Product Description
Nalbuphine is FDA indicated for moderate to severe pain in which an opioid agent is required when other alternative treatments have been insufficient. Non-FDA approved uses of nalbuphine do exist, such as treatment of labor pain, opioid-induced urinary retention, opioid-induced respiratory depression, and pruritus associated with neuraxial opioid use.
Mechanisms of Action: OPRM Antagonist,OPRK Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous,Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Austria | Bangladesh | Brazil | Canada | Chile | Colombia | Czech | Denmark | Dominican Republic | Egypt | France | Germany | Greece | Hong Kong | Hungary | India | Ireland | Korea | Lebanon | Malaysia | Mexico | Netherlands | New Zealand | Pakistan | Peru | Philippines | Poland | Portugal | Russia | Singapore | Slovenia | South Africa | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Ukraine | United Kingdom | United States | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Trevi
Company Location: NEW HAVEN CT 06510
Company CEO: Jennifer L. Good
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Canada, Chile, France, Germany, Italy, Netherlands, Poland, Spain, Turkey, United Kingdom, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Prurigo|Pruritus
Phase 2: Idiopathic Pulmonary Fibrosis|Refractory Chronic Cough|Unexplained Chronic Cough
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NAL03-202 | P2 |
Unknown Status |
Idiopathic Pulmonary Fibrosis |
2025-06-30 |
|
| CORAL | P2 |
Recruiting |
Idiopathic Pulmonary Fibrosis |
2025-04-01 |
|
| RIVER | P2 |
Active, not recruiting |
Unexplained Chronic Cough|Refractory Chronic Cough |
2025-01-01 |
|
| 2018-001219-53 | P3 |
Active, not recruiting |
Prurigo |
2023-09-06 |