Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSI-953 · 3 trials · 2 indications
Safety
| Arm | Type | Description |
|---|---|---|
| GSI+Placebo | OTHER | - |
| A | EXPERIMENTAL | - |
| B | PLACEBO_COMPARATOR | - |
| Single Dose of GSI-953 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSI-953 | DRUG | Oral capsule, 10- and 50-mg, either once a day for 14 days or twice a day for 14 days, depending on cohort assignment. |
| Placebo | OTHER | - |
Inclusion Criteria: * Men or women, greater than or equal to 65 years of age. * Women of nonchildbearing potential (WONCP) may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with FSH greater than or equal t...
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GSI-953 is an investigational small molecule being studied for Alzheimer's disease and for use in healthy volunteers. It is being developed by Pfizer, Inc. (NYSE: PFE) and is currently in Phase 1 clinical development. GSI-953 has been evaluated in early-stage trials, but it is not approved by the FDA.
GSI-953 is being developed by Pfizer, Inc. (NYSE: PFE). The drug is an investigational small molecule in Phase 1 clinical development for Alzheimer's disease. Pfizer has conducted early-stage trials of GSI-953 in healthy volunteers and in patients with Alzheimer's disease.
GSI-953 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA. Pfizer has completed Phase 1 trials of GSI-953 in healthy volunteers and in patients with Alzheimer's disease, but the drug is not yet approved for any use.
GSI-953 has been studied in three completed Phase 1 clinical trials. NCT00441987 evaluated a single dose in 96 healthy male volunteers in Japan. NCT00479219 studied GSI-953 in healthy young volunteers and Alzheimer's patients in the United States. NCT00547560 evaluated multiple doses in 49 healthy elderly volunteers in the United States.
No, GSI-953 is not FDA approved. It is an investigational drug in Phase 1 clinical development. Pfizer has completed early-stage trials of GSI-953 in healthy volunteers and in patients with Alzheimer's disease, but the drug has not been approved for any indication.
GSI-953 is an investigational small molecule in Phase 1 clinical development. Pfizer has completed three Phase 1 trials of GSI-953, with a total enrollment of 145 participants. These trials were randomized, double-blind, and placebo-controlled. The drug is not approved and is no longer in active clinical trials.