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Alcoholism

22
Pipeline Programs
16
Companies
19
Clinical Trials
6
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
0
5
1
0
12
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1100%
+ 26 programs with unclassified modality

On Market (6)

Approved therapies currently available

Otsuka
ABILIFY ASIMTUFIIApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]intramuscular2023
13M Part D
Otsuka
ABILIFYApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2002
12M Part D
Johnson & Johnson
TOPAMAXApproved
topiramate
Johnson & Johnson
oral1998
Otsuka
MEZOFYApproved
aripiprazole
Otsuka
oral2025
Otsuka
OPIPZAApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2024
Otsuka
ABILIFY MAINTENA KITApproved
aripiprazole
Otsuka
intramuscular2013

Competitive Landscape

16 companies ranked by most advanced pipeline stage

Johnson & Johnson
Johnson & JohnsonNEW BRUNSWICK, NJ
3 programs
1
Topiramate and NaltrexonePHASE_11 trial
TOPAMAX(Topiramate)PHASE_21 trial
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral TherapyPHASE_31 trial
Active Trials
NCT00769158Completed4Est. Dec 2010
NCT00223639Completed29Est. Jul 2008
NCT00768508Completed300Est. Dec 2012
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
3 programs
1
2
AcamprosatePhase 4
Acamprosate or NaltrexonePhase 4
SCH 900435Phase 2
MSD
MSDIreland - Ballydine
3 programs
1
2
AcamprosatePhase 41 trial
Acamprosate or NaltrexonePhase 41 trial
SCH 900435Phase 21 trial
Active Trials
NCT00764660Terminated141Est. Jul 2010
NCT00159107Completed371Est. Dec 2006
NCT00317031Completed435Est. Jun 2008
Otsuka
OtsukaJapan - Tokushima
1 program
1
AripiprazolePhase 4Small Molecule1 trial
Active Trials
NCT00082199Completed400Est. Aug 2005
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
Seroquel XRPhase 41 trial
Active Trials
NCT00352469Completed20Est. Nov 2008
Abbott
AbbottABBOTT PARK, IL
1 program
1
divalproex sodium extended releasePhase 2/31 trial
Active Trials
NCT00202514Completed40Est. Jul 2006
Sound Pharmaceuticals
2 programs
1
Prazosin medicationPhase 21 trial
Experiential acceptanceN/A1 trial
Active Trials
NCT00760994Completed80Est. Aug 2012
NCT00762710Completed92Est. Jun 2014
Pfizer
PfizerNEW YORK, NY
1 program
1
CP-866,087Phase 21 trial
Active Trials
NCT00147576Completed88Est. Dec 2004
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
TopiramatePhase 21 trial
Active Trials
NCT02371889Completed320Est. Feb 2020
ViiV Healthcare
ViiV HealthcareNC - Durham
3 programs
3
GSK1521498Phase 1
GSK1521498Phase 1
single dosePhase 1
Lundbeck
LundbeckDenmark - Copenhagen
1 program
1
NalmefenePhase 11 trial
Active Trials
NCT02372318Terminated23Est. May 2016
Merck & Co.
Merck & Co.RAHWAY, NJ
2 programs
SCH 900435PHASE_2
AcamprosatePHASE_4
UCB Pharma
UCB PharmaBelgium - Brussels
2 programs
levetiracetamPHASE_21 trial
LevetiracetamPHASE_41 trial
Active Trials
NCT00141115Completed3Est. Jan 2008
NCT00325182Completed40Est. Oct 2009
Circle Pharma
Circle PharmaCA - South SF
1 program
Computerized Alcohol Misuse InterventionN/A1 trial
Active Trials
NCT02368899Completed61Est. Apr 2017
TheraNova
TheraNovaCA - San Francisco
1 program
Empower Neuromodulation SystemN/A1 trial
Active Trials
NCT05948605Completed35Est. Aug 2025
GSK
GSKLONDON, United Kingdom
1 program
single dosePHASE_11 trial
Active Trials
NCT01181908Completed21Est. Dec 2009

