Wednesday, July 8, 2026

Drug profile · INN

nalbuphine hydrochloride

nalbuphine hydrochloride (NALBUPHINE HYDROCHLORIDE) is a opioid receptors; mu/kappa/delta agonist. Route of administration: intramuscular, intravenous, subcutaneous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 6
Pipeline programs 8
News articles 0
Drug details — nalbuphine hydrochloride
US status
approved
Class
Route
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Patents
6
Programs
8
Data quality
0.84

Quick answer

nalbuphine hydrochloride (NALBUPHINE HYDROCHLORIDE) is a opioid receptors; mu/kappa/delta agonist. Route of administration: intramuscular, intravenous, subcutaneous. Current US regulatory status: approved.

Key facts

INN nalbuphine hydrochloride
Brand NALBUPHINE HYDROCHLORIDE
Mechanism Opioid receptors; mu/kappa/delta agonist
Target Opioid receptors; mu/kappa/delta
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Formulation INJECTABLE

Mechanism of action

Opioid receptors; mu/kappa/delta agonist

Primary target: Opioid receptors; mu/kappa/delta

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Nalbuphine ER Tablets Phase 3 · Trevi Therapeutics · Prurigo Nodularis
  2. nalbuphine HCl ER Phase 3 · Trevi Therapeutics · Uremic Pruritus
  3. nalbuphine HCl ER Phase 3 · Trevi Therapeutics · Prurigo Nodularis
  4. nalbuphine HCl ER tablets 60 mg BID Phase 3 · Trevi Therapeutics · Uremic Pruritus
  5. nalbuphine HCl ER tablets 90 mg BID Phase 3 · Trevi Therapeutics · Prurigo Nodularis
  6. NAL03-202 Phase 2 · Trevi Therapeutics · Idiopathic Pulmonary Fibrosis (IPF)
  7. Nalbuphine ER Phase 1 · Trevi Therapeutics · Hepatic Impairment
  8. Nalbuphine HCl solution Phase 1 · Trevi Therapeutics · Nalbuphine

Related & competitor drugs

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

Related patents

  1. US 12274696

    Methods of administering nalbuphine

    Expires Mon Apr 10 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10238646

    Methods for treating pruritus

    Expires Mon Mar 21 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 9624233

    Compounds for treating pruritic conditions

    Expires Mon Apr 13 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 8987289

    Methods for treating pruritus

    Expires Mon Mar 19 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 8940753

    Methods for treating pruritis

    Expires Mon Jan 22 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 6525062

    Method of treating pain using nalbuphine and opioid antagonists

    Expires Mon Feb 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is nalbuphine hydrochloride?

nalbuphine hydrochloride (NALBUPHINE HYDROCHLORIDE) is a opioid receptors; mu/kappa/delta agonist. Route of administration: intramuscular, intravenous, subcutaneous. Current US regulatory status: approved.

What is the brand name for nalbuphine hydrochloride?

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

What is the US approval status of nalbuphine hydrochloride?

nalbuphine 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.