NDASUBCUTANEOUSSOLUTION
Approved
Mar 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
9
Data completeness
5/8 — Partial
QFITLIA (fitusiran) by Sanofi. Approved for antithrombin-directed rna interaction [epc]. First approved in 2025.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QFITLIA (fitusiran) is a subcutaneous solution employing antithrombin-directed RNA interaction mechanism to treat bleeding disorders. It represents a novel approach to reducing excessive clotting factor activity by modulating antithrombin levels. The drug targets patients with hemophilia and related bleeding conditions who require improved hemostasis control.
Growth10.2 years to LOE
Recent approval positions this as an emerging growth asset with immediate commercial build-out requirements and expansion of haemophilia-focused teams.
Mechanism of Action
Pharmacologic Class:
Antithrombin-directed RNA Interaction
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
A 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
Started Dec 2025
85 enrolled
Hemophilia
A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab
Started Mar 2024
20 enrolled
Hemophilia A
A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
Started Feb 2023
91 enrolled
Hemophilia
Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B
Started Jan 2020
32 enrolled
Hemophilia
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
Started Jan 2019
281 enrolled
Hemophilia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.