Factor X, also known as Stuart-Prower factor, is a serine endopeptidase enzyme, which is synthesized in the liver and requires vitamin K for its synthesis, thus deficiency of both factor X and vitamin K results in hemolysis. Factor X inhibitors act as anticoagulants and competitively inhibit free and clot-bound factor Xa, which terminates the amplification of thrombin generation which is required to complete the clotting process. Factor X stimulants exert their action by binding to factor X and performing the required bridging activity for the launch of the coagulation cascade. Factor X inhibitors are indicated for the prevention of venous thromboembolic events, stroke, deep vein thrombosis, and pulmonary embolism. Factor X modulators are primarily used in the prevention of bleeding episodes. Daiichi Sankyo Pharmaceutical, Pfizer, Eisai, LEO Pharma, Roche, Astellas Pharma, AstraZeneca, Novartis, and Sanofi are some of the major players in the factor X modulators market.
Key Market Developments:
- In Feb 2023, Novo Nordisk and Genmab agreed to co-promote and co-develop MIM 8, a blood coagulation factor stimulant in the USA for hemophilia
- In Jun 2023, the NMPA granted approval to initiate ASTER and MANGOLIA for cancer-associated thrombosis and LILACTIMI 76 trial in atrial fibrillation in China for Novartis’s Abelacimab.
Approved Drug Molecules and Brand Names for Factor X Modulators:
- Rivaroxaban
- Enoxaparin sodium
- Apixaban
- Savaysa (Edoxaban)
- Fragmin (Dalteparin sodium)
- Fondaparinux
- Innohep (Tinzaparin)
- Fraxiparine (Nadroparin)
- Hemlibra (Emicizumab-kxwh)
- Hibor (Bemiparin)
- AndexXa (coagulation factor Xa (recombinant), inactivated zh-zo)
- Sandoparin (Certoparin sodium)
- Inhixa (Enoxaparin biosimilar)
- Prothromplex (Prothrombin complex)
Drugs under the Pipeline for Factor X Modulators:
- Darexaban maleate (YM150)
- Bevyxxa (Betrixaban)
- Ciraparantag (Aripazine)
- Abelacimab (MAA868)
- Idraparinux sodium (SANORG 34006)
- Otamixaban (XRP0673)
- MK-2060
- ALT 836
- Dimolegin (Dioxaban)
- IONIS-FXIRx
- Orgaran (Danaparoid)
- STSP-0601
- Gruticibart (Ab023)
- Ckd-344
- GCC-4401C
- REGN9933
- Fesomersen (IONIS-FXI-LRx)
- Byclot (freeze-dried activated human blood coagulation factor VIIa concentrate containing factor X)
- RBD4059
- REGN7508
- SYHA136
Clinical Activity and Developments of Factor X Modulators:
Currently, there are about 39 drug products in the Factor X modulators, including 14 approved products in the market and others are in the clinical trial phases.
- In Jan 2023, Regeneron Pharmaceuticals conducted a phase-I clinical trial for thrombosis in the UK in volunteers for REGN-7508, a factor XI inhibitor.
- In Jan 2023, Staidson Beijing BioPharmaceuticals conducted phase-II clinical trials for hemophilia A and hemophilia B in China for STSP-0601, a factor X activator injection.
|
Molecule Name |
Number of Studies |
|
Darexaban maleate (YM150) |
26 |
|
Bevyxxa (Betrixaban) |
13 |
|
Ciraparantag (Aripazine) |
8 |
|
Abelacimab (MAA868) |
8 |
|
Idraparinux sodium (SANORG 34006) |
7 |
|
Otamixaban (XRP0673) |
6 |
|
MK-2060 |
5 |
|
ALT 836 |
3 |
|
Dimolegin (Dioxaban) |
3 |
|
IONIS-FXIRx |
3 |
|
Orgaran (Danaparoid) |
3 |
|
STSP-0601 |
3 |
|
Gruticibart (Ab023) |
2 |
|
Ckd-344 |
2 |
|
GCC-4401C |
2 |
|
REGN9933 |
2 |
|
Fesomersen (IONIS-FXI-LRx) |
1 |
|
Byclot (freeze-dried activated human blood coagulation factor VIIa concentrate containing factor X) |
1 |
|
RBD4059 |
1 |
|
REGN7508 |
1 |
|
SYHA136 |
1 |
Target Indication Analysis of Factor X Modulators
Factor X inhibitors such as Rivaroxaban, Enoxaparin, Apixaban, Endoxaban, and others are indicated for deep vein thrombosis, embolism, pulmonary embolism, stroke, thromboembolism, thrombosis, venous thromboembolism. These drugs have also been registered for acute coronary syndromes and cardiovascular disorders, are in phase-III arterial thrombosis, peripheral arterial disorders, and venous thrombosis, and in phase-II for coronary thrombosis. Factor X stimulant like emicizumab is approved for the routine prophylaxis of bleeding episodes in patients with hemophilia A.
Regional Analysis of Factor X Modulators
Factor X Modulators Market
Bayer’s Xarelto had a total sale of US$ 516 million in 2021 and saw a decline to US$ 492 million in 2022 caused by the patent expiration. According to a report in 2019, around 1,95,263 were diagnosed with hemophilia and 80,302 had been diagnosed with von Willebrand disease in the USA. The number of people affected by deep vein thrombosis is 9,00,000 each year in the USA, with a mortality of 6000 to 1,00,000. This heavy burden of blood-related disorders will regulate the growth potential of factor X modulator market.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Rivaroxaban, Enoxaparin, Apixaban, Endoxaban, and Emicizumab are some of the approved Factor X modulators in the market.
Daiichi Sankyo Pharmaceutical, Pfizer, Eisai, LEO Pharma, Roche, Astellas Pharma, AstraZeneca, Novartis, and Sanofi are some of the major players in the factor X modulators market.
Major indications for Factor X modulators are prevention of venous thromboembolic events, stroke, deep vein thrombosis, and pulmonary embolism.
There are a total of 21 molecules in the clinical development phases for Factor X Modulators.
- Daiichi Sankyo Pharmaceutical
- Pfizer
- Eisai
- LEO Pharma
- Aspen Pharma
- Roche
- ROVI Pharmaceuticals Laboratories
- Astellas Pharma
- AstraZeneca
- Norgine
- Covis Pharma
- Novartis
- Sanofi
- Merck (MSD)
- Bayer
- Regeneron Pharmaceuticals
- Takeda Pharmaceutical
- CSPC Pharma