Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MBX 1416 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| MBX 1416 (INN imapextide) | EXPERIMENTAL | Single subcutaneous administration at different dose levels |
| MBX 1416 (Part A) | EXPERIMENTAL | Single ascending subcutaneous (SC) doses |
| MBX 1416 (Part B) | EXPERIMENTAL | Repeated ascending subcutaneous (SC) doses |
| Placebo | PLACEBO_COMPARATOR | - |
| MBX 1416 (Part C) | EXPERIMENTAL | Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen. |
| Name | Type | Description |
|---|---|---|
| MBX 1416 (INN imapextide) | DRUG | A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart. |
| MBX 1416 (Part A) | DRUG | Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg |
| MBX 1416 (Part B) | DRUG | Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg |
| Placebo | DRUG | Single dose or repeated subcutaneous (SC) dose of placebo. |
| MBX 1416 (Part C) | DRUG | Single subcutaneous (SC) dose of MBX 1416 and the single dose of rosuvastatin and acetaminophen pharmacokinetics. The doses selected for MBX 1416 in Part C will not exceed a dose of 200mg. |
Inclusion Criteria: 1. Participant must be ≥18 to ≤75 years of age at the time of signing the informed consent. 2. Participants must have undergone RYGB or SG surgery at least 12 months prior to study entry. 3. Participants should have a documented history of PBH, defined as Whipple's triad (sympto...
MBX 1416 is an investigational small molecule being developed for the treatment of postbariatric hypoglycemia, a condition of low blood sugar that can occur after bariatric surgery. It is in Phase 2 clinical development and is not yet approved by the FDA.
MBX 1416 is being developed by MBX Biosciences, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol MBX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
MBX 1416 is in Phase 2 clinical development for postbariatric hypoglycemia. It has completed two clinical trials, including a Phase 1 study in healthy subjects and a Phase 2 study in patients with the condition. The drug remains investigational and has not received FDA approval.
MBX 1416 has completed two clinical trials. NCT06036784 was a Phase 1 study in 69 healthy subjects evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics. NCT07029412, also known as STEADI, was a Phase 2 study in 20 patients with postbariatric hypoglycemia evaluating efficacy and dose response.
Yes, MBX 1416 is also known as Imapextide. The Phase 2 clinical trial NCT07029412, titled 'Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)', uses the name Imapextide to refer to the same investigational drug being developed by MBX Biosciences.