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Nalbuphine extended release - Trevi Therapeutics

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Drug Profile

Nalbuphine extended release - Trevi Therapeutics

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

Latest Information Update: 14 Aug 2026

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At a glance

  • Originator Penwest Pharmaceuticals
  • Developer Endo Pharmaceuticals; Trevi Therapeutics
  • Class Analgesics; Antifibrotics; 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 III Idiopathic pulmonary fibrosis
  • Phase II/III Pruritus
  • Phase II Cough
  • Suspended Prurigo nodularis
  • Discontinued Drug-induced dyskinesia; Pain

Most Recent Events

  • 07 Aug 2026 Trevi Therapeutics submitts a meeting request to the FDA to discuss the proposed development plan for non-IPF ILD-related chronic cough
  • 07 Aug 2026 Trevi Therapeutics plans a 12-week fixed dosing phase III OCEAN-2 trial for Cough in the third quarter of 2026
  • 30 Jun 2026 Trevi Therapeutics completes a phase I trial in Idiopathic pulmonary fibrosis in USA (PO) (NCT07036029)

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