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Qfitlia

(Fitusiran)

ApprovedRNA therapy

GGenzyme, a Sanofi Company

Qfitlia is a rna therapy that works as Antithrombin Sirna.[2] It is being used across 2 indications, with its most advanced program in Approved.[1]

Qfitlia is one of 32 sirna programs targeting Hemophilia A. It is currently in Approved.

2

Indications

9

Total Trials

4

Active Trials

31

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[3][1]

Indication

Hemophilia aActive, not recruiting

HemophiliaRecruiting

Hemophilia aPhase 3

Active, not recruiting

HemophiliaApproved

Recruiting

Competition

Competitive Landscape

35 competitors in Hemophilia a

#DrugCompanyPhaseTrials

Hemlibra

Rayos

RRoxane Laboratories

Cyklokapron

Qfitlia

GGenzyme, a Sanofi Company

Efanesoctocog Alfa

Advate

Marstacimab

Rfviia

PF-06741086

SCT800

SSinocelltech Ltd.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Hemophilia a

NCT03754790

Q1 2029

Phase 3Active, not recruiting

Hemophilia

NCT05662319

Q4 2029

Post-ApprovalRecruiting

Hemophilia

NCT06145373

Q4 2031

Phase 3Recruiting

Hemophilia

NCT07285460

Clinical

Trials by Indication[1]

Severe Hemophilia a4 trials

An Open-label Extension Study of an Investigational Drug, Fitusiran, in Patients With Moderate or Severe Hemophilia A or B

Completed· Sanofi logo

Sanofi·Phase 1/2·NCT02554773·34 enrolled

A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients Without Inhibitors

Completed· Sanofi logo

Sanofi·Phase 3·NCT03417245·120 enrolled

A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis

Completed· Sanofi logo

Sanofi·Phase 3·NCT03549871·80 enrolled

Show 1 more trial

A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors

Completed· Sanofi logo

Sanofi·Phase 3·NCT03417102·60 enrolled

Hemophilia4 trials

A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab

Recruiting· Sanofi logo

Sanofi·Phase 4·NCT06145373·20 enrolled

A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT05662319·91 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 3·NCT03974113·32 enrolled

Show 1 more trial

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

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT07285460·85 enrolled

Hemophilia A1 trial

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

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT03754790·281 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 28, 2025

QFITLIA

NDA NDA219019

Mar 28, 2025

QFITLIA

NDA NDA219019

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Fitusiran. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fitusiran compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fitusiran. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219019). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Qfitlia. U.S. Food & Drug Administration.
[6]
PubMed — 10 publications indexed for Fitusiran. U.S. National Library of Medicine.
[7]
SEC EDGAR — Genzyme, a Sanofi Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Antithrombin Sirna[2]
Modality: RNA therapy[2]
Highest Phase: Approved[1]
Company: GGenzyme, a Sanofi Company

Patent Landscape[5]

Patent Cliff

Mar 15, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9376680Mar 15, 2033

9127274Mar 22, 2033

11091759Dec 7, 2036

Key Publications[6]

METTL3-Mediated m6A Modification of COL5A2 Inhibits Ferroptosis Through an IGF2BP3-dependent Mechanism in Gastric Cancer.

Technol Cancer Res TreatDec 1, 2026DOI: 10.1177/15330338261481298

Microenvironment-adaptive drug delivery systems for ulcerative colitis: from pathological constraints to rational design.

Expert Opin Drug DelivAug 28, 2026DOI: 10.1080/17425247.2026.2726474

From operating room to circuit mechanisms: Clinical basic science partnerships as a strategic model for human neuroscience.

EpilepsiaAug 28, 2026DOI: 10.1002/epi.70462

Long-term efficacy of adjunctive cenobamate: Open-label extension of a randomized, placebo-controlled study in a multinational Asian population.

EpilepsiaAug 28, 2026DOI: 10.1002/epi.70459

Extended Follow-Up of Botensilimab Plus Balstilimab in an Expanded Cohort of Microsatellite-Stable Metastatic Colorectal Cancer Without Active Liver Metastases.

Clin Cancer ResAug 28, 2026DOI: 10.1158/1078-0432.CCR-26-1610

Managing Malaria outbreak in a village nested in tea garden of Jalpaiguri district, West Bengal, India 2023-2024.

J Vector Borne DisAug 28, 2026DOI: 10.4103/jvbd.jvbd_152_26

Implementation of a Digital Clinical Management Platform in a Tertiary Pediatric Hemato-Oncology Center: Impact on Clinical Outcomes and Patient Safety.

J Pediatr Hematol OncolAug 28, 2026DOI: 10.1097/MPH.0000000000003267

Association of Imaging-Defined Deep Invasion and Tumor Volume With Clinical Cervical Lymph Node Metastasis in Hypopharyngeal Carcinoma.

J Comput Assist TomogrAug 28, 2026DOI: 10.1097/RCT.0000000000001919

Clinical and Epidemiological Characteristics of Infants <6 Months With Leukemia, Neuroblastoma, and Retinoblastoma in a Single Center in Iran.

J Pediatr Hematol OncolAug 28, 2026DOI: 10.1097/MPH.0000000000003268

68Ga-FAPI PET/CT for assessing fibroblast activation and disease activity in primary Sjögren's disease: a prospective case-control study.

Rheumatology (Oxford)Aug 28, 2026DOI: 10.1093/rheumatology/keag440

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