KRN 23

Drug Profile

KRN 23

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

Latest Information Update: 25 Mar 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 16 Feb 2017 Ultragenyx announces intention to submit BLA to the USFDA in the second quarter of 2017
  • 05 Jan 2017 European Medicines Agency accepts MAA for X-linked dominant hypophosphataemic rickets (In adults, In children, In infants) for review
  • 31 Dec 2016 Preregistration for X-linked dominant hypophosphataemic rickets (In children, In adults, In infants) in European Union prior to December 2016 (SC)
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at so we can help.

Back to top