A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)

A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.

Start Date27 Dec 2022

Sponsor / Collaborator

Anthos Therapeutics, Inc.

[+1]

NCT05171075

/ Active, not recruitingPhase 3

A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTE

This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)

Start Date27 Sep 2022

Sponsor / Collaborator

Anthos Therapeutics, Inc.

[+1]

NCT05171049

/ TerminatedPhase 3

A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab Relative to Apixaban on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With Cancer Associated VTE

This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)

Start Date05 May 2022

Sponsor / Collaborator

Anthos Therapeutics, Inc.

[+1]

100 Clinical Results associated with Abelacimab

100 Translational Medicine associated with Abelacimab

100 Patents (Medical) associated with Abelacimab

Literatures (Medical) associated with Abelacimab

01 Nov 2025·JAMA Cardiology

Safety of Factor XI Inhibition With Abelacimab in Atrial Fibrillation by Kidney Function

Article

Author: Bloomfield, Dan ; Wojakowski, Wojciech ; Murphy, Sabina A. ; Goodman, Shaun G. ; Kiss, Robert G. ; Morrow, David A. ; Weitz, Jeffrey I. ; Patel, Siddharth M. ; Parkar, Sanobar ; Giugliano, Robert P. ; Ruff, Christian T. ; Sabatine, Marc S. ; Joung, Boyoung ; Chen, Shih-Ann ; Hug, Bruce ; Goodrich, Erica L.

Importance:

Chronic kidney disease is common in patients with atrial fibrillation (AF) and is associated with higher rates of bleeding with anticoagulation. In the AZALEA-TIMI 71 randomized clinical trial, abelacimab, a novel factor XI inhibitor, reduced rates of major or clinically relevant nonmajor (CRNM) bleeding compared with rivaroxaban in patients with AF.

Objective:

To examine the safety of abelacimab vs rivaroxaban across a range of kidney function.

Design, Setting, and Participants:

The AZALEA-TIMI 71 study randomized patients with AF to 1 of 2 abelacimab doses (150 mg or 90 mg monthly) or to rivaroxaban, with stratification by creatinine clearance (CrCl). Patients with CrCl less than 15 mL/min or receiving dialysis were excluded. This secondary analysis of AZALEA-TIMI 71 examines outcomes by randomized treatment and CrCl at randomization.

Intervention:

Patients randomized to rivaroxaban with a CrCl greater than 50 mL/min received rivaroxaban, 20 mg, daily, and those with a CrCl of 50 mL/min or less received rivaroxaban, 15 mg, daily. Patients randomized to abelacimab received the assigned dose irrespective of CrCl.

Main Outcomes and Measure:

The primary outcome was major bleeding or CRNM bleeding.

Results:

Among 1284 patients, median (IQR) age was 74 (69-78) years and 572 patients (44.5%) were female. Median (IQR) CrCl was 71 (54-90) mL/min, with 264 patients (20.6%) having a CrCl of 50 mL/min or less. In the rivaroxaban group, patients with CrCl of 50 mL/min or less experienced higher rates of major or CRNM bleeding compared with those with CrCl greater than 50 mL/min despite dose reduction (incidence rates, 13.6 vs 7.0 per 100 person-years). Abelacimab reduced major or CRNM bleeding vs rivaroxaban irrespective of CrCl (CrCl ≤50 mL/min: hazard ratio [HR], 0.26; 95% CI, 0.12-0.54; &gt;50 mL/min: HR, 0.40; 95% CI, 0.26-0.62; P value for interaction = .33), with absolute risk reductions of 10.1 vs 4.2 per 100 person-years in those with CrCl of 50 mL/min or less vs greater than 50 mL/min, respectively ( P value for interaction = .09). This risk reduction was consistent for major bleeding alone and for a broader composite inclusive of major, CRNM, and minor bleeding. Results were similar when comparing the individual abelacimab doses to rivaroxaban.

Conclusions and Relevance:

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.

