Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BAY3018250
BAY3018250 Dose 1 · 3 trials · 4 indications
Area under the curve (AUC) with respect to the measurement time points at 6 hours, 24 hours, 7 days and 30 days of the ratio to baseline of clot burden
The classify of bleeding events use the International Society on Thrombosis and Haemostasis (ISTH) definitions.
| Arm | Type | Description |
|---|---|---|
| BAY3018250 Dose 1 | EXPERIMENTAL | Participants will receive BAY3018250 Dose 1. |
| BAY3018250 Dose 2 | EXPERIMENTAL | Participants will receive BAY3018250 Dose 2. |
| Placebo to BAY3018250 | PLACEBO_COMPARATOR | Participants will receive placebo to BAY3018250. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive the matching placebo to BAY3018250. |
| Dose step 1 (Part A) | EXPERIMENTAL | Participants will receive a single dose of BAY3018250 dose step 1 via infusion in part A. |
| Dose step 2 (Part A) | EXPERIMENTAL | Participants will receive a single dose of BAY3018250 dose step 2 via infusion in part A. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Participants will receive a single dose of BAY3018250 matching placebo via infusion in part A. |
| Dose step 2 (Part B) | EXPERIMENTAL | Participants will receive a single dose of BAY3018250 dose step 2 via injection in part B. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Participants will receive a single dose of BAY3018250 matching placebo via injection in part B. |
| Name | Type | Description |
|---|---|---|
| BAY3018250 | DRUG | Dose 1 or dose 2 of BAY3018250 |
| Placebo to BAY3018250 | DRUG | Matching placebo to BAY3018250 |
| BAY3018250 Dose 1 | DRUG | Single dose |
| Placebo | DRUG | Matching placebo to BAY3018250 |
| BAY3018250 Dose 2 | DRUG | Single dose |
| BAY3018250 Dose 2 infusion | DRUG | Infusion, single dose |
| BAY3018250 Dose 2 injection | DRUG | Injection, single dose |
Inclusion Criteria: * Male and female (if postmenopausal or hysterectomized) aged 18 years or older * Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following: * duration of symptoms 14 days or less * Proximal DVT involving at le...
BAY3018250 is being developed for acute venous and arterial thrombotic and thromboembolic events and for thrombolysis. It is a small molecule therapeutic candidate studied in conditions including symptomatic proximal deep vein thrombosis. It is investigational and has not been approved for any indication.
BAY3018250 is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical program evaluating the drug in thrombotic and thromboembolic conditions and in thrombolysis.
BAY3018250 is in Phase 1 development. Two Phase 1 trials have been completed, and a Phase 2 study in symptomatic proximal deep vein thrombosis has also been completed. The drug remains investigational and is not approved.
BAY3018250 has been studied in NCT06619483, a Phase 1 trial in healthy Chinese participants, NCT06562985, a Phase 1 trial in healthy Japanese men and adults aged 18 to 55, and NCT06149520, a Phase 2 trial in symptomatic proximal deep vein thrombosis. All three trials are completed.
Yes. BAY3018250 Dose 1 is an alternative name for BAY3018250, the small molecule developed by Bayer AG for acute venous and arterial thrombotic and thromboembolic events and thrombolysis. Both names refer to the same investigational drug candidate.