Alteplase
As of the edition of 20 October 2026, Alteplase is an enzyme: marketed, first approved in 1987 (US); US protection ended in 1999.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Enzyme
- Brand name
- Activase
- First approved
- 13 November 1987 (US)
- Approvals on record
- 13 in 7 regions
- Holder of the most recent approval
- Boehringer Ingelheim; 5 holders in all
- Registered trials
- 126, 22 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Lungs and airways; Infections; Eye; Injuries
US protection
US protection ended in 1999.
US protection ended in 1999, 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.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 42 | 20 | 5 | 6 |
| Phase 1 | 8 | 2 | 2 | 4 |
| Phase 2 | 20 | 14 | 1 | 2 |
| Phase 3 | 38 | 23 | 5 | 7 |
| Phase 4 | 18 | 8 | 5 | 3 |
| All trials | 126 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 1987 to now |
| Boehringer Ingelheim | Applicant and Lead sponsor of trials | 1988 to now |
| Mitsubishi Tanabe Pharma | Applicant |