Fludarabine phosphate
As of the edition of 20 October 2026, Fludarabine phosphate is a small molecule: marketed, first approved in 1991 (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 2007
- Kind
- Small molecule
- Brand name
- Fludara
- First approved
- 18 April 1991 (US)
- Approvals on record
- 10 in 3 regions
- Holder of the most recent approval
- Sanofi; 4 holders in all
- Registered trials
- 412, 89 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Inherited and neonatal; 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.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Fludarabine phosphate.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| RRM1 | Ribonucleoside-diphosphate reductase large subunit | P23921 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 14 | 1 | 7 |
| Phase 1 | 97 | 46 | 26 | 20 |
| Phase 2 | 267 | 160 | 32 | 60 |
| Phase 3 | 23 | 17 | 2 | 2 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 412 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Acquired holder and Lead sponsor of trials | 2000 to now |
| Bayer | Applicant and Lead sponsor of trials | 2003 to now |
| Caplin One | Acquired holder | 2026 to now |