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Alcohol Use Disorder

34
Pipeline Programs
30
Companies
49
Clinical Trials
12 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
1
23
2
3
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
267%
Small Molecule
133%
+ 54 programs with unclassified modality

Competitive Landscape

28 companies ranked by most advanced pipeline stage

Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
11 programs
1
5
1
1
injectable naltrexonePhase 41 trial
CannabidiolPhase 2/31 trial
BrexpiprazolePhase 2Small Molecule1 trial
CannabidiolPhase 21 trial
Full-Spectrum CannabidiolPhase 21 trial
+6 more programs
Active Trials
NCT06105138Completed37Est. Mar 2022
NCT04303676Completed399Est. Apr 2023
NCT05999344Completed146Est. Aug 2024
+8 more trials
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
2 programs
1
NaltrexonePhase 41 trial
Sleep extension and advanceN/A1 trial
Active Trials
NCT05684094Recruiting90Est. Feb 2027
NCT06426303Recruiting100Est. Dec 2028
Prevail Therapeutics
3 programs
1
2
LY3537031Phase 3
LY3537031Phase 3
MazdutidePhase 2Peptide
Adial Pharmaceuticals
Adial PharmaceuticalsCHARLOTTESVILLE, VA
1 program
1
ondansetronPhase 31 trial
Active Trials
NCT04101227Completed302Est. Mar 2022
Coordination Pharmaceuticals
1 program
1
Oxytocin nasal sprayPhase 2/3
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
10 programs
1
6
ANS-6637 Low DosePhase 2
EndotoxinPhase 21 trial
IbudilastPhase 2
IbudilastPhase 21 trial
Intravenous AlcoholPhase 21 trial
+5 more programs
Active Trials
NCT06304467Active Not Recruiting30Est. Sep 2026
NCT03428490Completed56Est. Apr 2021
NCT05007470Active Not Recruiting80Est. Sep 2025
+5 more trials
Sound Pharmaceuticals
2 programs
1
PrazosinPhase 21 trial
Collaborative Care InterventionN/A1 trial
Active Trials
NCT01400581Completed304Est. Dec 2015
NCT02322047Completed31Est. Oct 2018
Kinnov Therapeutics
Kinnov TherapeuticsFrance - Orléans
2 programs
1
1
CyproheptadinePhase 21 trial
Prazosin + cyproheptadinePhase 11 trial
Active Trials
NCT06147622Completed12Est. Dec 2024
NCT04108104Completed154Est. Jan 2022
Purdue Pharma
Purdue PharmaCT - Stamford
2 programs
2
SunobinopPhase 21 trial
SunobinopPhase 21 trial
Active Trials
NCT06545916Active Not Recruiting200Est. May 2026
NCT06545929Completed40Est. Jul 2025
Imbrium Therapeutics
2 programs
2
SunobinopPhase 2
SunobinopPhase 2
Amygdala Neurosciences
1 program
1
ANS-6637Phase 22 trials
Active Trials
NCT04311294Withdrawn0Est. Mar 2022
NCT03203499Completed48Est. Nov 2017
Astellas
AstellasChina - Shenyang
1 program
1
ASP8062Phase 21 trial
Active Trials
NCT05096117Completed60Est. Mar 2023
Indivior
IndiviorUK - Slough
1 program
1
Arbaclofen PlacarbilPhase 21 trial
Active Trials
NCT02511886Completed18Est. Jan 2016
Mapreg
MapregFrance - Paris
1 program
1
MAP4343Phase 21 trial
Active Trials
NCT04157114Withdrawn0Est. Dec 2022
Alkermes
AlkermesDUBLIN 4, Ireland
1 program
1
XR-NTXPhase 21 trial
Active Trials
NCT01932801Completed308Est. Jun 2019
Newleos
NewleosMA - Boston
1 program
1
NTX-2001Phase 11 trial
Active Trials
NCT07520292Recruiting50Est. Mar 2027
TheraNova
TheraNovaCA - San Francisco
2 programs
Empower Neuromodulation SystemN/A1 trial
TENSN/A1 trial
Active Trials
NCT03983317Completed25Est. Mar 2020
NCT03807544Completed17Est. Mar 2019
Eppendorf
EppendorfGermany - Hamburg
2 programs
MCIIN/A1 trial
Virtual reality approach avoidance trainingN/A1 trial
Active Trials
NCT03684798Completed122Est. Mar 2019
NCT04283305Unknown135Est. Jul 2021
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
2 programs
PIT paradigmN/A1 trial
Oxytocin nasal sprayPHASE_2_31 trial
Active Trials
NCT06256952Not Yet Recruiting100Est. Jun 2027
NCT05093296Completed62Est. Sep 2023
Innovation Pharmaceuticals
1 program
CBTN/A1 trial
Active Trials
NCT05855668Recruiting400Est. Dec 2027
BrainsWay
BrainsWayJerusalem, Israel
1 program
Deep TMSN/A1 trial
Active Trials
NCT07216872Recruiting186Est. Dec 2027
DyAnsys
DyAnsysCA - San Mateo
1 program
Drug Relief VN/A1 trial
Active Trials
NCT04106739Completed44Est. Dec 2021
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
Parent-Child Assistance Program - One-Year VersionN/A1 trial
Active Trials
NCT06163651Recruiting80Est. Sep 2026
SPARK Biopharma
SPARK BiopharmaKorea - Seoul
1 program
Sparrow AscentN/A1 trial
Active Trials
NCT07281261Recruiting20Est. Aug 2026
Spark Biomedical
Spark BiomedicalTX - Dallas
1 program
Sparrow AscentN/A
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
transcranial direct current stimulationN/A1 trial
Active Trials
NCT04135599Unknown40Est. Apr 2020
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
DCR-AUDPHASE_11 trial
Active Trials
NCT05845398Completed16Est. Aug 2023
MediciNova
MediciNovaLA JOLLA, CA
1 program
IbudilastPHASE_21 trial
Active Trials
NCT03594435Completed102Est. Apr 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Oregon TherapeuticsNaltrexone
Colorado Therapeuticsinjectable naltrexone
Adial Pharmaceuticalsondansetron
Colorado TherapeuticsCannabidiol
Heidelberg PharmaOxytocin nasal spray
Angeles TherapeuticsEndotoxin
Colorado TherapeuticsFull-Spectrum Cannabidiol
Purdue PharmaSunobinop
Purdue PharmaSunobinop
Angeles TherapeuticsIntravenous Alcohol
Colorado TherapeuticsSemaglutide 3 MG [Rybelsus]
AstellasASP8062
MapregMAP4343
Colorado TherapeuticsCannabidiol
Colorado TherapeuticsTolcapone

Showing 15 of 49 trials with date data

Clinical Trials (49)

Total enrollment: 4,999 patients across 49 trials

Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder

Start: May 2024Est. completion: Dec 2028100 patients
Phase 4Recruiting

In Hospital IM Naltrexone: A Pilot Study

Start: Mar 2022Est. completion: Jun 20230
Phase 4Withdrawn

Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms

Start: Feb 2020Est. completion: Mar 2022302 patients
Phase 3Completed

Alcohol Use Disorder and Cannabidiol

Start: Apr 2023Est. completion: Apr 2027180 patients
Phase 2/3Recruiting
NCT05093296Heidelberg PharmaOxytocin nasal spray

Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use Disorder

Start: Dec 2021Est. completion: Sep 202362 patients
Phase 2/3Completed

Endotoxin Exposure to Examine the Role of Inflammation in Alcohol Use

Start: Jun 2026Est. completion: Jul 202864 patients
Phase 2Not Yet Recruiting
NCT07279558Colorado TherapeuticsFull-Spectrum Cannabidiol

Cannabidiol and Alcohol Use Disorder Phenotypes

Start: Mar 2026Est. completion: Aug 2029150 patients
Phase 2Recruiting

Study of Sunobinop on Craving in Alcohol Use Disorder

Start: Jan 2025Est. completion: Jul 202540 patients
Phase 2Completed

Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder

Start: Oct 2024Est. completion: May 2026200 patients
Phase 2Active Not Recruiting

Motivation for IV Alcohol Self-Administration in Humans

Start: Jan 2024Est. completion: Jun 2027210 patients
Phase 2Recruiting
NCT05892432Colorado TherapeuticsSemaglutide 3 MG [Rybelsus]

Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)

Start: Jan 2024Est. completion: Nov 202550 patients
Phase 2Completed

Human Laboratory Study of ASP8062 for Alcohol Use Disorder

Start: Dec 2021Est. completion: Mar 202360 patients
Phase 2Completed

MAP4343 Treatment for Alcohol Use Disorder

Start: Dec 2021Est. completion: Dec 20220
Phase 2Withdrawn

CBD for the Treatment of Alcohol Use Disorder

Start: Aug 2021Est. completion: May 202345 patients
Phase 2Completed

COMT Inhibition Among Individuals With Comorbid AUD/ADHD

Start: Aug 2021Est. completion: Mar 202562 patients
Phase 2Recruiting

Brexpiprazole in Alcohol Use Disorder

Start: Oct 2020Est. completion: Aug 2026250 patients
Phase 2Recruiting

Development of a Selective ALDH2 Inhibitor to Treat AUD

Start: Apr 2020Est. completion: Mar 20220
Phase 2Withdrawn

Clinical Outcome of a Patented Pharmaceutical Composition (KT-110) to Treat Alcohol Use Disorder While Avoiding Major Side Effects

Start: Nov 2019Est. completion: Jan 2022154 patients
Phase 2Completed

Ibudilast for the Treatment of Alcohol Use Disorder

Start: Oct 2018Est. completion: Apr 2023102 patients
Phase 2Completed

Ibudilast and Withdrawal-Related Dysphoria

Start: Jul 2018Est. completion: Mar 202052 patients
Phase 2Completed
NCT02511886IndiviorArbaclofen Placarbil

