Leucovorin
As of the edition of 20 October 2026, Leucovorin is a small molecule: marketed, first approved in 1982 (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 2021
- Kind
- Small molecule
- Brand name
- Wellcovorin
- First approved
- 1 January 1982 (US)
- Approvals on record
- 18 in 5 regions
- Holder of the most recent approval
- Avyxa; 5 holders in all
- Registered trials
- 1,095, 180 stopped early
- Disease areas
- Cancer; Digestive system; Immune system; Blood and lymph; Hormones; 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 | 39 | 21 | 4 | 5 |
| Phase 1 | 188 | 116 | 43 | 22 |
| Phase 2 | 613 | 280 | 132 | 130 |
| Phase 3 | 243 | 125 | 56 | 23 |
| Phase 4 | 12 | 4 | 5 | 0 |
| All trials | 1,095 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Later holder and Lead sponsor of trials | 1983 to now |
| Pfizer | Applicant, Acquired holder, Earlier holder and Lead sponsor of trials | 1996 to now |
| Xanodyne Pharmaceutics | Acquired holder | 2008 to now |
| Avyxa | Later holder | 2026 to now |