(21174) Relative bioavailability study to investigate the pharmacokinetics of a single oral dose of asundexian administered as 50 mg pediatric formulation in comparison to 50 mg tablet (adult formulation) in fasted state and to investigate the effect of a high-fat, high-calorie meal on the 50 mg pediatric formulation in healthy adult participants

Start Date06 May 2026

Sponsor / Collaborator

Bayer AG

CTIS2023-509447-28-00

/ Not yet recruitingPhase 1

A study to learn about the amount of asundexian in the blood when healthy participants take different types of asundexian tablets

Start Date26 Jul 2024

Sponsor / Collaborator

Bayer AG

CTIS2023-509488-26-00

/ CompletedPhase 1

A study to learn how asundexian affects the amount of metformin in the blood when healthy participants take them together

Start Date18 Jul 2024

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Asundexian

100 Translational Medicine associated with Asundexian

100 Patents (Medical) associated with Asundexian

Literatures (Medical) associated with Asundexian

01 Aug 2026·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Comparison of the effects of abelacimab, asundexian, and milvexian on medical device-induced clotting and thrombin generation in vitro

Article

Author: Guo, Xinyi ; Weitz, Jeffrey I ; Fredenburgh, James C

BACKGROUND:

Medical devices, such as central venous catheters and mechanical heart valves (MHVs), are associated with an increased risk of thrombosis. Clotting on these devices is initiated by contact with the system surface. Adsorbed factor (F)XII undergoes autoactivation and activates FXI, which then propagates coagulation. Abelacimab, asundexian, and milvexian are FXI or FXIa inhibitors currently undergoing or having completed phase 3 evaluation.

OBJECTIVES:

To compare the effects of abelacimab, asundexian, and milvexian on activated partial thromboplastin time (APTT), catheter-induced clotting, and device-induced thrombin generation.

METHODS:

The effects of abelacimab, asundexian, and milvexian on APTT (measured with HemosIL APTT-SP reagent), catheter-induced clotting, and thrombin generation induced by catheter segments or MHV leaflets were assessed in human platelet-poor plasma. Thrombin generation was monitored over time using a fluorogenic substrate, and peak thrombin and endogenous thrombin potential were quantified.

RESULTS:

Abelacimab, asundexian, and milvexian prolonged APTT and catheter-induced clotting time and attenuated device-induced thrombin generation in a concentration-dependent manner. At clinically relevant concentrations, abelacimab and milvexian had more pronounced effects on APTT, catheter-induced clotting, and device-induced thrombin generation than asundexian. Even at the highest concentration tested, asundexian showed less inhibition of device-induced thrombin generation than the other inhibitors.

CONCLUSION:

At the concentrations achieved by the dosing regimens evaluated in the phase 3 trials, abelacimab and milvexian had greater effects on APTT, catheter-induced clotting, and thrombin generation induced by catheters or MHVs than asundexian.

01 May 2026·ADVANCES IN THERAPY

Factor XI Inhibitors in Atrial Fibrillation: Insights and Implications from Recent Trials

Review

Author: McCarty, Owen J T ; Piatski, Marie E ; Malhotra, Aditya ; Seifer, Lukas ; Falama, Rosemary B ; Matsumoto, Lisa R ; Shatzel, Joseph J

Stroke prevention remains a cornerstone of the management of atrial fibrillation (AF) given the increased risk of thromboembolic events. While direct oral anticoagulants (DOACs) have significantly advanced stroke prophylaxis in AF, bleeding risks remain a challenge and preclude use in some populations. Furthermore, evidence indicates significant undertreatment in AF, with up to 40% of patients receiving incorrect anticoagulant dosing or no anticoagulation at all, further elevating their stroke risk. Novel anticoagulants targeting factor (F)XI are emerging as a promising alternative, offering the potential to reduce thromboembolic events whilst minimizing bleeding risks. Inhibitors under development include small molecules, monoclonal antibodies, and antisense oligonucleotides. These agents have demonstrated favorable safety profiles when compared to DOACs in early phase and some late phase trials. For example abelacimab, an anti-FXI monoclonal antibody, demonstrated superior safety with lower bleeding rates when compared to rivaroxaban in patients with AF. However, the efficacy of these drugs remains uncertain. However, the OCEANIC-AF trial, which studied the small molecule FXI inhibitor asundexian, was terminated early due to lack of efficacy as there was an increased rate of stroke and systematic embolism compared to the DOAC apixaban, raising new concerns about the utility of targeting FXI. However, many FXI inhibitors are currently undergoing phase 3 trials, and as such the true efficacy of the full class of FXI inhibitors remains to be elucidated. This review aims to provide a comprehensive synopsis of the landscape of FXI inhibitors in development for AF, their advantages, challenges, and known utility with a focus on how they may be applied to future anticoagulation therapy for AF.

