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Sodium oxybate controlled release - Tris pharma

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Drug Profile

Sodium oxybate controlled release - Tris pharma

Alternative Names: TRN-257

Latest Information Update: 12 Dec 2025

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At a glance

  • Originator Tris Pharma
  • Class Butyric acids; Hydroxybutyrates; Sleep disorder therapies; Small molecules
  • Mechanism of Action GABA B receptor agonists
  • 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

Highest Development Phases

  • Preregistration Idiopathic hypersomnia; Narcolepsy

Most Recent Events

  • 09 Dec 2025 Preregistration for Idiopathic hypersomnia (In adults) in USA (PO) before December 2025
  • 09 Dec 2025 Preregistration for Narcolepsy (In adults) in USA (PO) before December
  • 09 Dec 2025 US FDA accepts NDA for TRN 257 for Narcolepsy and Idiopathic hypersomnia for review in USA (PO)

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