Cladribine
As of the edition of 20 October 2026, Cladribine is a small molecule: marketed, first approved in 1993 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Leustatin
- First approved
- 26 February 1993 (US)
- Approvals on record
- 9 in 6 regions
- Holder of the most recent approval
- MAWDSLEYS PHARMACEUTICALS DO BRASIL LTDA; 9 holders in all
- Registered trials
- 115, 10 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Nervous system; 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 11 | 4 | 3 | 0 |
| Phase 1 | 19 | 10 | 2 | 6 |
| Phase 2 | 56 | 25 | 19 | 4 |
| Phase 3 | 18 | 5 | 5 | 0 |
| Phase 4 | 11 | 7 | 2 | 0 |
| All trials | 115 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lipomed | Applicant | 2004 to now |
| Merck KGaA | Later holder and Lead sponsor of trials | 2005 to now |
| Johnson & Johnson | Applicant and Acquired holder | 2011 to now |
| Merck & Co. | Applicant | 2019 to now |