Approval Probability
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Palopegteriparatide · 1 trial · 1 indication
The multi-component endpoint is the percentage of participants who met the following criteria at Week 26: 1) albumin-adjusted serum calcium within the normal range ; 2) independence from active vitamin D, and 3) independence from therapeutic doses of calcium
| Arm | Type | Description |
|---|---|---|
| Palopegteriparatide, once daily | EXPERIMENTAL | Participants will receive palopegteriparatide by subcutaneous injection for 234 weeks |
| Name | Type | Description |
|---|---|---|
| Palopegteriparatide | COMBINATION_PRODUCT | Subcutaneous injection for 234 weeks |
Inclusion Criteria: * 1\. Males and females, 12 to less than 18 years of age * 2\. Participants with postsurgical chronic hypoparathyroidism, or auto-immune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks * 3\. Normal levels of serum 25(OH) vitamin D and magnesium * 4\. Estimated g...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | eneboparatide |
| Ascendis Pharma A/S | ASND | 3 | PHASE3 | Palopegteriparatide Experimental Arm, Palopegteriparatide Control Arm |
| MBX Biosciences, Inc. | MBX | 1 | PHASE2 | 400 µg of MBX 2109 once-weekly by, 200-1600 µg of MBX 2109 once-weekly by |
Palopegteriparatide is an investigational drug being studied for the treatment of hypoparathyroidism, a condition characterized by low levels of parathyroid hormone. It is currently in Phase 3 clinical development for this indication, specifically in adolescents with long-term hypoparathyroidism.
Palopegteriparatide targets the parathyroid hormone 1 receptor (PTH1R) and acts as an agonist. By activating this receptor, it is designed to mimic the actions of parathyroid hormone, which may help address the hormone deficiency seen in hypoparathyroidism.
Palopegteriparatide is being developed by Ascendis Pharma A/S, a biopharmaceutical company listed on the stock exchange under the ticker symbol ASND. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with hypoparathyroidism.
Palopegteriparatide is in Phase 3 clinical development. It is currently being studied in an ongoing Phase 3 trial (NCT07706764) that is recruiting participants. The drug is investigational and has not yet been approved by regulatory authorities.
Palopegteriparatide is being evaluated in a Phase 3 clinical trial with the identifier NCT07706764. This study is titled 'A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidism' and is currently recruiting participants in France and Poland.
Palopegteriparatide is also known by the name TransCon PTH. This alternative name is sometimes used in clinical and scientific contexts to refer to the same investigational drug being developed by Ascendis Pharma for hypoparathyroidism.