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: *
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: None
Known Adverse Events: None
Company: Boehringer Ingelheim
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Venous Thromboembolism|Injuries/wounds Unspecified
Phase 1: Healthy Volunteers|Other
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| RIC-ICH | N/A |
Completed |
Intracranial Hemorrhages |
2021-12-31 |
2022-04-08 |
||
| NCT02946931 | N/A |
Completed |
Other |
2020-11-03 |
2022-09-10 |
Patient Enrollment|Primary Endpoints|Treatments |
|
| NCT03359889 | N/A |
Completed |
Thromboembolism |
2020-01-13 |
2023-08-27 |
||
| NCT02798107 | N/A |
Withdrawn |
Injuries/wounds Unspecified |
2019-05-23 |
2019-07-21 |
||
| CTR20160575 | P1 |
Completed |
Healthy Volunteers |
2017-09-28 |
2025-04-29 |
Patient Enrollment|Treatments |
|
| NCT03086356 | P1 |
Completed |
Healthy Volunteers |
2017-09-12 |
2019-03-21 |
||
| NCT02028780 | P1 |
Completed |
Healthy Volunteers |
2014-08-01 |
2019-03-20 |
Treatments |
|
| NCT01955720 | P1 |
Completed |
Other |
2014-05-01 |
2019-03-20 |
Treatments |
|
| NCT01688830 | P1 |
Completed |
Healthy Volunteers |
2013-11-01 |
2019-03-19 |
Treatments |
|
| CTR20171130 | P3 |
Completed |
Injuries/wounds Unspecified |
2020-12-10 |
2025-04-29 |
Patient Enrollment|Treatments |
|
| NCT03343704 | P3 |
Completed |
Injuries/wounds Unspecified |
2020-07-02 |
28% |
2021-08-21 |
Primary Endpoints|Treatments |
| NCT02815670 | P3 |
Completed |
Venous Thromboembolism |
2019-10-19 |
37% |
2019-11-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| 2015-002177-37 | P3 |
Completed |
Venous Thromboembolism |
2017-04-24 |
37% |
2025-07-06 |
Treatments |
| 2013-004813-41 | P3 |
Completed |
Injuries/wounds Unspecified |
2016-10-20 |
2022-03-13 |
Treatments |
|
| NCT02831660 | P3 |
Completed |
Injuries/wounds Unspecified |
2016-09-16 |
2019-03-20 |
Treatments |
|
| NCT02104947 | P3 |
Completed |
Injuries/wounds Unspecified |
2016-07-25 |
2019-03-20 |
||
| JapicCTI-152847 | P3 |
Completed |
Injuries/wounds Unspecified |
None |