Drug Profile


Alternative Names: Anti-FGF 23 monoclonal antibody; Anti-fibroblast growth factor 23 monoclonal antibody; KRN-23; UX 023

Latest Information Update: 30 Jun 2017

Price : $50

At a glance

  • Originator Kyowa Hakko Kirin
  • Developer Kyowa Hakko Kirin; Ultragenyx Pharmaceutical
  • Class Monoclonal antibodies
  • 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
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 23 Jun 2017 The US FDA agrees to accept available clinical data for BLA submission for paediatric and adult X-linked hypophosphataemia
  • 22 Jun 2017 Kyowa Hakko Kirin Pharma plans a phase III trial for X-linked dominant hypophosphataemic rickets and Osteomalacia (In infants, In children) in Japan (JapicCTI-173614)
  • 04 May 2017 Efficacy data from a phase III trial in X-linked dominant hypophosphataemic rickets released by Ultragenyx Pharmaceutical
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