Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 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 |
MBX 2109 is an investigational small molecule being developed for hypoparathyroidism, a condition where the body produces insufficient parathyroid hormone. It has also been studied in healthy volunteers and in people with renal impairment to assess safety and pharmacokinetics. The drug is not yet approved and remains in clinical development.
MBX 2109 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects, and for safety, pharmacokinetics, and efficacy in patients with hypoparathyroidism.
MBX 2109 is being developed by MBX Biosciences, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol MBX. MBX Biosciences is conducting clinical trials of MBX 2109 in the United States and other countries.
MBX 2109 has completed Phase 1 and Phase 2 clinical trials. A Phase 1 study in healthy subjects and a Phase 1 study in subjects with renal impairment have been completed, as has a Phase 2 study in patients with hypoparathyroidism. The drug is investigational and not FDA approved.
MBX 2109 has been studied in three completed clinical trials. NCT05158335 was a Phase 1 study in 76 healthy adults. NCT06465108 was a Phase 2 study in 64 patients with hypoparathyroidism. NCT06496217 was a Phase 1 study in 25 adults with normal and impaired renal function.
MBX 2109 is the sole name provided for this drug; no alternative names have been disclosed. It is a distinct investigational small molecule being developed by MBX Biosciences for hypoparathyroidism and related conditions.