Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).
VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening.
Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information.
The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old.
The main information that researchers will collect in this study:
* Age, gender, and other information about the child and their illness
* Type of VTE treatment given to the child
* Occurrence of medically important bleeding and its severity
Further information that researchers will collect:
* Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE
* Return of VTE symptoms
* Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study.
The data for this study will be collected from electronic health records and health insurance claims data until 2026.
Researchers will observe each child during treatment until:
* end of the anticoagulation treatment period e.g. discontinuation of all study drugs,
* their information is no longer available, or
* the study ends.

Start Date31 Dec 2025

Sponsor / Collaborator

Bayer AG

[+1]

TCTR20240719002

/ Not yet recruitingPhase 1IIT

A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Rivaroxaban 20 mg tablets relative to Xarelto 20 mg tablets, in healthy Thai volunteers under fed condition.

Start Date12 Jul 2025

Sponsor / Collaborator

Bio-innova Co., Ltd

NCT06396858

/ Not yet recruitingPhase 4IIT

A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke

The ARCHIMEDES study (Anti-inflammatory and anti-thRombotic therapy with colCHicine and low dose rIvaroxaban for Major adverse cardiovascular Events reDuction in ischEmic Stroke) will be a randomized, double-blind, 2x2 factorial clinical trial, which will include at least 3000 and up to a maximum of 4500 patients with ischemic stroke without indication of oral anticoagulation.

Start Date01 Jul 2025

Sponsor / Collaborator-

100 Clinical Results associated with Rivaroxaban

100 Translational Medicine associated with Rivaroxaban

100 Patents (Medical) associated with Rivaroxaban

10,045

Literatures (Medical) associated with Rivaroxaban

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Decision model to evaluate the cost of clinical events associated with switching from apixaban to rivaroxaban among patients with non-valvular atrial fibrillation in the United States and Germany

Article

Author: Dworatzek, Elke ; Kongnakorn, Thitima ; Duan, Cecilia ; Shah, Anshul ; Kisser, Agnes ; Hines, Dionne M. ; Subash, Rupesh ; Hagan, Melissa ; Zhang, Michelle

AIMS:

Direct-acting oral anticoagulants (DOACs) have emerged as the preferred treatment for nonvalvular atrial fibrillation (NVAF). However, evidence concerning the economic outcomes of DOAC switching remains limited. This study aimed to assess the economic outcomes of DOAC switching in the US and Germany, two countries with a high AF prevalence and DOAC utilization.

METHODS:

A decision model was developed to assess the incidence and cost of stroke/systemic embolism (SE) and major bleeding (MB) associated with switching from apixaban to rivaroxaban in patients with NVAF. The model compared two scenarios: continuers (patients continuing apixaban) and switchers (patients switching from apixaban to rivaroxaban). Model inputs on clinical event rates were sourced from a published real-world study, cost inputs were from a standard costing database and published literature. The analysis was conducted over a 1-year time horizon from US Medicare fee-for-service and German public healthcare payer perspectives.

RESULTS:

Over one year, 47,036 patients among a hypothetical plan size of 1,000,000 US Medicare fee-for-service members and 1,019,079 patients among the German adult population size of 70,107,122 were estimated to be treated for NVAF with apixaban. Switching all patients from apixaban to rivaroxaban resulted in 1,498 and 32,447 additional clinical events (stroke/SE and MB) and deaths in the US and Germany, respectively, compared to continuing with apixaban. This led to a total incremental cost of $17.3 million and €153 million from Medicare fee-for-service and German public healthcare perspectives, respectively.

LIMITATIONS:

The incidence and hazard ratios of clinical events informing this analysis were based on a US commercial and Medicare Advantage population and may not be generalizable to other populations.

CONCLUSIONS:

Switching from apixaban to rivaroxaban was associated with increased clinical events, deaths, and higher medical care costs, potentially representing a less favorable strategy economically compared to continuing apixaban among patients with NVAF.

