Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for… FDA label
Also known as Rivaroxaban (BAY 59-7939), Xarelto
rivaroxaban · 34 trials · 16 indications
a composite efficacy endpoint of symptomatic VTE, VTE-related death, and/or VTE detected by mandatory bilateral lower limbs venous duplex scan and computed tomography pulmonary angiogram on day 35+/-4 post-hospital discharge
Recurrent VTE during the 3-month treatment period including all symptomatic DVT (lower limbs distal and proximal DVTs, iliac and caval thrombosis, visceral thrombosis and deep vein thrombosis of the arm)
Recurrent VTE during the 3-month treatment period including symptomatic PE
Recurrent VTE during the 3-month treatment period including clinically unsuspected PE and DVT discovered incidentally
Recurrent VTE during the 3-month treatment period including worsening of pulmonary vascular obstruction or venous obstruction on the systematic examinations performed at the end of the 3-month treatment period
Vascular death or death of unknown cause, stroke, myocardial infarction or systemic embolism
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population
Incidence rates for all children except those aged \< 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population.
The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.
The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life (such as loss of school days or hospitalization).
Incidence rates for all children except those aged \< 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life.
Complete resolution is characterized as the subject is completely thrombus-free confirmed on transesophageal echocardiography
Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for \>= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.
Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (\>)1 total subjects were reported.
The primary efficacy outcome was the composite of death from any cause, symptomatic pulmonary embolism (confirmed by ventilation-perfusion scanning, helical computed tomography, pulmonary angiography, or autopsy), symptomatic deep vein thrombosis (confirmed by ultrasonography or venography), or symptomatic extension towards the saphenofemoral junction or symptomatic recurrence of superficial vein thrombosis (confirmed by ultrasonography) up to day 45.
Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life.
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or * leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or * occurring in a critical site, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: * medical intervention, or * unscheduled contact (visit or telephone call) with a physician, or * cessation (temporary) of study treatment, or * discomfort for the child such as pain or * impairment of activities of daily life (such as loss of school days or hospitalization).
Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or * leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or * occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: * medical intervention, or * unscheduled contact (visit or telephone call) with a physician, or * cessation (temporary) of study treatment, or * discomfort for the child such as pain or * impairment of activities of daily life (such as loss of school days or hospitalization).
Area under the concentration versus time curve from zero to infinity (AUC)
Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.
Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.
The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.
The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
| Arm | Type | Description |
|---|---|---|
| Rivaroxaban | EXPERIMENTAL | Rivaroxaban 10mg OD for 35+/- 4 days post-hospital discharge |
| No intervention | NO_INTERVENTION | control |
| Low-molecular-weight heparin | ACTIVE_COMPARATOR | dalteparin, 200 IU/kg subcutaneously once daily for one month followed by 150 IU/kg subcutaneously once daily for 2 months |
| Rivaroxaban (20 mg) | EXPERIMENTAL | Rivaroxaban 20 mg od (n \~ 2250); 15 mg od (once daily) in patients with creatinine clearance (CrCl) 15-49 ml/min |
| Vitamin K antagonists (VKA) | ACTIVE_COMPARATOR | Any approved VKA in the participating country (n \~ 2250); VKA titrated to achieve an INR of 2.0-3.0 |
| Placebo | PLACEBO_COMPARATOR | Rivaroxaban-placebo orally twice daily |
| BAY59-7939 | EXPERIMENTAL | Rivaroxaban (tablets and oral suspension) Dose: Age and body weight-adjusted dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban. |
