Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Megestrol/mL · 1 trial · 5 indications
Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment
| Arm | Type | Description |
|---|---|---|
| Megestrol acetate oral suspension nanocrystal dispersion | EXPERIMENTAL | Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL |
| Megestrol acetate oral suspension micronized formulation | ACTIVE_COMPARATOR | Megestrol acetate oral suspension micronized formulation 60 mg/mL |
| Name | Type | Description |
|---|---|---|
| Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL | DRUG | Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose) |
| Megestrol acetate oral suspension 40 mg/mL | DRUG | Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose) |
Inclusion Criteria: * Capable of and willing to provide informed consent * Evidence of HIV infection (either HIV-seropositive, CD4+ T-cell count of ≤350/mm3 or other clinically accepted indicator) * An unintentional weight loss resulting in a weight 10% less than the lower limit of Ideal Body Weigh...
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Megestrol is a small molecule being studied for pharmacokinetics, specifically to evaluate the effect of food on its absorption. It is in Phase 1 clinical development for this purpose. The drug is being developed by BrainsWay Ltd. and is in the gastrointestinal therapeutic area.
Megestrol does not have a specified molecular target or target class. It is a small molecule being studied for its pharmacokinetic properties, particularly how food affects its absorption. The drug is in Phase 1 clinical development.
Megestrol is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is in Phase 1 clinical development for pharmacokinetic studies. BrainsWay Ltd. is conducting research on this small molecule in the gastrointestinal therapeutic area.
Megestrol is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied for pharmacokinetics. The drug has completed one Phase 1 trial, which evaluated the effect of food on its absorption.
Megestrol has one completed clinical trial, NCT00638079, titled 'Evaluating the Effect of Food on Absorption of Megace ES'. This Phase 1 study enrolled 24 healthy male volunteers in Canada and was active-controlled. The trial focused on pharmacokinetics, bioavailability, and absorption.
Megestrol is the drug being studied, and the clinical trial NCT00638079 evaluates 'Megace ES', which is a formulation of megestrol. The trial assesses the effect of food on the absorption of this formulation. Megestrol is in Phase 1 development for pharmacokinetics.