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Glycerol phenylbutyrate - Horizon Therapeutics

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Drug Profile

Glycerol phenylbutyrate - Horizon Therapeutics

Alternative Names: GT4P; HPN-100; Ravicti

Latest Information Update: 07 Jan 2025

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At a glance

  • Originator Ucyclyd Pharma
  • Developer Horizon Pharma; Horizon Therapeutics plc; Immedica; National Jewish Health; Winhealth Pharma
  • Class Hepatoprotectants; Phenylbutyrates; Small molecules
  • Mechanism of Action Ammonia scavengers
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Inborn urea cycle disorders; Hepatic encephalopathy; Epilepsy; Spinal muscular atrophy
  • New Molecular Entity No

Highest Development Phases

  • Marketed Inborn urea cycle disorders
  • Phase I/II Cystic fibrosis
  • Discontinued Hepatic encephalopathy

Most Recent Events

  • 27 Dec 2024 Preregistration for Inborn urea cycle disorders in Japan (PO)
  • 25 Dec 2024 Glycerol phenylbutyrate receives Orphan Drug status for Inborn urea cycle disorders in Japan
  • 21 Mar 2024 Registered for Inborn urea cycle disorders (Adjunctive treatment) in Taiwan (PO)

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