Clofarabine
As of the edition of 20 October 2026, Clofarabine is a small molecule: marketed, first approved in 2004 (US); acts on RRM1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Clolar
- First approved
- 28 December 2004 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Withdrawn from market
- 18 October 2023 (in some regions)
- Registered trials
- 157, 40 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Inherited and neonatal; Heart and blood vessels; Infections
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| RRM1 | Ribonucleoside-diphosphate reductase large subunit | P23921 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 1 | 0 |
| Phase 1 | 41 | 30 | 1 | 10 |
| Phase 2 | 105 | 60 | 11 | 30 |
| Phase 3 | 7 | 6 | 1 | 0 |
| All trials | 157 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 2002 to now |