Alcohol Patent Expiration


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Clinical Trials

Recent Clinical Trials on Alcohol:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) National Institute on Drug Abuse (NIDA) NA NOT YET RECRUITING
(Sep 21, 2026)
PHASE1
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder National Institute of Mental Health (NIMH) NA RECRUITING
(Sep 16, 2026)
PHASE1
Stibium Metallicum Praeparatum D6 Versus Placebo in the Reduction of Paclitaxel-induced Peripheral Neurotoxicity University of Bern NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting Pontificia Universidade Católica do Rio Grande do Sul NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
MDMA for AUD/PTSD Comorbidity Carolina L Haass-Koffler NA COMPLETED
(Sep 1, 2026)
PHASE2
Efficacy and Safety of Patidegib Gel 2% for Preventing Basal Cell Carcinomas on the Face of Adults With Gorlin Syndrome Sol-Gel Technologies, Ltd. NA COMPLETED
(Sep 1, 2026)
PHASE3
Genetic Basis of the Risk and Consequences of Cannabis Exposure in Humans Yale University NA RECRUITING
(Sep 1, 2026)
PHASE1
The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD) Yale University NA RECRUITING
(Sep 1, 2026)
PHASE1
Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment Johns Hopkins University NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) 89bio, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE3
The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration University of Rochester NA RECRUITING
(Sep 1, 2026)
PHASE1
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study Pharmacotherapies for Alcohol and Substance Use Disorders Alliance NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors Neonc Technologies, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH 89bio, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE3
A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017) Merck Sharp & Dohme LLC NA COMPLETED
(Sep 1, 2026)
PHASE2
Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder Centre for Addiction and Mental Health NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Pregnenolone to Target Concurrent PTSD and Stress Induced Alcohol Use in Veterans: A Dose Finding Study Pharmacotherapies for Alcohol and Substance Use Disorders Alliance NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis Boehringer Ingelheim NA RECRUITING
(Sep 1, 2026)
PHASE3
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis Boehringer Ingelheim NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Test the Effects of Nezavist at Different Doses in Healthy Adults Lohocla Research Corporation NA TERMINATED
(Sep 1, 2026)
PHASE1
Diclofenac Dose Response Study University of Maryland, Baltimore NA COMPLETED
(Sep 1, 2026)
PHASE1
PT150 Drug for Use in Alcohol Use Disorder Pop Test Oncology LLC NA RECRUITING
(Sep 1, 2026)
PHASE1
A-TANGO Phase 2 Study Yaqrit Ltd NA RECRUITING
(Sep 1, 2026)
PHASE2
Mediterranean Diet and Inequality in Early Breast Cancer Esbjerg Hospital - University Hospital of Southern Denmark NA RECRUITING
(Sep 1, 2026)
PHASE2
Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking Ohio State University NA RECRUITING
(Sep 1, 2026)
PHASE2
Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE) VA Office of Research and Development NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Brenipatide in Participants With Alcohol Use Disorder Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder Eli Lilly and Company NA RECRUITING
(Sep 1, 2026)
PHASE3
Phase 1 Study of Intravaginal KB15A ZabBio Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1
Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS) Yale University NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) University of Arkansas NA RECRUITING
(Sep 1, 2026)
PHASE2
Cannabidiol and Alcohol Use Disorder Phenotypes University of Colorado, Denver NA RECRUITING
(Sep 1, 2026)
PHASE2
Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder Brigham and Women's Hospital NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B) National Institute of Mental Health (NIMH) NA RECRUITING
(Aug 13, 2026)
PHASE1
Environment and Alcohol: A Pilot Study National Institute on Drug Abuse (NIDA) NA RECRUITING
(Aug 10, 2026)
PHASE1
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms National Institute on Alcohol Abuse and Alcoholism (NIAAA) NA RECRUITING
(Aug 6, 2026)
PHASE1, PHASE2
Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old Immedica Pharma AB NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD NYU Langone Health NA RECRUITING
(Aug 1, 2026)
PHASE2
Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. MedSIR NA RECRUITING
(Aug 1, 2026)
PHASE3
Choline and Iron Deficiency University of Minnesota NA RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
PsiloStudy: Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD) Nathan Brashares Sackett NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR) Ablative Solutions, Inc. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving Johns Hopkins University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
Methylphenidate and Response to Alcohol Cues University of Florida NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors National Institute on Alcohol Abuse and Alcoholism (NIAAA) NA RECRUITING
(Jul 30, 2026)
PHASE1
Tirzepatide in MetALD National Institute on Alcohol Abuse and Alcoholism (NIAAA) NA RECRUITING
(Jul 16, 2026)
PHASE2
Emergency Department-Initiated Medications for Alcohol Use Disorder Yale University NA RECRUITING
(Jul 1, 2026)
PHASE3
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment QuantumLeap Healthcare Collaborative NA RECRUITING
(Jul 1, 2026)
PHASE2
Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury University of South Florida NA RECRUITING
(Jul 1, 2026)
PHASE3
Impact of Daily Oral Cannabis Doses in Patients With Cancer Shanna Babalonis, PhD NA RECRUITING
(Jul 1, 2026)
PHASE1
A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease GlaxoSmithKline NA RECRUITING
(Jul 1, 2026)
PHASE2
Aging Resilience Through Microbiota Optimization and Regulation Gonzalo Jorquera, PhD NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Study of Tirzepatide for Recovery and Alcohol Use Management Brigham and Women's Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder Eli Lilly and Company NA COMPLETED
(Jul 1, 2026)
PHASE2
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health University of Colorado, Denver NA RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED University of Monastir NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial Samer Gawrieh NA RECRUITING
(Jul 1, 2026)
PHASE2
Periprostatic Neurolysis in Prostate Cancer University of Texas Southwestern Medical Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Combination Therapy for Alcohol Use Disorder Johns Hopkins University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Cognitive Strategies in Early Psychosis 2 University of Minnesota NA RECRUITING
(Jul 1, 2026)
PHASE3
A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer R-Pharm NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Cannabidiol for Reducing Drinking in Alcohol Use Disorder Hôpital le Vinatier NA TERMINATED
(Jun 1, 2026)
PHASE2
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant University of Virginia NA RECRUITING
(Jun 1, 2026)
PHASE2
Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers Yale University NA RECRUITING
(Jun 1, 2026)
PHASE1
Study of Cannabidiol in Sanfilippo Syndrome Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder Knoa Pharma LLC NA COMPLETED
(Jun 1, 2026)
PHASE2
Study of Sunobinop on Craving in Alcohol Use Disorder Knoa Pharma LLC NA COMPLETED
(Jun 1, 2026)
PHASE2
Study to Examine the Effect of Silicone Mouth Tape on Snoring and Mild Sleep Apnea. Johns Hopkins University NA RECRUITING
(Jun 1, 2026)
PHASE2
Suvorexant for Treatment of AUD and PTSD Pharmacotherapies for Alcohol and Substance Use Disorders Alliance NA RECRUITING
(Jun 1, 2026)
PHASE2
A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1) Aldeyra Therapeutics, Inc. NA COMPLETED
(Jun 1, 2026)
PHASE2
Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya University of Chicago NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Effects of Ketones on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder University of Pennsylvania NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Mindfulness Meditation for Insomnia Brigham and Women's Hospital NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery Rush University Medical Center NA RECRUITING
(Jun 1, 2026)
PHASE2
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder Yale University NA RECRUITING
(Jun 1, 2026)
PHASE2
MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder VA Office of Research and Development NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Boosting Olfactory and Sensory Training Study (BOOST) University of Alabama at Birmingham NA RECRUITING
(Jun 1, 2026)
PHASE2
Behavioral Economic Attributes of Recreation Rush University Medical Center NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus Shanghai Jiao Tong University School of Medicine NA RECRUITING
(Jun 1, 2026)
PHASE2
Nasal Inhalation of Isopropyl Alcohol for the Treatment of Nausea in Patients With Cancer M.D. Anderson Cancer Center NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Citicoline in Youth Alcohol Use Disorder Medical University of South Carolina NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Bicalutamide Therapy in Young Women With NAFLD and PCOS University of California, San Francisco NA RECRUITING
(May 1, 2026)
PHASE1
