MedPath

Acamprosate

Generic Name
Acamprosate
Brand Names
Campral
Drug Type
Small Molecule
Chemical Formula
C5H11NO4S
CAS Number
77337-76-9
Unique Ingredient Identifier
N4K14YGM3J

Overview

Alcohol use disorder is responsible for a large worldwide burden of morbidity, premature mortality, and economic consequences resulting from accidents, violence, incarceration, decreased productivity, and increased healthcare spending. Acamprosate, also known by the brand name Campral, is a drug used for the maintenance of alcohol abstinence. It is a structural analogue of the neurotransmitter γ-aminobutyric acid (GABA). Acamprosate is the first medication specifically formulated for the maintenance of alcohol abstinence in ethanol-dependent patients after alcohol detoxification, unlike naltrexone and disulfiram. It was first approved by the FDA in 2004 and initially marketed by Forest Laboratories.

Indication

Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. It is also indicated for the maintenance of alcohol abstinence in patients who have undergone alcohol detoxification. This drug should be used with a psychosocial support program providing adequate support.

Associated Conditions

  • Alcohol Abstinence
  • Alcohol Dependency

Research Report

Published: Aug 21, 2025

A Comprehensive Monograph on Acamprosate (DB00659)

Section 1: Executive Summary & Introduction

Acamprosate, chemically known as calcium acetylhomotaurinate, is a centrally acting small molecule drug established as a cornerstone in the pharmacotherapeutic management of Alcohol Use Disorder (AUD).[1] It is one of only three medications approved by the U.S. Food and Drug Administration (FDA) for this indication, alongside disulfiram and naltrexone, and was the first agent specifically formulated for the maintenance of alcohol abstinence in patients following detoxification.[1] The core therapeutic principle of acamprosate is to support sustained sobriety by reducing alcohol cravings and mitigating the protracted withdrawal symptoms that often lead to relapse.[4] It achieves this not by inducing an aversive reaction to alcohol, as seen with disulfiram, but by targeting the underlying neurobiological dysregulation caused by chronic alcohol consumption.[5] Specifically, acamprosate is hypothesized to restore the homeostatic balance between the brain's primary excitatory (glutamate) and inhibitory (gamma-aminobutyric acid, or GABA) neurotransmitter systems, which is profoundly disrupted by long-term alcohol exposure.[4]

Continue reading the full research report

Clinical Trials

View More Clinical Trials

Sign in to access the complete clinical trial database with detailed study information.

FDA Drug Approvals

View More FDA Approvals

Sign in to access additional FDA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

View More EMA Approvals

Sign in to access additional EMA-approved drug information with detailed regulatory data.

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

View More HSA Approvals

Sign in to access additional HSA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

View More NMPA Approvals

Sign in to access additional NMPA-approved drug information with detailed regulatory data.

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

View More PPB Approvals

Sign in to access additional PPB-approved drug information with detailed regulatory data.

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

View More TGA Approvals

Sign in to access additional TGA-approved drug information with detailed regulatory data.

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

View More Health Canada Approvals

Sign in to access additional Health Canada approved drug information with detailed regulatory data.

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

View More CIMA AEMPS Approvals

Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

View More Philippines FDA Approvals

Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

View More Saudi SFDA Approvals

Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

View More Malaysia NPRA Approvals

Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

View More UK EMC Drug Information

Sign in to access additional UK EMC drug information with detailed pharmaceutical data.

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.