Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as eneboparatide
AZP-3601 · 2 trials · 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).
Number of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25).
| 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 |
| AZP-3601 | EXPERIMENTAL | subcutaneous (sc) administration once daily |
| Placebo (Parts A and B) | PLACEBO_COMPARATOR | subcutaneous (sc) administration once daily |
| 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 |
| AZP-3601 | DRUG | Lyophilized powder of AZP-3601 to be reconstituted with water for injection before injection |
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...
AZP-3601 is an investigational small molecule being developed for the treatment of chronic hypoparathyroidism, a condition characterized by low levels of parathyroid hormone. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AZP-3601 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for chronic hypoparathyroidism.
AZP-3601 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 1 trial has been completed, and the drug remains under investigation for chronic hypoparathyroidism.
AZP-3601 has one completed Phase 1 clinical trial, identified as NCT05239221. This study was a single ascending dose and multiple ascending dose trial conducted in healthy subjects and patients with hypoparathyroidism, enrolling 132 participants across Hungary and the Netherlands.
AZP-3601 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being studied under the clinical trial identifier NCT05239221 for chronic hypoparathyroidism.