| Standard of Care | EXPERIMENTAL | Subcutaneous low molecular weight heparin (LMWH), subcutaneous fondaparinux and/or oral vitamin K antagonist (VKA) Dose : as per standard of care |
| Rivaroxaban 2.5mg + Aspirin 100mg | EXPERIMENTAL | Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part. |
| Rivaroxaban 5mg + Aspirin Placebo | EXPERIMENTAL | Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part. |
| Rivaroxaban Placebo + Aspirin 100mg | ACTIVE_COMPARATOR | Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part. |
| Rivaroxaban (Xarelto, BAY59-7939) | EXPERIMENTAL | A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. Rivaroxaban will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with rivaroxaban will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. Rivaroxaban will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion. |
| Vitamin K antagonist (VKA) | ACTIVE_COMPARATOR | A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. VKA will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with VKA will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. VKA will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion. |
| Fondaparinux | ACTIVE_COMPARATOR | Fondaparinux for 45 days subcutaneous application: 2,5 mg OD |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | ACTIVE_COMPARATOR | - |
| Arm 4 | ACTIVE_COMPARATOR | - |
| Warfarin | ACTIVE_COMPARATOR | Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period |
| Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939)) | EXPERIMENTAL | Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening. |
| Enoxaparin 30 mg twice a day (bid) | ACTIVE_COMPARATOR | Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening. |
| Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - <18 | EXPERIMENTAL | Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR (immediate-release) tablet once daily (OD) under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg. |
| Comparator, Age: 12 - <18 years | ACTIVE_COMPARATOR | Subjects aged from 12 - \<18 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist). |
| Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - <12 years | EXPERIMENTAL | Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kg received a dose (equivalent to 20 mg in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg. |
| Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - <12 years | EXPERIMENTAL | Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily (BID). Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg. |
| Comparator, Age: 6 - <12 years | ACTIVE_COMPARATOR | Subjects aged from 6 - \<12 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or INR-adjusted (vitamin K antagonist). |
| Arm 5 | EXPERIMENTAL | - |
| Arm 6 | ACTIVE_COMPARATOR | - |
| Treatment A-B | EXPERIMENTAL | Subjects received a single oral dose of 10 mg rivaroxaban tablet in the fasted state on Day 1 (Treatment A) during intervention period 1; and then a single oral dose of 10 mg rivaroxaban oral suspension in the fasted state on Day 1 (Treatment B) during intervention period 2. A wash-out of at least 7 days was maintained between the treatments. |
| Treatment B-A | EXPERIMENTAL | Subjects received a single oral dose of 10 mg rivaroxaban oral suspension in the fasted state on Day 1 (Treatment B) during intervention period 1; and then a single oral dose of 10 mg rivaroxaban tablet in the fasted state on Day 1 (Treatment A) during intervention period 2. A wash-out of at least 7 days was maintained between the treatments. |
| BAY59-7939 granule | EXPERIMENTAL | - |
| BAY59-7939 tablet | ACTIVE_COMPARATOR | - |
| BAY59-7939 Rivaroxaban granule | EXPERIMENTAL | - |
| BAY59-7939 Rivaroxaban tablet | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Rivaroxaban 10 MG | DRUG | No intervention |
| rivaroxaban | DRUG | rivaroxaban, 15 mg BD (Bis in die) for 3 weeks followed by 20mg OD (Omni die) for 9 weeks |
| Low-molecular-weight heparin | DRUG | dalteparin, 200 IU/kg OD for 4 weeks followed by 150 IU/kg OD for 8 weeks |
| Rivaroxaban (20 mg) | DRUG | Rivaroxaban is non-inferior to VKAs for the prevention of stroke or systemic embolism in patients with AF/flutter and RVHD and potentially superior to VKAs. |
| Vitamin K antagonists (VKA) | DRUG | - |
| Rivaroxaban (Xarelto, BAY59-7939) | DRUG | 2.5 mg, twice daily, orally, tablet |
| Rivaroxaban-Placebo | DRUG | matching placebo, twice daily, orally, tablet |
| Standard of Care | DRUG | LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy. dose : as per standard of care |
| Aspirin | DRUG | Tablet, 100 mg, once daily, oral |
