QFITLIA

Launch

fitusiran

NDASUBCUTANEOUSSOLUTION
Approved
Mar 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
9

Mechanism of Action

double-stranded siRNA that causes degradation of AT messenger RNA (mRNA) through RNA interference, reducing plasma AT levels.

Pharmacologic Class:

Antithrombin-directed RNA Interaction

Clinical Trials (5)

NCT07285460Phase 3Recruiting

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
NCT06145373Phase 4Recruiting

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
NCT05662319Phase 3Active Not Recruiting

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
NCT03974113Phase 3Active Not Recruiting

Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B

Started Jan 2020
32 enrolled
Hemophilia
NCT03754790Phase 3Active Not Recruiting

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

Loss of Exclusivity

LOE Date
Dec 7, 2036
131 months away
Patent Expiry
Dec 7, 2036
Exclusivity Expiry
Mar 28, 2032

Patent Records (3)

Patent #ExpiryTypeUse Code
9376680
Mar 15, 2033
SubstanceProduct
U-4165
9127274
Mar 22, 2033
SubstanceProduct
U-4165
11091759
Dec 7, 2036
U-4165