Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Canvuparatide · 1 trial · 1 indication
Responder status is defined as a study participant who meets the following composite criteria: * Independence from active vitamin D * Independence from therapeutic doses of calcium (standing elemental calcium dose of ≤ 600 mg/day) * 2 consecutive albumin-adjusted serum calcium results in the normal range (8.3-10.6 mg/dL) (2.07-2.64 mmol/L) * No increase in study drug
| Arm | Type | Description |
|---|---|---|
| Canvuparatide | ACTIVE_COMPARATOR | Canvuparatide is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of canvuparatide via a manual SC injection. Dosing is once weekly. |
| Placebo | PLACEBO_COMPARATOR | Placebo is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of placebo via a manual SC injection. Dosing is once weekly. |
| Name | Type | Description |
|---|---|---|
| Canvuparatide | DRUG | • Drug per vial: Each DDC contains 1 vial of lyophilized drug product. The reconstituted strengths are 400 μg/mL, 600 μg/mL, 800 μg/mL, 1000 μg/mL, 1200 μg/mL, 1400 μg/mL, and 1600 μg/mL. |
| Placebo | OTHER | • Drug per vial: Each DDC contains 1 vial of lyophilized drug product. The reconstituted strengths are 400 μg/mL, 600 μg/mL, 800 μg/mL, 1000 μg/mL, 1200 μg/mL, 1400 μg/mL, and 1600 μg/mL. |
Key Inclusion Criteria: 1. Is an adult ≥18 years of age. 2. Has a documented diagnosis of post-surgical, chronic HypoPT or genetic, idiopathic, or autoimmune HypoPT for at least 12 months prior to screening. 3. Intact PTH level below the median value of the normal range 4. Minimum requirement for a...
| 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 |
Canvuparatide is an investigational small molecule being developed for the treatment of hypoparathyroidism, a condition characterized by insufficient parathyroid hormone. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being studied in adult patients with this endocrine disorder.
Canvuparatide is a peptide-based small molecule, indicated by its -tide suffix, that is being studied for its effects in hypoparathyroidism. The specific molecular target is not disclosed in the available information, but the drug is designed to address the underlying hormone deficiency associated with the condition.
Canvuparatide is being developed by MBX Biosciences, Inc., a biopharmaceutical company traded under the ticker symbol MBX. The company is conducting a Phase 3 clinical trial of the drug in the United States for the treatment of hypoparathyroidism.
Canvuparatide is currently in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted orphan drug designation by the FDA, reflecting its potential to treat a rare condition. The ongoing Phase 3 trial is actively recruiting participants.
Canvuparatide is being evaluated in a Phase 3 clinical trial registered as NCT07699471. This randomized, double-blind, placebo-controlled study is investigating the drug compared with placebo in adult patients with hypoparathyroidism. The trial is recruiting 160 participants in the United States and is currently active.
No alternative names for Canvuparatide have been reported. The drug is being developed under this single name by MBX Biosciences, Inc. It is a distinct investigational compound currently in Phase 3 trials for hypoparathyroidism, with no known synonyms or previous brand names.