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 targets the parathyroid hormone (PTH) pathway. It is a peptide-based agent designed to address the hormonal deficiency characteristic of chronic hypoparathyroidism. By engaging this pathway, it aims to restore physiological functions that depend on adequate parathyroid hormone activity.
Eneboparatide is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on major stock exchanges under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for 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. This randomized, double-blind, placebo-controlled study is assessing the safety and efficacy of eneboparatide in patients with chronic hypoparathyroidism. The trial is active but not recruiting, with an enrollment target of 165 participants across multiple countries.
Yes, eneboparatide is also known as AZP-3601. The Phase 3 clinical trial NCT05778071, which evaluates the safety and efficacy of eneboparatide in patients with chronic hypoparathyroidism, refers to the drug by this alternative name, confirming that both names identify the same investigational therapy.