Back to discover
Disease

Embolism

Late-stage therapeutic developmentEmerging researchSteady momentum
MeSHEmbolism
4
Publications
24
Clinical trials
5
Related conditions
2023
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 4 clinical trials expected to report results, the earliest in Q1 2028.
  • 3 industry developments reported.
Upcoming Milestones
Clinical Milestones8View
Results posted 1
Results expected 4
Recently completed 1
Other updates 2
Industry & Market3View
Regulatory Updates1View
  • 2025-11-21Generic approval — RivaroxabanPrevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or kneereplacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.)
Activity timeline12

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Rivaroxabanapproved

Generic approval — Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or k… (2025)

Apixabanapproved

Generic approval — Adults Prevention of stroke and systemic embolism in adult patients with non-valvula… (2020)

Edoxabanapproved

Original application approval — Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibr… (2017)

Enoxaparinapproved

Biosimilar approval — Inhixa is indicated for adults for: Prophylaxis of venous thromboembolism, particularly… (2016)

Clinical trials

18 sponsors · 2 new · 1 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies

A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)

Phase 3 · Recruiting · Regeneron Pharmaceuticals

Percutaneous Embolectomy, Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism (STRATIFY II)

Phase 3 · Recruiting · Jesper Kjaergaard

The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Patients With Venous Thromboembolism.

Phase 4 · Active, not recruiting · Herlev and Gentofte Hospital

The DISTINCT Trial: inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT: a National, Multicenter, Randomized, Multi-arm, Open-label Trial.

Phase 4 · Recruiting · Leiden University Medical Center

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial

Phase 4 · Recruiting · Drahomir Aujesky

Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Phase 3 · Recruiting · Ottawa Hospital Research Institute
Recruiting

A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)

Phase 3 · Recruiting · Regeneron Pharmaceuticals

Percutaneous Embolectomy, Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism (STRATIFY II)

Phase 3 · Recruiting · Jesper Kjaergaard

The DISTINCT Trial: inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT: a National, Multicenter, Randomized, Multi-arm, Open-label Trial.

Phase 4 · Recruiting · Leiden University Medical Center

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial

Phase 4 · Recruiting · Drahomir Aujesky

Statins for Venous Event Reduction in Patients With Venous Thromboembolism

Phase 3 · Recruiting · Ottawa Hospital Research Institute
Recently completed

A Multicentre, Randomized Trial of Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism (PRAGUE-26)

Phase 4 · Completed · Faculty Hospital Kralovske Vinohrady

Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement: Balancing Safety and Effectiveness

Phase 4 · Completed · Dartmouth-Hitchcock Medical Center

Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event

Phase 4 · Completed · Yonsei University

Randomized Controlled Trial of Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in High-Risk Patients With Provoked Venous Thromboembolism

Phase 4 · Completed · Brigham and Women's Hospital

Multicenter, Open Label, Randomized Comparative Trial of the Efficacy and Safety of a Single Bolus Recombinant Non-immunogenic Staphylokinase and Bolus-infusion of Alteplase in Patients With Massive Pulmonary Embolism (FORPE)

Phase 3 · Completed · Supergene, LLC

Anti-Xa Concentrations With Continuous Intravenous Infusion and Subcutaneous Administration of Enoxaparin After Coronary Artery Bypass Grafting: Randomized Clinical Trial

Phase 4 · Completed · Tampere University Hospital

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

Product approvals and authorisations
2025emaGeneric approval — Rivaroxaban· Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or kneereplacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) source ↗
2021emaGeneric approval — Rivaroxaban· Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.  Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.  ------ Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.  Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. ------- Adults  Prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.   source ↗
2020emaGeneric approval — Rivaroxaban· Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients). Adults Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA) alone or with ASA plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1). Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. source ↗
2020emaGeneric approval — Apixaban· Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).   Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).   Paediatric population  Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Adults  Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.   Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).   Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).   Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. source ↗
2017emaOriginal application approval — Edoxaban· 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 ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. source ↗
2016emaBiosimilar approval — Enoxaparin· Inhixa is indicated for adults for: Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL). Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism. Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA). Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL). Blood clot prevention in the extracorporeal circulation during haemodialysis. source ↗
2011emaOriginal application approval — Apixaban· Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).Paediatric populationTreatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.  source ↗
2008emaOriginal application approval — Rivaroxaban· Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

4 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
2011–2023
Most influential

2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM).

European heart journal · 2015 · 3,182 cites

Apixaban in patients with atrial fibrillation.

The New England journal of medicine · 2011 · 1,598 cites

Clinical presentation, aetiology and outcome of infective endocarditis. Results of the ESC-EORP EURO-ENDO (European infective endocarditis) registry: a prospective cohort study.

European heart journal · 2019 · 558 cites

Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes.

The New England journal of medicine · 2023 · 283 cites
Recent publications

Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes.

The New England journal of medicine · 2023 · 283 cites

Clinical presentation, aetiology and outcome of infective endocarditis. Results of the ESC-EORP EURO-ENDO (European infective endocarditis) registry: a prospective cohort study.

European heart journal · 2019 · 558 cites

2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM).

European heart journal · 2015 · 3,182 cites

Apixaban in patients with atrial fibrillation.

The New England journal of medicine · 2011 · 1,598 cites
Major themes4
  • Factor Xa Inhibitors2
  • Anticoagulants1
  • Arrhythmias, Cardiac1
  • Embolism1
Leading journals2
  • European heart journal2
  • The New England journal of medicine2
Leading researchers8
  • Diener HC2
  • Erba PA2
  • Habib G2
  • Iung B2
  • Lancellotti P2
  • Afzal R1
  • Antunes MJ1
  • Avezum A1
Affiliations (unnormalised)6
  • Aix Marseille University1
  • ANMCO Research Center1
  • Anthea Hospital1
  • Bichat Hospital1
  • Center for Cardiovascular Diseases (CHVZ)1
  • Echocardiography Research Center1

Related conditions

5 matches

Diseases frequently studied alongside this one. Number shows shared papers.

Arrhythmias, Cardiac2Atrial Fibrillation2Hemorrhage2Prosthesis-Related Infections2Stroke2

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Blocking of a blood vessel by an embolus which can be a blood clot or other undissolved material in the blood stream.

Identifiers
MeSHEmbolism
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.