Wednesday, July 8, 2026

Drug profile · INN

naloxone hydrochloride

naloxone hydrochloride (NALOXONE HYDROCHLORIDE) is a opioid receptors; mu/kappa/delta antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: intramuscular, subcutaneous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 3
Pipeline programs 26
News articles 2
Drug details — naloxone hydrochloride

Quick answer

naloxone hydrochloride (NALOXONE HYDROCHLORIDE) is a opioid receptors; mu/kappa/delta antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: intramuscular, subcutaneous. Current US regulatory status: approved.

Key facts

INN naloxone hydrochloride
Brand NALOXONE HYDROCHLORIDE
Mechanism Opioid receptors; mu/kappa/delta antagonist
Target Opioid receptors; mu/kappa/delta
Route INTRAMUSCULAR, SUBCUTANEOUS
Formulation TABLET, EXTENDED RELEASE

Mechanism of action

Opioid receptors; mu/kappa/delta antagonist

Primary target: Opioid receptors; mu/kappa/delta

Approval history

Authority Status Date
FDA approved

Recent coverage

Pipeline programs

  1. Buprenorphine/Naloxone Phase 3 · BRIGHT MINDS BIOSCIENCES · HIV Infections
  2. Buprenorphine/naloxone Phase 3 · BRIGHT MINDS BIOSCIENCES · Heroin Dependence
  3. Buprenorphine/naloxone Phase 3 · BRIGHT MINDS BIOSCIENCES · Opioid-Related Disorders
  4. Buprenorphine Naloxone Phase 2 · BRIGHT MINDS BIOSCIENCES · Maternal Opioid Use Disorder
  5. Buprenorphine/naloxone Film Strip Phase 2 · Indivior Pty · Opioid-Related Disorders
  6. Target-controlled naloxone-infusion Phase 2 · BRIGHT MINDS BIOSCIENCES · Central Nervous System Sensitization
  7. Buprenorphine/Naloxone + BEM/RZR Phase 1 · Atea Pharmaceuticals · Healthy Volunteer Study
  8. Four naloxone nasal spray doses (1 every 2.5 min) Phase 1 · BRIGHT MINDS BIOSCIENCES · Healthy Subjects

Related & competitor drugs

  1. codeine phosphate Opioid receptors; mu/kappa/delta agonist
  2. hydrocodone bitartrate Opioid receptors; mu/kappa/delta agonist
  3. naltrexone Alimentary tract and metabolism (A08)
  4. naltrexone hydrochloride Opioid receptors; mu/kappa/delta antagonist
  5. oxymorphone hydrochloride Opioid receptors; mu/kappa/delta agonist
  6. codeine sulfate Opioid receptors; mu/kappa/delta agonist
  1. US 11135216

    Sublingual and buccal film compositions

    Expires Mon Sep 30 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 9687454

    Sublingual and buccal film compositions

    Expires Mon Jun 22 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 6193949

    Method of sire selection using naloxone challenge tests and kits thereof

    Expires Mon Feb 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is naloxone hydrochloride?

naloxone hydrochloride (NALOXONE HYDROCHLORIDE) is a opioid receptors; mu/kappa/delta antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: intramuscular, subcutaneous. Current US regulatory status: approved.

What is the brand name for naloxone hydrochloride?

NALOXONE HYDROCHLORIDE is a marketed brand name for naloxone hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of naloxone hydrochloride?

naloxone hydrochloride 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.