01 Dec 2025·Journal of Gastrointestinal Cancer

Advances and Challenges in the Application of Novel Oral Anticoagulants for Venous Thromboembolism Prevention Following Colorectal Cancer Surgery

Review

Author: Kun, Yang ; Song, Zhao

BACKGROUND:

Venous thromboembolism (VTE) is a common but severe complication following colorectal cancer (CRC) surgery. Traditional anticoagulants such as low molecular weight heparin (LMWH) and vitamin K antagonists face limitations in clinical due to requirements for frequent monitoring, subcutaneous administration, and poor patient adherence. Novel Oral Anticoagulants (NOACs), with advantages including oral administration, stable pharmacokinetics, and no requirement for routine monitoring, have emerged as potential alternatives for postoperative VTE prophylaxis.

METHODS:

This narrative review synthesized evidence from PubMed and Web of Science (up to October 2024). Initial plans for a systematic review were adjusted due to limited CRC-specific trials, focusing instead on bridging existing evidence to emerging clinical applications.

RESULTS:

Postoperative VTE incidence remains heterogeneous, influenced by symptom-driven versus systematic detection and temporal improvements in perioperative care. Extended LMWH reduces VTE risk, yet adherence remains low. The PROLAPS II trial demonstrated rivaroxaban's efficacy in reducing VTE after laparoscopic CRC surgery, with comparable major bleeding rates to placebo. Meta-analyses confirm NOACs' non-inferiority to LMWH for short-term prophylaxis, but CRC-specific extended regimens lack validation. Safety concerns include heightened gastrointestinal/genitourinary bleeding risks and potential drug interactions with anticancer therapies. Clinician familiarity gaps and patient resistance to injectable agents further impede guideline adherence. Conflicting guidelines underscore unresolved debates on ideal regimens.

CONCLUSION:

NOACs offer practical advantages over LMWH for extended thromboprophylaxis in CRC surgery, particularly in enhancing adherence. However, bleeding risks and limited high-quality evidence necessitate cautious clinical integration. Future research must prioritize large-scale RCTs to validate LMWH-NOAC sequential regimens, optimize risk-stratified protocols, and address interactions within enhanced recovery pathways. Harmonized guidelines and provider education are critical to bridging implementation gaps.

01 Jun 2025·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

How to deal with interference on heparin anti-Xa activity caused by oral factor FXa inhibitors: communication from the ISTH SSC Subcommittee on Control of Anticoagulation

Review

Author: Thachil, Jecko ; Cuker, Adam ; Gendron, Nicolas ; Gosselin, Robert C ; Castellucci, Lana A

Monitoring unfractionated heparin (UFH) to ensure effective anticoagulation may be performed using anti-factor Xa activity (anti-Xa) instead of the activated partial thromboplastin time. However, in patients who have been treated with oral factor (F)Xa inhibitors (apixaban, rivaroxaban, and edoxaban) while switching to UFH therapy, there is a risk that these oral anti-FXa drugs could interfere with UFH-calibrated anti-Xa monitoring. This may lead to inappropriate anticoagulation management. This report of the International Society on Thrombosis and Haemostasis (ISTH) Subcommittee on Control of Anticoagulation summarizes the evidence on the risk of interference from previous treatment with oral FXa inhibitors and UFH anti-Xa after heparin initiation. This communication provides pragmatic recommendations for UFH initiation and management with anti-Xa monitoring after switching from oral FXa inhibitors.

298

News (Medical) associated with Rivaroxaban

22 May 2025

·www.prnewswire.com

CytoSorbents Therapy Significantly Reduces Bleeding in Urgent CABG Patients on Ticagrelor in New Data Presented at EuroPCR 2025

