Piflufolastat
As of the edition of 20 October 2026, Piflufolastat is a small molecule: marketed, first approved in 2021 (US); acts on FOLH1; US protection ends in 2037.
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
- Pylarify
- First approved
- 26 May 2021 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Aphelion; 3 holders in all
- Registered trials
- 51, 9 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Digestive system; Pregnancy and women's health; Skin and connective tissue; Hormones
US protection
US protection ends in 2037.
The last listed US drug-substance patent ends in 2037. The application that gives this date is held by Lantheus Biosciences.
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 product7 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Piflufolastat.
See the 2 companies 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 | 8 | 5 | 2 | 0 |
| Phase 1 | 10 | 5 | 3 | 1 |
| Phase 2 | 21 | 4 | 12 | 4 |
| Phase 3 | 7 | 2 | 1 | 3 |
| Phase 4 | 5 | 1 | 3 | 1 |
| All trials | 51 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lantheus Biosciences | Originator and Lead sponsor of trials | 2016 to now |
| Curium PET | Applicant | 2023 to now |
| Aphelion | Later holder | 2026 to now |