Fluciclovine
As of the edition of 20 October 2026, Fluciclovine is a small molecule: marketed, first approved in 2016 (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
- Axumin
- First approved
- 27 May 2016 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- Nihon Medi-Physics; 3 holders in all
- Registered trials
- 50, 7 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Nervous system; Pregnancy and women's health; Skin and connective tissue; Blood and lymph
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 | 5 | 3 | 0 | 1 |
| Phase 1 | 15 | 8 | 6 | 1 |
| Phase 2 | 19 | 10 | 6 | 3 |
| Phase 3 | 6 | 4 | 1 | 0 |
| Phase 4 | 5 | 0 | 2 | 2 |
| All trials | 50 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Blue Earth Diagnostics | Originator, Applicant and Lead sponsor of trials | 2015 to now |
| Nihon Medi-Physics | Applicant | 2021 to now |