Real-World Analysis Shows Statistically Significant Reduction in Severe Bleeding and Transfusion Needs in CABG Patients on the Blood Thinner, Ticagrelor, with CytoSorbents Therapy PRINCETON, N.J., May 22, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announced today's presentation at EuroPCR 2025 of a new contemporary real-world data analysis highlighting the intraoperative use of its technology to significantly reduce the severity of bleeding in urgent coronary artery bypass grafting (CABG) patients on the blood thinner, ticagrelor (Brilinta®, AstraZeneca) who had not completed the recommended drug washout period. Presented by Professor Robert F. Storey, Academic Director and Honorary Consultant Interventional Cardiologist for the Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust (U.K.) and co-Principal Investigator of the international STAR (Safe and Timely Antithrombotic Removal) Registry, the findings were shared during the session titled, "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data." Key Study Insights The analysis compared two patient populations undergoing urgent CABG surgery on ticagrelor before completing the guideline-recommended 3-day washout period. The device group consisted of an updated cohort of 150 patients from the STAR Registry who were all operated on with the use of CytoSorbents' device, while the control group comprised 644 similar patients from a recent publication who were all operated on without the use of the device. The results showed statistically significant and clinically meaningful reductions in severe bleeding complications with device use, including: Reductions in the rate of BARC-4 (validated measure of severe bleeding after CABG) severe bleeding: 10.7% vs. 33% control, p<0.001) Reduction in large transfusion events (≥5 units of blood): 6% vs. 27% control, p<0.001) Reduction in the need for re-operations to control bleeding (4% vs. 9.6% control, p=0.02) Importantly, no device-related adverse events or device deficiencies were reported by participating centers, underscoring the device's ease-of-use and safety in real-world clinical practice. Professor Storey concluded his presentation, stating, "A device that removes free ticagrelor from blood and is easily integrated into the CPB circuit appears safe and effective in mitigating excess bleeding in ticagrelor-treated patients undergoing CABG surgery before completing the 3-day washout," Dr. Efthymios Deliargyris, MD, Chief Medical Officer of CytoSorbents stated, "Today's presentation in Paris is a vital addition to the growing evidence base of blood thinner removal with our technology. The data show that device use is simple and safe but more importantly establish that patients on ticagrelor undergoing urgent CABG at heart centers using our device as part of their standard care, experience significantly lower bleeding complications compared to patients operated without the device. We are thrilled with these new data that support routine use of our device as an effective solution to address the major unmet medical need of patients on blood thinners like ticagrelor requiring urgent cardiac surgery." Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, noted, "We are proud to see the updated STAR Registry data presented alongside one of the largest and most recent meta-analyses of non-device treated CABG patients on Brilinta®. With growing adoption of our technology by cardiac surgery centers worldwide, this important real-world evidence from our registry reinforces the clinical value of our therapy that we hope to bring to all countries and patients around the world." Additional Presentation and Study Details In today's oral presentation titled "Ticagrelor Removal to Reduce Bleeding after Urgent CABG: Comparative Analysis of Real-world Data" at the 2025 EuroPCR conference in Paris, France, the world-leading course in interventional cardiovascular medicine with over 