Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mibavademab · 4 trials · 3 indications
Part A
Part A
Part B
Part B
Part B
| Arm | Type | Description |
|---|---|---|
| Part A: Arm A | EXPERIMENTAL | - |
| Part A: Arm B | EXPERIMENTAL | - |
| Part A: Arm C | EXPERIMENTAL | - |
| Part A: Arm D | PLACEBO_COMPARATOR | - |
| Part B | EXPERIMENTAL | - |
| Mibavademab | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Mibavademab | DRUG | Administered as per the protocol |
| Placebo | DRUG | Administered as per the protocol |
Key Inclusion Criteria: 1\. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines For Part A only: 1. Participants ≥2 years of age at screening 2. At least one of the below criteria are fulfilled during screening (measurements can be repeated once during screenin...
Mibavademab is an investigational antibody being developed for monogenic obesity, functional hypothalamic amenorrhea (FHA), and generalized lipodystrophy. It is being studied in pediatric and adult patients across these endocrine conditions.
Mibavademab is being developed by Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN). The company is conducting clinical trials of the drug in the United States, Germany, Brazil, and France.
Mibavademab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Ongoing trials include a Phase 2 study in functional hypothalamic amenorrhea and Phase 3 studies in generalized lipodystrophy and monogenic obesity.
Mibavademab is being evaluated in several trials. NCT07235917 is a Phase 2 study in adult women with functional hypothalamic amenorrhea. NCT07220772 studies the drug in monogenic obesity due to leptin gene mutations. NCT07220785 and NCT06548100 evaluate it in generalized lipodystrophy.
Mibavademab is not the same as metreleptin. One clinical trial, NCT06548100, studies participants switching from metreleptin to mibavademab for generalized lipodystrophy, indicating they are distinct treatments.
Mibavademab is a monoclonal antibody, indicated by its -mab suffix. Its specific molecular target has not been disclosed in available clinical trial information.