Cytarabine
As of the edition of 20 October 2026, Cytarabine is a small molecule: marketed, first approved in 1970 (ES); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Depocyt
- First approved
- 1 December 1970 (ES)
- Approvals on record
- 19 in 7 regions
- Holder of the most recent approval
- Jazz Pharmaceuticals; 6 holders in all
- Registered trials
- 1,161, 191 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Infections; Inherited and neonatal; Nervous system
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Jazz Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 59 | 21 | 11 | 8 |
| Phase 1 | 223 | 121 | 38 | 55 |
| Phase 2 | 636 | 325 | 133 | 114 |
| Phase 3 | 210 | 104 | 50 | 13 |
| Phase 4 | 33 | 21 | 3 | 1 |
| All trials | 1,161 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant, Earlier holder and Lead sponsor of trials | 1996 to now |
| Pacira Pharmaceuticals | Acquired holder and Lead sponsor of trials | 1997 to now |
| SkyePharma | Later holder | 1999 to now |
| Teva | Acquired holder | 2008 to now |
| Jazz Pharmaceuticals | Applicant and Lead sponsor of trials | 2016 to now |
| Nippon Shinyaku | Applicant | 2020 to now |