Nalbuphine extended release - Trevi Therapeutics
Alternative Names: Haduvio; Nalbuphine ER; Nalbuphine extended-release; PW-4142; T 111Latest Information Update: 01 Jul 2025
At a glance
- Originator Penwest Pharmaceuticals
- Developer Endo Pharmaceuticals; MentiNova; Rutgers; Trevi Therapeutics
- Class Analgesics; Antipruritics; Antitussives; Morphinans; Opioid analgesics; Skin disorder therapies; Small molecules
- Mechanism of Action Opioid kappa receptor agonists; Opioid mu receptor antagonists
-
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes
Highest Development Phases
- Phase II/III Prurigo nodularis; Pruritus
- Phase II Cough
- Phase I Idiopathic pulmonary fibrosis
- No development reported Drug-induced dyskinesia
- Discontinued Pain
Most Recent Events
- 16 Jun 2025 Phase-I clinical trials in Idiopathic pulmonary fibrosis in United Kingdom (PO) (NCT07036029)
- 11 Jun 2025 Trevi Therapeutics plans a phase I Pharmacokinetic trial (In volunteers) (PO) in June 2025 (NCT07015398 )
- 02 Jun 2025 Trevi Therapeutics plans to request an End-of-phase II meeting with the US FDA later this year