Guanfacine for Alcohol Use Disorder (AUD) Indiana University NA RECRUITING
(May 1, 2026)
PHASE2
Door-Through-Door Companion Rideshare Technology for Individuals With Alzheimer's Disease and Related Dementias (AD/ADRD) Onward Health, Inc NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients Tanta University NA RECRUITING
(May 1, 2026)
PHASE2
GLP-1 Receptor Agonists to Decrease Ethanol and CVD Risk in HIV Vanderbilt University Medical Center NA RECRUITING
(May 1, 2026)
PHASE2
Acute Effects of Cannabis on Cognition and Affect Washington State University NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment GlaxoSmithKline NA RECRUITING
(May 1, 2026)
PHASE1
LSD Treatment for Persons With Alcohol Use Disorder Felix Mueller NA RECRUITING
(Apr 1, 2026)
PHASE2
Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2) Stanford University NA RECRUITING
(Apr 1, 2026)
PHASE2
Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD Texas A&M University NA RECRUITING
(Apr 1, 2026)
PHASE2
Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2 Yale University NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Effect of Nutritional Ketosis on Alcohol Metabolism University of Pennsylvania NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Ketamine for Combined Depression and Alcohol Use Disorder University Hospital of North Norway NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults Akyso Therapeutics, LLC NA COMPLETED
(Apr 1, 2026)
PHASE1
A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD) Boehringer Ingelheim NA COMPLETED
(Apr 1, 2026)
PHASE3
Motivation for IV Alcohol Self-Administration in Humans University of California, Los Angeles NA RECRUITING
(Apr 1, 2026)
PHASE2
A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder Tempero Bio, Inc. NA TERMINATED
(Apr 1, 2026)
PHASE2
Efficacy of a Smartphone-Based JITAI to Reduce Drinking Among Adults Experiencing Homelessness University of Oklahoma NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor Kristina Simonyan NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE1
Ipilimumab and Nivolumab With SBRT in Locally Advanced Hepatocellular Cancer University of Hawaii NA RECRUITING
(Apr 1, 2026)
PHASE1
Targeted Naltrexone to Support Individuals Participating in Dry January Brigham and Women's Hospital NA COMPLETED
(Apr 1, 2026)
PHASE2
Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC) Nantes University Hospital NA RECRUITING
(Apr 1, 2026)
PHASE2
Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study Florida A&M University NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers Biocon Biologics UK PLC NA RECRUITING
(Apr 1, 2026)
PHASE1
Human Laboratory Study of Apremilast for Alcohol Use Disorder National Institute on Alcohol Abuse and Alcoholism (NIAAA) NA RECRUITING
(Apr 1, 2026)
PHASE2
Sleep Health in U.S. Marines San Diego State University NA RECRUITING
(Apr 1, 2026)
PHASE2
MDMA for Co-occurring PTSD and OUD After Childbirth University of New Mexico NA RECRUITING
(Mar 1, 2026)
PHASE2
Low-dose Naltrexone for Post-COVID Fatigue Syndrome Luis Nacul NA COMPLETED
(Mar 1, 2026)
PHASE2
A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects Clearmind Medicine Inc. NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
The Effectiveness of CBD and CBN in the Treatment of Facial Pain and Headache of Muscular Origin Wroclaw Medical University NA ENROLLING BY INVITATION
(Mar 1, 2026)
PHASE2, PHASE3
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD) Marialena Mouzaki NA RECRUITING
(Mar 1, 2026)
PHASE2
Effects of Ketone Supplementation on Acute Alcohol Withdrawal University of Pennsylvania NA ENROLLING BY INVITATION
(Mar 1, 2026)
PHASE2, PHASE3
miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial Miromatrix Medical Inc. NA COMPLETED
(Mar 1, 2026)
PHASE1
A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients Visirna Therapeutics HK Limited NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Digoxin In NASH (CODIN) Yale University NA RECRUITING
(Mar 1, 2026)
PHASE2
ACT_for Alcohol Use Disorder and Depression Centre hospitalier de l'Université de Montréal (CHUM) NA RECRUITING
(Mar 1, 2026)
Effects of Ketone Supplement and Alcohol on Brain Metabolism University of Pennsylvania NA RECRUITING
(Mar 1, 2026)
PHASE2, PHASE3
Probenecid Administration for Alcohol Craving and Consumption Brown University NA RECRUITING
(Mar 1, 2026)
PHASE2
Observational Study on GER in Patients With Simple Obesity Jing Ma NA COMPLETED
(Mar 1, 2026)
Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH) Cascade Pharmaceuticals, Inc NA RECRUITING
(Mar 1, 2026)
PHASE2


Alcohol Generic API Manufacturers

Only one generic application has been filed for Alcohol.

Given below is the list of companies who have filed for Alcohol generic, along with the locations of their manufacturing plants worldwide.