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PaTHway CHINA TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism

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PaTHway CHINA TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism

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

Latest Information Update: 19 Aug 2024

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At a glance

  • Drugs Palopegteriparatide (Primary)
  • Indications Hypoparathyroidism
  • Focus Registrational; Therapeutic Use
  • Acronyms PaTHway China
  • Sponsors VISEN Pharmaceuticals

    • 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.
    • 12 Aug 2024 Results presented in the VISEN Pharmaceuticals Media Release.
    • 15 Nov 2023 According to an Ascendis Pharma media release, company has resubmitted its New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adults with hypoparathyroidism to the U.S. Food & Drug Administration (FDA), following Type A meeting held in August.

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