Florquinitau
As of the edition of 20 October 2026, Florquinitau is a small molecule: marketed, first approved in 2026 (US); acts on MAPT; US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Tauklarify
- First approved
- 13 August 2026 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- CERVEAU TECHNOLOGIES INC A LANTHEUS CO
- Registered trials
- 18, 2 stopped early
- Disease areas
- Nervous system; Mental health; Hormones; Nutrition and metabolism; Heart and blood vessels; Immune system
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 CERVEAU TECHNOLOGIES INC A LANTHEUS CO.
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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MAPT | Microtubule-associated protein tau | P10636 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 2 | 0 |
| Phase 1 | 8 | 4 | 3 | 1 |
| Phase 2 | 5 | 1 | 4 | 0 |
| Phase 3 | 2 | 0 | 1 | 1 |
| All trials | 18 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Lead sponsor of trials | 2015 to now |
| Sinotau Pharmaceutical | Lead sponsor of trials | 2024 to now |