Fitusiran is under clinical development by Sanofi and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Fitusiran’s likelihood of approval (LoA) and phase transition for Hemophilia A (Factor VIII Deficiency) took place on 11 Jul 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 11 Jul 2022 increased Fitusiran’s LoA and PTSR for Hemophilia B (Factor IX Deficiency).

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Fitusiran Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Fitusiran overview

Fitusiran (SAR-439774) is under development for the treatment of hemophilia A and B and other rare bleeding disorders. ALN-AT3 is administered through subcutaneous route. It is developed based on GalNAc-siRNA conjugate delivery platform and enhanced stabilization chemistry (ESC)-GalNAc delivery platform.

Sanofi overview

Sanofi is a healthcare company, which is engaged in the discovery, development, manufacturing and marketing of a wide range of medicines and vaccines. Its portfolio includes medicines for the treatment of cancer, diabetes, rare diseases, multiple sclerosis and cardiovascular diseases; human vaccines for protection against various bacterial and viral diseases; and other products. The company also offers consumer healthcare products for digestion; allergy; cough, cold, flu and sinus; pain; women’s health; and vitamins, minerals and supplements. Sanofi‘s R&D efforts focus on advancing a combination drugs to increase the effectiveness of treatments and on advancing the formulation of new biologics to produce precision medicines. It has operations in Europe, the Americas, Asia-Pacific, Africa and the Middle East. Sanofi is headquartered in Paris, France.

Quick View Fitusiran LOA Data

Report Segments
  • Innovator
Drug Name
  • Fitusiran
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Hematological Disorders
Key Developers
  • Sponsor Company: Sanofi
  • Originator: Alnylam Pharmaceuticals
Highest Development Stage
  • Phase III


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.