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fitusiran

Generic: FITUSIRAN SODIUM·Brand: QFITLIA, Qfitlia

fitusiran: 5 clinical trials tracked.

fitusiran evidence translation

What we can confirm

5 tracked trials

No verified listed company relationship

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about fitusiran, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 1 study sponsors

Related indications

Clinical Trial Registry Records (5)

An Open-label, Parallel, Phase 3, Two-arm Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B With or Without Inhibitory Antibodies to Factors VIII or IX

NCT07285460Registry updated 2026-08-17·Phase 3·SNY
Recruiting

Primary endpoint: Annualized treated bleeding rate (ABR) in the fitusiran primary efficacy period and in the SOC period

Interventionalopen85 targetStarted 2025-12Completion 2031-1230 sites · Belgium, Brazil, Canada, China…Sanofi

An Open-label, Single-arm Treatment Study to Investigate the Safety and Tolerability of Switching From Emicizumab to Fitusiran Prophylaxis in Male Participants Aged ≥12 Years of Age With Severe Hemophilia A, With or Without Inhibitors

NCT06145373Registry updated 2026-06-02·Phase 4·SNY
Recruiting

Primary endpoint: Number of participants with Adverse events (AEs) during the fitusiran treatment

Interventionalopen20 targetStarted 2024-03Completion 2030-012 sites · Taiwan, United StatesSanofi

A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ≥ 12 Years With Severe Hemophilia A or B With or Without Inhibitory Antibodies to Factor VIII or IX

NCT05662319Registry updated 2026-02-04·Phase 3·SNY
Active, not recruiting

Primary endpoint: Annualized bleeding rate (ABR) in the fitusiran primary efficacy period

Interventionalopen91 targetStarted 2023-02Completion 2029-0150 sites · Canada, China, France, Germany…Sanofi

ATLAS-PEDS: An Open-label, Multinational Study of Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B

NCT03974113Registry updated 2026-06-22·Phase 2/Phase 3
Active, not recruiting

Primary endpoint: Plasma antithrombin (AT) activity levels

Interventionalopen32 targetStarted 2020-01Completion 2026-1216 sites · Canada, India, Italy, Spain…Genzyme, a Sanofi Company

An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

NCT03754790Registry updated 2025-12-17·Phase 3
Active, not recruiting

Primary endpoint: Number of participants with treatment emergent adverse events (TEAEs)

Interventionalopen281 targetStarted 2019-01Completion 2026-1150 sites · Australia, Canada, China, Denmark…Genzyme, a Sanofi Company