Trial Profile
A Phase 2, 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 II
Latest Information Update: 14 Dec 2023
Price :
$35
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At a glance
- Drugs Palopegteriparatide (Primary)
- Indications Hypoparathyroidism
- Focus Registrational; Therapeutic Use
- Acronyms PaTH Forward
- Sponsors Ascendis Pharma
- 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.
- 31 Oct 2023 According to an Ascendis Pharma media release, company will host a conference call and webcast on November 7, 2023, at 4:30 p.m. Eastern Time (ET) to discuss third quarter 2023 financial results and operations.