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Nalbuphine extended release - Trevi Therapeutics

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Drug Profile

Nalbuphine extended release - Trevi Therapeutics

Alternative Names: Haduvio; Nalbuphine ER; Nalbuphine extended-release; PW-4142; T 111

Latest Information Update: 01 Jul 2025

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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.

    No
  • 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

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