01 Nov 2025·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Factor XI/XIa inhibitors versus direct oral anticoagulants in atrial fibrillation with stroke risk: a GRADE-assessed meta-analysis of randomized controlled trials

Review

Author: Aldemerdash, Mohamed A ; Hemmeda, Lina ; Emara, Mohamed ; Murad, Mohamed R ; Ellebedy, Mohamed ; Elgendy, Mohamed S ; Gadelmawla, Ahmed Farid ; Emara, Ahmed ; Mohammed, Ahmed Abduljalil ; Abdelazeem, Basel

Direct oral anticoagulants (DOACs) prevent stroke in atrial fibrillation (AF) but are associated with an increased risk of major bleeding. Factors XI/XIa (FXI) inhibitors, such as Abelacimab and Asundexian, offer a promising alternative. This meta-analysis compares FXI/XIa inhibitors' safety and efficacy versus DOACs in AF with stroke risk. A systematic review and meta-analysis of randomized controlled trials (RCTs) was performed from PubMed, Scopus, Cochrane, and Web of Science up to March 2025. The analysis presented risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI) using RevMan v5.4. Three RCTs involving 16,852 patients were included, with 8777 (52.1%) receiving FXI inhibitors which significantly reduced the risk of major bleeding (0.4% vs. 1.0%, RR 0.31, 95% CI 0.21-0.46, p < 0.00001) and minor bleeding (3.3% vs. 4.7%, RR 0.66, 95% CI 0.47-0.93; p = 0.02) compared with DOACs. However, FXI inhibitors were associated with a significantly higher risk of stroke or systemic embolism (1.4% vs. 0.4%, RR 3.17, 95% CI 2.18-4.62, p < 0.00001). Safety outcomes showed no difference in total adverse events (AEs) (p = 0.91), serious AEs (p = 0.4768), and all-cause mortality (p = 0.15). In conclusion, current evidence suggests that FXI inhibitors significantly reduce major and minor bleeding events in AF patients at risk of thromboembolic disorders compared to DOACs. However, they are associated with a significant increase in stroke or systemic embolism risk. Further large-scale RCTs are needed to confirm these findings.

01 Oct 2025·JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Effect of heparins, direct oral anticoagulants, and factor XII/factor XI inhibitors on catheter-initiated thrombin generation in platelet-rich plasma: an in vitro study

Article

Author: Lecompte, Thomas ; Mullier, François ; Douxfils, Jonathan ; Thonon, Henri ; Vassart, Julie ; Lessire, Sarah ; Gouin-Thibault, Isabelle ; Hardy, Michael

BACKGROUND:

Invasive endovascular procedures often require anticoagulation to prevent device-associated thrombosis. High doses of unfractionated heparin (UFH) are the gold standard. The efficacy of factor (F)XII(a) and FXI(a) inhibitors remains unexplored.

OBJECTIVES:

We aimed to investigate, using a validated in vitro model of catheter-initiated thrombin generation (TG) in platelet-rich plasma (PRP), the effects of garadacimab, abelacimab, asundexian, and milvexian and of commonly used anticoagulants apixaban, dabigatran, fondaparinux and heparins (enoxaparin and UFH).

METHODS:

Anticoagulants were added to PRP at 6 concentrations and effects compared with UFH as a reference. The impact of adding anticoagulants into collection tubes before most preanalytical contact activation was also assessed. Concentrations achieving a 50% reduction in TG peak height (PH) were determined (IC₅₀).

RESULTS:

All anticoagulants prolonged lag time (LT) and reduced PH and endogenous thrombin potential, albeit to varying extents. UFH was the only anticoagulant able to suppress TG at clinically achieved concentrations (1 U/mL). The following IC₅₀ were found: milvexian, 2400 ng/mL; apixaban and dabigatran, 175 ng/mL; fondaparinux, 2.4 μg/mL; enoxaparin, 0.5 U/mL; and UFH, 0.25 U/mL. Asundexian up to 5000 ng/mL failed to reduce TG PH by 50%. Adding garadacimab and abelacimab to collection tubes resulted in greater efficacy than when added to PRP: LT increased by 89% and 32%, respectively; IC₅₀ were 25 and 12.5 μg/mL, respectively.

