Alcohol Dependence

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

VIVITROLApproved

naltrexone

Alkermes

intramuscular2006

62M Part D

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

LundbeckDenmark - Copenhagen

7 programs

Selincro® 18 mg with continuous psychosocial support: Cohort APhase 41 trial

nalmefenePhase 41 trial

Nalmefene hydrochloridePhase 3

Nalmefene 18 mg, then placeboPhase 11 trial

+2 more programs

Active Trials

NCT02492581Completed700Est. Apr 2018

NCT01969617Completed22

NCT02195817Terminated378Est. Feb 2016

+1 more trials

AlkermesDUBLIN 4, Ireland

3 programs

VIVITROL(naltrexone)Phase 45 trials

RDC-0313Phase 24 trials

baclofenPhase 11 trial

Active Trials

NCT00802035Completed16Est. Feb 2009

NCT01098435Completed69Est. Jun 2011

NCT01046539Completed12Est. Jul 2010

+7 more trials

OtsukaJapan - Tokushima

4 programs

Nalmefene hydrochloridePhase 31 trial

nalmefene hydrochloride 10 mgPhase 11 trial

Nalmefene Hydrochloride HydrateN/A1 trial

Active Trials

NCT04107051Completed533Est. Feb 2024

NCT02679469Completed7Est. Mar 2016

NCT02364947Completed678Est. Jul 2016

+1 more trials

Alliance PharmaceuticalsUK - Wiltshire

2 programs

MecamylaminePhase 31 trial

PT150Phase 11 trial

Active Trials

NCT03548714Completed10Est. Jul 2019

NCT00563797Completed21Est. Jul 2014

Prevail TherapeuticsNY - New York

4 programs

LY2196044Phase 21 trial

LY686017Phase 21 trial

opioid receptor kappa antagonistPhase 11 trial

Active Trials

NCT01232439Completed13Est. Apr 2011

NCT00804570Completed375Est. Feb 2010

NCT00310427Completed66Est. Mar 2008

+1 more trials

AbbVieNORTH CHICAGO, IL

1 program

ABT-436Phase 21 trial

Active Trials

NCT01613014Completed150Est. Jul 2015

Vyne TherapeuticsIsrael - Ness Ziona

1 program

Comparator: MK0594 5 mg/dayPhase 21 trial

Active Trials

NCT00835718Terminated162Est. Mar 2010

PfizerNEW YORK, NY

1 program

VareniclinePhase 21 trial

Active Trials

NCT01071187Unknown40Est. Sep 2011

Quotient TherapeuticsMA - Cambridge

1 program

GET 73Phase 1/21 trial

Active Trials

NCT01842503Completed25Est. Nov 2018

Johnson & JohnsonNEW BRUNSWICK, NJ

2 programs

Ondansetron + Cognitive Behavioral TherapyPHASE_31 trial

Topiramate + Cognitive Behavioral TherapyPHASE_31 trial

Active Trials

NCT00382642Completed283Est. Dec 2009

NCT00448825Unknown180Est. Jun 2013

EppendorfGermany - Hamburg

1 program

Inhibit AATN/A1 trial

Active Trials

NCT04054336Unknown90Est. Aug 2020

UCB PharmaBelgium - Brussels

1 program

levetiracetamPHASE_31 trial

Active Trials

NCT00758277Completed201Est. Dec 2009

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

Alkermesnaltrexone

Lundbecknalmefene

LundbeckSelincro® 18 mg with continuous psychosocial support: Cohort A

Alkermesnaltrexone

OtsukaNalmefene hydrochloride

Alkermesnaltrexone

Alliance PharmaceuticalsMecamylamine

Showing 15 of 47 trials with date data

Clinical Trials (47)

