Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
eneboparatide · 1 trial · 3 indications
After 24 weeks of treatment, the proportion of patients in the eneboparatide treatment group vs. placebo: * Achieving complete independence from active vitamin D; * Achieving independence from therapeutic doses of oral calcium (i.e. taking oral elemental calcium supplements ≤600 mg/day); and * With albumin-adjusted serum calcium within the normal range (8.3 to 10.6 mg/dL).
| Arm | Type | Description |
|---|---|---|
| eneboparatide | EXPERIMENTAL | Starting dose of 20 mcg; Administered once daily by subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Administered once daily by subcutaneous injection |
| Name | Type | Description |
|---|---|---|
| eneboparatide | COMBINATION_PRODUCT | Supplied as a solution (concentration of 250 mcg/mL or 500 mcg/mL) in single-patient-use prefilled pens |
| Placebo | COMBINATION_PRODUCT | Placebo is supplied as a solution (containing the excipient solution for eneboparatide) in single-patient-use prefilled pens |
Inclusion Criteria: 1. Males and Females, 18-80 years of age 2. Patients with cHP for ≥12 months at the time of screening 3. Two paired measurements of showing low parathyroid hormone (PTH) and serum calcium either below normal or within normal under standard of care 4. Requirement for therapy with...
Eneboparatide is an investigational small molecule being developed for the treatment of chronic hypoparathyroidism, a condition where the parathyroid glands produce insufficient parathyroid hormone. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Eneboparatide is a peptide-based therapeutic, classified as a -tide (peptide) agent. It is designed to act on pathways related to parathyroid hormone regulation, though its specific molecular target is not disclosed in the available clinical trial information.
Eneboparatide is being developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 3 clinical trial to evaluate the drug's safety and efficacy in patients with chronic hypoparathyroidism.
Eneboparatide is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and effectiveness for treating chronic hypoparathyroidism.
Eneboparatide is being evaluated in a Phase 3 clinical trial registered as NCT05778071, titled 'Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism.' This randomized, double-blind, placebo-controlled study has an enrollment of 165 participants and is active but not recruiting.
Yes, eneboparatide is also known as AZP-3601. The Phase 3 clinical trial NCT05778071 explicitly refers to the drug as 'Eneboparatide (AZP-3601),' confirming that these names refer to the same investigational compound being developed for chronic hypoparathyroidism.