Overview
Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of naloxone. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.
Indication
Used as an adjunct to a medically supervised behaviour modification program in the maintenance of opiate cessation in individuals who were formerly physically dependent on opiates and who have successfully undergone detoxification. Also used for the management of alcohol dependence in conjunction with a behavioural modification program.
Associated Conditions
- Alcohol Dependency
- Cholestatic pruritus
- Obesity
- Opioid Dependence
- Severe Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/25 | Phase 2 | Not yet recruiting | Central Institute of Mental Health, Mannheim | ||
2025/02/25 | Phase 4 | Recruiting | Carmen Dietvorst | ||
2025/02/05 | Phase 4 | Recruiting | The Royal's Institute of Mental Health Research | ||
2024/10/09 | Phase 2 | Recruiting | |||
2024/10/02 | Phase 2 | Not yet recruiting | |||
2024/05/23 | Phase 4 | Recruiting | Milky Kohno | ||
2024/04/18 | Phase 1 | Recruiting | |||
2024/04/16 | Phase 2 | Recruiting | |||
2024/03/12 | Phase 4 | ENROLLING_BY_INVITATION | Hospital for Special Surgery, New York | ||
2024/02/07 | Phase 2 | Completed | Allodynic Therapeutics, Inc |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Advanced Pharmaceutical Technology, Inc. | 57377-010 | SUBCUTANEOUS | 1000 mg in 1 1 | 10/4/2022 | |
| Bryant Ranch Prepack | 63629-1046 | ORAL | 50 mg in 1 1 | 6/18/2019 | |
| Precision Dose Inc. | 68094-853 | ORAL | 50 mg in 1 1 | 9/16/2022 | |
| REMEDYREPACK INC. | 70518-1146 | ORAL | 50 mg in 1 1 | 2/14/2024 | |
| Major Pharmaceuticals | 0904-7036 | ORAL | 50 mg in 1 1 | 5/27/2020 | |
| Bryant Ranch Prepack | 72162-1566 | ORAL | 50 mg in 1 1 | 12/5/2023 | |
| A-S Medication Solutions | 50090-3076 | ORAL | 50 mg in 1 1 | 6/18/2019 | |
| Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc | 23155-886 | ORAL | 50 mg in 1 1 | 10/3/2023 | |
| SpecGx LLC | 0406-1170 | ORAL | 50 mg in 1 1 | 9/6/2022 | |
| A-S Medication Solutions | 50090-6820 | ORAL | 50 mg in 1 1 | 9/6/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/26/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CONTRAVE PROLONGED RELEASE TABLET 8MG/90MG | SIN16411P | TABLET, FILM COATED, EXTENDED RELEASE | 8.00mg | 1/3/2022 | |
| NARPAN TABLET 50 mg | SIN10002P | TABLET | 50 mg | 9/15/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Naltrexone Hydrochloride Implants | 国药准字H20240031 | 化学药品 | 植入剂 | 6/25/2024 | |
| Naltrexone Hydrochloride Tablets | 国药准字H20020666 | 化学药品 | 片剂 | 12/24/2020 | |
| Naltrexone Hydrochloride Tablets | 国药准字H20000296 | 化学药品 | 片剂 | 8/27/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CONTRAVE PROLONGED-RELEASE TABLETS 8MG/90MG | N/A | N/A | N/A | 12/10/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| REVIATREXONE naltrexone hydrochloride 50 mg tablet blister pack | 386566 | Medicine | A | 4/11/2023 | |
| O'Neil Long Acting Naltrexone Implant | 167474 | Medicine | A | 12/11/2009 | |
| ARX-NALTREXONE naltrexone hydrochloride 50 mg tablet blister pack | 386568 | Medicine | A | 4/11/2023 | |
| NALTREXONE INTAS naltrexone hydrochloride 50 mg tablet blister pack | 386565 | Medicine | A | 4/11/2023 | |
| CONTRAVE 8/90 naltrexone hydrochloride 8 mg and bupropion hydrochloride 90 mg modified-release tablet blister pack | 288372 | Medicine | A | 8/24/2018 | |
| NALTREXONE GH naltrexone hydrochloride 50mg film coated tablets blister pack | 128710 | Medicine | A | 8/31/2007 | |
| NALTREXONE ASTRON naltrexone hydrochloride 50 mg tablet blister pack | 386567 | Medicine | A | 4/11/2023 | |
| NALTREXONE-APOTEX naltrexone hydrochloride 50 mg film coated tablets bottle | 271012 | Medicine | A | 1/24/2017 |
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