12,000 attendees, Professor Robert Storey presented the results of a comparative analysis in patients on ticagrelor undergoing CABG surgery before completing the recommended three-day washout period with or without the intraoperative use of the CytoSorb® device. Device group: 150 patients from the STAR Registry that is actively enrolling at 28 sites in 6 European countries (Germany, United Kingdom, Austria, Belgium, Sweden and Switzerland) who were all operated with the use of the device Control group: 644 similar patients from the recently published individual patient data meta-analysis in the peer-reviewed journal, European Journal of Cardiothoracic Surgery, who were all operated without the use of the device Key Data Highlights: There were no significant differences in baseline characteristics between the two groups (device vs. control), including age (65 vs. 67 years), acute coronary syndrome presentation (90.5% vs. 89.1%) and overall perioperative risk according to Euroscore II (2.5 vs. 2.8%). Most importantly, the two groups had near identical distribution of the time of CABG relative to the last dose of ticagrelor, a very strong factor determining bleeding risk (within 1 day of last dose 41.4% vs. 41.9%, more than 1 but less than 3 days 58.6% vs. 58.1%). The primary outcome of the analysis was incidence of the composite of severe bleeding according to the Bleeding Academic Research Consortium (BARC)-4 definition that includes: intracranial bleeding; re-operation for bleeding; transfusion ≥ 5 units of packed red blood cells (pRBC) and 24-hour chest tube drainage of ≥ 2 liters. Additional individual outcomes included the rate of large transfusion events (≥ 5 units of pRBC) and the rate of re-operation for bleeding. BARC-4 bleeding was significantly reduced with the use of the device (10.7% vs. 33% control, p<0.001) as were large transfusion events (6% vs. 27% control, p<0.001) and re-operations for bleeding (4% vs. 9.6% control, p=0.02). Mortality at 30 days was not different between the 2 groups (4.4% vs. 6.5%, p=ns). Importantly, there were no device deficiencies or device-related adverse events reported by participating centers, underscoring the ease and safety of the use of the device in the real world. About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than a quarter million devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. On April 25, 2025, the FDA issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. The Company believes these items can be most effectively and expeditiously resolved through the formal appeal process, which facilitates engagement with FDA senior leadership and our external surgical experts. Given the expedited timelines associated with the appeal process, the Company believes that a final regulatory decision can be achieved in 2025. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. CytoSorbents' DrugSorb-ATR application with Health Canada remains under advanced review. While Health Canada has indicated that application reviews are currently delayed beyond their target Market Authorization Times (MAT) due to a backlog, they have reaffirmed their commitment to issuing a decision at the earliest opportunity. The Company remains confident in receiving a final regulatory decision in 2025. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. Forward-Looking Statements This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, our ability to resolve deficiencies in the FDA denial letter through a successfully appeal the FDA's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. Please Click to Follow Us on Facebook and X U.S. Company Contact: Peter J. Mariani, Chief Financial Officer 305 College Road East Princeton, NJ 08540 [email protected] Investor Relations Contact: Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected] SOURCE Cytosorbents Corp WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalBreakthrough Therapy

