future revenue, contingent on FDA approval, would flow through traditional pharmaceutical prescription channels, likely specialty pharmacy for AT177 (gastroenterology) and addiction treatment specialists for AD04. The company's Q1 2026 balance sheet showed approximately $4.58 million in cash against a net loss of approximately $2.02 million. In June 2026, Adial closed a PIPE financing of up to $64 million in gross proceeds ($32 million upfront, with an additional $32 million tied to AT177 Phase 1 initiation), led by Coastlands Capital with Boxer Capital, Stonepine Capital, and AuGC BioFund. Following the Azora acquisition, Azora equity holders own approximately 51.0% of the combined entity on a fully-diluted basis, legacy Adial holders approximately 7.7%, and PIPE investors approximately 41.3%.

Name

Adial Pharmaceuticals (NASDAQ: ADIL)

Legal name

Adial Pharmaceuticals, Inc.

Website

https://adial.com

Company type

Public

Founded year

2010

Operating status

Operating

Short description

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company developing two therapeutic candidates: AT177, a colon-targeted AhR agonist for ulcerative colitis acquired via Azora Therapeutics, and AD04, a genetically targeted serotonin-3 receptor antagonist in Phase 3 for Alcohol Use Disorder.

Ownership category

akta.pro rank

Product category

Clinical-Stage Biopharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)

Keywords

• Clinical-stage biopharmaceuticals
• Addiction therapeutics
• Inflammatory disease drugs
• AhR receptor agonists
• Genetically targeted therapies

Headquarters

HQ city

Glen Allen

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, Others

Revenue model

1. Pharmaceutical Product Revenue: Pre-revenue clinical-stage biopharmaceutical company. Following successful clinical development and regulatory approval, the company expects to generate revenue through the sale of prescription pharmaceutical products (AT177 for ulcerative colitis, AD04 for Alcohol Use Disorder). Revenue model will be based on product sales through pharmacy distribution channels.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company developing two therapeutic candidates: AT177, a proprietary colon-targeted aryl hydrocarbon receptor (AhR) agonist in development for ulcerative colitis, and AD04, a genetically targeted serotonin-3 receptor antagonist advancing through a new Phase 3 clinical trial program for Alcohol Use Disorder in patients with specific target genotypes. The company has no commercialized products and is pre-revenue, with plans to generate revenue through pharmaceutical product sales upon regulatory approval.

Product overview

Adial Pharmaceuticals is a biopharmaceutical company with a pipeline of two clinical-stage programs: AT177 and AD04. Following the June 2026 acquisition of Azora Therapeutics, AT177 (a colon-targeted AhR agonist for ulcerative colitis) became the lead program. The company's historical investigational product AD04 (a genetically targeted serotonin-3 receptor antagonist) continues to be advanced through Phase 3 trials for Alcohol Use Disorder.

Differentiator

Problem solved

Functional benefit

Products and services

• AT177 AT177 is a proprietary, fully synthetic, patented oral aryl hydrocarbon receptor (AhR) agonist prodrug of indirubin with a colon-targeted formulation designed to restore mucosal immune homeostasis at the site of disease while minimizing systemic exposure. It is in development for the treatment of ulcerative colitis in patients who have not achieved durable remission on currently available therapies.
• AD04 AD04 is a genetically targeted serotonin-3 receptor antagonist therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients with certain target genotypes. It is being advanced through a new Phase 3 clinical trial program as a precision-medicine approach for AUD.

Quantifiable outcome

• Phase 1 clinical trial initiation for AT177 in ulcerative colitis planned for mid-2027
• +1 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Two partnerships are on record, tiered flagship and core.

• Azora TherapeuticsflagshipStrategic or Co-development Partner · 11 June 2026Acquired Azora Therapeutics, a biopharmaceutical company focused on treatments for serious inflammatory diseases. Azora was spun out of Stanford University after being incubated in the translational medicine SPARK program. Azora's lead program AT177 is now Adial's primary pipeline asset.
• Stanford University SPARK ProgramcoreStrategic or Co-development Partner · 11 June 2026Azora Therapeutics was incubated in Stanford University's translational medicine SPARK program. The company's technology is based on development of potential best-in-class oral agonists of the aryl hydrocarbon receptor.

Scale indicators6 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Palisade Bio: Clinical-stage biopharma focused on inflammatory bowel disease and UC with novel mechanism approaches. Comparable in stage, indication focus, and micro-cap status.
• Landos Biopharma: Clinical-stage biopharma developing oral therapies for ulcerative colitis and other autoimmune diseases, including AhR-related mechanisms. Most directly comparable peer given overlapping UC therapeutic focus and oral small-molecule approach.
• Assembly Biosciences: Clinical-stage biopharma with gastroenterology and inflammatory disease programs in similar micro-cap stage. Comparable in clinical development profile and indication overlap with AT177.
• Provention Bio: Clinical-stage biopharma developing immunology therapies with autoimmune and inflammatory indications. Comparable in stage and mechanism-modality focus (though now acquired by Sanofi).
• Praxis Precision Medicines: Clinical-stage CNS precision medicine company developing genetically targeted therapies. Highly comparable to AD04's genotype-guided approach in CNS indications.
• BioXcel Therapeutics: Clinical-stage biopharma developing CNS and inflammation therapies using AI-enabled drug re-purposing. Comparable in clinical-stage neuroscience focus and micro-cap market positioning.

Broad incumbents

• Alkermes: Specialty CNS biopharma with approved addiction treatments (Vivitrol for AUD/OUD) and broader neuroscience portfolio. Relevant for AD04's AUD market given established addiction commercial footprint.
• Indivior: Global specialty pharmaceutical company focused on addiction treatment including opioid and alcohol use disorders. Directly relevant to AD04's commercial competitive context despite being a much larger incumbent.

Emerging players

• Ventyx Biosciences: Clinical-stage immunology biopharma with TYK2 and other inflammatory pathway programs targeting IBD indications including UC. Relevant for AT177's competitive landscape analysis.
• Tonix Pharmaceuticals: Clinical-stage CNS specialty pharma with multiple neurology/psychiatry programs. Comparable in micro-cap clinical-stage status and CNS therapeutic focus overlapping with AD04.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/AdialPharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about Adial Pharmaceuticals (NASDAQ: ADIL)