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An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

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Trial Profile

An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2023

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At a glance

  • Drugs Burosumab (Primary)
  • Indications Osteomalacia; X-linked dominant hypophosphataemic rickets
  • Focus Registrational; Therapeutic Use
  • Sponsors Kyowa Kirin

Most Recent Events

  • 01 Sep 2022 Results assessing the effect of burosumab on bone material properties, published in the Journal of Bone and Mineral Research.
  • 19 Aug 2022 According to a Kyowa Kirin media release, the European Commission (EC) approved CRYSVITA (burosumab) for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.
  • 24 Jun 2022 According to a Kyowa Kirin media release, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that CRYSVITA (burosumab) be approved for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.

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