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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
Otsuka
MEZOFYApproved
aripiprazole
Otsuka
oral2025
Johnson & Johnson
TOPAMAXApproved
topiramate
Johnson & Johnson
oral1998
Otsuka
ABILIFY MAINTENA KITApproved
aripiprazole
Otsuka
intramuscular2013
Otsuka
OPIPZAApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2024

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 41 trial
Acamprosate or NaltrexonePhase 41 trial
SCH 900435Phase 21 trial
Active Trials
NCT00764660Terminated141Est. Jul 2010
NCT00159107Completed371Est. Dec 2006
NCT00317031Completed435Est. Jun 2008
MSD
MSDIreland - Ballydine
3 programs
1
2
AcamprosatePhase 4
Acamprosate or NaltrexonePhase 4
SCH 900435Phase 2
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
Sharp TherapeuticsAcamprosate
Sharp TherapeuticsAcamprosate or Naltrexone
Johnson & JohnsonOndansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Abbottdivalproex sodium extended release
Human BioSciencesTopiramate
Sharp TherapeuticsSCH 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
NCT00159107Sharp TherapeuticsAcamprosate

Integrative Therapy in Alcoholism

Start: May 2003Est. completion: Dec 2006371 patients
Phase 4Completed
NCT00317031Sharp TherapeuticsAcamprosate 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
NCT00764660Sharp TherapeuticsSCH 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.