Total enrollment: 8,246 patients across 47 trials

NCT02978417 Alkermesnaltrexone

Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings

Start: Sep 2017Est. completion: Jun 201914 patients

Phase 4Completed

NCT02197598 Lundbecknalmefene

Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use

Start: Sep 201445 patients

Phase 4Completed

NCT02195817 LundbeckSelincro® 18 mg with continuous psychosocial support: Cohort A

Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

Start: Aug 2014Est. completion: Feb 2016378 patients

Phase 4Terminated

NCT01471145 Alkermesnaltrexone

Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT

Start: Jan 2013Est. completion: Oct 201440 patients

Phase 4Completed

NCT01563718 Alkermesnaltrexone

Pre-Release VIVITROL for Opioid Dependent Inmates

Start: Mar 2012Est. completion: Aug 201526 patients

Phase 4Completed

NCT00620750 Alkermesnaltrexone

Extended-release Naltrexone for Alcohol Dependence in Primary Care

Start: Jul 2007Est. completion: Feb 201072 patients

Phase 4Completed

NCT00511836 Alkermesnaltrexone

ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults

Start: Jul 2007Est. completion: Oct 200931 patients

Phase 4Completed

NCT02696434 Alkermesnaltrexone

Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

Start: Apr 2016Est. completion: Nov 2017101 patients

Phase 3Completed

NCT02537574 Alkermesnaltrexone

Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)

Start: Aug 2015Est. completion: Jan 2017380 patients

Phase 3Completed

NCT02382276 OtsukaNalmefene hydrochloride

A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

Start: Jul 2015Est. completion: Jan 2017405 patients

Phase 3Completed

NCT02364947 OtsukaNalmefene hydrochloride

A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)

Start: Feb 2015Est. completion: Jul 2016678 patients

Phase 3Completed

NCT01180647 Alkermesnaltrexone

Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

Start: May 2010Est. completion: Jul 201348 patients

Phase 3Completed

NCT00834080 Alkermesnaltrexone

ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

Start: Mar 2009Est. completion: May 201238 patients

Phase 3Completed

NCT00678418 Alkermesnaltrexone

ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

Start: Jun 2008Est. completion: Nov 2010250 patients

Phase 3Completed

NCT00563797 Alliance PharmaceuticalsMecamylamine

Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence

Start: Aug 2007Est. completion: Jul 201421 patients

Phase 3Completed

NCT00501631 Alkermesnaltrexone

ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence

Start: Jul 2007Est. completion: Mar 2011300 patients

Phase 3Completed

NCT00758277 UCB Pharmalevetiracetam

Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

Start: May 2007Est. completion: Dec 2009201 patients

Phase 3Completed

NCT00448825 Johnson & JohnsonTopiramate + Cognitive Behavioral Therapy

Novel Pharmacotherapy for Dual Dependence

Start: Mar 2007Est. completion: Jun 2013180 patients

Phase 3Unknown

NCT00382642 Johnson & JohnsonOndansetron + Cognitive Behavioral Therapy

Pharmacological Treatment for Alcoholism

Start: Jun 2006Est. completion: Dec 2009283 patients

Phase 3Completed

NCT00156936 Alkermesnaltrexone

ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])

Start: Aug 2004Est. completion: Jan 2007108 patients

Phase 3Terminated

NCT00156923 Alkermesnaltrexone

ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

Start: Oct 2003Est. completion: Jan 2007108 patients

Phase 3Completed

NCT01218997 Alkermesnaltrexone

ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)

Start: Aug 2003Est. completion: Mar 2005436 patients

Phase 3Completed

NCT01218971 Alkermesnaltrexone

ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)

Start: Aug 2002Est. completion: Sep 2004332 patients

Phase 3Completed

NCT01218958 Alkermesnaltrexone

ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults

Start: Feb 2002Est. completion: Sep 2003624 patients

Phase 3Completed

NCT01613014 AbbVieABT-436

ABT-436 for Alcohol Dependence

Start: Feb 2013Est. completion: Jul 2015150 patients

Phase 2Completed

NCT01690546 Alkermesnaltrexone

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

Start: Sep 2012Est. completion: Feb 201538 patients

Phase 2Completed

NCT01449565 Alkermesnaltrexone

Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)