01 Apr 2026·BIOORGANIC CHEMISTRY

Development of selective NBD-based fluorescent probes for in vitro detection of factor XIa and Thrombus imaging

Article

Author: Yang, Han ; Zou, Meijuan ; Li, Qing ; Zhou, Fengjiao ; Zhuang, Xinyu ; Zhao, Xingyu ; Li, Ruixing

Factor XIa (FXIa) is a promising target for safer anticoagulants. Herein, a series of NBD-based fluorescent probes (FNC2-FNC6) were developed by linking an FXIa inhibitor scaffold to an NBD fluorophore via alkyl chains of varying lengths. Molecular dynamics simulations revealed that shorter linkers, especially a two‑carbon chain, stabilize NBD binding in the FXIa pocket, enhancing fluorescence. Among these probes, FNC2 displayed potent FXIa inhibition (Ki = 14.2 nM) and selectivity over related proteases. It exhibited linear fluorescence increase upon FXIa binding (R² = 0.9952; LOD = 1.19 μg/mL), enabling accurate quantification in immunoglobulin products (recovery: 94.41%-103.76%; RSD < 2%). FNC2 visualized FXIa in human plasma clots with 2.7-fold higher signal than free NBD, suppressed dose-dependently by asundexian. This structure-guided approach yields selective probes for FXIa detection and thrombus imaging.

News (Medical) associated with Asundexian

02 Sep 2026

·www.biospace.com

Stripped of AstraZeneca safety net, BMS could face ‘carnage’ if high-risk clinical trial fails

