Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bivamelagon · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Bivamelagon (open-label) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bivamelagon | DRUG | daily dose of oral bivamelagon |
Key Inclusion Criteria: * Completed LG-MCCL005 and participant demonstrated adequate safety and tolerability in that study as determined by the Investigator. * Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after. Ke...
Bivamelagon is an investigational small molecule being developed for the treatment of hypothalamic obesity, a form of obesity that results from damage to the hypothalamus. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Bivamelagon targets the melanocortin 4 receptor (MC4R), a key regulator of energy balance and appetite. By acting on this receptor, the drug aims to address the underlying mechanisms of hypothalamic obesity.
Bivamelagon is being developed by Rhythm Pharmaceuticals, Inc., a biopharmaceutical company focused on rare genetic diseases of obesity. The company's stock is traded under the ticker symbol RYTM on the NASDAQ.
Bivamelagon is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies and is still undergoing clinical trials to evaluate its safety and efficacy.
Bivamelagon is being studied in a Phase 2 clinical trial with the identifier NCT07156578. This long-term study is enrolling 25 participants with hypothalamic obesity by invitation in the United States and United Kingdom. The trial is open to individuals aged 12 years and older.
No, Bivamelagon is a distinct investigational drug developed by Rhythm Pharmaceuticals. It is a small molecule targeting the MC4R pathway, whereas setmelanotide is a separate, already-approved therapy for certain forms of obesity. Bivamelagon is not an alternative name for setmelanotide.