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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: 17 Jan 2026

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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 Pruritus
  • Phase II Cough
  • Phase I Idiopathic pulmonary fibrosis
  • Suspended Prurigo nodularis
  • No development reported Drug-induced dyskinesia
  • Discontinued Pain

Most Recent Events

  • 08 Jan 2026 Trevi Therapeutics plans to schedule an End of phase II meeting with the US FDA for the NDA of Nalbuphine extended release for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis in the first quarter of 2026
  • 08 Jan 2026 Trevi Therapeutics plans to initiate phase IIb trial for Cough in the first half of 2026
  • 26 Sep 2025 Trevi Therapeutics completes a phase I pharmacokinetic trial (In volunteers) in USA (PO) (NCT07015398)

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