Product Description
Caplacizumab, an anti–von Willebrand factor humanized, bivalent variable-domain-only immunoglobulin fragment, inhibits interaction between von Willebrand factor multimers and platelets. (Sourced from: https://www.nejm.org/doi/full/10.1056/NEJMoa1806311)
Mechanisms of Action: VWF Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous, Subcutaneous
FDA Designation: *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Colombia | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Saudi Arabia | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Belgium, Canada, Czech Republic, France, Germany, Greece, Italy, Japan, Netherlands, Spain, United Kingdom, United States
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Purpura, Thrombocytopenic|Purpura, Thrombotic Thrombocytopenic
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| MAYARI | P3 |
Completed |
Purpura, Thrombocytopenic|Purpura, Thrombotic Thrombocytopenic |
2024-12-26 |
12% |
2025-01-24 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| CAPLAVIE | P2 |
Active, not recruiting |
Purpura, Thrombocytopenic|Purpura, Thrombotic Thrombocytopenic |
2023-03-14 |
2022-03-13 |
Treatments |
|
| EFC16521 | P3 |
Completed |
Purpura, Thrombotic Thrombocytopenic|Purpura, Thrombocytopenic |
2024-11-06 |
2025-05-02 |
Treatments |
|
| JapicCTI-194939 | P3 |
Active |
Purpura, Thrombocytopenic|Purpura, Thrombotic Thrombocytopenic |
2021-07-31 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/19/2024 |
News Article |
TargED Biopharmaceuticals doses first participant in Phase 1 clinical trial of TGD001, a groundbreaking thrombolytic in acute ischemic stroke (AIS) and TTP |
|
07/10/2024 |
News Article |
Antonin (Tony) de Fougerolles appointed as new Chair of etherna |
|
07/10/2024 |
News Article |
Antonin (Tony) de Fougerolles appointed as new Chair of etherna |
|
01/16/2023 |
News Article |
Bleeding Disorder Treatment Market Size is expected to reach at USD 26,177 Million by 2030 |