Pralatrexate
As of the edition of 20 October 2026, Pralatrexate is a small molecule: marketed, first approved in 2009 (US); acts on DHFR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Folotyn
- First approved
- 24 September 2009 (US)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Servier; 4 holders in all
- Registered trials
- 39, 5 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Lungs and airways; Digestive system
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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Pralatrexate.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| DHFR | Dihydrofolate reductase | P00374 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 1 | 0 |
| Phase 1 | 14 | 8 | 4 | 2 |
| Phase 2 | 19 | 15 | 3 | 1 |
| Phase 3 | 3 | 1 | 0 | 2 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 39 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Acrotech Biopharma | Acquired holder and Lead sponsor of trials | 2006 to now |
| Mundipharma | Later holder and Lead sponsor of trials | 2014 to now |
| Mundipharma | Applicant | 2017 to now |
| Servier | Applicant | 2018 to now |