Flotufolastat
As of the edition of 20 October 2026, Flotufolastat is a small molecule: in active development; acts on FOLH1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2025
- Kind
- Small molecule
- Registered trials
- 7, 0 stopped early
- Disease areas
- Cancer; Urinary and reproductive
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.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Flotufolastat.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| FOLH1 | Glutamate carboxypeptidase 2 | Q04609 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 2 | 0 | 2 | 0 |
| Phase 2 | 3 | 0 | 3 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 7 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Blue Earth Diagnostics | Lead sponsor of trials | 2024 to now |
| Sinotau Pharmaceutical | Lead sponsor of trials | 2025 to now |