Alcoholism

20
Pipeline Programs
8
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
1
0
4
1
5
9
Early DiscoveryClinical DevelopmentMarket

On Market (6)

Approved therapies currently available

UP
KEPPRAApproved
levetiracetam
UCB Pharma
intravenous2006
UP
KEPPRA XRApproved
levetiracetam
UCB Pharma
oral2008
U
LEVETIRACETAMApproved
levetiracetam
Unknown Company
oral2012
U
LEVETIRACETAM IN SODIUM CHLORIDEApproved
levetiracetam
Unknown Company
intravenous2020
U
SPRITAMApproved
levetiracetam
Unknown Company
oral2015
J&
TOPAMAXApproved
topiramate
Johnson & Johnson
oral1998

Competitive Landscape

8 companies ranked by most advanced pipeline stage

J&
Johnson & JohnsonNEW BRUNSWICK, NJ
3 programs
1
1
1
1
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral TherapyPhase 31 trial
TOPAMAX(Topiramate)Phase 25 trials
Topiramate and NaltrexonePhase 11 trial
Active Trials
NCT00769158Completed4Est. Dec 2010
NCT02201251Completed63Est. Apr 2020
NCT02098941Unknown2,500Est. Dec 2014
+4 more trials
M&
Merck & Co.RAHWAY, NJ
2 programs
1
1
AcamprosatePhase 42 trials
SCH 900435Phase 21 trial
Active Trials
NCT00764660Terminated141Est. Jul 2010
NCT00159107Completed371Est. Dec 2006
NCT00317031Completed435Est. Jun 2008
UP
UCB PharmaBelgium - Brussels
2 programs
1
1
LevetiracetamPhase 41 trial
levetiracetamPhase 21 trial
Active Trials
NCT00141115Completed3Est. Jan 2008
NCT00325182Completed40Est. Oct 2009
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
Seroquel XRPhase 41 trial
Active Trials
NCT00352469Completed20Est. Nov 2008
Alkermes
AlkermesDUBLIN 4, Ireland
4 programs
4
Medisorb naltrexone 190 mgPhase 31 trial
Medisorb naltrexone 380 mgPhase 31 trial
Medisorb naltrexone 380 mgPhase 31 trial
Medisorb naltrexone 380 mgPhase 31 trial
Active Trials
NCT01218958CompletedEst. Sep 2003
NCT01218997CompletedEst. Mar 2005
NCT00156923CompletedEst. Jan 2007
+1 more trials
Abbott
AbbottABBOTT PARK, IL
1 program
1
divalproex sodium extended releasePhase 2/31 trial
Active Trials
NCT00202514Completed40Est. Jul 2006
Pfizer
PfizerNEW YORK, NY
1 program
1
CP-866,087Phase 21 trial
Active Trials
NCT00147576Completed88Est. Dec 2004
Circle Pharma
Circle PharmaCA - South SF
1 program
Computerized Alcohol Misuse InterventionN/A1 trial
Active Trials
NCT02368899Completed61Est. Apr 2017

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate
AstraZenecaSeroquel XR
UCB PharmaLevetiracetam
Johnson & JohnsonTopiramate
Johnson & JohnsonTopiramate
Merck & Co.Acamprosate
Merck & Co.Acamprosate
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: 13,434 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

Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine

Start: Jun 2005Est. completion: Jun 2007406 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

Integrative Therapy in Alcoholism

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

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
NCT00156936AlkermesMedisorb naltrexone 380 mg

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 2007
Phase 3Terminated

A Comparison of the Effectiveness and Safety of Topiramate and Phenytoin in Patients With New Onset Epilepsy Requiring Rapid Initiation of Antiepileptic Drug Treatment

Start: Jun 2004Est. completion: Aug 2007262 patients
Phase 3Completed

An Open Label Extension of a Study of Topiramate in Chronic Migraine.

Start: Feb 2004Est. completion: Aug 2005200 patients
Phase 3Completed

Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches

Start: Feb 2004Est. completion: Nov 2005347 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
NCT00156923AlkermesMedisorb naltrexone 380 mg

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

Start: Oct 2003Est. completion: Jan 2007
Phase 3Completed

A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches

Start: Sep 2003Est. completion: Apr 2005328 patients
Phase 3Completed
NCT01218997AlkermesMedisorb naltrexone 380 mg

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

Start: Aug 2003Est. completion: Mar 2005
Phase 3Completed
NCT01218958AlkermesMedisorb naltrexone 190 mg

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

Start: Feb 2002Est. completion: Sep 2003
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 Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.

Start: Oct 2001Est. completion: Feb 2004223 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 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 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 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 Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity

Start: Sep 2003Est. completion: Mar 2005407 patients
Phase 2/3Completed

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

Continuous Treatment Study of Topiramate in Migraine Participants

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

Phase Legend

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

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
8 companies competing in this space