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# Ascendis NDA for Hypoparathyroidism Therapy
- URL: https://www.fdaweb.com/ascendis-nda-for-hypoparathyroidism-therapy/
- Published: 2022-09-01T12:00:00.000Z
- Updated: 2026-09-14T17:58:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152654

Ascendis Pharma has submitted an NDA for TransCon PTH, an investigational prodrug designed to restore parathyroid hormone (PTH \[1-34\]) to physiological levels over 24 hours in adult patients with hypoparathyroidism. The submission is based on data from the global Phase 3 PaTHway Trial, the Phase 2 PaTH Forward Trial, and an ongoing open-label extension studies for both trials. “Notably, 57 out of 59 patients continue in the open-label portion of the Phase 2 trial beyond two years of treatment, and 78 out of 79 patients continue in the open-label portion of the Phase 3 trial of TransCon PTH,” the company says. “In these studies, TransCon PTH has been generally well tolerated, with no discontinuations related to study drug.”

Hypoparathyroidism is a rare endocrine disorder where patients experience insufficient levels of parathyroid hormone, which results in low calcium and elevated phosphate levels in the blood.