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A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome and a Post-marketing Study of KRN23 Switched From the Phase 2 Trial

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Trial Profile

A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome and a Post-marketing Study of KRN23 Switched From the Phase 2 Trial

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 22 Dec 2022

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At a glance

  • Drugs Burosumab (Primary)
  • Indications Nevus; Osteomalacia
  • Focus Therapeutic Use
  • Sponsors Kyowa Kirin

    • Most Recent Events

    • 31 Aug 2022 According to ClinicalTrials .gov record, protocol has been amended as change in timeframe of primary endpoint from 44weeks to 224 weeks.
    • 18 Jun 2020 Results presented in a Food and Drug Administration Media Release.
    • 18 Jun 2020 According to a Ultragenyx Pharmaceutical media release, based on the data of UX023T-CL201 and KRN23-002 studies, the U.S. Food and Drug Administration (FDA) has approved Crysvita (burosumab) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older.
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