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Burosumab - Kyowa Hakko Kirin Pharma/Ultragenyx Pharmaceutical

Drug Profile

Burosumab - Kyowa Hakko Kirin Pharma/Ultragenyx Pharmaceutical

Alternative Names: Anti-FGF23 monoclonal antibody; Anti-fibroblast growth factor 23 monoclonal antibody; burosumab-twza; Crysvita; KRN 23; UX 023

Latest Information Update: 26 May 2025

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At a glance

  • Originator Kyowa Hakko Kirin
  • Developer Kyowa Hakko Kirin; Kyowa Kirin; Ultragenyx Pharmaceutical
  • Class Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Fibroblast growth factor 23 inhibitors
  • Orphan Drug Status

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

    Yes - X-linked dominant hypophosphataemic rickets; Osteomalacia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Osteomalacia; X-linked dominant hypophosphataemic rickets
  • Phase II Nevus

Most Recent Events

  • 27 Sep 2024 Adverse events and efficacy data from a phase III trial in X-linked dominant hypophosphataemic rickets presented at the Annual Meeting of the American Society for Bone and Mineral Research 2024 (ASBMR-2024)
  • 16 Sep 2024 9425186- Observational trial, hence not covered
  • 07 Aug 2024 Kyowa Kirin enters into a distribution agreement with NewBridge Pharmaceuticals to commercialise burosumab in Middle East and North Africa

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