Product Description
Alteplase injection is used to dissolve blood clots that have formed in the blood vessels. It is used immediately after symptoms of a heart attack occur to improve patient survival. It is also used after symptoms of a stroke and to treat blood clots in the lungs (pulmonary embolism). (Sourced from: https://www.mayoclinic.org/drugs-supplements/alteplase-recombinant-intravenous-route/description/drg-20070819)
Mechanisms of Action: PA Inhibitor, PLA Activator
Novel Mechanism: No
Modality: Coagulation Factor
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Boehringer Ingelheim
Company Location: Europe
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Belgium, Canada, China, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovenia, Spain, Switzerland
Active Clinical Trial Count: 11
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Acute Respiratory Distress Syndrome|Atrial Fibrillation|Brain Infarction|COVID-19|Cerebral Hemorrhage|Intracranial Hemorrhages|Ischemic Stroke|Macular Degeneration|Pulmonary Embolism|Retinal Artery Occlusion
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2020-004917-10 |
TIGER | P3 |
Active, not recruiting |
Macular Degeneration |
2029-02-28 |
|||
NCT06878066 |
SIFT | P3 |
Recruiting |
Ischemic Stroke|Cerebral Hemorrhage|Intracranial Hemorrhages|Brain Infarction|Atrial Fibrillation |
2028-12-31 |
2025-04-30 |
Primary Endpoints|Start Date|Treatments |
|
2020-002913-16 |
2020-002913-16 | P3 |
Active, not recruiting |
COVID-19|Acute Respiratory Distress Syndrome |
2022-08-26 |
46% |
2022-03-13 |
Treatments |
NCT04430569 |
PEITHO-3 | P3 |
Recruiting |
Pulmonary Embolism |
2026-09-01 |
76% |
2025-05-17 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2021-000183-29 |
2021-000183-29 | P3 |
Active, not recruiting |
Retinal Artery Occlusion |
2025-12-13 |
|||
CTR20244138 |
CTR20244138 | P2 |
Recruiting |
Ischemic Stroke |
None |
2025-04-29 |
Patient Enrollment|Treatments|Trial Status |
|
2017-002061-22 |
THEIA | P3 |
Active, not recruiting |
Retinal Artery Occlusion |
2019-12-12 |
|||
2023-506935-14-01 |
2020PI054 | P3 |
Not yet recruiting |
Ischemic Stroke |
2029-05-31 |
2025-05-02 |
Treatments |
|
CTR20210640 |
CTR20210640 | P3 |
Completed |
Ischemic Stroke |
2023-10-20 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT04688320 |
FORPE | P3 |
Completed |
Pulmonary Embolism |
2023-07-27 |
31% |
2023-08-05 |
|
NCT05295173 |
CRAD-001-03 | P3 |
Completed |
Ischemic Stroke |
2023-06-22 |
8% |
2023-09-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/17/2025 |
News Article |
Health Canada authorizes TNKase® (tenecteplase) for the treatment of Acute Ischemic Stroke (AIS) |
|
11/26/2025 |
News Article |
Teleneurology Market Size to Worth USD 20.30 Billion by 2034 |
|
10/23/2025 |
News Article |
[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong sales growth momentum of 7% (CER) in the first nine months of 2025; full-year earnings outlook raised |
|
07/24/2025 |
News Article |
[Ad hoc announcement pursuant to Art. 53 LR] Roche continues strong momentum with 7% growth (CER) in the first half of 2025 |