21 May 2025

·pipelinereview.com

Bayer starts Phase I study with GIRK4 inhibitor for treatment of patients with atrial fibrillation

BAY 3670549 is an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor with potential to help control the electrical activity of cardiomyocytes in patients with atrial fibrillation (AFib) With GIRK4 inhibitor Bayer explores an opportunity to address the high medical need for developing a fast-acting and well tolerated treatment option, offering high value for patients and physicians This approach for rapid cardioversion to normal sinus rhythm aims to enable immediate treatment without the need for anesthesia/sedation and external defibrillator, thus reducing the patients’ time spent in hospital Derived from the strategic research alliance with the Broad Institute of MIT and Harvard, BAY 3670549 is further strengthening Bayer’s cardiovascular development portfolio BERLIN, Germany I May 21, 2025 I Bayer announced today initiation of a Phase I clinical trial with BAY 3670549, an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, which has the potential to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib). This investigative approach for rapid cardioversion to normal sinus rhythm is aiming to enable immediate treatment without the need for anesthesia/sedation and electrical shock and to significantly reduce the patients’ time spent in hospital. The first-in-human dose escalation study in a randomized, double-blind, placebo-controlled, group-comparison design will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BAY 3670549 in healthy participants. AFib is the most common type of cardiac arrhythmia (irregular heart rhythm), affecting more than 60 million people worldwide, and a significant risk factor for stroke and heart failure. 1, 2, 3 “Initiating clinical development of our investigational GIRK4 inhibitor marks an important milestone of our ambition transforming atrial fibrillation treatment with a fast-acting, effective and well tolerated first-line pharmacological therapy for acute cardioversion, alleviating the burdens of electrical cardioversion on patients, physicians and healthcare systems”, said Andrea Haegebarth, Ph.D., Global Head of Research and Early Development for Cardiovascular, Renal, Immunology at Bayer’s Pharmaceuticals Division. “We look forward to advancing the program through clinical development, which will strengthen Bayer’s cardiovascular portfolio and advance research efforts to the benefit of a broad patient population in need for novel and better medicines.” The current gold standard to treat acute AFib episodes is electric cardioversion (ECV). This is an effective but resource-intensive and logistically challenging procedure, which is normally scheduled in advance and typically requires sedation or even anesthesia to safely deliver an electrical shock to the patient and restore the heart to its normal sinus rhythm. 4, 5 On the other hand, currently available anti-arrhythmic drugs (AADs), which are commonly used for the management of symptomatic AFib, can’t be applied to broad patient populations due to a number of contraindications (such as for patients with structural heart disease) and safety risks, including abnormal heart rhythms and sudden death. Additionally, they show limited, short-term efficacy, require close monitoring and bear the risk of serious side effects. 6, 7 Investigational GIRK4 inhibitor (BAY 3670549) is derived from Bayer’s strategic research alliance with the Broad Institute. About GIRK4 inhibitor (BAY 3670549) BAY 3670549 is an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor with potential to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib). GIRK4 channels are specialized proteins that regulate the electrical activity of heart cells by facilitating the flow of potassium ions (K+) in response to the neurotransmitter acetylcholine (ACh). This mechanism is particularly crucial during the later phases of the heart’s electrical signaling, specifically during so-called atrial effective refractory period (AERP). Increased activity of these channels shortens the AERP in the atria (the upper chambers of the heart), thereby reducing the recovery time after each heartbeat. This alteration in recovery time can contribute to the onset and persistence of AFib. About Atrial fibrillation AFib is one of the most common sustained cardiac rhythm disorders (arrhythmias). It results from rapid, disorganized electrical signals in the upper chambers (atria) of the heart, causing them to quiver and contract quickly and irregularly. As a result, the atria do not empty completely, and blood does not flow properly, causing blood clots to form. These blood clots can break loose and travel to the brain, resulting in a stroke. The prevalence of AFib continues to increase globally. Projection studies show that the number of people with AFib will rise to 15.9 million in 2050 in America and 17.9 million in 2060 in Europe. 8 People with AFib are 5 times more likely to suffer a stroke than people without AFib. 9 AFib-related strokes are also associated with a 50% likelihood of death within one year. 10 About Bayer’s Commitment in Cardiovascular Diseases Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products as well as compounds in various stages of preclinical and clinical development. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer 1 Atrial fibrillation: epidemiology, screening and digital health , Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786 2 American Heart Association, Why Atrial Fibrillation Matters | American Heart Association 3 Kornej J, Benjamin EJ, Magnani JW, Atrial fibrillation: global burdens and global opportunities, Heart 2021;107:516-518. 4 Nusair M, Flaker GC, Chockalingam A. Electric cardioversion of atrial fibrillation. Mo Med. 2010 Jan-Feb;107(1):59-64. PMID: 20222298; PMCID: PMC6192814. 5 Why Atrial Fibrillation Matters | American Heart Association 6 Andrade JG. Ablation or drug therapy for initial atrial fibrillation. Ann Cardiothorac Surg 2024;13(1):71-76. doi: 10.21037/acs-2023-afm-0159 7 Journal Article, Zimetbaum, Peter, Antiarrhythmic Drug Therapy for Atrial Fibrillation 2012, Circulation 381-389, 125, N 2 doi:10.1161/CIRCULATIONAHA.111.019927, https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.111.019927 8 Atrial fibrillation: epidemiology, screening and digital health, Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786 9 Singleton MJ, Imtiaz‐Ahmad M, Kamel H, O’Neal WT, Judd SE, Howard VJ, Howard G, Soliman EZ, Bhave PD. Association of atrial fibrillation without cardiovascular comorbidities and stroke risk: from the REGARDS study. Journal of the American Heart Association. 2020 Jun 16;9(12):e016380. 10 Alberts M, Chen YW, Lin JH, Kogan E, Twyman K, Milentijevic D. Risks of Stroke and Mortality in Atrial Fibrillation Patients Treated With Rivaroxaban and Warfarin. Stroke. 2020 Feb;51(2):549-555. doi: 10.1161/STROKEAHA.119.025554. Epub 2019 Dec 31. PMID: 31888412; PMCID: PMC7004448. SOURCE: Bayer

