Trial Profile
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: 22 Nov 2023
Price :
$35
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At a glance
- Drugs Palopegteriparatide (Primary)
- Indications Hypoparathyroidism
- Focus Registrational; Therapeutic Use
- Acronyms PaTHway China
- Sponsors VISEN Pharmaceuticals
- 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.
- 05 Sep 2023 According to an Ascendis Pharma media release, in June 2023, the Company requested a Type A meeting with FDA and submitted an updated control strategy. A Type A meeting held with FDA in late Aug based as per availability. Following a constructive Type A meeting, the Company submitted additional information to FDA supporting the updated control strategy. Ascendis believes materials submitted to FDA combined with the Type A meeting discussions will position the Company to resubmit the NDA.
- 05 Sep 2023 According to an Ascendis Pharma media release, company expects to resubmit NDA to FDA for TransCon PTH in October 2023; EC decision on MAA for TransCon PTH expected during the fourth quarter of 2023. If approved, first country launch planned in Germany in early 2024.