Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY86-6150 · 1 trial · 1 indication
A bleed was defined as successfully treated, if no administration of rescue medication was required.
Proportion of successful treatments of bleeding episodes was calculated as number of bleeding episodes treated successfully - without rescue medication - divided by the total number of bleeding episodes on a dose level.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY86-6150 | DRUG | Four dose levels (6.5 µg/kg, 20 µg/kg, 50 µg/kg and 90 µg/kg) of BAY86-6150 will be studied. |
| eptacog alfa [activated] | DRUG | comparative PK/PD (pharmacokinetics/pharmacodynamics) evaluation |
Inclusion Criteria: * Male subjects * 12 to 62 years-of-age * History of moderate or severe congenital hemophilia A or B with inhibitors to FVIII or FIX * 4 or more bleeding episodes in the last 6 months before enrollment. Exclusion Criteria: * Clinically relevant coagulation disorder other than ...
BAY86-6150 is an investigational small molecule being developed for the treatment of hemophilia A and hemophilia B. It is currently in Phase 2 clinical development and is not approved by regulatory authorities. The drug is intended for male patients aged 12 years and older.
BAY86-6150 is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The drug is an investigational small molecule in Phase 2 clinical development for hemophilia A and hemophilia B.
BAY86-6150 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The drug is being studied for the treatment of hemophilia A and hemophilia B in male patients aged 12 years and older.
BAY86-6150 has one completed clinical trial, NCT01625390, titled "A Phase 2/3 Trial to Evaluate the Efficacy and Safety of BAY86-6150." This trial enrolled 10 participants with hemophilia A and hemophilia B across multiple countries, including the United States, Australia, Brazil, and many others.
BAY86-6150 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for hemophilia A and hemophilia B. The drug has completed one clinical trial, but it remains under investigation and has not received marketing approval from regulatory authorities.
BAY86-6150 is a small molecule being developed for hemophilia A and hemophilia B. Its specific molecular target has not been disclosed in available information. The drug is currently in Phase 2 clinical development, with one completed trial evaluating its efficacy and safety.