Edoxaban tosylate is under clinical development by Daiichi Sankyo and currently in Phase III for Chronic Thromboembolic Pulmonary Hypertension. According to GlobalData, Phase III drugs for Chronic Thromboembolic Pulmonary Hypertension have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Edoxaban tosylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Edoxaban tosylate overview

Edoxaban tosylate (Lixiana, Savaysa, Roteas) is an oral anticoagulant that directly inhibits factor Xa, an important factor in the coagulation process. It is formulated as film coated tablets, coated tablets and tablets for oral route of administration.  Edoxaban tosylate is used for the prevention of venous thromboembolism (VTE) in patients undergoing total knee arthroplasty, total hip arthroplasty and hip fracture surgery and severe pulmonary embolism. It is also indicated for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age more than or equal to 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Edoxaban is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Edoxaban (DU-176b) is under development for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH),venous thromboembolism, thromboembolism, pulmonary embolism, atrial fibrillation, mitral valve stenosis and venous (vein) thrombosis in elderly patients (80 years and older) with non-valvular atrial fibrillation in Japan and cardiac diseases at risk of thromboembolic events.

It was also under development for  coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), ischemic stroke.

Daiichi Sankyo overview

Daiichi Sankyo is a holding company, which carries out the research, development, manufacture, and marketing of pharmaceutical products. The company offers a wide range of prescription drugs, over the counter (OTC) drugs, vaccines, and others. Its portfolio encompasses medicines for cardiovascular, neurological, nephrological, diabetic, metabolic, and infectious diseases, and various types of cancers. Besides cancer, the company’s other research areas include rare diseases and immune disorders. Daiichi Sankyo sells its products through its group companies and an extensive network of medical representatives. It has operations in North America, South and Central America, Europe, and Asia. Daiichi Sankyo is headquartered in Tokyo, Japan.

For a complete picture of Edoxaban tosylate’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 22 April 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.