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Phase 3 trial of TransCon PTH in adults with hypoparathyroidism

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Trial Profile

Phase 3 trial of TransCon PTH in adults with hypoparathyroidism

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Aug 2024

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At a glance

  • Drugs Palopegteriparatide (Primary)
  • Indications Hypoparathyroidism
  • Focus Therapeutic Use
  • Acronyms PaTHway Japan
  • Sponsors Ascendis Pharma

    • Most Recent Events

    • 13 Aug 2024 According to a Ascendis Pharma media release, the company announced that the U.S. Food & Drug Administration (FDA) has approved YORVIPATH for the treatment of hypoparathyroidism in adults. The FDA based its approval of YORVIPATH on their review of the clinical package for TransCon PTH (palopegteriparatide) submitted with the Company's New Drug Application, including data from the global Phase 2 PaTH Forward and Phase 3 PaTHway trials.
    • 07 Jan 2024 Status changed from active, no longer recruiting to completed.as per Ascendis Pharma media release.
    • 05 Sep 2023 According to an Ascendis Pharma media release, 145 out of 154 participants continue in the open label extension (OLE) portions of the Phase 2 PaTH Forward, Phase 3 PaTHway, and PaTHway Japan trials

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