Which alcohol use disorder drugs are in Phase 3?

Phase 3 (or later) programs for alcohol use disorder include Brenipatide.

What are the next alcohol use disorder trial readouts?

Upcoming catalysts include Brenipatide (Primary completion Apr 2028 (RENEW-ALC-2)), Brenipatide (Primary completion Apr 2028 (RENEW-ALC-1)) and PT150 (Org 34517) (July 2028).

How many clinical trials are recruiting for alcohol use disorder?

92 drug-interventional alcohol use disorder trials are currently recruiting participants, out of 367 registered interventional trials.

Substance Use Disorders

Alcohol use disorder drug pipeline

ICD-11 6C40
MeSH D000437

3 compounds from 3 companies are in active clinical development for alcohol use disorder, including 1 at Phase 3 or beyond.

3Compounds

3Companies

1Phase 3+

3Upcoming readouts

94Trials recruiting

Phase 11

PT150 (Org 34517)Pop Test Oncology LLC (dba Palisades Therapeutics)Glucocorticoid receptor Antagonist

Phase 21

BPL-003 (intranasal 5-MeO-DMT benzoate)Atai Beckley N.V. (AtaiBeckley)5-HT1A Agonist

Phase 31

BrenipatideEli Lilly and CompanyGlucagon-like peptide 1 receptor Agonist

Mechanisms: Peptide (1) · Psychedelic (1) · Small molecule (1)

Pipeline data compiled October 2026 · every fact sourced.

Upcoming readouts & recent results

Primary completion Apr 2028 (RENEW-ALC-2)AnticipatedBrenipatideTopline dataNCT07219953
Primary completion Apr 2028 (RENEW-ALC-1)AnticipatedBrenipatideTopline dataNCT07219966
July 2028AnticipatedPT150 (Org 34517)Registry resultsNCT06712602
ClinicalTrials.gov estimated primary completion of the PT150 human laboratory study in alcohol use disorder (NCT06712602): July 2028. ↗
2025-08-11ReportedPT150 (Org 34517)Full resultsmetNCT04331288
Phase 1 ethanol-interaction study of PT150: no significant pharmacokinetic interaction with alcohol and no serious adverse events (J Addict Med, 2025). ↗
2025-01-28ReportedBPL-003 (intranasal 5-MeO-DMT benzoate)Topline datametNCT05674929
BPL-003 Phase 2a open-label AUD study positive topline: single 10 mg dose + psychological support cut heavy drinking days (56%->13%) and raised abstinent days (33%->81%) at Week 12, with 50% maintaining complete abstinence over 3 months; well tolerated, no serious/severe AEs. ↗

See the full catalyst calendar →

Compounds in development (3)

Compound	Company	Phase	Status	Mechanism
Brenipatide	Eli Lilly and Company	Phase 3	Active	Glucagon-like peptide 1 receptor Agonist
BPL-003 (intranasal 5-MeO-DMT benzoate)	Atai Beckley N.V. (AtaiBeckley)	Phase 2	Completed	5-HT1A Agonist
PT150 (Org 34517)	Pop Test Oncology LLC (dba Palisades Therapeutics)	Phase 1	Active	Glucocorticoid receptor Antagonist

Trials recruiting now (92)

92 drug-interventional alcohol use disorder trials recruiting now, of 367 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
Acamprosate calcium
National Institute on Alcohol Abuse and Alcoholism (NIAAA)n=48United States · 1 siteStarted May 2025NCT06269627
Phase 4Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder
Naltrexone
Milky Kohnon=100United States · 1 siteStarted May 2024NCT06426303
Phase 4A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
N-acetyl cysteine, Placebo
University of Sydneyn=280Australia · 3 sitesStarted Feb 2023NCT05408247
Phase 4Naltrexone in AUD Reward Drinkers
XR-NTX 380 mg, intramuscular injection, Placebo intramuscular injection
University of Pennsylvanian=60United States · 1 siteStarted Mar 2022NCT05028062
Phase 4ANCHORS Alcohol & Sexual Health Study: UH3 Project
PrEP acronym (pre-exposure prophylaxis)
University of Floridan=88United States · 1 siteStarted Jan 2021NCT04331704
Phase 3Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of a GLP-1 Receptor Agonist Semaglutide in U.S. Veterans With Alcohol Use Disorder
Semaglutide, Placebo
VA Office of Research and Developmentn=622United States · 1 siteStarted Jul 2026NCT07218354
Phase 3Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
Cystine
University of Chicagon=300Kenya · 2 sitesStarted Jun 2026NCT06790342
Phase 3Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms
Psilocybin (high dose), Psilocybin (low dose)
Centre Hospitalier Universitaire de Nīmesn=172France · 8 sitesStarted Jun 2026NCT07638553
Phase 3Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder
Naltrexone, placebo
Shenzhen Sciencare Medical Industries Co., Ltd.n=240Started Mar 2026NCT07433413
Phase 3Emergency Department-Initiated Medications for Alcohol Use Disorder
Naltrexone Pill, Naltrexone Injection, Gabapentin Pill
Yale Universityn=240United States · 1 siteStarted Aug 2024NCT05827159
Phase 2/3Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Cannabidiol (CBD), Placebo
Johns Hopkins Universityn=105United States · 1 siteStarted Aug 2026NCT07148843
Phase 2/3MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder
Full Dose MDMA, Active Placebo Dose MDMA
VA Office of Research and Developmentn=80United States · 2 sitesStarted May 2026NCT07118839

Showing the 12 most advanced of 92 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for alcohol use disorder?: 3 compounds from 3 companies are in active clinical development for alcohol use disorder, including 1 at Phase 3 or beyond.
Which alcohol use disorder drugs are in Phase 3?: Phase 3 (or later) programs for alcohol use disorder include Brenipatide.
What are the next alcohol use disorder trial readouts?: Upcoming catalysts include Brenipatide (Primary completion Apr 2028 (RENEW-ALC-2)), Brenipatide (Primary completion Apr 2028 (RENEW-ALC-1)) and PT150 (Org 34517) (July 2028).
How many clinical trials are recruiting for alcohol use disorder?: 92 drug-interventional alcohol use disorder trials are currently recruiting participants, out of 367 registered interventional trials.