Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Asundexian · 2 trials · 8 indications
ISTH=International Society on Thrombosis and Hemostasis
\*AUC(0-tlast) and AUC(0 tlast)/D will be used as main parameter, respectively, if mean AUC cannot be reliably determined in all participants. In case of dose adaptation for Child Pugh B patients, AUC/D\*will be evaluated instead of AUC.
\* AUC(0-tlast)u and AUC(0-tlast)u/D will be used as main parameter, respectively, if mean AUC cannot be reliably determined in all participants. In case of dose adaptation for Child Pugh B patients, AUCu/D\*, will be evaluated instead of AUCu.
In case of dose adaptation for Child Pugh B patients, Cmax/D will be evaluated instead of Cmax.
In case of dose adaptation for Child Pugh B patients, Cmax,u/D will be evaluated instead of Cmax,u.
| Arm | Type | Description |
|---|---|---|
| Asundexian | EXPERIMENTAL | Participants will receive asundexian. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo. |
| Arm A: Child-Pugh A | EXPERIMENTAL | Participants with mildly impaired hepatic function (Child-Pugh A) |
| Arm B: Child-Pugh B | EXPERIMENTAL | Participants with moderately impaired hepatic function (Child-Pugh B) |
| Arm C: Normal hepatic (Matched A and B) | EXPERIMENTAL | Participants with normal hepatic function matched to Arm A and B |
| Name | Type | Description |
|---|---|---|
| Asundexian (BAY2433334) | DRUG | Once daily, oral |
| Placebo | DRUG | Placebo to asundexian, once daily, oral |
Inclusion Criteria: * Participants must be ≥ 18 years of age * Acute non-cardioembolic stroke or high-risk TIA * Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct Exclusion Criteria: * Ischemic stroke ≤ 7 days before the index event * Index stroke following procedures or st...
Asundexian is an investigational small molecule being developed for the prevention of ischemic stroke and the prevention of thromboembolic events. It is being studied in patients after acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack, as well as in conditions such as atrial fibrillation and acute myocardial infarction.
Asundexian is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY.
Asundexian is in Phase 3 clinical development. A Phase 3 trial, NCT05686070, has been completed, studying the drug for preventing stroke after an acute ischemic stroke or high-risk transient ischemic attack. Asundexian remains investigational and is not yet approved by regulatory authorities.
Asundexian has been studied in two completed clinical trials. NCT05686070 was a Phase 3 study with 12,327 participants evaluating stroke prevention after acute ischemic stroke or high-risk transient ischemic attack. NCT05419635 was a Phase 1 study with 27 participants examining how the drug moves through the body in people with mild or moderate liver impairment.
Asundexian is a distinct investigational compound and no alternative names have been reported. It is being studied under its own name in clinical trials registered with ClinicalTrials.gov, including NCT05686070 and NCT05419635.