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# Ascendis Pharma Refiles NDA on TransCon PTH
- URL: https://www.fdaweb.com/ascendis-pharma-refiles-nda-on-transcon-pth/
- Published: 2023-11-15T12:00:00.000Z
- Updated: 2026-09-14T14:16:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155802

Ascendis Pharma has resubmitted an NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism. In May, FDA issued a complete response letter on the original NDA, citing manufacturing control strategy concerns related to the variability of the delivered dose in the drug/device combination product, according to the company.

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. The investigational prodrug is designed to restore parathyroid hormone (PTH \[1-34\]) to physiological levels over 24 hours in adult patients with hypoparathyroidism, according to Ascendis.