Phase 1AHA

15 May 2025

·pharma.economictimes.indiatimes.com

Alembic blood thinner generic receives FDA final nod

New Delhi: Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for its generic tablet ‘Rivaroxaban’. The drug is a blood thinner indicated to patients with coronary artery disease (CAD), peripheral artery disease (PAD), and patients after recent lower extremity revascularization to reduce the risk of major cardiovascular events . The generic tablet is therapeutically equivalent to the reference listed drug (RLD), Xarelto of Janssen Pharmaceuticals . As per IQVIA database as of March 2025, the 2.5 mg version of the tablets has an estimated market size of $445 million (around ₹3,750 crore). In a stock exchange filing the company announced that it will launch the 2.5 mg strength in “Q1FY26.” Besides this the estimated market size for remaining strengths of Rivaroxaban is estimated at $8,052 million (around ₹67,200 crore) for the twelve month period ending March 2025. By Online Bureau ,

Drug Approval

100 Deals associated with Rivaroxaban

External Link

KEGG	Wiki	ATC	Drug Bank
D07086	Rivaroxaban	B01AF01	DB06228

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Thromboembolism	Japan	Bayer Yakuhin Ltd.	24 Nov 2023
Thrombosis	United States	Janssen Pharmaceuticals, Inc.	20 Dec 2021
Atherosclerosis	European Union	Viatris Ltd. (New Zealand)	12 Nov 2021
Atherosclerosis	Iceland	Viatris Ltd. (New Zealand)	12 Nov 2021
Atherosclerosis	Liechtenstein	Viatris Ltd. (New Zealand)	12 Nov 2021
Atherosclerosis	Norway	Viatris Ltd. (New Zealand)	12 Nov 2021
Atrial Fibrillation	China	Bayer AG	31 Mar 2009
Myocardial Infarction	Australia	Bayer Australia Ltd.	24 Nov 2008
Recurrent deep vein thrombosis	Australia	Bayer Australia Ltd.	24 Nov 2008
Stroke	Australia	Bayer Australia Ltd.	24 Nov 2008
Systemic embolism	Australia	Bayer Australia Ltd.	24 Nov 2008
Acute Coronary Syndrome	European Union	Bayer AG	30 Sep 2008
Acute Coronary Syndrome	Iceland	Bayer AG	30 Sep 2008
Acute Coronary Syndrome	Liechtenstein	Bayer AG	30 Sep 2008
Acute Coronary Syndrome	Norway	Bayer AG	30 Sep 2008
Embolism	European Union	Bayer AG	30 Sep 2008
Embolism	Iceland	Bayer AG	30 Sep 2008
Embolism	Liechtenstein	Bayer AG	30 Sep 2008
Embolism	Norway	Bayer AG	30 Sep 2008
Peripheral arterial occlusive disease	European Union	Bayer AG	30 Sep 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cardiovascular Diseases	Phase 3	Australia	Bayer AG	14 Dec 2020
Cardiovascular Diseases	Phase 3	Canada	Bayer AG	14 Dec 2020
Cardiovascular Diseases	Phase 3	France	Bayer AG	14 Dec 2020
Cardiovascular Diseases	Phase 3	India	Bayer AG	14 Dec 2020
Cardiovascular Diseases	Phase 3	Malaysia	Bayer AG	14 Dec 2020
Cardiovascular Diseases	Phase 3	Saudi Arabia	Bayer AG	14 Dec 2020
Cardiovascular Diseases	Phase 3	Singapore	Bayer AG	14 Dec 2020
Cardiovascular Diseases	Phase 3	Taiwan Province	Bayer AG	14 Dec 2020
Cardiovascular Diseases	Phase 3	Tunisia	Bayer AG	14 Dec 2020
Chronic Kidney Diseases	Phase 3	Australia	Bayer AG	14 Dec 2020

