Campral

(Acamprosate)

ApprovedSmall molecule

Acamprosate helps people who have stopped drinking alcohol stay sober by restoring normal brain function that has been altered by heavy drinking. It is used alongside counseling and support to reduce the urge to drink again.[2] Campral is currently approved and in use across 10 indications[4].[1]

Campral is one of 173 small molecule programs targeting Autism Spectrum Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

172

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Autism Spectrum DisorderApproved

Methamphetamine DependenceApproved

Parkinson DiseaseActive, not recruiting

Alcohol AbuseActive, not recruiting

Addictive Alcohol UseActive, not recruiting

Compulsive BehaviorsActive, not recruiting

Driving Under the InfluenceTerminated

Alcohol DependenceWithdrawn

Pathological GamblingCompleted

SchizophreniaCompleted

Autism Spectrum DisorderApproved

Approved

Methamphetamine DependenceApproved

Approved

Parkinson DiseasePreclinical

Active, not recruiting

Alcohol AbusePreclinical

Active, not recruiting

Addictive Alcohol UsePreclinical

Active, not recruiting

Compulsive BehaviorsPreclinical

Active, not recruiting

Driving Under the InfluencePreclinical

Terminated

Alcohol DependenceApproved

Withdrawn

Pathological GamblingApproved

Completed

SchizophreniaApproved

Completed

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Campral

FForest Laboratories

Approved

2 2

Ozempic

Novo Nordisk

Preclinical

1 3

Inapsine

Jazz Pharmaceuticals

Preclinical

1 4

Resotran

Takeda

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Catapres

Boehringer Ingelheim

Preclinical

1 9

Luvox

SSolvay Pharmaceuticals

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2029

Phase 2Recruiting

Alcohol-Associated Hepatitis

NCT07060638

Clinical

Trials by Indication[1]

Alcohol Dependence4 trials

Trial for the Treatment of Alcohol Dependence

Unknown status·UUniversity of Sydney·Phase 4·NCT00120601·200 enrolled

Comparative Trial Of Disulfiram, Naltrexone And Acamprosate In The Treatment Of Alcohol Dependence

Completed·FFinnish Institute for Health and Welfare·Phase 4·NCT00435435·243 enrolled

Safety of Acamprosate for Alcohol Dependence in the Elderly: An Open-Label Study (SAFADIE)

Withdrawn·UUniversity of New Mexico·Phase 4·NCT00655967

Show 1 more trial

Study of Campral (Acamprosate) for Alcohol Dependence in a Family Medicine Clinic

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT00381043·100 enrolled

Alcohol4 trials

Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00605904·37 enrolled

Acamprosate Initiated During Alcohol Detoxification

Completed·FForest Laboratories·Phase 2·NCT00360594·40 enrolled

Open Label Trial of Acamprosate in Bipolar Alcoholics

Completed·MMedical University of South Carolina·Phase 1/2·NCT00330486·9 enrolled

Show 1 more trial

Acamprosate vs. Placebo in Bipolar Alcoholics

Completed·MMedical University of South Carolina·Phase 4·NCT00466661·33 enrolled

Fragile X Syndrome2 trials

Acamprosate in Youth With Fragile X Syndrome

Completed·IIndiana University·Phase 2·NCT01300923·14 enrolled

Study of Acamprosate in Fragile x Syndrome

Completed·—·Phase 1·NCT01911455·46 enrolled

Alcoholism2 trials

Integrative Therapy in Alcoholism

Completed·HHeinrich-Heine University, Duesseldorf·Phase 4·NCT00159107·371 enrolled

Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Completed·TThe Scripps Research Institute·Phase 2·NCT00656630·68 enrolled

Schizophrenia2 trials

Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism

Completed·YYale University·Phase 3·NCT00463346·23 enrolled

Biomarker Study of Acamprosate in Schizophrenia

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT00688324·36 enrolled

21 more indications

Anxiety2 trials

An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants

Completed·SState University of New York - Upstate Medical University·N/A·NCT00591565·13 enrolled

Acamprosate in Alcoholics With Comorbid Anxiety or Depression

Completed·MMedical University of South Carolina·Phase 4·NCT00330174·90 enrolled

MPR2 trials

COMBINE (Acamprosate/Naltrexone)

