Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1093884 · 2 trials · 3 indications
Area under the concentration vs. time curve from time 0 to the last data point \> LLOQ
AUC(0-tlast) divided by dose
Maximum observed drug concentration in measured matrix after single dose administration
Cmax divided by dose
Adverse events including abnormal laboratory findings and local injection site reactions
AUC from time 0 to the last data point \> LLOQ (lower limit of quantitation)
AUC(0-last) divided by dose
Maximum observed drug concentration in measured matrix after single dose administration
Cmax divided by dose
| Arm | Type | Description |
|---|---|---|
| BAY1093884 in subjects with Hemophilia | EXPERIMENTAL | Single dose of BAY1093884 over 30 minutes administered in subjects with severe congenital Hemophilia A or B, with inhibitors or without inhibitors |
| Without inhibitors | EXPERIMENTAL | Dose escalation steps for participants without inhibitors - intravenous infusion and subcutaneous injection |
| With inhibitors | EXPERIMENTAL | Dose escalation steps for participants with inhibitors - intravenous infusion and subcutaneous injection |
| Without inhibitors_multiple dose | EXPERIMENTAL | Multiple dose cohort for participants without inhibitors - a single subcutaneous injection once a week for 6 weeks |
| Name | Type | Description |
|---|---|---|
| BAY1093884 | DRUG | 0.3 mg/kg given intravenously |
Inclusion Criteria: * Males with severe congenital hemophilia A or B defined as \<1% FVIII or \<2% FIX concentration by measurement at the time of screening or from reliable prior documentation (e.g., measurement in other clinical Bayer trials, or diagnostic genetic testing) * Male with any inhibit...
BAY1093884 is an investigational small molecule being developed for the treatment of hemophilia A and hemophilia B. It is intended for patients with severe forms of these conditions, including those with or without inhibitors. The drug is currently in clinical development and has not been approved by regulatory authorities.
BAY1093884 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being studied for its effects in patients with severe hemophilia A or B, with or without inhibitors, based on its mechanism of action in the coagulation pathway.
BAY1093884 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with hemophilia.
BAY1093884 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 38 participants enrolled across studies. The drug remains investigational and has not received FDA approval or any other regulatory approval for commercial use.
BAY1093884 has been studied in two completed Phase 1 trials. The first, NCT02571569, enrolled 32 male subjects with severe hemophilia A or B, with or without inhibitors, across Bulgaria, Germany, Japan, Ukraine, and the United Kingdom. The second, NCT03481946, enrolled 6 male patients in Israel to assess pharmacokinetics and pharmacodynamics.
Yes, BAY1093884 and BAY 1093884 refer to the same investigational drug. The name is written with or without a space in clinical trial registries and publications. Both names denote the same small molecule being developed by Bayer AG for hemophilia A and B.