iStock, Afry Harvy BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers. The collapse of AstraZeneca’s reported merger talks with Bristol Myers Squibb extended the long wait for a deal between two major drugmakers and deprived BMS of one possible solution to growth problems that could be compounded soon if a key upcoming readout does not meet expectations. Analysts saw merging with AstraZeneca as a way for BMS to manage its patent cliff. About 80% of the company’s revenue base will face generic or biosimilar competition by 2031, Raghuram Selvaraju, senior healthcare equity research analyst at H.C. Wainwright & Co., told BioSpace via email. Unless the oral FXIa inhibitor milvexian succeeds in the clinic and offsets lost sales, Selvaraju believes BMS may face challenges that could have implications across the Big Pharma landscape. “We think that consolidation among the weaker large-cap companies is inevitable. If BMS blows up with milvexian, there may be a feeding frenzy once the carnage is over and the dust settles,” Selvaraju said. “Other companies that could be the subject of takeover speculation include the weakest of the traditional large-caps, namely GSK and Pfizer.” M&A No deal between AstraZeneca and BMS, senior source insists: Reuters Reuters has deflated rumors that AstraZeneca and Bristol Myers Squibb are discussing a possible merger, letting the air out of industry-wide speculation over what could have been the largest deal in pharma history. August 5, 2026 · 1 min read · Gabrielle Masson Read more BMS’ binary event Selvaraju sees LIBREXIA AF, a Phase 3 trial of milvexian in atrial fibrillation, as the key readout for BMS’ future, regardless of whether the company delivers positive results elsewhere in its portfolio. BMS expects to report LIBREXIA AF data next year. Milvexian has become a risky prospect, given the previous failure of the LIBREXIA ACS pivotal program for reducing cardiovascular risk and prior setbacks in stroke, Selvaraju said. Bayer’s rival oral FXIa inhibitor, asundexian, also failed to reduce the risk of stroke in atrial fibrillation, leading the German drugmaker to end the trial in 2023. Noting the readthrough from Bayer’s failure, Selvaraju said it is “not totally clear” why there remains “significant faith in milvexian.” In an email to BioSpace , Seamus Fernandez, senior managing director at Guggenheim Securities, put milvexian’s chances of success in the atrial fibrillation trial at 60%. Milvexian has a 70% chance of succeeding in a secondary stroke prevention study, Fernandez said. BMS does not currently have sufficient backup programs to weather the possibility of milvexian failing in Phase 3, Selvaraju said. If milvexian is totally written off, BMS’ share price could fall 40% to 50% from its current levels, the analyst added. “If milvexian fails in atrial fibrillation, that leaves a gaping hole in the portfolio and a revenue base void that could prove impossible to fill, with significant top-line sales attrition likely to occur in 2029 through the early 2030s,” Selvaraju said. BMS reported Eliquis and Opdivo revenues of $8.6 billion and $4.6 billion, respectively, in the first half of 2026. The drugs accounted for more than half of BMS’ sales. Selvaraju predicts the entire Eliquis revenue base could be erased by 2030, reflecting expectations that generics will start to erode sales quickly when the patent expires later this year. The company is working to hold on to a larger share of Opdivo sales for longer. Not only does Opdivo have a couple extra years of exclusivity, going off patent in 2028, but biosimilars typically take longer to win market share than generics. BMS aims to further dull the impact of biosimilars by driving uptake of its subcutaneous product, Opdivo Qvantig. H.C. Wainwright analysts model Opdivo sales falling from about $11 billion in 2027 to less than $5 billion by 2030. Biosimilars “are likely to eat into Opdivo sales relatively quickly,” Selvaraju said, because BMS lacks “a clear life cycle management strategy” and Qvantig will only partly cushion the blow. Selvaraju added that “Opdivo has been getting creamed by Keytruda in the checkpoint inhibitor wars for years.” Life beyond milvexian BMS’ LPA1 antagonist admilparant is widely seen as another important R&D program. The pulmonary fibrosis drug candidate is “probably the most exciting and high-probability prospect” in the company’s clinical pipeline, Selvaraju said. BMS aims to publish Phase 3 data for the asset in idiopathic pulmonary fibrosis this year, with results in progressive pulmonary fibrosis due in 2027. Boehringer Ingelheim’s Jascayd has set the bar in these indications. Selvaraju predicts that BMS can dominate the markets if admilparant matches Jascayd’s “relatively low” efficacy benchmark and meets the “readily achievable” goal of improving on the drug’s safety and tolerability. In that scenario, peak annual sales of admilparant could exceed $3 billion. Fernandez is bullish on the drug candidate, telling investors to “watch the extraordinary launch of Jascayd as a benchmark for just how poorly served the market is.” The Guggenheim analyst sees the U.S. market growing to “well over” $30 billion at peak and values the admilparant opportunity at more than $5 billion. Admilparant could join Camzyos and Breyanzi among BMS’ key commercial products. Heart disease drug Camzyos “has particularly strong long-term sales potential given its first-in-class status and favorable positioning following recent label expansions,” Selvaraju said. The H.C. Wainwright analyst said the cell therapy Breyanzi is an underappreciated asset and an “eminently defensible” franchise. Selvaraju is more downbeat on Cobenfy, the schizophrenia treatment that BMS acquired in its $14 billion takeover of Karuna Therapeutics. Turning Cobenfy into a blockbuster will be challenging, the analyst said, and “label expansion into the elderly Alzheimer’s disease population shall be difficult due to the well-documented side effects of the drug.” BMS’ struggles to grow Cobenfy, sales of which totaled $119 million in the first half of 2026, are dialing up the pressure on the rest of the business. Drug candidates such as lymphoma prospect golcadomide and PD-L1/VEGF-A bispecific antibody pumitamig could take some of the slack. Yet the magnitude of the patent cliff means Selvaraju believes milvexian will be key to securing BMS’ future. Its failure, Selvaraju said, could leave BMS “hanging by a thread.” Neurodegenerative disease BMS’ neuro renaissance was built on back of Celgene mega-merger Well-known for its oncology efforts and making recent headlines for a rumored mega merger with AstraZeneca, Bristol Myers Squibb is also dedicating considerable resources to neurological and psychiatric diseases, with a “continuum of care” mindset. August 31, 2026 · 7 min read · Heather McKenzie Read more