| Aspirin placebo | DRUG | Aspirin matching placebo, once daily, oral |
| Rivaroxaban placebo | DRUG | Rivaroxaban matching placebo, twice daily, oral |
| Pantoprazole | DRUG | Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole |
| Pantoprazole placebo | DRUG | Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo |
| Vitamin K antagonist (VKA) | DRUG | VKA orally once daily titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive); the VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards |
| Fondaparinux | DRUG | Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous |
| Unfractionated heparin | DRUG | To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control) |
| Warfarin | DRUG | To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5) |
| Rivaroxaban (BAY59-7939) | DRUG | daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days) |
| Enoxaparin | DRUG | daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days) |
| Warfarin placebo | DRUG | Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values) |
| Placebo: tablet of Rivaroxaban | DRUG | Placebo tablet of rivaroxaban administered once daily in the evening. |
| Placebo: syringes of Enoxaparin | DRUG | Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening. |
| Active comparator | DRUG | Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist). |
| Rivaroxaban (BAY59-7939) suspension | DRUG | Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. |
| Xarelto (Rivaroxaban, BAY59-7939) | DRUG | 10mg od |
| (LMW) Heparin + Vitamin K Antagonist | DRUG | Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks |
| Enoxaparin/Vitamin K-Antagonist | DRUG | Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days |
| Rivaroxaban, (BAY59-7939) | DRUG | 5mg bid |
| Enoxaparine | DRUG | 30mg bid |
| Rivaroxaban (BAY 59-7939) | DRUG | Rivaroxaban granule 10mg for one day |
| Rivaroxaban (Xarelto, BAY 59-7939) | DRUG | Rivaroxaban tablet 10mg for one day |
Inclusion Criteria: * Male and nonpregnant female patients 18 years of age or older * Positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 in a respiratory tract sample * Pneumonia confirmed by chest imaging * Additional risk factors for VTE, as indicated by a tota...
Top 5 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 3 | PHASE3 | REGN7508, REGN9933 |
| Johnson & Johnson | JNJ | 14 | PHASE3 | Milvexian |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Abelacimab, PKN605 |
| Milestone Pharmaceuticals, Inc. | MIST | 1 | PHASE3 | Etripamil |
| Bayer | BAYRY | 1 | PHASE2 | BAY 3670549 |
Rivaroxaban is an anticoagulant studied and used in cardiovascular and thromboembolic conditions, including atrial fibrillation, deep vein thrombosis, embolism, venous thrombosis, peripheral artery disease, and cancer-associated thrombosis. It has also been studied in hospitalized COVID-19 patients for extended thrombosis prophylaxis. It is a small molecule drug developed by Bayer AG.
Rivaroxaban targets coagulation factor X, also known as F10. It acts as an inhibitor of this factor, which is part of the blood coagulation cascade. By inhibiting factor X, rivaroxaban reduces thrombin generation and clot formation, which is the basis for its use in conditions involving abnormal or excessive blood clotting.
Rivaroxaban is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the company associated with the drug's clinical development program across cardiovascular and thromboembolic indications. The compound is also identified by the research code BAY 59-7939.
Yes, Xarelto is the brand name for rivaroxaban. Other names and identifiers used for the same drug include rivaroxaban (BAY 59-7939), rivaroxaban (BAY59-7939), Xarelto (rivaroxaban, BAY59-7939), rivaroxaban 20 mg tablet, and rivaroxaban 10 mg. These all refer to the same small molecule factor X inhibitor.
Rivaroxaban has been studied in Phase 3 clinical trials, and the trials listed in its development record are completed. It is a small molecule factor X inhibitor developed by Bayer AG. Its clinical program spans cardiovascular and thromboembolic indications, including atrial fibrillation, deep vein thrombosis, and cancer-associated thrombosis.
Rivaroxaban trials include NCT02832544, a Phase 3 study in rheumatic heart disease with atrial fibrillation across multiple countries, and NCT04662684, the Phase 3 MICHELLE trial of extended thrombosis prophylaxis in hospitalized COVID-19 patients. Other studies include NCT02746185 in cancer-associated thrombosis and NCT04720092, a Phase 1 trial of a liquid formulation in healthy male participants.