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Alcoholism

22
Pipeline Programs
16
Companies
50
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
Otsuka
OPIPZAApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2024
Otsuka
ABILIFY MAINTENA KITApproved
aripiprazole
Otsuka
intramuscular2013
Johnson & Johnson
TOPAMAXApproved
topiramate
Johnson & Johnson
oral1998

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_25 trials
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral TherapyPHASE_31 trial
Active Trials
NCT00769158Completed4Est. Dec 2010
NCT02201251Completed63Est. Apr 2020
NCT02098941Unknown2,500Est. Dec 2014
+4 more trials
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
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
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
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate
AstraZenecaSeroquel XR
UCB PharmaLevetiracetam
OtsukaAripiprazole
Johnson & JohnsonTopiramate
MSDAcamprosate
MSDAcamprosate or Naltrexone
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 13,409 patients across 50 trials

First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients

Start: Feb 2010Est. completion: Jan 201155 patients
Phase 4Completed

A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy

Start: May 2008Est. completion: Jan 2010139 patients
Phase 4Completed

An Efficacy and Tolerability Study of Topiramate in Participants With Migraine

Start: Jul 2006Est. completion: Jul 2008250 patients
Phase 4Completed

Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety

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

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

Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)

Start: Mar 2004Est. completion: Dec 201812 patients
Phase 4Terminated
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

Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)

Start: Jan 2002Est. completion: Jan 201923 patients
Phase 4Completed

Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians

Start: Oct 2001Est. completion: Mar 200460 patients
Phase 4Completed

Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)

Start: Jul 2001Est. completion: Sep 200440 patients
Phase 4Completed

Topiramate: Long-Term Maintenance of Weight Loss Induced by Low-Calorie Diet in Obese Subjects

Start: Aug 2000Est. completion: Jun 2002701 patients
Phase 4Terminated

A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

Start: Oct 2014Est. completion: Apr 202063 patients
Phase 3Completed

NINDS CRC Chronic Migraine Treatment Trial

Start: Oct 2008Est. completion: Sep 2010191 patients
Phase 3Completed
NCT00768508Johnson & JohnsonOndansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy

Combined Pharmacotherapies for Alcoholism

Start: Sep 2008Est. completion: Dec 2012300 patients
Phase 3Completed

An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.

Start: Oct 2004Est. completion: Dec 200820 patients
Phase 3Completed

A Randomized, Placebo-controlled, Tourette Syndrome Study.

Start: Sep 2004Est. completion: Dec 200829 patients
Phase 3Completed

The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine

Start: Dec 2003Est. completion: Jul 200559 patients
Phase 3Completed

The Prolonged Use of Topiramate for Preventing Migraine Headaches

Start: Nov 2003Est. completion: Aug 2006834 patients
Phase 3Completed

An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.

Start: Nov 2003Est. completion: Apr 200573 patients
Phase 3Completed

A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder

Start: Jan 2002Est. completion: Apr 200213 patients
Phase 3Completed

A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia

Start: May 2001Est. completion: Jun 2002179 patients
Phase 3Terminated

A Study of Efficacy and Safety of Topiramate in the Treatment of Obese Patients With Mild to Moderate Essential Hypertension

Start: Mar 2001Est. completion: Jun 2002531 patients
Phase 3Completed

A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

Start: Mar 2001Est. completion: Nov 2002768 patients
Phase 3Completed

A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

Start: Feb 2001Est. completion: Sep 2002763 patients
Phase 3Completed

A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet

Start: Jan 2001Est. completion: May 2002541 patients
Phase 3Completed

A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder

Start: Jan 2001Est. completion: May 2003434 patients
Phase 3Completed

A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin

Start: Oct 2000Est. completion: Jun 2002211 patients
Phase 3Completed

A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder

Start: Oct 2000Est. completion: Sep 2002363 patients
Phase 3Completed

A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program

Start: Aug 2000Est. completion: Jun 2002561 patients
Phase 3Completed

A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

Start: Jul 2000Est. completion: Jun 20021,293 patients
Phase 3Completed

A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy

Start: Jul 1999Est. completion: Sep 2003750 patients
Phase 3Completed

A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure

Start: Nov 1995Est. completion: Aug 2002451 patients
Phase 3Completed

A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures

Start: Dec 1994Est. completion: Dec 199680 patients
Phase 3Completed

A Study of the Efficacy and Safety of Topiramate as "Add on" Treatment in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures

Start: Mar 1994Est. completion: Dec 199980 patients
Phase 3Completed

A Study of the Efficacy and Safety of Topiramate Treatment in Patients With Epilepsy

Start: Oct 1992Est. completion: Apr 199751 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

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

Study of the Medication Prazosin for Alcohol Dependence

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

Continuous Treatment Study of Topiramate in Migraine Participants

Start: Aug 2007Est. completion: Nov 2009296 patients
Phase 2Completed

A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine

Start: Apr 2007Est. completion: Jan 2009387 patients
Phase 2Completed

Topiramate to Reduce Cocaine Dependence

Start: Jan 2007Est. completion: Dec 201025 patients
Phase 2Completed

New Medications to Treat Alcohol Dependence

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

Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Start: Mar 2005Est. completion: Dec 2013320 patients
Phase 2Unknown

An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence

Start: Mar 2004Est. completion: Aug 2006371 patients
Phase 2Completed

Levetiracetam for the Treatment of Alcohol Dependence and Anxiety

Start: Mar 2004Est. completion: Jan 20083 patients
Phase 2Completed

A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin

Start: Feb 2004Est. completion: Oct 2004113 patients
Phase 2Completed

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

Phase Legend

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