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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: 05 Feb 2025

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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 Dec 2024 According to a Teijin Pharma media release, the company announced that it has applied for manufacturing and marketing approval in Japan for palopegteriparatide.
  • 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.

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