Asparaginase
As of the edition of 20 October 2026, Asparaginase is an enzyme: marketed, first approved in 1978 (US); US protection ended in 1990.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Enzyme
- Brand name
- Elspar
- First approved
- 10 January 1978 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- STEINCARES FARMACEUTICA DO BRASIL LTDA; 4 holders in all
- Registered trials
- 115, 11 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Infections; Inherited and neonatal; Nervous system
US protection
US protection ended in 1990.
US protection ended in 1990, 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 Recordati Rare Diseases. 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 | 13 | 9 | 0 | 1 |
| Phase 1 | 4 | 3 | 0 | 1 |
| Phase 2 | 44 | 28 | 6 | 5 |
| Phase 3 | 40 | 27 | 2 | 4 |
| Phase 4 | 14 | 12 | 0 | 0 |
| All trials | 115 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Recordati Rare Diseases | Applicant | 1978 to now |
| Medac Gesellschaft fuer klinische Spezialpraeparate mbH | Applicant | 2016 to now |