Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FXR 450 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Arm 1: FXR 450 |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| FXR 450 | DRUG | capsule, single oral doses from 10 mg to 450 mg |
| placebo | DRUG | capsule similar to active drug |
Inclusion Criteria: * Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening. * Healthy as determined by the investigator on the basis of screening evaluations. * Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to...
FXR 450 is an investigational small molecule drug developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 clinical trial in healthy adult subjects. The specific disease or condition it is intended to treat has not been disclosed.
FXR 450 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer sponsored the Phase 1 study of FXR 450 conducted in the United States.
FXR 450 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study evaluated the safety of FXR 450 in healthy subjects.
FXR 450 has been evaluated in one completed Phase 1 clinical trial, NCT00499629, titled "Study Evaluating the Safety of FXR-450 in Healthy Subjects." The trial enrolled 64 healthy adult participants in the United States and was randomized, double-blind, and placebo-controlled.
FXR 450 is not approved by the FDA. It remains an investigational drug in Phase 1 clinical development, with only a completed Phase 1 safety study in healthy volunteers. No regulatory approval has been granted for any indication.