Levoleucovorin
As of the edition of 20 October 2026, Levoleucovorin is a small molecule: marketed, first approved in 2004 (FR).
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
- Fusilev
- First approved
- 31 March 2004 (FR)
- Approvals on record
- 10 in 3 regions
- Holder of the most recent approval
- Acrotech Biopharma; 4 holders in all
- Registered trials
- 51, 7 stopped early
- Disease areas
- Cancer; Digestive system; Blood and lymph; Hormones; Immune system; Infections
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 1 | 0 |
| Phase 1 | 4 | 1 | 1 | 2 |
| Phase 2 | 26 | 6 | 13 | 4 |
| Phase 3 | 18 | 7 | 10 | 1 |
| All trials | 51 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 2002 to now |
| Acrotech Biopharma | Acquired holder and Lead sponsor of trials | 2013 to now |
| Actavis | Later holder | 2016 to now |
| Zydus Worldwide DMCC | Originator | 2008 to 2022 |