Nalbuphine

Overview

A narcotic used as a pain medication. It appears to be an agonist at kappa opioid receptors and an antagonist or partial agonist at mu opioid receptors. Nalbuphine is the only opioid analgesic that is not a controlled substance in the United States.

Indication

For the relief of moderate to severe pain.

Associated Conditions

Severe Pain
Moderate Pain
Obstetrical analgesia therapy

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Nalbuphine Versus Tramadol on Post Operative Analgesia in Abdominal Surgery on Pediatric Cancer Patient	2025/08/07	NCT07110051	Not Applicable	Recruiting	National Cancer Institute, Egypt
Erector Spinae Plane Block for Analgesia During ESWL	2025/07/16	NCT07067996	Not Applicable	Recruiting	Sohag University
NAL ER IPF Respiratory Function and Safety Study	2025/06/25	NCT07036029	Phase 1	Recruiting	Trevi Therapeutics
A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants	2025/06/11	NCT07015398	Phase 1	Recruiting	Trevi Therapeutics
Exploring the Impact of Genetic Variations on The Clinical Efficacy of Nalbuphine in Postoperative Pain Management	2025/05/30	NCT06996561	Phase 2	Not yet recruiting	Dr. Asma Abdus Salam
Comparative Study of Opioid-Free Anesthesia Versus Opioid Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy	2024/12/16	NCT06736496	Phase 4	Not yet recruiting	Assiut University
Comparison of the Efficacy of Intraperitoneal Instillation of Fentanyl Versus Nalbuphine As Adjuvants to Bupivacaine for Postoperative Pain Relief in Patients Undergoing Laparoscopic Cholecystectomy	2024/12/09	NCT06722963	Phase 4	Not yet recruiting	Assiut University
Comparsion Between Intrathecal Fentanyl and Intravenous Nalbuphine As a Postoperative Analgesia in Lower Limb Surgeries	2024/12/06	NCT06720506	Phase 4	Not yet recruiting	Assiut University
The Analgesic Efficacy of Perineural Nalbuphine as an Adjuvant to Bupivacaine in Ultrasound Guided Superficial Cervical Plexus Nerve Block for Thyroid Surgeries. A Double Blinded Randomized Controlled Trial.	2024/10/09	NCT06633068	Phase 2	Recruiting	Cairo University
Comparison of IV Nalbuphine Versus Ibuprofen for Postoperative Pain Control in Cesarean Section	2024/09/13	NCT06594224	Not Applicable	Completed	Muhammad Aamir Latif

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nalbuphine Hydrochloride	Hospira, Inc.	0409-1463	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	10 mg in 1 mL	12/1/2022
Nalbuphine Hydrochloride	Hospira, Inc.	0409-1465	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	20 mg in 1 mL	12/1/2022
Nalbuphine hydrochloride	Somerset Therapeutics, LLC	70069-671	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	10 mg in 1 mL	3/26/2025
Nalbuphine Hydrochloride	Hospira, Inc.	0409-1467	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	20 mg in 1 mL	12/1/2022
Nalbuphine Hydrochloride	Medical Purchasing Solutions, LLC	71872-7114	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	10 mg in 1 mL	5/23/2023
Nalbuphine Hydrochloride	Henry Schein, Inc.	0404-9917	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	20 mg in 1 mL	11/10/2023
Nalbuphine Hydrochloride	Hospira, Inc.	0409-1463	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	10 mg in 1 mL	12/1/2022
Nalbuphine Hydrochloride	Hospira, Inc.	0409-1464	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	10 mg in 1 mL	12/1/2022
Nalbuphine hydrochloride	Somerset Therapeutics, LLC	70069-672	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	20 mg in 1 mL	3/26/2025
NALBUPHINE HCI	HF Acquisition Co LLC, DBA HealthFirst	51662-1418	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	20 mg in 1 mL	2/22/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NUBAIN INJECTION 20MG/ML	Sandoz Canada, Inc.	01913972	Solution - Intramuscular , Subcutaneous , Intravenous	20 MG / ML	12/31/1993
NUBAIN INJECTION 10MG/ML	Sandoz Canada, Inc.	01913980	Solution - Subcutaneous , Intramuscular , Intravenous	10 MG / ML	12/31/1993

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.

Related News

Stifel Raises Price Target on Trevi Therapeutics as Haduvio Shows Promise for Chronic Cough Treatment

7 months ago

Stifel investment bank has increased its price target for Trevi Therapeutics (TRVI) from $8 to $12, maintaining a Buy rating as the company approaches key trial data readout.

Trevi Therapeutics' Haduvio Shows Promise for IPF-Related Cough Treatment, Receives Buy Rating

8 months ago

Leerink Partners analyst maintains a Buy rating for Trevi Therapeutics with a $7.00 price target, citing Haduvio's potential in treating idiopathic pulmonary fibrosis (IPF) cough.

Trevi Therapeutics' Haduvio Phase 2b Trial for IPF-Related Chronic Cough Nears Completion

9 months ago

Trevi Therapeutics' Phase 2b CORAL trial evaluating Haduvio for chronic cough in IPF patients has reached 75% enrollment, indicating strong progress.

Trevi Therapeutics' Oral Nalbuphine Demonstrates Reduced Abuse Potential in Clinical Study

10 months ago

• Trevi Therapeutics' oral nalbuphine showed statistically significant lower "Drug Liking" compared to IV butorphanol in a human abuse potential (HAP) study. • The study assessed three doses of oral nalbuphine (81mg, 162mg, 486mg) against IV butorphanol and placebo in recreational drug users. • Secondary endpoints were consistent with the primary endpoint, with no serious adverse events reported during the study. • These results support nalbuphine's potential as a non-scheduled option for chronic cough without the abuse risks of traditional opioids.

Trevi Therapeutics Announces Clinical Trial Progress for Haduvio in Chronic Cough

a year ago

Trevi Therapeutics' Phase 2b CORAL trial for chronic cough in IPF reaches 50% enrollment; sample size re-estimation results are expected in December 2024.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access