Completed·UUniversity of North Carolina, Chapel Hill·Phase 3·NCT00006206·1,375 enrolled

Acamprosate: Genes Associated With Response

Completed·MMayo Clinic··NCT00662571·485 enrolled

Treatment2 trials

Acamprosate Treatment: Mechanisms of Action

Completed·YYale University·Phase 2·NCT00004552·120 enrolled

Alcohol Detoxification in Primary Care Treatment (ADEPT)

Completed·UUniversity of Bristol·Phase 4·NCT00855699·36 enrolled

Autism1 trial

Study of Acamprosate in Autism

Completed·—·Phase 1·NCT01813318·36 enrolled

Tinnitus1 trial

Clinical Trial of Acamprosate for Tinnitus

Completed·OOregon Health and Science University·Phase 1·NCT00596531·154 enrolled

Essential Tremor1 trial

Acamprosate and Methazolamide for Essential Tremor

Withdrawn·HHenry Ford Health System·Phase 2·NCT06312800

Pathological Gambling1 trial

Acamprosate in the Treatment of Pathological Gambling

Completed·UUniversity of Iowa·Phase 4·NCT00571103·26 enrolled

Eating Disorder1 trial

Acamprosate in the Treatment of Binge-Eating Disorder

Completed·LLindner Center of HOPE·Phase 2/3·NCT00511940·40 enrolled

Cocaine Dependence1 trial

Pilot Trial of Acamprosate for the Treatment of Cocaine Dependence

Completed·UUniversity of Pennsylvania·Phase 2·NCT00385268·60 enrolled

Treatment Outcome1 trial

Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome

Completed·MMayo Clinic·Phase 4·NCT03818191·288 enrolled

Acute1 trial

Neurophysiological and Acute Pharmacological Studies in FXS Patients

Completed·—·Phase 1·NCT02998151·29 enrolled

Relapse1 trial

Study of Acamprosate to Prevent Alcohol Relapse in Criminal Justice Supervisees

Terminated·VVirginia Commonwealth University·Phase 4·NCT00249379·26 enrolled

Liver Transplant1 trial

Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations

Completed·UUniversity of Southern California·Phase 2·NCT06471686·30 enrolled

Methamphetamine1 trial

A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction

Completed·NNYU Langone Health·Phase 1/2·NCT00571922·72 enrolled

Alcohol Withdrawal1 trial

Acamprosate to Reduce Symptoms of Alcohol Withdrawal

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 2·NCT00106106·56 enrolled

Driving Under the Influence1 trial

Study of Acamprosate in Driving Under the Influence (DUI) Court Participants

Terminated·UUniversity of Oklahoma·N/A·NCT00425711·4 enrolled

Alcohol Use1 trial

Vortioxetine for Treatment of Depressive Mood and Alcohol Use

Unknown status·HHanyang University Seoul Hospital·Phase 2·NCT04498897·128 enrolled

Depression1 trial

Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism

Completed·MMassachusetts General Hospital·Phase 4·NCT00452543·23 enrolled

Compulsive behaviors1 trial

Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease

Withdrawn·—·N/A·NCT00640952

Alcohol-Associated Hepatitis1 trial

Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial

Recruiting·SSamer Gawrieh·Phase 2·NCT07060638·216 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 29, 2004

CAMPRAL

NDA NDA021431

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for Acamprosate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Campral drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Acamprosate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Acamprosate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021431). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Forest Laboratories company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glutamate [NMDA] Receptor Antagonist; GABA-a Receptor; Anion Channel Positive Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: FForest Laboratories

Campral

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2029

Trials by Indication[1]

Alcohol Dependence4 trials

Alcohol4 trials

Fragile X Syndrome2 trials

Alcoholism2 trials

Schizophrenia2 trials

Anxiety2 trials

MPR2 trials

Treatment2 trials

Autism1 trial

Tinnitus1 trial

Essential Tremor1 trial

Pathological Gambling1 trial

Eating Disorder1 trial

Cocaine Dependence1 trial

Treatment Outcome1 trial

Acute1 trial

Relapse1 trial

Liver Transplant1 trial

Methamphetamine1 trial

Alcohol Withdrawal1 trial

Driving Under the Influence1 trial

Alcohol Use1 trial

Depression1 trial

Compulsive behaviors1 trial

Alcohol-Associated Hepatitis1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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