Reteplase
As of the edition of 20 October 2026, Reteplase is an enzyme: marketed, first approved in 1996 (US); US protection ended in 2008.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Enzyme
- Brand name
- Retavase
- First approved
- 30 October 1996 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Chiesi
- Withdrawn from market
- 26 January 2024 (in some regions)
- Registered trials
- 9, 4 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Chemically induced; Injuries
US protection
US protection ended in 2008.
US protection ended in 2008, 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 Chiesi. 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 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 6 | 2 | 1 | 3 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 9 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Critical Therapeutics | Earlier holder | 1996 to now |
| Chiesi | Acquired holder | 2020 to now |