Start: Sep 2012Est. completion: Mar 2016100 patients

Phase 2Completed

NCT01098435 AlkermesRDC-0313

ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder

Start: May 2010Est. completion: Jun 201169 patients

Phase 2Completed

NCT01071187 PfizerVarenicline

Varenicline for Alcohol Dependence

Start: Mar 2010Est. completion: Sep 201140 patients

Phase 2Unknown

NCT00981617 AlkermesRDC-0313

ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence

Start: Oct 2009Est. completion: Aug 2010406 patients

Phase 2Completed

NCT00777062 Alkermesnaltrexone

VIVITROL as a Treatment for Cocaine and Alcohol Dependence

Start: Jul 2009Est. completion: Sep 201380 patients

Phase 2Completed

NCT00835718 Vyne TherapeuticsComparator: MK0594 5 mg/day

A Study of MK0594 in Patients With Alcohol Dependence (0594-020)

Start: Feb 2009Est. completion: Mar 2010162 patients

Phase 2Terminated

NCT00805441 Prevail TherapeuticsLY686017

A Study in the Treatment of Alcohol Dependence.

Start: Dec 2008Est. completion: Jul 2009190 patients

Phase 2Completed

NCT00804570 Prevail TherapeuticsLY2196044

A Study for the Treatment of Alcohol Dependence

Start: Nov 2008Est. completion: Feb 2010375 patients

Phase 2Completed

NCT00310427 Prevail TherapeuticsLY686017

Effect of LY686017 on Alcohol Craving

Start: Mar 2006Est. completion: Mar 200866 patients

Phase 2Completed

NCT01218984 Alkermesnaltrexone

ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids

Start: Mar 2002Est. completion: May 200327 patients

Phase 2Completed

NCT01842503 Quotient TherapeuticsGET 73

Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent

Start: Nov 2014Est. completion: Nov 201825 patients

Phase 1/2Completed

NCT03548714 Alliance PharmaceuticalsPT150

Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol

Start: Sep 2018Est. completion: Jul 201910 patients

Phase 1Completed

NCT02679469 Otsukanalmefene hydrochloride 10 mg

A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects

Start: Feb 2016Est. completion: Mar 20167 patients

Phase 1Completed

NCT01969617 LundbeckNalmefene 18 mg, then placebo

Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge

Start: Nov 201322 patients

Phase 1Completed

NCT01232439 Prevail Therapeuticsopioid receptor kappa antagonist

A Study of Brain Receptor Occupancy in Healthy Subjects

Start: Dec 2010Est. completion: Apr 201113 patients

Phase 1Completed

NCT01046539 AlkermesRDC-0313

Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

Start: Jan 2010Est. completion: Jul 201012 patients

Phase 1Completed

NCT00800319 AlkermesRDC-0313

ALK33-001: A Study of RDC-0313 Administered to Healthy Adults

Start: Dec 2008Est. completion: Jun 200916 patients

Phase 1Completed

NCT00802035 Alkermesbaclofen

ALK29-002: A Study of Baclofen Formulations in Healthy Adults

Start: Nov 2008Est. completion: Feb 200916 patients

Phase 1Completed

NCT04107051 OtsukaNalmefene Hydrochloride Hydrate

Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence

Start: Oct 2019Est. completion: Feb 2024533 patients

N/ACompleted

NCT04054336 EppendorfInhibit AAT

The Approach and Avoidance Task (AAT) in Alcoholic Inpatients

Start: Feb 2017Est. completion: Aug 202090 patients

N/AUnknown

NCT02492581 LundbeckNalmefene

Use of Selincro and Impact on Usual Practice

Start: Feb 2016Est. completion: Apr 2018700 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs, potential near-term approvals

12 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.