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SAM-315 · 2 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| SAM-315 | DRUG | - |
Inclusion criteria: * Men aged 20 to 45 years (inclusive) at the time of getting informed consent. * Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI = \[weight (kg)\]/\[height (m)\]2). * Healthy as determined by the investigator on the basis of medical history, p...
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SAM-315 is an investigational small molecule being developed for Alzheimer Disease. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities. Studies have been conducted in healthy volunteers to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.
SAM-315 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability in healthy volunteers, including a study specifically in healthy Japanese males.
SAM-315 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved for any use. Further clinical studies would be needed to assess its potential in Alzheimer Disease.
SAM-315 has been studied in two completed Phase 1 trials. NCT00479440 enrolled 56 healthy adults to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics. NCT00480467 enrolled 32 healthy Japanese males. Both trials were completed and involved healthy volunteers, not patients with Alzheimer Disease.
SAM-315 is not FDA approved. It is an investigational drug in Phase 1 clinical development for Alzheimer Disease. The completed trials were early-stage studies in healthy volunteers, and the drug has not yet demonstrated efficacy or received regulatory approval for any indication.