Factor Xa Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2023

Factor X is the zymogen of a serine protease. Factor X, also known by the eponym Stuart–Prower factor, is an enzyme of the coagulation cascade. It is a serine endopeptidase. Factor X is synthesized in the liver and requires vitamin K for its synthesis. Factor X is activated by hydrolysis into factor Xa by both factor IX and factor VII with its cofactor, tissue factor. It is therefore the first member of the final common pathway or thrombin pathway. Factor Xa is generated by both the extrinsic and intrinsic coagulation pathways and is responsible for activating prothrombin to thrombin. Mechansism of action (MOA) of Factor Xa Inhibitor is that work by selectively and reversibly blocking the activity of clotting factor Xa, preventing clot formation. They affect both factor Xa within the blood and within a preexisting clot and do not affect platelet aggregation. Factor Xa Inhibitor for the treatment and prevention of deep vein thrombosis, acute pulmonary embolism, to reduce the risk of stroke and embolism in people with nonvalvular atrial fibrillation, reperfusion injury, acute coronary syndrome, heart diseases, kidney diseases, etc. Increased prevalence of cardiovascular disorders and changing lifestyle are the key drivers for the Factor Xa Inhibitor market. For instance, According to the Centers for Disease Control And Prevention 2021, every year, about 805,000 people in the United States have a heart attack. Launch of newer products by the market players could seek opportunities that influence extensive research and development in the Factor Xa Inhibitor market. For instance, Daiichi Sankyo Savaysa (Edoxaban) is used to treat venous thromboembolism, and atrial fibrillation. Moreover, the development of novel molecules by many market player are coming up to overcome challenges in therapy. For instance, Pfizer’s Marstacimab (PF-06741086)  for the treatment to prevent or reduce the frequency of bleeding episodes in individuals with severe hemophilia A are under the various stages of clinical studies.

Factor Xa Inhibitor Market Key Developments:

• In May 2018, Portola Pharmaceuticals received FDA approval for Andexxa (Coagulation Factor Xa (Recombinant), Inactivated-Zhzo) for the treatment of reversal of factor Xa inhibitors.
• In April 2021, Aspen Pharma (Nadroparin) has found that high therapeutic nadroparin dosages in preterm and term neonates seem to be safe with Venous Thromboembolism.

Approved Drug Molecules and Brand Names for Factor Xa Inhibitor:

• Savaysa (Edoxaban)
• Innohep (Tinzaparin)
• Fraxiparine (Nadroparin)
• Hibor (Bemiparin)
• Andexxa (Coagulation Factor Xa (Recombinant), Inactivated -Zhzo)
• Bevyxxa (Betrixaban)
• Orgaran (Danaparoid)

Drugs under the Pipeline for Factor Xa Inhibitor:

• Darexaban Maleate (YM150)
• Ciraparantag (Aripazine)
• Sandoparin (Certoparin Sodium)
• Idraparinux Sodium (SANORG 34006)
• Otamixaban (XRP0673)
• Inhixa (Enoxaparin Biosimilar)
• Dimolegin (Dioxaban)
• Ckd-344
• Gcc-4401c
• Syha136

Clinical Activity and Developments of Factor Xa Inhibitor:

Till June 2023, more than 15 companies having approximately 21 molecules targetting the number of cardiovascualr diseases. For these molecules, more than 347 clinical trials are being conducted and majority are in phase-2, phase-3 clinical trials by the players across the globe. For instance,

• In February 2023, AstraZeneca’s Bevyxxa (Betrixaban) has completed phase 3, a multicenter, randomized, active-controlled study for evaluating the safety and efficacy for the prevention of venous thromboembolism in acute ill patients.
• In February 2021, Merck’s Danaparoid completed phase 1, double blind, randomised, single centre, parallel group study for evaluating the safety and tolerability of Danaparoid (DNDI-0690) in healthy subjects for cutaneous leishmaniasis.