Pafolacianine
As of the edition of 20 October 2026, Pafolacianine is a small molecule: marketed, first approved in 2021 (US); acts on FOLR1; US protection ends in 2035.
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
- Cytalux
- First approved
- 29 November 2021 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- On Target
- Registered trials
- 17, 2 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Hormones; Digestive system; Lungs and airways
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by On Target.
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 product8 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 Pafolacianine.
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 |
|---|---|---|
| FOLR1 | Folate receptor alpha | P15328 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 6 | 1 | 3 | 2 |
| Phase 2 | 4 | 3 | 1 | 0 |
| Phase 3 | 3 | 2 | 1 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| On Target | Originator and Lead sponsor of trials | 2014 to now |