CONCLUSION:

Heparins were by far the most effective anticoagulants in our in vitro model. FXIIa and FXI(a) inhibitors did not adequately prevent coagulation on the studied artificial surface. Direct oral anticoagulants and fondaparinux showed limited efficacy, aligning with clinical observations.

News (Medical) associated with Abelacimab

24 Nov 2025

·www.biopharmadive.com

Bayer’s experimental blood-thinner notches trial win in stroke prevention

Dive Brief:Bayers experimental blood thinner asundexianmet its main goal in a closely watched Phase 3 stroke prevention trial, reducing the recurrence of a stroke in people who took the therapy along with standard treatments. The trial compared treatment with a combination of asundexian and an antiplatelet therapy against a placebo and the same antiplatelet treatment.The German-based company didnt release detailed data, stating that researchers will disclose them at an upcoming medical meeting while company executives discuss them with regulators ahead of possible approval applications.Results of the trial lifted optimism for asundexian'sdrug class, called Factor XIa inhibitors, following a series of clinical setbacks. Most recently, a rival drug missed its main goal in a trial of people whod had a recent heart attack.Dive Insight:The spotlight has been on Factor XIa inhibitors as the next big innovation in cardiovascular medicine, with drugmakers and researchers hoping they will prove safer and more effective than aging franchises like Bristol Myers Squibbs Eliquis. These drugs, which include asundexian,Bristol Myers and Johnson & Johnsons milvexian and Novartis abelacimab, block a protein involved in forming blood clots but is believed to be less essential in stopping bleeding.The balancing act in preventing stroke or any acute cardiovascular episode due to blood vessel blockages is in suppressing clotting without raising the risk that people will have uncontrolled bleeding incidents. In people who have irregular heartbeats, Eliquis is able to do just that better than an older drug called warfarin or aspirin.In treating people whove already had one stroke that wasnt caused by an irregular heartbeat, in a setting called secondary prevention, doctors use one or two drugs to thin the blood, known as antiplatelet medications. The drugs used include aspirin, clopidogrel, AstraZenecas Brilinta and Eli Lillys Effient.In the trial called Oceanic Stroke, Bayer aimed to measure whether adding asundexianto the mix would help, testing it against a placebo in over 12,000 people. The company said the experimental drug reduced the risk of ischemic stroke compared to placebo and added that its addition didnt increase the risk of major bleeding episodes.Bayers German-listed shares rose more than 12% following the news, changing hands at about 31 euros apiece. Two years ago, Bayer terminated a head-to-head trial of asundexianagainst Eliquis in people with irregular heartbeats, an early Phase 3 readout that cast some doubt over the promise of Factor XIa inhibitors.Milvexiansfailure in acute coronary syndrome earlier this month didnt boost optimism, but the asundexianresults may reverse some of the doubt.After a string of class setbacks, this is a needed win, wrote Cantor Fitzgerald analyst Carter Gould, who covers Bristol Myers, in a note to clients.Bristol Myers and J&J are expecting milvexiansPhase 3 trials in people with irregular heartbeats, as well as secondary stroke prevention, in the fourth quarter of 2026. Bristol Myers shares rose 5% in morning trading. '

Phase 3

20 Nov 2025

·endpoints.news

Novartis raises the sales bar for key cancer drugs, tweaks yearly growth guidance