Phase 3AcquisitionCell Therapy

20 Aug 2026

·www.biospace.com

Bayer to Present New Phase III Data from Its Cardiovascular, Kidney, and Stroke Clinical Trial Programs at ESC 2026

Presentations include investigational late-breaking KERENDIA ® (finerenone) data in chronic kidney disease (CKD), including a pooled analysis from studies in patients with and without diabetes and a subanalysis in patients with CKD without diabetes, and for iodine 124 evuzamitide (I 124 evuzamitide) from a Phase III study in patients with suspected cardiac amyloidosis. WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer Summary Bayer today announced that 11 oral presentations across its cardiovascular, kidney, and secondary stroke prevention programs will be featured at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, from August 28-31, 2026. Key Facts Data from two late-breaking presentations will be featured, including a pre-specified subgroup analysis from the Phase III FIND-CKD trial, which evaluated KERENDIA ® (finerenone) in patients with CKD without diabetes and hypertensive nephropathy, and data from the INFINITY pooled analysis evaluating the efficacy and safety of KERENDIA in patients with chronic kidney disease (CKD) with and without a history of atherosclerotic cardiovascular disease (ASCVD). Additional subanalysis data will also be presented for KERENDIA in people living with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%. KERENDIA is currently approved by the FDA for use in adults with CKD associated with type 2 diabetes (T2D), as well as adults with HF with LVEF ≥40%. Full results from the Phase III REVEAL study, which evaluated the investigational PET radiotracer I 124 evuzamitide for the sensitivity and specificity of cardiac amyloidosis based on visual scan interpretation, will be shared for the first time. A new analysis from the previously presented Phase III OCEANIC-STROKE trial will explore how participant characteristics affected their response to asundexian in secondary stroke prevention. Why This Matters “Bayer is committed to further researching and providing resources to support prevention, early diagnosis, and management for people with heart and kidney conditions, as well as stroke. These data reflect Bayer’s commitment to that cause,” said Robert Perkins, MD, Vice President, US Medical Affairs. "We look forward to advancing the scientific dialogue across the spectrum of cardiovascular and cerebrovascular disease care." BAYER PRESENTATIONS AT ESC 2026: Cardiac Amyloidosis A phase 3, open-label, multicenter study of investigational positron emission tomography (PET) radiotracer iodine 124 evuzamitide in the assessment of patients with suspected cardiac amyloidosis Session: Late-Breaking Clinical Science: cardiac amyloidosis August 30, 2026, 1:45 PM CEST to 2:00 PM CEST, Achgabat (Hall A3) Chronic Kidney Disease Effects of finerenone in patients with hypertensive nephropathy Session: Late-Breaking Clinical Science: renin-angiotensin-aldosterone pathway inhibition August 30, 2026, 1:45 PM CEST to 2:00 PM CEST, Rome (ICM) Efficacy and safety of finerenone in patients with chronic kidney disease and cardiovascular diseases: An individual participant data pooled analysis (INFINITY) Session: Late-Breaking Clinical Science: renin-angiotensin-aldosterone pathway inhibition August 30, 2026, 2:45 PM CEST to 3:00 PM CEST, Rome (ICM) Systolic blood pressure variability and effect of finerenone treatment in patients with chronic kidney disease and type 2 diabetes: a FIDELITY analysis Session: Secondary prevention after myocardial infarction August 29, 2026, 08:35–08:45 CEST, Science Box 2 - Research Gateway - Hall A1 Simultaneous versus sequential initiation of CKM therapies: an indirect comparison of CONFIDENCE and FIDELITY Session: Optimising pharmacotherapy in heart failure August 30, 2026, 12:24–12:36 CEST, Science Box 5 - Research Gateway - Hall A1 Finerenone with empagliflozin according to body mass index in chronic kidney disease and type 2 diabetes Session: Unexpected consequences of cardiometabolic disease August 30, 2026, 15:10–15:30 CEST, Science Box 3 - Research Gateway - Hall A1 Real-world effectiveness and safety of finerenone in patients with chronic kidney disease and type 2 diabetes in the United States: A FOUNTAIN platform analysis Session: Cardiovascular pharmacotherapy in advanced kidney disease: efficacy, safety, and outcomes August 29, 2026, 16:35–16:45 CEST, Science Box 1 - Research Gateway - Hall A1 Heart Failure Finerenone and serum sodium in patients with heart failure and mildly reduced or preserved ejection fraction: an analysis of FINEARTS-HF