Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Apixaban IR · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Apixaban Cross-over | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Apixaban IR | DRUG | immediate release tablet, 10 mg, single dose |
| Apixaban MR1 | DRUG | modified release tablet 1, 10 mg, single dose |
| Apixaban MR2 | DRUG | modified release tablet 2, 10 mg, single dose |
| Apixaban MR3 | DRUG | modified release tablet 3, 10 mg, single dose |
Inclusion Criteria: * Healthy male or female patients * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 Exclusion Criteria: * Any condition possibly affecting drug absorption * History or evidence of abnormal bleeding or clotting disorder
Top 3 of 12 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 5 | PHASE3 | REGN7508, REGN9933 |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE2 | Thrombate III |
| Johnson & Johnson | JNJ | 1 | - | Rivaroxaban |
Apixaban IR is an immediate-release small molecule developed by Pfizer, Inc. (ticker PFE) for thrombosis in the cardiovascular therapeutic area. It is an investigational Phase 1 asset. The IR designation refers to the immediate-release tablet form studied in a bioavailability comparison against a modified-release formulation.
Apixaban IR targets coagulation factor X, also known as F10, and acts as an inhibitor of that target. By inhibiting factor X, the drug is designed to reduce thrombin generation and clot formation, which is the rationale for studying it in thrombosis.
Pfizer, Inc., which trades under the ticker PFE, is the developer of Apixaban IR. The company is listed as the sponsor of the clinical program for this immediate-release factor X inhibitor in thrombosis.
Apixaban IR is in Phase 1 clinical development. It is an investigational agent and is not described as approved. The program has one completed Phase 1 trial, and no active trials are currently listed for this asset.
Apixaban IR has been studied in one completed Phase 1 trial, NCT00914641, titled a bioavailability study comparing modified-release to immediate-release apixaban tablets in healthy volunteers. That trial enrolled 16 participants in the United States, was randomized, and used an uncontrolled design.
Yes. The Phase 1 trial NCT00914641 for Apixaban IR enrolled healthy volunteers aged 18 years and older of all sexes. It was a randomized bioavailability comparison of modified-release versus immediate-release apixaban tablets, conducted in the United States with 16 participants, and it is now completed.