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AstraZenecaSeroquel XR
UCB PharmaLevetiracetam
OtsukaAripiprazole
MSDAcamprosate
MSDAcamprosate or Naltrexone
Johnson & JohnsonOndansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Abbottdivalproex sodium extended release
Human BioSciencesTopiramate
MSDSCH 900435
Sound PharmaceuticalsPrazosin medication
Johnson & JohnsonTopiramate
UCB Pharmalevetiracetam
PfizerCP-866,087
LundbeckNalmefene
GSKsingle dose

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 2,503 patients across 19 trials

NCT00352469AstraZenecaSeroquel XR

Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety

Start: Feb 2006Est. completion: Nov 200820 patients
Phase 4Completed
NCT00325182UCB PharmaLevetiracetam

The Effects of Levetiracetam on Alcohol Dependent Subjects

Start: Jan 2006Est. completion: Oct 200940 patients
Phase 4Completed
NCT00082199OtsukaAripiprazole

Study of Aripiprazole in Subjects With Alcoholism

Start: Apr 2004Est. completion: Aug 2005400 patients
Phase 4Completed
NCT00159107MSDAcamprosate

Integrative Therapy in Alcoholism

Start: May 2003Est. completion: Dec 2006371 patients
Phase 4Completed
NCT00317031MSDAcamprosate or Naltrexone

Individually Adapted Therapy of Alcoholism

Start: Nov 2002Est. completion: Jun 2008435 patients
Phase 4Completed
NCT00768508Johnson & JohnsonOndansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy

Combined Pharmacotherapies for Alcoholism

Start: Sep 2008Est. completion: Dec 2012300 patients
Phase 3Completed
NCT00202514Abbottdivalproex sodium extended release

Placebo Controlled Trial of Depakote ER in Alcohol Dependent Patients With Mood and/or Anxiety Symptoms

Start: Sep 2004Est. completion: Jul 200640 patients
Phase 2/3Completed
NCT02371889Human BioSciencesTopiramate

A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers

Start: Dec 2014Est. completion: Feb 2020320 patients
Phase 2Completed
NCT00764660MSDSCH 900435

Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)

Start: Feb 2009Est. completion: Jul 2010141 patients
Phase 2Terminated
NCT00762710Sound PharmaceuticalsPrazosin medication

Study of the Medication Prazosin for Alcohol Dependence

Start: Jan 2008Est. completion: Jun 201492 patients
Phase 2Completed
NCT00223639Johnson & JohnsonTopiramate

New Medications to Treat Alcohol Dependence

Start: Sep 2005Est. completion: Jul 200829 patients
Phase 2Completed
NCT00141115UCB Pharmalevetiracetam

Levetiracetam for the Treatment of Alcohol Dependence and Anxiety

Start: Mar 2004Est. completion: Jan 20083 patients
Phase 2Completed
NCT00147576PfizerCP-866,087

Study To Examine Effect Of CP-866,087 On Consumption And Craving Of Alcohol In Alcohol Dependent Subjects.

Start: Dec 2003Est. completion: Dec 200488 patients
Phase 2Completed
NCT02372318LundbeckNalmefene

Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity

Start: Apr 2015Est. completion: May 201623 patients
Phase 1Terminated
NCT01181908GSKsingle dose

Alcohol Interaction Study

Start: Nov 2009Est. completion: Dec 200921 patients
Phase 1Completed
NCT00769158Johnson & JohnsonTopiramate and Naltrexone

Combining Medications for the Treatment of Alcohol Dependence: An Inpatient Preliminary Study

Start: Oct 2008Est. completion: Dec 20104 patients
Phase 1Completed
NCT05948605TheraNovaEmpower Neuromodulation System

EMPOWER AUD Pivotal Trial

Start: Dec 2023Est. completion: Aug 202535 patients
N/ACompleted
NCT02368899Circle PharmaComputerized Alcohol Misuse Intervention

Computerized Alcohol Misuse Intervention System for Health Care

Start: Nov 2016Est. completion: Apr 201761 patients
N/ACompleted
NCT00760994Sound PharmaceuticalsExperiential acceptance

Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance

Start: Jan 2009Est. completion: Aug 201280 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

16 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.