fitusiran
Nucleic acidapprovedOrphan Drug FDA
Approved
Mar 28, 2025
Clinical trial activity
11 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
8
Phase 3
7
Phase 4
0
Earliest trial started Jan 1, 2014 (NCT02035605)
Timeline
Indications
Approved for
Studied for
Mechanism of action
- Antithrombin mRNARNAI INHIBITOR
Antithrombin mRNA RNAi inhibitor
Approval history
- approvedMar 28, 2025
Chemistry & pharmacology
- Inorganic
- No
- Polymer
- No
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4297754 ↗
Also known as
- aln-at3sc
- fitusiran
- fitusiran
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07285460 | Phase 3 | Dec 19, 2025 | Sanofi |
| NCT06145373 | Phase 1 | Dec 15, 2023 | Sanofi |
| NCT05662319 | Phase 3 | Jan 13, 2023 | Sanofi |
| NCT04394286 | Phase 1/Phase 2 (Phase 2) | May 30, 2020 | Shire |
| NCT03974113 | Phase 2/Phase 3 (Phase 3) | Jun 17, 2019 | Genzyme, Sanofi |
| NCT03754790 | Phase 3 | Jan 9, 2019 | Genzyme, Sanofi |
| NCT03417245 | Phase 3 | Jul 2, 2018 | Genzyme, Sanofi |
| NCT03549871 | Phase 3 | May 28, 2018 | Sanofi |
| NCT03417102 | Phase 3 | Mar 22, 2018 | Genzyme, Sanofi |
| NCT02554773 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2015 | Alnylam Pharmaceuticals |
| NCT02035605 | Phase 1 | Jan 1, 2014 | Alnylam Pharmaceuticals |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 8 | 4 | 2 | 2018 |
| Genzyme | For profit | 4 | 4 | 1 | 2018 |
| Alnylam Pharmaceuticals | For profit | 2 | 2 | 2 | 2014 |
| Shire | For profit | 1 | 1 | 1 | 2020 |
4 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Genzyme | For profit | MKTG | Mar 28, 2025 |