Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Palopegteriparatide Experimental Arm, Palopegteriparatide Control Arm
Palopegteriparatide · 2 trials · 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.
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 Experimental Arm | EXPERIMENTAL | Palopegteriparatide administered once daily by subcutaneous injection and titrated to an optimal dose by a novel titration algorithm. |
| Palopegteriparatide Control Arm | ACTIVE_COMPARATOR | Palopegteriparatide administered once daily by subcutaneous injection and titrated to an optimal dose by a previously evaluated titrated algorithm |
| Palopegteriparatide, once daily | EXPERIMENTAL | Participants will receive palopegteriparatide by subcutaneous injection for 234 weeks |
| Name | Type | Description |
|---|---|---|
| Palopegteriparatide Experimental Arm | COMBINATION_PRODUCT | Palopegteriparatide is administered as separate SC injection in a prefilled, single-patient use pen. Treatment duration 78 weeks. |
| Palopegteriparatide Control Arm | COMBINATION_PRODUCT | Palopegteriparatide is administered as separate SC injection in a prefilled, single-patient use pen. Treatment duration 78 weeks. |
| Palopegteriparatide | COMBINATION_PRODUCT | Subcutaneous injection for 234 weeks |
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 |
| MBX Biosciences, Inc. | MBX | 1 | PHASE2 | Canvuparatide |
Palopegteriparatide is being developed for the treatment of hypoparathyroidism, an endocrine condition in which the parathyroid glands do not produce enough parathyroid hormone. It is under investigation in both adults and adolescents with long-term hypoparathyroidism. It is not yet approved and remains in clinical development.
Palopegteriparatide targets PTH1R, the parathyroid hormone 1 receptor, and acts as an agonist at that receptor. By stimulating PTH1R, it is designed to replace the parathyroid hormone signaling that is deficient in hypoparathyroidism. It is a small molecule agonist being studied in Phase 3 trials.
Palopegteriparatide is being developed by Ascendis Pharma A/S, which trades under the ticker ASND. The company is running the Phase 3 clinical program evaluating the drug in patients with hypoparathyroidism, including both adult and adolescent populations.
Palopegteriparatide is in Phase 3 clinical development. Two Phase 3 trials are currently recruiting, and no trials have been completed. The drug is investigational and has not been approved for any indication. Development is focused on hypoparathyroidism in adults and adolescents.
Palopegteriparatide is being studied in two recruiting Phase 3 trials. NCT07706764 is testing it in adolescents aged 12 and older with long-term hypoparathyroidism in France and Poland, enrolling 12 participants. NCT07081997 is evaluating doses greater than 30 micrograms per day in adults with hypoparathyroidism in the United States, enrolling 36 participants.
Yes, palopegteriparatide experimental arm and palopegteriparatide control arm are alternative names used for palopegteriparatide in trial records. They refer to the same investigational drug, which is being developed by Ascendis Pharma A/S for hypoparathyroidism and is currently in Phase 3 testing.