Tenecteplase
As of the edition of 20 October 2026, Tenecteplase is an enzyme: marketed, first approved in 2000 (US); US protection ended in 2012.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2001
- Kind
- Enzyme
- Brand name
- TNKase
- First approved
- 2 June 2000 (US)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Roche; 3 holders in all
- Withdrawn from market
- 9 August 2005 (in some regions)
- Registered trials
- 95, 9 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Lungs and airways; Chemically induced; Infections; Injuries
US protection
US protection ended in 2012.
US protection ended in 2012, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Roche. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 4 | 5 | 0 |
| Phase 1 | 3 | 1 | 1 | 1 |
| Phase 2 | 14 | 9 | 2 | 1 |
| Phase 3 | 54 | 24 | 24 | 5 |
| Phase 4 | 14 | 4 | 5 | 2 |
| All trials | 95 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Applicant and Lead sponsor of trials | 2000 to now |
| Roche | Applicant and Lead sponsor of trials | 2000 to now |