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Nalbuphine ER
Nalbuphine ER is a Small molecule drug developed by Trevi Therapeutics. It is currently FDA-approved. Also known as: NAL ER, Nalbuphine, Nalbuphine HCl Injection, nalbuphine.
Nalbuphine ER, marketed by Trevi Therapeutics, is an extended-release formulation of nalbuphine with a key composition patent expiring in 2028. The drug's primary strength lies in its unique mechanism of action, which differentiates it from other analgesics in the market. The primary risk is the potential for increased competition as the patent expiration approaches in 2028.
At a glance
| Generic name | Nalbuphine ER |
|---|---|
| Also known as | NAL ER, Nalbuphine, Nalbuphine HCl Injection, nalbuphine, Group N |
| Sponsor | Trevi Therapeutics |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants (PHASE1)
- Study of Nalbuphine ER in Participants With Hepatic Impairment (PHASE1)
- NAL ER IPF Respiratory Function and Safety Study (PHASE1)
- A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants (PHASE1)
- Cough Reduction in IPF With Nalbuphine ER (PHASE2)
- PRISM Study-Pruritus Relief Through Itch Scratch Modulation (PHASE2, PHASE3)
- A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough (PHASE2)
- Phase 1 Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nalbuphine ER CI brief — competitive landscape report
- Nalbuphine ER updates RSS · CI watch RSS
- Trevi Therapeutics portfolio CI
Frequently asked questions about Nalbuphine ER
What is Nalbuphine ER?
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Related
- Manufacturer: Trevi Therapeutics — full pipeline
- Also known as: NAL ER, Nalbuphine, Nalbuphine HCl Injection, nalbuphine, Group N
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing