Parathyroid hormone (PTH) plays a critical role in controlling calcium, phosphate and calcitriol (active vitamin D) levels in the blood and bone. Through its primary actions, PTH directly involves the kidneys, bone and other organs in maintaining key biological functions.
Palopegteriparatide is designed to restore physiologic levels and activity of parathyroid hormone (“PTH”) throughout 24 hours per day, thereby addressing full aspects of the HP disease, including normalizing serum and urinary calcium and serum phosphate levels.
In January 2023, the double-blind period of China phase 3 pivotal trial of palopegteriparatide was completed and met its primary objective. Palopegteriparatide was approved by the European Commission (EC), the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, and the Food and Drug Administration (FDA) in the United States in November 2023, June 2024, and August 2024, respectively, and it is used for hormone replacement therapy in adult patients with chronic hypoparathyroidism.