-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On March 15, Ascendis Pharma announced that its investigational therapy, TransCon PTH, received positive top-line data from the randomized, double-blind, placebo-controlled portion of a Phase 3 clinical trial in adult patients with hypoparathyroidism (HP)
Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH), resulting in low calcium and elevated phosphate levels in the blood
TransCon PTH is a once-daily long-acting parathyroid hormone prodrug
▲Ascendis Pharma's R&D pipeline (Image source: Ascendis Pharma's official website)
This randomized, double-blind, placebo-controlled Phase 3 clinical trial was conducted in 82 adults with chronic hypoparathyroidism
Patients achieved statistically significant reductions in both physical and cognitive symptoms as measured by the Hypoparathyroidism Patient Experience Scale (HPES)
In terms of safety, TransCon PTH was generally well tolerated with no study drug-related discontinuations
Ascendis plans to submit a New Drug Application (NDA) to the US FDA for TransCon PTH for the treatment of hypoparathyroidism in adults in the third quarter of 2022 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the fourth quarter of 2022
References:
[1] Ascendis Pharma A/S Announces Phase 3 PaTHway Trial of TransCon™ PTH in Adults with Hypoparathyroidism Met Primary and All Key Secondary Endpoints.
