Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Palopegteriparatide Experimental Arm · 1 trial · 3 indications
The proportion of participants with: Albumin-adjusted serum calcium (sCa) measured within 4 weeks prior to and on the Week 26 visit within the normal range (8.3-10.6 mg/dL); and independence from active vitamin D; and independence from therapeutic doses of calcium; and no increase in prescribed investigational product within 4 weeks prior to Week 26 visit.
| Arm | Type | Description |
|---|---|---|
| Palopegteriparatide Experimental Arm | EXPERIMENTAL | Palopegteriparatide at doses at or greater than 30 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose by a novel titration algorithm. |
| Palopegteriparatide Control Arm | ACTIVE_COMPARATOR | Palopegteriparatide at doses at or greater than 30 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose by a previously evaluated titrated algorithm |
| Name | Type | Description |
|---|---|---|
| Palopegteriparatide Experimental Arm | COMBINATION_PRODUCT | Palopegteriparatide is supplied as a solution with a concentration of 0.3 mg/mL in a single-patient-use prefilled pen intended for subcutaneous injection. |
| Palopegteriparatide Control Arm | COMBINATION_PRODUCT | Palopegteriparatide is supplied as a solution with a concentration of 0.3 mg/mL in a single-patient-use prefilled pen intended for subcutaneous injection. |
Inclusion criteria: 1. Males and females, ≥18 years of age at the time of providing informed consent 2. Participants with postsurgical chronic hypoparathyroidism (HP), or auto-immune, genetic, or idiopathic HP, for at least 26 weeks 3. Receiving doses of palopegteriparatide at or above 30 µg/day ...
| 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 where the parathyroid glands produce too little parathyroid hormone. It is currently in Phase 3 clinical development for this indication.
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 is deficient in patients with hypoparathyroidism.
Palopegteriparatide is being developed by Ascendis Pharma A/S, a biopharmaceutical company listed on the Nasdaq 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 evaluated in a randomized, active-controlled trial in adult participants with hypoparathyroidism. The drug is investigational and has not been approved by regulatory authorities.
Palopegteriparatide is being studied in a Phase 3 clinical trial with the identifier NCT07081997. This trial is recruiting 36 adult participants in the United States and is investigating the safety and efficacy of palopegteriparatide at doses greater than 30 μg/day in patients with hypoparathyroidism.
Palopegteriparatide is a distinct investigational drug being developed by Ascendis Pharma. It is not known to be the same as any other marketed medication. It is being studied specifically for its potential role in treating hypoparathyroidism.