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: *
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: None
Company: Hoffmann-La Roche
Company Location:
Company Founding Year: 1896
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Colombia, France, Germany, Israel, Italy, Japan, Malaysia, Netherlands, Poland, South Africa, Spain, Sweden, Thailand, Turkey, United Kingdom, United States
Active Clinical Trial Count: 14
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Hemophilia A results on 2024-12-07 for Emicizumab
Highest Development Phases
Phase 3: Hemophilia A|Hemophilia B|von Willebrand Disease, Type 3|von Willebrand Diseases
Phase 1: Factor V Deficiency|Factor VII Deficiency
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06998524 |
WILL-EMI | P3 |
Recruiting |
von Willebrand Diseases|von Willebrand Disease, Type 3 |
2027-04-30 |
74% |
2026-05-19 |
|
NCT04563520 |
SAFE | P3 |
Recruiting |
Hemophilia A|Hemophilia B |
2027-03-01 |
50% |
2026-02-19 |
|
CTR20254539 |
CTR20254539 | P1 |
Completed |
Factor V Deficiency|Factor VII Deficiency|Hemophilia A |
2026-06-28 |
2026-11-01 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
2023-505964-13-00 |
MO41787 | P3 |
Active, not recruiting |
Hemophilia A |
2030-05-18 |
68% |
2025-05-02 |
Treatments |
2024-515622-80-00 |
WP45338 | P3 |
Not yet recruiting |
von Willebrand Disease, Type 3|von Willebrand Diseases |
2028-11-30 |
74% |
||
jRCT2071250029 |
jRCT2071250029 | P3 |
Not yet recruiting |
von Willebrand Diseases |
2028-11-30 |
|||
NCT06938659 |
AFEEL | P3 |
Not yet recruiting |
Hemophilia A |
2026-05-31 |
2025-04-23 |
||
2023-506610-52-00 |
BO41423 | P3 |
Active, not recruiting |
Hemophilia A |
2025-12-31 |
41% |
2025-05-02 |
Treatments |
2026-000042-29 |
HAVEN 5 | P3 |
Completed |
Hemophilia A |
2025-11-27 |
|||
NCT04431726 |
HAVEN 7 | P3 |
Active, not recruiting |
Hemophilia A |
2023-05-22 |
68% |
2023-01-05 |
Primary Completion Date|Primary Endpoints|Treatments |
2019-002179-32 |
2019-002179-32 | P3 |
Active, not recruiting |
Hemophilia A |
2021-10-08 |
41% |
2022-03-13 |
Treatments |
CTR20180012 |
CTR20180012 | P3 |
Active, not recruiting |
Hemophilia A |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
NCT05500807 |
BCDI-XII | P1 |
Recruiting |
von Willebrand Diseases|Hemophilia A|von Willebrand Disease, Type 3 |
2027-06-01 |
27% |
2026-04-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05345197 |
AHAEmi | P2 |
Active, not recruiting |
Hemophilia A |
2026-07-01 |
39% |
2025-11-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |