Last reviewed · How we verify
Bypassing Agents
Bypassing agents are coagulation factors that activate the coagulation cascade downstream of factors VIII and IX to restore thrombin generation in patients with inhibitors to these factors.
Bypassing agents are coagulation factors that activate the coagulation cascade downstream of factors VIII and IX to restore thrombin generation in patients with inhibitors to these factors. Used for Hemophilia A with factor VIII inhibitors, Hemophilia B with factor IX inhibitors, Bleeding episodes in inhibitor patients.
At a glance
| Generic name | Bypassing Agents |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | Bypassing coagulation agent |
| Target | Factor X / Tissue factor pathway |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
These agents work by circumventing the need for functional factor VIII or factor IX, which are blocked by inhibitory antibodies in some hemophilia patients. They directly activate factor X or provide alternative pathways to generate thrombin, thereby restoring hemostatic capacity and preventing or treating bleeding episodes.
Approved indications
- Hemophilia A with factor VIII inhibitors
- Hemophilia B with factor IX inhibitors
- Bleeding episodes in inhibitor patients
Common side effects
- Thrombotic events
- Injection site reactions
- Headache
Key clinical trials
- A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B (PHASE3)
- Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (PHASE3)
- A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease (PHASE3)
- A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia (PHASE3)
- Emicizumab in Patients With Acquired Hemophilia A (PHASE2)
- A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab (PHASE4)
- Global Haemostatic Methods Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors
- Clinical Outcomes Between Pulsatile and Non-Pulsatile Flow During Cardiopulmonary Bypass
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bypassing Agents CI brief — competitive landscape report
- Bypassing Agents updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI