Alcohol use disorder drug pipeline

Upcoming readouts & recent results

• 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 (1)

Trials recruiting now (94)

94 drug-interventional alcohol use disorder trials recruiting now, of 369 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 3A Study of Brenipatide in Participants With Alcohol Use Disorder

  LY3537031, Placebo

  Eli Lilly and Companyn=1,100Belgium, China +6 · 117 sitesStarted Oct 2025NCT07219953
• Phase 3A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder

  LY3537031, Placebo

  Eli Lilly and Companyn=1,100Belgium, China +6 · 121 sitesStarted Oct 2025NCT07219966
• Phase 3Emergency Department-Initiated Medications for Alcohol Use Disorder

  Naltrexone Pill, Naltrexone Injection, Gabapentin Pill

  Yale Universityn=240United States · 1 siteStarted Aug 2024NCT05827159

Showing the 12 most advanced of 94 recruiting drug trials · see all on ClinicalTrials.gov →