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Also known as Asundexian (BAY2433334)
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 being developed for the prevention of ischemic stroke and the prevention of thromboembolic events. Its clinical program includes patients after an acute non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, also called a mini stroke, as well as conditions such as atrial fibrillation and acute myocardial infarction.
Asundexian is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsors the clinical program for the drug, including the Phase 3 study in patients after an acute ischemic stroke or high-risk transient ischemic attack.
Asundexian is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 program includes a completed trial in stroke prevention, and a completed Phase 1 study evaluated the drug in participants with mild or moderate reduction of liver function.
Asundexian has been studied in the Phase 3 trial NCT05686070, which enrolled 12,327 participants after an acute ischemic stroke or high-risk transient ischemic attack across many countries, and in the Phase 1 trial NCT05419635, which enrolled 27 participants with mild or moderate hepatic impairment in Germany.
Yes. Asundexian is also known as BAY2433334, which is Bayer's internal compound designation for the same investigational drug. Searches for either name refer to the same small molecule being developed for prevention of ischemic stroke and thromboembolic events.
Asundexian is being studied for preventing ischemic stroke caused by a clot in patients who have had an acute non-cardioembolic ischemic stroke or a high-risk transient ischemic attack. The completed Phase 3 trial NCT05686070 evaluated this use in 12,327 participants and was randomized, double-blind, and placebo-controlled.