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.
Background
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 |
---|---|---|---|---|---|
2025/06/25 | Phase 1 | Recruiting | |||
2025/06/11 | Phase 1 | Not yet recruiting | |||
2025/05/30 | Phase 2 | Not yet recruiting | Dr. Asma Abdus Salam | ||
2024/12/16 | Phase 4 | Not yet recruiting | |||
2024/12/09 | Phase 4 | Not yet recruiting | |||
2024/12/06 | Phase 4 | Not yet recruiting | |||
2024/10/09 | Phase 2 | Recruiting | |||
2024/09/13 | Not Applicable | Completed | Muhammad Aamir Latif | ||
2024/07/08 | Phase 4 | Not yet recruiting | Kasr El Aini Hospital | ||
2024/06/26 | Not Applicable | Completed | Atif Shafqat |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Hospira, Inc. | 0409-1463 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 10 mg in 1 mL | 12/1/2022 | |
Hospira, Inc. | 0409-1465 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 20 mg in 1 mL | 12/1/2022 | |
Somerset Therapeutics, LLC | 70069-671 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 10 mg in 1 mL | 3/26/2025 | |
Hospira, Inc. | 0409-1467 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 20 mg in 1 mL | 12/1/2022 | |
Medical Purchasing Solutions, LLC | 71872-7114 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 10 mg in 1 mL | 5/23/2023 | |
Henry Schein, Inc. | 0404-9917 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 20 mg in 1 mL | 11/10/2023 | |
Hospira, Inc. | 0409-1463 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 10 mg in 1 mL | 12/1/2022 | |
Hospira, Inc. | 0409-1464 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 10 mg in 1 mL | 12/1/2022 | |
Somerset Therapeutics, LLC | 70069-672 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 20 mg in 1 mL | 3/26/2025 | |
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 |
---|---|---|---|---|---|
Nalbuphine Hydrochloride Injection | 国药准字H20213884 | 化学药品 | 注射剂 | 11/24/2021 | |
Nalbuphine Hydrochloride Injection | 国药准字H20130127 | 化学药品 | 注射剂 | 8/11/2023 | |
Nalbuphine Hydrochloride Injection | 国药准字H20227102 | 化学药品 | 注射剂 | 8/11/2023 | |
Nalbuphine Hydrochloride Injection | 国药准字H20213459 | 化学药品 | 注射剂 | 6/8/2021 | |
Nalbuphine Hydrochloride Injection | 国药准字H20243242 | 化学药品 | 注射剂 | 2/23/2024 | |
Nalbuphine Hydrochloride Injection | 国药准字H20243241 | 化学药品 | 注射剂 | 2/23/2024 | |
Nalbuphine Hydrochloride Injection | 国药准字H20223205 | 化学药品 | 注射剂 | 4/8/2022 | |
Nalbuphine Hydrochloride Injection | 国药准字H20237124 | 化学药品 | 注射剂 | 10/23/2023 |
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. |