Fludarabine
As of the edition of 20 October 2026, Fludarabine is a small molecule: marketed, first approved in 1991 (US); acts on POLA1; 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
- 12 in 5 regions
- Holder of the most recent approval
- Sanofi; 5 holders in all
- Registered trials
- 1,148, 245 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Skin and connective tissue; Heart and blood vessels; Urinary and reproductive
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Fludarabine.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| POLA1 | DNA polymerase alpha catalytic subunit | P09884 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 50 | 17 | 9 | 6 |
| Phase 1 | 427 | 86 | 179 | 93 |
| Phase 2 | 580 | 191 | 201 | 136 |
| Phase 3 | 72 | 28 | 26 | 8 |
| Phase 4 | 19 | 10 | 0 | 2 |
| All trials | 1,148 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Acquired holder and Lead sponsor of trials | 2005 to now |
| Caplin One | Acquired holder | 2026 to now |
| Bayer | Applicant |