Disulfiram

Overview

A carbamate derivative used as an alcohol deterrent. It is a relatively nontoxic substance when administered alone, but markedly alters the intermediary metabolism of alcohol. When alcohol is ingested after administration of disulfiram, blood acetaldehyde concentrations are increased, followed by flushing, systemic vasodilation, respiratory difficulties, nausea, hypotension, and other symptoms (acetaldehyde syndrome). It acts by inhibiting aldehyde dehydrogenase.

Indication

For the treatment and management of chronic alcoholism

Associated Conditions

Chronic Alcoholism

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Anxiety During Abstinence in AUD	2025/01/27	NCT06793488	Early Phase 1	Recruiting	Columbia University
The Effects of Disulfiram (Antabuse®) on Visual Acuity in Patients With Retinal Degeneration	2024/03/20	NCT06319872	Phase 1	Recruiting	University of Rochester
Treatment of Advance Gastric Cancer With Disulfiram	2022/12/28	NCT05667415	Not Applicable	Not yet recruiting	First People's Hospital of Hangzhou
Disulfiram for Treatment of Retinal Degeneration	2022/11/25	NCT05626920	Phase 1	Recruiting	University of Washington
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refractory Sarcomas	2022/01/27	NCT05210374	Phase 1	Recruiting	Case Comprehensive Cancer Center
Body Weight Response With Disulfiram in Humans	2021/12/17	NCT05162001	Early Phase 1	UNKNOWN	Universidad de Guanajuato
Clinical Study to Evaluate the Effects of Disulfiram in Patients With Moderate COVID-19	2020/10/20	NCT04594343	Phase 2	Completed	ETICA
Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma	2020/08/20	NCT04521335	Phase 1	Terminated	University of Utah
Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder	2020/08/06	NCT04502589	Phase 1	Completed	Virginia Commonwealth University
DISulfiram for COvid-19 (DISCO) Trial	2020/07/24	NCT04485130	Phase 2	Terminated	University of California, San Francisco

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Disulfiram	Bryant Ranch Prepack	63629-5466	ORAL	250 mg in 1 1	4/7/2025
Disulfiram	Alvogen Inc.	47781-607	ORAL	250 mg in 1 1	8/31/2012
Disulfiram	Sigmapharm Laboratories, LLC	42794-028	ORAL	250 mg in 1 1	1/11/2022
Disulfiram	Chartwell RX, LLC	62135-432	ORAL	500 mg in 1 1	10/5/2023
Antabuse	Physicians Total Care, Inc.	54868-5034	ORAL	250 mg in 1 1	4/18/2012
Disulfiram	Carilion Materials Management	68151-2694	ORAL	250 mg in 1 1	12/30/2013
Disulfiram	Sigmapharm Laboratories, LLC	42794-029	ORAL	500 mg in 1 1	1/11/2022
Disulfiram	Chartwell RX, LLC	62135-431	ORAL	250 mg in 1 1	10/5/2023
Disulfiram	Golden State Medical Supply, Inc.	60429-196	ORAL	250 mg in 1 1	12/19/2023

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.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ANTABUSE disulfiram 200mg tablet bottle	70468	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/19/1999

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ANTABUSE TAB 250MG	wyeth-ayerst canada inc.	02041375	Tablet - Oral	250 MG / TAB	12/31/1994
TRUE TEST	Smartpractice Denmark ApS	02271885	Patch - Topical	0.005 MG	3/16/2006
ANTABUSE TAB 0.25GM	ayerst laboratories	00002534	Tablet - Oral	250 MG / TAB	12/31/1966
ANTABUSE TAB 500MG	wyeth-ayerst canada inc.	02041391	Tablet - Oral	500 MG / TAB	12/31/1994

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TRUTEST 36 APOSITO ADHESIVO PARA PRUEBA DE PROVOCACION CON ALERGENOS	Smartpractice Denmark Aps	85395	APÓSITO ADHESIVO PARA PRUEBA DE PROVOCACIÓN CON ALERGENOS	Medicamento Sujeto A Prescripción Médica	Commercialized
EPITEST 24 APOSITO ADHESIVO PARA PRUEBA DE PROVOCACION CON ALERGENOS	Smartpractice Denmark Aps	81160	APÓSITO ADHESIVO PARA PRUEBA DE PROVOCACIÓN CON ALERGENOS	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ANTABUS 250 mg COMPRIMIDOS	Laboratorios Bohm S.A.	12723	COMPRIMIDO	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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