Product Description
Emicizumab is a medication used in the management and treatment of hemophilia A. It belongs to the bispecific monoclonal antibody class of medications. The drug emicizumab is a bispecific monoclonal antibody that restores the function of missing activated FVIII by bridging FIXa and FX, basically mimicking activated Factor VIIIa independently of Factor VIII levels. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK559180/)
Mechanisms of Action: FXa Activator,FIX Activator
Novel Mechanism: No
Modality: Bispecific Antibody
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Factor V Deficiency | Factor VII Deficiency | Factor X Deficiency | Injuries/wounds Unspecified
Known Adverse Events: Headache | Arthralgia
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Israel, Italy, Malaysia, Netherlands, Poland, South Africa, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 14
Highest Development Phases
Phase 3: Deficiency Diseases|Factor V Deficiency|Factor VII Deficiency|Hemophilia|Hemophilia A
Phase 1: von Willebrand Disease, Type 3|von Willebrand Diseases
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| MO41787 | P3 |
Unknown Status |
Hemophilia A |
2030-05-18 |
|
| 2020-001733-12 | P3 |
Active, not recruiting |
Hemophilia A |
2030-04-15 |
|
| SFY17741 | P1 |
Recruiting |
Hemophilia A |
2026-09-19 |
21% |
| SFY17741 | P1 |
Recruiting |
Hemophilia A |
2026-09-19 |
21% |
| BO41423 | P3 |
Unknown Status |
Hemophilia A |
2025-12-31 |