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Naltrexone

Generic Name
Naltrexone
Brand Names
Contrave, Embeda, Vivitrol, Mysimba
Drug Type
Small Molecule
Chemical Formula
C20H23NO4
CAS Number
16590-41-3
Unique Ingredient Identifier
5S6W795CQM

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

Research Report

Published: Jul 18, 2025

A Comprehensive Monograph on Naltrexone: Pharmacology, Clinical Efficacy, and Therapeutic Applications

Drug Identification and Physicochemical Profile

Naltrexone is a small molecule drug that has become a cornerstone in the management of substance use disorders. Its unambiguous identification and characterization are fundamental to its application in clinical practice, pharmaceutical manufacturing, and research. This section details its nomenclature, molecular properties, and key physicochemical characteristics.

Nomenclature and Chemical Identifiers

Naltrexone is known by several names across chemical, pharmaceutical, and regulatory domains. Its primary non-proprietary name is Naltrexone.[1] The systematic name, according to the International Union of Pure and Applied Chemistry (IUPAC), is (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7aH)-one.[3] An alternative systematic name frequently cited is 17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one.[1]

Throughout its development and marketing, Naltrexone has accumulated numerous synonyms and brand names. Chemical synonyms include N-Cyclopropylmethylnoroxymorphone and N-Cyclopropylmethyl-14-hydroxydihydromorphinone.[1] Its developmental code was EN 1639A.[2] It is marketed globally under brand names such as Revia, Depade, Trexan, Vivitrol, Contrave (in combination with bupropion), Mysimba, Celupan, Nalorex, and Nemexin.[1] International non-proprietary names include Naltrexona (Spanish), Naltrexon (German), and Naltrexonum (Latin).[1]

For precise identification in scientific databases and regulatory filings, the following identifiers are used:

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/30
Not Applicable
Recruiting
AgelessRx
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

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
Bryant Ranch Prepack
71335-2743
ORAL
50 mg in 1 1
7/29/2025
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

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
No NMPA approvals found for this drug.

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CONTRAVE
bausch health, canada inc.
02472945
Tablet (Extended-Release) - Oral
8 MG
3/16/2018
REVIA - TAB 50MG
dupont merck pharma inc.
02158655
Tablet - Oral
50 MG / TAB
12/31/1995
REVIA
teva canada limited
02213826
Tablet - Oral
50 MG
10/23/1997
RPC-NALTREXONE
rusan pharma canada inc.
02558343
Tablet - Oral
50 MG
N/A
APO-NALTREXONE
02444275
Tablet - Oral
50 MG
11/10/2015
NALTREXONE HYDROCHLORIDE TABLETS USP
sterinova inc.
02451883
Tablet - Oral
50 MG
5/30/2017

CIMA AEMPS Drug Approvals

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

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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