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Berotralstat - BioCryst Pharmaceuticals

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Drug Profile

Berotralstat - BioCryst Pharmaceuticals

Alternative Names: PrORLADEYO; BCX-7353; Berotralstatum; ORLADEYO

Latest Information Update: 12 Aug 2025

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At a glance

  • Originator BioCryst Pharmaceuticals
  • Developer BioCryst Pharmaceuticals; Pint Pharma
  • Class Amides; Fluorinated hydrocarbons; Pyrazoles; Skin disorder therapies; Small molecules; Vascular disorder therapies
  • Mechanism of Action Kallikrein inhibitors
  • Orphan Drug Status

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

    Yes - Hereditary angioedema
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hereditary angioedema

Most Recent Events

  • 04 Aug 2025 PDUFA action date extended by US FDA to 12/12/2025 for NDA for Hereditary angioedema
  • 16 Jun 2025 Efficacy data from a phase III APeX-P trial in Hereditary angioedema released by BioCryst Pharmaceuticals
  • 13 Jun 2025 Registered for Hereditary angioedema (Prevention, In adolescents, In adults) in Colombia (PO)

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