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 |
|---|---|---|---|---|---|
2025/01/27 | Early Phase 1 | Not yet recruiting | |||
2024/03/20 | Phase 1 | Not yet recruiting | |||
2022/12/28 | Not Applicable | Not yet recruiting | First People's Hospital of Hangzhou | ||
2022/11/25 | Phase 1 | Recruiting | |||
2022/01/27 | Phase 1 | Recruiting | |||
2021/12/17 | Early Phase 1 | UNKNOWN | |||
2020/10/20 | Phase 2 | Completed | ETICA | ||
2020/08/20 | Phase 1 | Terminated | |||
2020/08/06 | Phase 1 | Completed | |||
2020/07/24 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-5466 | ORAL | 250 mg in 1 1 | 4/7/2025 | |
| Alvogen Inc. | 47781-607 | ORAL | 250 mg in 1 1 | 8/31/2012 | |
| Sigmapharm Laboratories, LLC | 42794-028 | ORAL | 250 mg in 1 1 | 1/11/2022 | |
| Chartwell RX, LLC | 62135-432 | ORAL | 500 mg in 1 1 | 10/5/2023 | |
| Physicians Total Care, Inc. | 54868-5034 | ORAL | 250 mg in 1 1 | 4/18/2012 | |
| Carilion Materials Management | 68151-2694 | ORAL | 250 mg in 1 1 | 12/30/2013 | |
| Sigmapharm Laboratories, LLC | 42794-029 | ORAL | 500 mg in 1 1 | 1/11/2022 | |
| Chartwell RX, LLC | 62135-431 | ORAL | 250 mg in 1 1 | 10/5/2023 | |
| 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 | Medicine | A | 8/19/1999 |
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