Wednesday, July 8, 2026

Drug profile · INN

naltrexone

naltrexone (ARX-NALTREXONE) is a opioid receptors; mu/kappa/delta antagonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: intramuscular. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Alimentary tract and metabolism (A08) A08AA
US status approved
Patents linked 1
Pipeline programs 38
News articles 0
Drug details — naltrexone
US status
approved
Class
Alimentary tract and metabolism (A08)
Route
INTRAMUSCULAR
Patents
1
Programs
38
Data quality
0.89

Quick answer

naltrexone (ARX-NALTREXONE) is a opioid receptors; mu/kappa/delta antagonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: intramuscular. Current US regulatory status: approved.

Key facts

INN naltrexone
Brand ARX-NALTREXONE
Mechanism Opioid receptors; mu/kappa/delta antagonist
Target Opioid receptors; mu/kappa/delta
Therapeutic class Alimentary tract and metabolism (A08)
Route INTRAMUSCULAR
Formulation FOR SUSPENSION, EXTENDED RELEASE
ATC code A08AA

Mechanism of action

Opioid receptors; mu/kappa/delta antagonist

Primary target: Opioid receptors; mu/kappa/delta

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. 811095 Phase 3 · BRIGHT MINDS BIOSCIENCES · Amphetamine Dependence
  2. Buprenorphine + Naltrexone Phase 3 · BRIGHT MINDS BIOSCIENCES · Cocaine Dependence
  3. Depot naltrexone Phase 3 · BRIGHT MINDS BIOSCIENCES · Opiate Addiction
  4. Extended Release Naltrexone Phase 3 · BRIGHT MINDS BIOSCIENCES · Opioid Use Disorder
  5. Naltrexone Phase 3 · BRIGHT MINDS BIOSCIENCES · Alcoholism
  6. Oxycodone Naltrexone (a) Phase 3 · ELITE PHARMACEUTICALS INC · Pain
  7. Oxycodone/Naltrexone Capsules Phase 3 · ELITE PHARMACEUTICALS INC · Withdrawal Symptoms
  8. Vivitrol Phase 3 · BRIGHT MINDS BIOSCIENCES · Opioid-use Disorder

Related & competitor drugs

  1. agalsidase alfa Alimentary tract and metabolism (A16)
  2. alogliptin Alimentary tract and metabolism (A10)
  3. alogliptin benzoate Alimentary tract and metabolism (A10)
  4. aprepitant Alimentary tract and metabolism (A04)
  5. budesonide Alimentary tract and metabolism (A07)
  6. canagliflozin Alimentary tract and metabolism (A10)
  1. WO 2023156493

    FORMES CRISTALLINES DE NALTREXONE

    Expires Wed Aug 19 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is naltrexone?

naltrexone (ARX-NALTREXONE) is a opioid receptors; mu/kappa/delta antagonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: intramuscular. Current US regulatory status: approved.

What is the brand name for naltrexone?

ARX-NALTREXONE is a marketed brand name for naltrexone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of naltrexone?

naltrexone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.