Product Description
Dabigatran etexilate is a low-molecular-weight prodrug that exhibits no pharmacological activity. After oral administration, dabigatran etexilate is converted to its active form, dabigatran, a potent, competitive, and reversible direct inhibitor of the active site of thrombin, the final effector in blood coagulation (Sourced from: https://www.ahajournals.org/doi/10.1161/circulationaha.110.004424)
Mechanisms of Action: DT Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Malta | Netherlands | New Zealand | Norway | Philippines | Poland | Portugal | Romania | Russia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela | Vietnam
Approved Indications: Atrial Fibrillation | Embolism | Embolism and Thrombosis | Thrombosis | Venous Thrombosis | Stroke | Pulmonary Embolism
Known Adverse Events: Injuries/wounds Unspecified
Company: Boehringer Ingelheim
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, United States
Active Clinical Trial Count: 3
Highest Development Phases
Phase 1: Cushing Syndrome|Healthy Volunteers|Male Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| BUS-P1-12 | P1 |
Completed |
Healthy Volunteers |
2023-10-13 |
|
| BUS-P1-12 | P1 |
Completed |
Healthy Volunteers |
2023-10-13 |
|
| D8532C00004 | P1 |
Completed |
Male Breast Cancer |
2022-12-13 |
44% |
| CORT125134-132 | P1 |
Completed |
Cushing Syndrome |
2022-07-19 |
21% |