Product Description
Idarucizumab, a monoclonal antibody fragment, binds dabigatran with an affinity that is 350 times as high as that observed with thrombin. Consequently, idarucizumab binds free and thrombin-bound dabigatran and neutralizes its activity. (Sourced from: https://www.nejm.org/doi/full/10.1056/nejmoa1502000)
Mechanisms of Action: Dabigatran Antagonist
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | 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 | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Injuries/wounds Unspecified
Known Adverse Events: Delirium | Headache | Hypokalemia | Pneumonia | Constipation
Company: Boehringer Ingelheim
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Injuries/wounds Unspecified|Venous Thromboembolism
Phase 2: Ischemic Stroke
Phase 1: Healthy Volunteers|Other
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| STROACT (STRoke on Oral AntiCoagulants for Thrombolysis) | P2 |
Active, not recruiting |
Ischemic Stroke |
2025-10-21 |
|
| RIC-ICH | N/A |
Completed |
Intracranial Hemorrhages |
2021-12-31 |
|
| CTR20171130 | P3 |
Completed |
Injuries/wounds Unspecified |
2020-12-10 |
|
| NCT02946931 | N/A |
Completed |
Other |
2020-11-03 |