Session: Optimising pharmacotherapy in heart failure August 30, 2026, 12:48–13:00 CEST, Science Box 5 - Research Gateway - Hall A1 Time in blood pressure range and cardiovascular outcomes in HFmrEF/HFpEF: a pooled participant-level analysis of four large-scale trials Session: Drivers of heart failure with preserved ejection fraction August 30, 2026, 17:30–17:40 CEST, Science Box 3 - Research Gateway - Hall A1 Cardiovascular-kidney-metabolic overlap and finerenone in heart failure: insights from the FINEARTS-HF Trial Session: HFpEF: targeting the underlying pathophysiology August 31, 2026, 14:40–14:50 CEST, Science Box 3 - Research Gateway - Hall A1 GenePHIT Phase 2 baseline characteristics: a double blind, placebo-controlled trial to assess safety and efficacy of AB-1002 gene therapy in heart failure with reduced ejection fraction Session: Targeting the pathophysiology of HFrEF August 29, 2026, 17:10-17:20 CEST, Science Box 3 – Research Gateway – Hall A1 Secondary Stroke Prevention Dual antiplatelet therapy (DAPT) during the first 90 days post-randomisation in OCEANIC-STROKE: participant characteristics and interaction with asundexian Session: Advances in stroke prevention: anticoagulation, antiplatelet therapy and left atrial appendage closure August 31, 2026, 1:15 PM CEST to 1:30 PM CEST, Bratislava (ICM) ABOUT KERENDIA INDICATIONS: KERENDIA (finerenone) is indicated to reduce the risk of: sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets) cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Hypersensitivity to any component of this product Concomitant use with strong CYP3A4 inhibitors Patients with adrenal insufficiency WARNINGS AND PRECAUTIONS: Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium. Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed. Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly . Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m 2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function. MOST COMMON ADVERSE REACTIONS: CKD associated with T2D : From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%). HF LVEF ≥40% : From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). 1 Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%). DRUG INTERACTIONS: Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice. Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate. Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers. Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions. USE IN SPECIFIC POPULATIONS: Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment. Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B). Please see the Prescribing Information for KERENDIA. ABOUT I 124 EVUZAMITIDE Iodine 124 evuzamitide (I 124 evuzamitide) is an investigational radioactive diagnostic imaging agent being studied in patients with suspected cardiac amyloidosis. I 124 evuzamitide has received FDA Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis as well as Orphan Drug designation for both light-chain amyloidosis (AL) and transthyretin amyloidosis (ATTR) in the U.S. and EU. I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication. ABOUT ASUNDEXIAN Asundexian, a direct inhibitor of Factor XIa (FXIa), is theorized to reduce thrombus formation, without an increase in major bleeding. Asundexian is currently being evaluated as a potential treatment option to reduce the risk of stroke in adults after a non cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication. ABOUT BAYER’S COMMITMENT IN CARDIOVASCULAR, KIDNEY AND CEREBROVASCULAR MEDICINE Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments for cardiovascular, kidney and cerebrovascular diseases with high unmet medical needs. The company has set a clear focus on developing therapies to treat such diseases (e.g., heart failure, cardiomyopathies, chronic kidney disease and secondary stroke prevention), and it is our ambition to take a leading role in the care of patients with these diseases. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular, kidney and cerebrovascular diseases are treated. 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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at Follow us on X: @BayerPharma Follow us on LinkedIn: Follow us on Facebook: Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. ____________________ 1 Data on file. PP-EVU-US-0009-1 8/26 Contacts U.S. contacts for media inquiries: Elaine Colón (evuzamitide) Phone: +1-732-236-1587 Email: elaine.colon@bayer.com Joshua Mansbach (KERENDIA) Phone: +1-201-626-8929 Email: joshua.mansbach@bayer.com Sarra Herzog (asundexian) Phone: +1-862-460-8764 Email: sarra.herzog@bayer.com

