abelacimab (MAA868) / Novartis - LARVOL DELTA

Factor XI Inhibitors in Atrial Fibrillation: Insights and Implications from Recent Trials. (PubMed, Adv Ther) - "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 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."

Journal • Review • Atrial Fibrillation • Cardiovascular

Direct Oral Anti-Xa Anticoagulants and the Future of Factor XI/FXIa Inhibition: A New Paradigm in Thrombosis Prevention. (PubMed, Pharmacy (Basel)) - "This biological paradigm has catalyzed the development of novel FXI/FXIa inhibitors, including small-molecule agents (asundexian, milvexian) and biological therapies (abelacimab). Clinical trials such as AXIOMATIC-TKR, PACIFIC-AF, and OCEANIC-AF, and ongoing programmes including ASTER and MAGNOLIA suggest that FXI inhibition may preserve antithrombotic efficacy while substantially reducing bleeding risk. This review summarizes the current landscape of oral FXa inhibitors, outlines the biological rationale for FXI/FXIa inhibition, and discusses the evolving clinical evidence supporting what may represent the next major advance in anticoagulant therapy."

Journal • Review • Cardiovascular • Gastroenterology • Genito-urinary Cancer • Geriatric Disorders • Hematological Disorders • Nephrology • Oncology • Renal Disease • Thrombosis • Venous Thromboembolism

Factor XI inhibition in atrial fibrillation: where do we stand? (PubMed, G Ital Cardiol (Rome)) - "The phase II AZALEA-TIMI 71 trial was terminated early after showing a significant reduction in the incidence of major bleeding with abelacimab compared with rivaroxaban. In contrast, the phase III OCEANIC-AF trial of asundexian was halted due to inferiority versus apixaban...While FXI inhibitors represent a potential innovation in the treatment of AF, additional evidence is required to clearly and definitively define their role in clinical practice. This review aims to examine the pathophysiological rationale underlying the use of FXI inhibitors, to describe the different molecular subclasses currently under development, and to summarize the results of both completed and ongoing clinical trials of this novel therapeutic class, with the goal of outlining future perspectives for thromboembolic prevention in patients with AF."

Journal • Review • Acute Coronary Syndrome • Atrial Fibrillation • Cardiovascular • Ischemic stroke

ASTER: A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE (clinicaltrials.gov) - P3 | N=1150 | Terminated | Sponsor: Anthos Therapeutics, Inc. | Trial completion date: Feb 2027 ➔ Feb 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2026 ➔ Feb 2026; Sponsor decision

Trial completion date • Trial primary completion date • Trial termination • Cardiovascular • Oncology • Respiratory Diseases • Venous Thromboembolism

Antithrombotic therapy for cancer-associated venous thromboembolism. (PubMed, Clin Res Cardiol) - "Ongoing phase 3 trials of abelacimab may provide critical evidence to refine anticoagulation strategies in patients with complex clinical profiles. Cancer-associated VTE remains a major clinical challenge requiring individualized decision-making and continuous reassessment. Emerging therapies may further improve outcomes in this vulnerable population."

Journal • Review • Cardiovascular • Hematological Disorders • Lung Cancer • Nephrology • Oncology • Renal Disease • Solid Tumor • Thrombocytopenia • Venous Thromboembolism

Abelacimab vs Rivaroxaban in Older Individuals With Atrial Fibrillation: A Prespecified Analysis of the Phase 2b AZALEA-TIMI 71 Trial. (PubMed, JAMA Cardiol) - P2 | "The results of ongoing phase 3 trials are necessary to establish the efficacy and benefit-to-risk ratio of abelacimab. ClinicalTrials.gov Identifier: NCT04755283."

Clinical • Journal • P2b data • Atrial Fibrillation • Cardiovascular

Simplifying the next-generation of anticoagulants: Elexians - Why a unified nomenclature for FXI/Xia inhibitors is needed. (PubMed, Thromb Res) - No abstract available

Journal

Abelacimab: Regulatory submission for atrial fibrillation in 2028 (Novartis) - Q4 & FY2025 Results

Filing • Atrial Fibrillation • Cardiovascular

Abelacimab: Data readout from P3 LILAC-TIMI 76 trial (NCT05712200) for stroke prevention in atrial fibrillation in 2026 (Novartis, 44th Annual J.P. Morgan Healthcare Conference)

P3 data • Atrial Fibrillation • Cardiovascular

Abelacimab: Data readout from P3 LILAC-TIMI 76 trial (NCT05712200) for stroke prevention in atrial fibrillation in 2026 (Novartis, 44th Annual J.P. Morgan Healthcare Conference)

P3 data • Atrial Fibrillation • Cardiovascular

MAGNOLIA: A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE (clinicaltrials.gov) - P3 | N=417 | Active, not recruiting | Sponsor: Anthos Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=1020 ➔ 417

Enrollment change • Enrollment closed • Cardiovascular • Genito-urinary Cancer • Oncology • Respiratory Diseases • Solid Tumor • Venous Thromboembolism

Abelacimab: Regulatory submission for atrial fibrillation in 2027 (Novartis) - Q3 2025 Results

Filing • Atrial Fibrillation • Cardiovascular

Abelacimab for Acute Pulmonary Embolism: Translating Dual FXI/XIa Inhibition from Mechanism to Clinical Prospects. (PubMed, Clin Appl Thromb Hemost) - "For these patients, anticoagulation is the mainstay, but the use of conventional agents (warfarin, DOACs, heparins) is severely limited by the risk of major bleeding, creating a substantial unmet medical need...Clinically, abelacimab demonstrated significantly lower rates of major bleeding or clinically relevant non-major bleeding compared to rivaroxaban in atrial fibrillation prophylaxis (AZALEA-TIMI 71 trial) and to enoxaparin in post-arthroplasty venous thromboembolism prevention (ANT-005 trial), establishing a favorable clinical safety profile...However, current evidence is extrapolated from AF/VTE prophylaxis studies, lacking direct human data for acute PE management. Urgent phase III trials (eg, PE-FOCUS) are therefore essential to validate efficacy and safety in acute PE, potentially redefining the anticoagulation paradigm."

