Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Monlunabant · 1 trial · 1 indication
Number of events
| Arm | Type | Description |
|---|---|---|
| Monlunabant dose 1 | EXPERIMENTAL | Dose 1 of monlunabant treatment |
| Monlunabant dose 2 | EXPERIMENTAL | Dose 2 of monlunabant treatment |
| Monlunabant dose 3 | EXPERIMENTAL | Dose 3 of the monlunabant treatment |
| Placebo (monlunabant) | PLACEBO_COMPARATOR | Placebo treatment |
| Name | Type | Description |
|---|---|---|
| Monlunabant | DRUG | Oral monlunabant |
| Placebo (monlunabant) | DRUG | Oral placebo (monlunabant) |
Inclusion Criteria: * Male. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit,...
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Monlunabant is an investigational small molecule being developed for obesity. It is a metabolic therapeutic currently in Phase 1 clinical development. The drug is being studied in healthy weight Japanese and Caucasian men to evaluate its safety and concentration in the blood after a single oral dose.
Monlunabant is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the New York Stock Exchange under the ticker NVO. The company is conducting clinical research on this investigational drug for the treatment of obesity.
Monlunabant is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed, and the drug remains in early-stage clinical research for obesity.
Monlunabant has one completed clinical trial, NCT06542536, a Phase 1 study in the United States. The trial enrolled 73 healthy male volunteers, both Japanese and Caucasian, to investigate the safety and blood concentration of a single oral dose of Monlunabant.
Monlunabant is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for obesity. The completed Phase 1 trial focused on safety and pharmacokinetics in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory review.