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Also known as BAY Factor VII (BAY86-6150)
BAY Factor VII · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| BAY Factor VII (6.5 µg/kg) / Placebo | EXPERIMENTAL | n = 4, randomized 3:1; 6.5 µg/kg BAY 86-6150 (B0189):Placebo |
| BAY Factor VII (20 µg/kg) / Placebo | EXPERIMENTAL | n = 4, randomized 3:1; 20 µg/kg BAY 86-6150 (B0189):Placebo |
| BAY Factor VII (50 µg/kg) / Placebo | EXPERIMENTAL | n = 4, randomized 3:1; 50 µg/kg BAY 86-6150 (B0189):Placebo |
| BAY Factor VII (90 µg/kg) / Placebo | EXPERIMENTAL | n = 4, randomized 3:1; 90 µg/kg BAY 86-6150 (B0189):Placebo |
| Name | Type | Description |
|---|---|---|
| BAY Factor VII (BAY86-6150) | DRUG | BAY Factor VII (BAY86-6150), 6.5 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1. |
| Placebo | DRUG | Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1. |
Inclusion Criteria: * History of moderate or severe congenital hemophilia A or B with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) * Male subjects 18-65 years of age inclusive * Able to dismiss factor replacement therapy during the course of the study unless required for the trea...
Top 8 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 15 | PHASE3 | Concizumab, Mim8, Denecimig, NNC0442-0344 A, turoctocog alfa pegol |
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Fitusiran, efanesoctocog alfa |
| Pfizer Inc. | PFE | 8 | PHASE3 | Fidanacogene elaparvovec, Marstacimab |
| BioMarin Pharmaceutical Inc. | BMRN | 2 | PHASE3 | Valoctocogene roxaparvovec |
| Hoffmann-La Roche | RHHBY | 8 | PHASE3 | Emicizumab, NXT007, SPK-8011QQ, SPK-8011, SPK-8016 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | REGV131, LNP1265 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE1 | AskBio009 |
| Bayer | BAYRY | 6 | - | Damoctocog-alfa-pegol |
BAY Factor VII is an investigational therapy being studied for hemophilia A, a bleeding disorder caused by missing or defective clotting factor VIII. It was evaluated in a Phase 1 trial in adults with moderate or severe hemophilia A or B, with or without inhibitors. It is not an approved treatment.
BAY Factor VII is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the clinical program for this factor VIIa variant, including the Phase 1 study conducted in Poland, South Africa, and the United Kingdom.
BAY Factor VII is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program enrolled 16 participants in a randomized, double-blind, controlled study. BAY Factor VII is investigational and has not been approved by the FDA.
BAY Factor VII was studied in NCT01921855, a completed Phase 1 trial titled Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors. It enrolled 16 male participants aged 18 and older across Poland, South Africa, and the United Kingdom.
Yes. BAY Factor VII is also known as BAY86-6150, and the two names refer to the same Bayer compound. The Phase 1 trial for this factor VIIa variant was registered under the BAY86-6150 designation, so searches for either name point to the same investigational hemophilia therapy.