Drug ApprovalPhase 3Breakthrough TherapyPhase 2Orphan Drug

04 Aug 2026

·firstwordpharma.com

Bayer calls for asundexian to be 'appropriately valued' ahead of potential German launch

Bayer's asundexian is speeding towards a potential approval, with marketing applications under review in the EU, Japan and the US, but questions around the oral factor XIa inhibitor on the company's second-quarter earnings call on Tuesday were firmly focused on its launch strategy, particularly in its home market."We hope to launch asundexian around the world, including in Europe and in Germany," said CEO Bill Anderson, although he conceded that recent healthcare reforms in its domestic market, coupled with pricing changes in the US, increase uncertainty. "We certainly need to have conversations, and we're having those conversations to make sure that it's appropriately valued."In February, Bayer unveiled results from the Phase III OCEANIC-STROKE study, which showed that compared to placebo, asundexian led to a 26% reduction in the risk that individuals who've already had one stroke would experience another — without increasing the risk of major bleeding. The drug is seen as key to the company's pharmaceutical unit, with analysts predicting peak annual sales of €3 billion ($3.5 billion).For related analysis, see — Physician Views Results: Asundexian leads factor XIa pack in stroke prevention, but doctors stop short of broader readthrough."Asundexian is a great example where if you can prevent…second strokes, that has enormous impact on healthcare systems in addition to the impact it has on patients' lives and the lives of their families," Anderson remarked. "Unfortunately, in Europe today, that's not appropriately valued. We're working hard on this with policymakers and we definitely need them to step up and do their part."Aside from asundexian, the current narrative in Bayer's pharmaceutical unit is dominated by growth from Nubeqa and Kerendia versus declines for Xarelto and Eylea. The two cancelled each other out in the second quarter, with sales in the pharmaceutical division flat at €4.5 billion.In the three-month period, sales of the prostate cancer drug Nubeqa jumped 61.2% to €880 million, while chronic kidney disease treatment Kerendia grew 79.8% to €329 million. In contrast, revenue from the anti-VEGF therapy Eylea slipped 33.5% to €573 million, with the oral anticoagulant Xarelto down 42.5% to €374 million.($1 = €0.86865432)

