Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSI 136 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Subject on active drug |
| 2 | PLACEBO_COMPARATOR | Subject on placebo |
| GSI 136 | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GSI-136 | DRUG | - |
| Placebo | OTHER | - |
| GSI 136 | DRUG | - |
\<Inclusion: 1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years or greater than 65 years, inclusive, at screening. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than 1 year (with follicle-stimulat...
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GSI 136 is an investigational small molecule being studied for Alzheimer disease. It has been evaluated in Phase 1 clinical trials involving healthy volunteers, including young and elderly subjects, rather than in patients with confirmed Alzheimer disease. It is not an approved treatment.
GSI 136 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored both Phase 1 trials of the compound, one conducted in Japan and one in the United States.
GSI 136 is in Phase 1 development. Two Phase 1 trials have been completed, and no active trials are currently listed. The studies together enrolled 152 participants and were randomized, double-blind, and placebo-controlled.
GSI 136 has been studied in two completed Phase 1 trials: NCT00719394, which evaluated safety in young and elderly Japanese males and enrolled 72 participants, and NCT00718731, which studied healthy young and elderly subjects in the United States and enrolled 80 participants.
Yes, GSI 136 and GSI-136 refer to the same investigational compound. The hyphenated form appears in the title of the Phase 1 trial NCT00718731, while the unhyphenated form is used elsewhere. Both names describe the same small molecule developed by Pfizer for Alzheimer disease.