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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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/11
Not Applicable
Not yet recruiting
Samer Gawrieh
2024/06/24
Phase 2
Completed
2024/03/15
Phase 2
Withdrawn
2024/02/21
Phase 4
Recruiting
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
2020/08/05
Phase 2
UNKNOWN
Hanyang University Seoul Hospital
2019/01/28
Phase 4
Completed
2018/08/17
Phase 3
Completed
2016/12/20
Early Phase 1
Completed
2015/03/10
Phase 2
Withdrawn
2015/03/02
Phase 3
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Glenmark Pharmaceuticals Inc., USA
68462-435
ORAL
333 mg in 1 1
4/30/2020
Major Pharmaceuticals
0904-7213
ORAL
333 mg in 1 1
1/31/2022
Zydus Lifesciences Limited
70771-1057
ORAL
333 mg in 1 1
11/6/2023
Marlex Pharmaceuticals Inc
10135-636
ORAL
333 mg in 1 1
10/25/2019
Carilion Materials Management
68151-4760
ORAL
333 mg in 1 1
1/31/2012
Mylan Pharmaceuticals Inc.
0378-6333
ORAL
333 mg in 1 1
11/19/2014
Zydus Pharmaceuticals (USA) Inc.
68382-569
ORAL
333 mg in 1 1
11/6/2023
American Health Packaging
60687-121
ORAL
333 mg in 1 1
9/28/2023

EMA Drug Approvals

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

HSA Drug Approvals

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

NMPA Drug Approvals

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

PPB Drug Approvals

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CAMPRAL
Mylan Pharmaceuticals ULC
02293269
Tablet (Delayed-Release) - Oral
333 MG
7/30/2007

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
CAMPRAL 333 mg COMPRIMIDOS RECUBIERTOS
61201
COMPRIMIDO RECUBIERTO
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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

UK EMC Drug Information

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

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