A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder

Start: Sep 2015Est. completion: Jan 201618 patients
Phase 2Completed

Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders

Start: Mar 2015Est. completion: Oct 201831 patients
Phase 2Completed

Naltrexone for Individuals of East Asian Descent

Start: Dec 2013Est. completion: Sep 201687 patients
Phase 2Completed

Harm Reduction With Pharmacotherapy (HaRP)

Start: Aug 2013Est. completion: Jun 2019308 patients
Phase 2Completed

Development of Ivermectin for Alcohol Use Disorders

Start: Feb 2014Est. completion: Mar 201511 patients
Phase 1/2Completed

Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder

Start: Mar 2026Est. completion: Mar 202750 patients
Phase 1Recruiting

Enhancing the Effects of Alcohol Treatment With L-Carnitine

Start: Sep 2024Est. completion: May 202524 patients
Phase 1Completed
NCT06147622Kinnov TherapeuticsPrazosin + cyproheptadine

A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

Start: Apr 2024Est. completion: Dec 202412 patients
Phase 1Completed

Phase 1b Study of DCR-AUD in Healthy Volunteers

Start: Jan 2023Est. completion: Aug 202316 patients
Phase 1Completed

A Study to Evaluate the Safety of the Coadministration of ANS-6637 and Ethanol

Start: Feb 2017Est. completion: Nov 201748 patients
Phase 1Completed

tAN for Substance Use Disorder

Start: Jan 2026Est. completion: Aug 202620 patients
N/ARecruiting

Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD)

Start: Nov 2025Est. completion: Dec 2027186 patients
N/ARecruiting
NCT06163651Human BioSciencesParent-Child Assistance Program - One-Year Version

Evaluating a One-Year Version of the Parent-Child Assistance Program

Start: Jun 2025Est. completion: Sep 202680 patients
N/ARecruiting

Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use

Start: Oct 2024Est. completion: Jun 2027100 patients
N/ANot Yet Recruiting
NCT06304467Angeles TherapeuticsContingency Management

CM for Patients With ALD After Liver Transplant

Start: Sep 2024Est. completion: Sep 202630 patients
N/AActive Not Recruiting
NCT05684094Oregon TherapeuticsSleep extension and advance

Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function

Start: Sep 2023Est. completion: Feb 202790 patients
N/ARecruiting

Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment

Start: Nov 2022Est. completion: Dec 2027400 patients
N/ARecruiting

Alcoholic Liver Disease and the Gut Microbiome

Start: Jan 2022Est. completion: Sep 202580 patients
N/AActive Not Recruiting
NCT05999344Colorado Therapeuticscommercially available cannabis administered prior to commercially available alcohol

Alcohol and Cannabis Concentrates Co-Administration

Start: Dec 2021Est. completion: Aug 2024146 patients
N/ACompleted
NCT06105138Colorado Therapeutics200mg Cannabidiol oral solution

Cannabidiol Effects on Blood Alcohol Level and Intoxication

Start: Mar 2021Est. completion: Mar 202237 patients
N/ACompleted
NCT04303676Colorado TherapeuticsVirtual Practice Facilitation with e-Learning

Facilitating Alcohol Screening and Treatment (FAST)

Start: May 2020Est. completion: Apr 2023399 patients
N/ACompleted
NCT04283305EppendorfVirtual reality approach avoidance training

Virtual Reality Alcohol Avoidance Training

Start: Mar 2020Est. completion: Jul 2021135 patients
N/AUnknown
NCT04135599UNION therapeuticstranscranial direct current stimulation

A Study of the Effectiveness of Direct Current Stimulation for Alcohol Use Disorders

Start: Oct 2019Est. completion: Apr 202040 patients
N/AUnknown
NCT04106739DyAnsysDrug Relief V

A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear

Start: Oct 2019Est. completion: Dec 202144 patients
N/ACompleted
NCT03983317TheraNovaEmpower Neuromodulation System

Pilot Evaluation of the Empower Neuromodulation System in AUD Patients

Start: May 2019Est. completion: Mar 202025 patients
N/ACompleted

Treatment Parameters for the Empower Neuromodulation System (ENS)

Start: Jan 2019Est. completion: Mar 201917 patients
N/ACompleted
NCT03428490Angeles TherapeuticsFully integrated treatment

Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.

Start: Mar 2018Est. completion: Apr 202156 patients
N/ACompleted

Mental Contrasting With Implementation Intentions for Alcohol Use Disorders

Start: Aug 2017Est. completion: Mar 2019122 patients
N/ACompleted
NCT01400581Sound PharmaceuticalsCollaborative Care Intervention

Considering Healthier Drinking Options in Collaborative Care

Start: Nov 2011Est. completion: Dec 2015304 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
12 actively recruiting trials targeting 4,999 patients
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.