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ROCKET-AF;EINSTEIN DVT;EINSTEIN PE;EINSTEIN Extension;EINSTEIN CHOICE (Pubmed \| Drugs Aging)	Not Applicable	Venous Thromboembolism	-	Rivaroxaban	yhhdnifnrr(bzkwutrutx) = ktajnbssok ccsijtvndk (luwiwwmhrl )	Positive	31 Mar 2025
				Placebo	yhhdnifnrr(bzkwutrutx) = nanythfzts ccsijtvndk (luwiwwmhrl )
NCT04724460 (ONCO PE Trial, Pubmed \| Circulation)	Phase 4	-	179	18-month rivaroxaban treatment	wjvljahjbl(bqdevasucr) = yhsonmsbnp rskzpukevt (dytbcztbqi ) View more	Positive	04 Mar 2025
				6-month rivaroxaban treatment	wjvljahjbl(bqdevasucr) = fduxwwesyl rskzpukevt (dytbcztbqi, 0.44 - 4.70) View more
COMPASS (ISC2025)	Not Applicable	Constriction, Pathologic	-	Rivaroxaban 2.5mg bid plus asprin or clopidogrel	upzzxtdfnq(dscqfdzuyv) = mnvydldddz fikmhpczjm (exuubiuslw )	Positive	30 Jan 2025
				Antiplatelet therapy alone (dual antiplatelet therapy or antiplatelet monotherapy)	upzzxtdfnq(dscqfdzuyv) = hvulazwplm fikmhpczjm (exuubiuslw )
NCT03746301 (XARENAL, Pubmed \| Korean Circ J)	Not Applicable	Atrial Fibrillation renal impairment \| creatinine clearance \| estimated glomerular filtration rate	888	Rivaroxaban	kxxkxlyhvi(nqpugcuqjy) = bpxofdfpqg lujtwjlalh (vtaavbjuzb ) View more	Positive	01 Jan 2025
697 (ASH2024)	Not Applicable	Pulmonary Embolism	-	Rivaroxaban 15 mg or 20 mg	dphrsketwc(zbugbazxaj) = zflrvwywpe ckabyknuwf (fmsxdejcyg )	Positive	08 Dec 2024
				Warfarin	dphrsketwc(zbugbazxaj) = aroppfxwyn ckabyknuwf (fmsxdejcyg )
ASH2024	Not Applicable	Thromboembolism	-	Prophylactic dose apixaban (2.5 mg twice daily)	jidrcfdqta(zinrjkmgbp) = vkpnecpyxr weclilrlci (nrxijglxfk, 6.4 - 12.6) View more	-	08 Dec 2024
				Therapeutic dose apixaban (5 mg twice daily)	jidrcfdqta(zinrjkmgbp) = rwwdhxltyn weclilrlci (nrxijglxfk, 14.8 - 19.8) View more
NCT02024230 (REWRAPS, ESC2024)	Phase 4	Coronary Artery Disease \| Atrial Fibrillation \| Chronic Kidney Diseases	493	Rivaroxaban	elosnnmbtl(urjrntkncf) = muxobvdhyr hrclnvqdin (aeiyvdgmph, 0.55 - 1.11) View more	Positive	02 Sep 2024
				Warfarin	elosnnmbtl(urjrntkncf) = sprtsbftpw hrclnvqdin (aeiyvdgmph, 0.55 - 1.11) View more
NCT04970381 (R-DISSOLVE, CTgov)	Not Applicable	Thrombosis	75	rivaroxaban	xrewsftbcp = bzdqhxdjrj ixupqijnoi (ozpvcvabbr, qydsdqyoab - wlewndkwhp) View more	-	02 Aug 2024
NCT01606995 \| NCT01800006 \| NCT01750788 (XANTUS, Pubmed \| Europace)	Not Applicable	Atrial Fibrillation	-	Rivaroxaban	icseimzoza(ehhqmjbsqv) = dtggyoydbb dmxeraawip (jceakkxdho ) View more	-	02 Jul 2024
ChiCTR2000031649 (ASCO2024) Manual	Phase 2	Breast Cancer	402	Rivaroxaban 10 mg	xhsyzdgnku(gctrnfjoof) = motcnmhspl tbenacwajf (paqoeacada )	Positive	24 May 2024
				rivaroxaban (Control group (no prophylactic anticoagulation))	xhsyzdgnku(gctrnfjoof) = gghgbvyitv tbenacwajf (paqoeacada )

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