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PaTHway 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

Trial Profile

PaTHway 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: 14 Dec 2023

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At a glance

  • Drugs Palopegteriparatide (Primary)
  • Indications Hypoparathyroidism
  • Focus Registrational; Therapeutic Use
  • Acronyms PaTHway
  • Sponsors Ascendis Pharma Bone Diseases
  • Most Recent Events

    • 11 Dec 2023 According to an Ascendis Pharma media release, company announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Companys resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism and Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024.
    • 20 Nov 2023 According to an Ascendis Pharma media release, the European Commission (EC) has granted marketing authorization for YORVIPATH (palopegteriparatide) as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism and the company plans its first European Union (EU) launch of YORVIPATH in January 2024 in Germany.
    • 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).
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