Fitusiran
As of the edition of 20 October 2026, Fitusiran is an oligonucleotide: marketed, first approved in 2025 (US); acts on SERPINC1; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Oligonucleotide
- Brand name
- Qfitlia
- First approved
- 28 March 2025 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Sanofi
- Registered trials
- 9, 0 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Sanofi.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Target
| Gene | Protein | UniProt |
|---|---|---|
| SERPINC1 | Antithrombin-III | P01008 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 7 | 4 | 3 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 9 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator and Lead sponsor of trials | 2015 to now |