Phase 3Clinical ResultFinancial Statement

100 Deals associated with Asundexian

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D12838	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Thrombosis	NDA/BLA	Canada	Bayer, Inc.	01 Jul 2026
Ischemic stroke	NDA/BLA	China	Bayer AG	30 Apr 2026
Acute Ischemic Stroke	Phase 3	United States	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	China	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Japan	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Argentina	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Australia	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Austria	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Belgium	Bayer AG	26 Jan 2023
Acute Ischemic Stroke	Phase 3	Brazil	Bayer AG	26 Jan 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05686070 (OCEANIC-STROKE, Pubmed \| N Engl J Med)	Phase 3	Ischemic Attack, Transient \| Ischemic stroke	12,327	Asundexian 50 mg once daily	zlvxmupnxf(blvwgbfhah) = rqhlczbgmh imkkmxadoe (nuxzvqmptg ) View more	Positive	16 Apr 2026
				Placebo	zlvxmupnxf(blvwgbfhah) = qvgkqldlpt imkkmxadoe (nuxzvqmptg ) View more
NCT05686070 (OCEANIC-STROKE, Company_Website) Manual	Phase 3	Ischemic Attack, Transient \| Ischemic stroke	12,327	Asundexian	aowbqlvwxt(tprpfqcjdd) = orhmnnnhjn ppveeygwct (tudnqaqgun ) View more	Positive	05 Feb 2026
				placebo	aowbqlvwxt(tprpfqcjdd) = fyrafgbwhy ppveeygwct (tudnqaqgun ) View more
NCT05686070 (OCEANIC-STROKE, Company_Website) Manual	Phase 3	Ischemic stroke	-	Asundexian	vevmcylymo(efkpfzskcf) = Asundexian 50 mg once daily significantly reduced pfvzcvzlzl (wbnhakaysq ) Met View more	Positive	23 Nov 2025
				Placebo
NCT05643573 (OCEANIC-AF, Pubmed \| JAMA Cardiol)	Phase 3	Atrial Fibrillation	-	Asundexian	pzymtmvnna(mfkmlwtaoe) = lfevirebhm fnckwtmpxh (qskwmdrsmc )	Positive	01 Jun 2025
				Apixaban	pzymtmvnna(mfkmlwtaoe) = qqfcmrlrtt fnckwtmpxh (qskwmdrsmc )
NCT05643573 (OCEANIC-AF, CTgov)	Phase 3	Stroke \| Atrial Fibrillation \| Systemic embolism	14,830	Apixaban matching placebo+Asundexian (BAY2433334) (Asundexian)	ifayocomtq = ohwiemaklz yjnwondxps (pxzbocsobh, xjfazcogov - vngqhnrbru) View more	-	09 Dec 2024
				Asundexian matching placebo+Apixaban (Apixaban)	ifayocomtq = xjqoidfgiw yjnwondxps (pxzbocsobh, vwvfbnhhqr - ftubaitrdi) View more
NCT05643573 (OCEANIC-AF, Pubmed \| N Engl J Med)	Phase 3	Atrial Fibrillation	-	Asundexian 50 mg once daily	upbbqaoufv(puyhybecdw) = hctdvfvfef kqglqswmri (omeqigguec ) View more	Negative	01 Sep 2024
				Apixaban	upbbqaoufv(puyhybecdw) = zftejreihg kqglqswmri (omeqigguec ) View more
NCT05643573 (OCEANIC-AF, NEWS) Manual	Phase 3	Atrial Fibrillation	-	asundexian	rbwaexkxms(mwqigwcqrw) = Bayer is stopping a pivotal clinical trial for its experimental treatment for atrial fibrillation at the recommendation of an independent committee that concluded the drug would not be more effective than a Bristol Myers Squibb and Pfizer product widely used to treat the heart condition. vxudoqmhzk (ryulbnboku )	Negative	20 Nov 2023
				Eliquis
NCT04304508 (PACIFIC-STROKE, CTgov)	Phase 2	Thrombosis \| Acute Ischemic Stroke	1,808	Asundexian (BAY2433334) (Asundexian 10 mg)	rrwxpevdoz = qmntgmrfpg pzszpfwwpp (trpxdnmgnq, ypqjpltoqg - acxnkvmtzw) View more	-	19 Apr 2023
				Asundexian (BAY2433334) (Asundexian 20 mg)	rrwxpevdoz = exrtevubaq pzszpfwwpp (trpxdnmgnq, nvbxjfqqdr - uluxwwhzaz) View more
NCT04304534 (PACIFIC-AMI, CTgov)	Phase 2	Acute myocardial infarction	1,601	Asundexian (BAY2433334) (Asundexian 10 mg)	tjsmsawibe = hgwbxiilbt dpxyjtmslz (smpgisrpxc, heedzllcwh - frwgaxgvyr) View more	-	05 Apr 2023
				Asundexian (BAY2433334) (Asundexian 20 mg)	tjsmsawibe = ptorbbnepa dpxyjtmslz (smpgisrpxc, hjmzybuwps - mdcgmgrcjh) View more
NCT04218266 (PACIFIC-AF, CTgov)	Phase 2	Complication \| Atrial Fibrillation	755	Apixaban+Asundexian (BAY2433334) (Asundexian 20 mg)	gzzkmfctzi = bmlyweqqal aowjkczcyu (neevvspqra, tnnwzjsduw - mrbbrrwxnj) View more	-	27 Oct 2022
				Apixaban+Asundexian (BAY2433334) (Asundexian 50 mg)	gzzkmfctzi = wpxyedmqgx aowjkczcyu (neevvspqra, zdwghoynji - pcwfvfdhft) View more

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