Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY81-8973 · 1 trial · 1 indication
Area under the blood concentration vs time curve from zero to the last data point \> lower limit of quantification
| Arm | Type | Description |
|---|---|---|
| BAY81-8973 | EXPERIMENTAL | BAY81-8973 infusion to analyze pharmacokinetics |
| Advate | OTHER | Advate infusion to analyze pharmacokinetics. |
| Name | Type | Description |
|---|---|---|
| BAY81-8973 | DRUG | BAY81-8973 infusion to analyze pharmacokinetics |
| Advate | DRUG | Advate infusion to analyze pharmacokinetics. |
Inclusion Criteria: * Males, age 18 to 65 years * Subjects with Severe hemophilia A with a documented plasma FVIII level of \<1% * ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records Exclusion Criteria: * Evidence of current or past inhibitor antibody * History o...
BAY81-8973 is an investigational small molecule being developed for the treatment of Hemophilia A. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being studied to compare its pharmacokinetic parameters with those of Advate in patients with severe Hemophilia A.
BAY81-8973 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY on the OTC market. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of BAY81-8973 in patients with Hemophilia A.
BAY81-8973 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for the treatment of Hemophilia A.
BAY81-8973 has one completed clinical trial registered under NCT02483208. This was a single-dose, controlled study in 18 male subjects with severe Hemophilia A, conducted in Bulgaria. The trial compared the pharmacokinetic parameters of BAY81-8973 with those of Advate. The study was not double-blinded and did not use biomarker selection.
BAY81-8973 is a small molecule being developed for Hemophilia A. The specific molecular target of BAY81-8973 has not been disclosed in the available clinical trial information. As a small molecule, it is designed to interact with biological pathways relevant to the condition, but its exact mechanism of action remains under investigation.