Journal • Review • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Orthopedics • Pulmonary Embolism • Respiratory Diseases • Venous Thromboembolism

Factor XI and Cancer: Physiopathological Linkage and Clinical Perspectives. (PubMed, J Clin Med) - "Several molecules, such as asundexian and abelacimab, are in clinical trials for the prevention and treatment of venous thromboembolic events, catheter-related thrombosis, and arterial thromboembolic events in cancer patients. The use of FXI inhibitors emerges as a promising therapeutic strategy, offering potentially positive effects in the prevention and treatment of thromboembolic complications without significantly increasing the risk of bleeding, a limitation of conventional anticoagulants. The preliminary evidence is that further clinical trials are required and that the available data is not enough to make firm clinical recommendations."

Journal • Review • Cardiovascular • Hematological Disorders • Oncology • Thrombosis

Safety of Factor XI Inhibition With Abelacimab in Atrial Fibrillation by Kidney Function: A Prespecified Analysis of the AZALEA-TIMI 71 Randomized Clinical Trial. (PubMed, JAMA Cardiol) - "In this secondary analysis of the AZALEA-TIMI 71 randomized clinical trial, abelacimab consistently reduced the risk of bleeding relative to rivaroxaban irrespective of kidney function. These findings suggest that abelacimab may offer a particularly favorable safety profile among those with chronic kidney disease; however, larger studies are necessary to characterize the efficacy of abelacimab for stroke prevention in AF."

Clinical • Journal • Atrial Fibrillation • Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease

AZALEA-TIMI 71: Safety and Tolerability of Abelacimab (MAA868) vs. Rivaroxaban in Patients With Atrial Fibrillation (clinicaltrials.gov) - P2 | N=1287 | Active, not recruiting | Sponsor: Anthos Therapeutics, Inc. | Trial completion date: Dec 2025 ➔ Dec 2028

Trial completion date • Atrial Fibrillation • Cardiovascular

Renal function and factor XI inhibition in atrial fibrillation: a pre-specified analysis of AZALEA-TIMI 71 (ESC-WCC 2025) - "Patients with renal impairment are at higher risk of bleeding despite dose reduction of rivaroxaban. Abelacimab significantly reduces bleeding relative to rivaroxaban irrespective of renal function or rivaroxaban dose-reduction, with potential for greater absolute safety benefit in those with impaired renal function."

Atrial Fibrillation • Cardiovascular

Prior anticoagulation experience, bleeding risk, and safety of factor XI inhibition in atrial fibrillation: an analysis of AZALEA-TIMI 71 (ESC-WCC 2025) - "Prior OAC experience is an important indicator of bleeding risk among patients with AF. Compared with rivaroxaban, abelacimab consistently reduced the risk of bleeding irrespective of OAC experience, with potential for a greater absolute safety benefit among OAC-naïve patients."

Clinical • Atrial Fibrillation • Cardiovascular

ASTER: A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE (clinicaltrials.gov) - P3 | N=1150 | Active, not recruiting | Sponsor: Anthos Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=1655 ➔ 1150

Enrollment change • Enrollment closed • Cardiovascular • Oncology • Respiratory Diseases • Venous Thromboembolism

Low concentrations of recombinant activated factor VII normalize coagulation patterns by reversing the changes in viscoelastic testing parameters induced by abelacimab in vitro. (PubMed, Res Pract Thromb Haemost) - "Low concentrations of rFVIIa (0.5-1 μg/mL) corrected the effects of abelacimab as assessed by rotational thromboelastometry. Our data support using low doses of rFVIIa for bleeding management in patients treated with abelacimab."

Journal • Preclinical

Abelacimab versus rivaroxaban in patients with atrial fibrillation: Insights into the AZALEA-TIMI 71 study. (PubMed, Rev Invest Clin) - No abstract available

Journal • Atrial Fibrillation • Cardiovascular

Abelacimab Versus Rivaroxaban in Patients With Atrial Fibrillation Receiving Oral Antiplatelet Therapy: Definitely Safe, but How Effective? (PubMed, Circulation) - No abstract available

Journal • Atrial Fibrillation • Cardiovascular • Hematological Disorders

Protective Effects of FXI Inhibition by Abelacimab in a Baboon Model of Live Staphylococcus aureus Sepsis. (PubMed, J Thromb Haemost) - "FXI inhibition by abelacimab offers significant protection by attenuating activation of coagulation, reducing inflammation and preventing organ failure. Targeting FXI may be a promising therapeutic strategy for managing sepsis, addressing multiple facets of its complex pathophysiology."

Journal • Hematological Disorders • Infectious Disease • Inflammation • Septic Shock

Abelacimab Has Fewer Bleeds Than Rivaroxaban, But Study Has Several Important Biases. (PubMed, Am Fam Physician) - No abstract available

Journal

FXI inhibition with Abelacimab protects against S. aureus sepsis in a baboon model (ISTH 2025) - "Proteomic analysis revealed that abelacimab modulated pathways related to coagulation, inflammation, and tissue injury, contributing to improved survival. Table or Figure Upload"

Hematological Disorders • Infectious Disease • Inflammation • Septic Shock