Flotufolastat gallium
As of the edition of 20 October 2026, Flotufolastat gallium is a small molecule: marketed, first approved in 2023 (US); acts on FOLH1; US protection ends in 2038.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Posluma
- First approved
- 25 May 2023 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Blue Earth Diagnostics
- Registered trials
- 16, 1 stopped early
- Disease areas
- Cancer; Urinary and reproductive
US protection
US protection ends in 2038.
The last listed US drug-substance patent ends in 2038. The application that gives this date is held by Blue Earth Diagnostics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product6 listings count towards this date. The exact date and each listing are in the product.
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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 gallium.
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 | 3 | 0 | 3 | 0 |
| Phase 1 | 5 | 2 | 2 | 1 |
| Phase 2 | 3 | 0 | 3 | 0 |
| Phase 3 | 4 | 2 | 1 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Blue Earth Diagnostics | Originator and Lead sponsor of trials | 2019 to now |