Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MBX 2109 (Part A)
MBX 2109 · 3 trials · 3 indications
Proportion of patients pooled across MBX 2109 doses meeting the composite criteria at week 12/Visit 15 * Independence from active vitamin D supplements * Oral elemental calcium doses of ≤600 mg/day * Serum albumin-adjusted calcium (AdjCa) values of 8.2 to 10.6 mg/dL
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Assess the plasma pharmacokinetics (PK) of MBX 2109 and MBX 2099 following a single 900 µg subcutaneous (SC) dose
Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)
| Arm | Type | Description |
|---|---|---|
| Starting dose of 400 µg once-weekly by subcutaneous injection | EXPERIMENTAL | - |
| Starting dose of 600 µg once-weekly by subcutaneous injection | EXPERIMENTAL | - |
| Starting dose of 800 µg once-weekly by subcutaneous injection | EXPERIMENTAL | - |
| Placebo - once-weekly by subcutaneous injection | PLACEBO_COMPARATOR | - |
| Single 900 µg dose of MBX 2109 | EXPERIMENTAL | A single, 900 µg dose of MBX 2109 will be administered subcutaneously in the abdomen |
| MBX 2109 (Part A) | EXPERIMENTAL | Single ascending SC doses |
| MBX 2109 (Part B) | EXPERIMENTAL | Repeated ascending SC doses |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MBX 2109 | DRUG | Supplied as 1.5 mg per vial reconstituted in 1.4 mL water for injection to a concentration of 1.0 mg/mL |
| Placebo | OTHER | Supplied in 1.4 mL water for injection |
| MBX 2109 (Part A) | DRUG | Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg |
| MBX 2109 (Part B) | DRUG | Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg |
Inclusion Criteria: 1. Is an adult ≥18 years of age at the time of the Screening visit. a. If ≤25 years of age, radiological evidence of epiphyseal closure based on X-ray of non-dominant wrist and hand 2. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks ...
| 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 |
MBX 2109 is an investigational small molecule developed by MBX Biosciences, Inc. It has been studied in healthy adult volunteers, in patients with hypoparathyroidism, and in adults with impaired renal function. It is not approved and remains in clinical development.
MBX 2109 has been studied as a potential treatment for hypoparathyroidism, a condition in which the body produces insufficient parathyroid hormone. A completed Phase 2 trial, NCT06465108, evaluated its safety, pharmacokinetics, and efficacy in 64 patients with hypoparathyroidism across the United States, Argentina, and Turkey.
MBX 2109 is developed by MBX Biosciences, Inc., which trades under the ticker MBX. The company has sponsored the clinical program for the drug, including studies in healthy volunteers, patients with hypoparathyroidism, and adults with impaired renal function.
MBX 2109 is in clinical development and is not FDA approved. Its program includes completed Phase 1 studies and a completed Phase 2 trial in hypoparathyroidism. No active trials are currently listed for the drug.
MBX 2109 has been evaluated in three completed trials. NCT05158335 was a Phase 1 study in 76 healthy adults. NCT06496217 was a Phase 1 study in 25 adults with normal and impaired renal function. NCT06465108 was a Phase 2 study in 64 patients with hypoparathyroidism.
Yes, MBX 2109 (Part A) refers to the same investigational drug as MBX 2109, developed by MBX Biosciences, Inc. The parenthetical label distinguishes a portion of the clinical program rather than a separate compound.