Novartis said it has shifted the range of its mid-term growth target due to higher peak sales projections for some of its key medicines, as well as other growth drivers in its pipeline. The Swiss drugmaker now expects a compound annual growth rate of 5% to 6% from 2025 to 2030. Last month, Novartis said it expected a 6% annual growth rate from 2024 to 2029. During a call with the media Thursday morning, CEO Vas Narasimhan said he is confident Novartis will hit the new goal due to “three buckets of items.” The first consists of Novartis’ “in-line brands,” which continue to deliver “a really strong performance,” Narasimhan said. These include its breast cancer drug Kisqali, for which the company has upped peak sales guidance from at least $8 billion to at least $10 billion. New-to-brand prescriptions of Kisqali are about 70% in some ex-US markets, Narasimhan said. Another key medicine that should support Novartis’ growth is the chronic myeloid leukemia drug Scemblix. The company raised its peak sales guidance from at least $3 billion to at least $4 billion. “We see market shares [for Scemblix] really above 60% in the third-line setting, above 40% in the second-line setting, and climbing above 20% in the first-line setting in the markets that we’ve launched,” Narasimhan said. The second bucket comprises ongoing or upcoming launches that are “going to be very important to drive that growth,” Narasimhan said. In September, Novartis secured an FDA approval for its BTK inhibitor Rhapsido in chronic spontaneous urticaria. The company is currently launching the drug in the US and also testing it against Sanofi and Regeneron’s Dupixent in a Phase 3 trial that’s set to read out in 2027. In August, Novartis reported Phase 3 success for its Sjögren’s disease drug candidate ianalumab, and announced plans to file with the FDA. The drug has fast-track designation, meaning it could be eligible for a speedier review process. Narasimhan also spotlighted its “pipeline that we’ve built up with 30 plus high value assets.” At least 10 of those assets were acquired or licensed over the past two years, according to the release. Novartis’ list of future growth drivers is “fairly familiar,” Jefferies analysts wrote in a same-day note, adding that it includes ianalumab and the cholesterol drug pelacarsen. But the analysts highlighted that the company is now touting three new candidates as potential blockbusters: abelacimab for thrombosis; farabursen for autosomal dominant polycystic kidney disease; and pacibekitug for inflammatory diseases.

Phase 3Drug ApprovalFast Track

09 Sep 2025

·www.biospace.com

Novartis Deals in Cardio Again, Dropping $1.4B to Acquire Tourmaline

iStock, TBE Novartis has been investing heavily in its cardiovascular pipeline this year, forging partnerships with Flagship startup ProFound Therapeutics and China’s Argo Biopharmaceutical, among others. For the fourth time this year, Novartis is using its wallet to beef up its heart disease pipeline, acquiring New York-based Tourmaline Bio. Under the terms of the deal, announced early on Tuesday , Novartis, through an “indirect, wholly owned” but undisclosed subsidiary, will purchase all of Tourmaline’s outstanding shares for $48 apiece—an offer that, according to analysts at Truist Securities, represents a roughly 60% premium on the biotech’s closing trade price on Monday. All told, the acquisition agreement values Tourmaline at around $1.4 billion on a fully diluted basis. Truist, in a Tuesday morning note, called the transaction “a good deal” given the pharma’s “strong footprint” in the cardiovascular space. The companies expect to complete the buyout in the fourth quarter, pending customary conditions. The respective boards of directors of both companies have already unanimously signed off on the arrangement. Shares of Tourmaline were up 13% at close Monday and are up 58% in pre-market trading Tuesday. The centerpiece of the acquisition is pacibekitug, an investigational monoclonal antibody that works by targeting the IL-6 protein and is being trialed for atherosclerotic cardiovascular disease (ASCVD). In May, Tourmaline presented topline data from the Phase II TRANQUILITY study, touting a “ rapid, deep, and durable ” reduction in levels of high-sensitivity C-reactive protein, a key marker of inflammation linked to elevated cardiovascular disease. At the time, Tourmaline positioned findings from TRANQUILITY as the “starting point” of the clinical development program of pacibekitug in ASCVD and other cardiovascular conditions. Pacibekitug “represents a potential breakthrough” in lowering residual inflammation in ASCVD patients, Novartis Chief Medical Officer Shreeram Aradhye said in a statement on Tuesday. Novartis has yet to provide details regarding its plans for pacibekitug moving forward. Tuesday’s acquisition of Tourmaline comes shortly after Novartis expanded its partnership with China’s Argo Biopharmaceutical. The pharma last week paid $160 million upfront and pledged up to $5.2 billion in milestone payments to collaborate on “multiple” RNAi assets for cardiovascular disease, as well as leveraging the biotech’s siRNA drug development platform. Argo and Novartis first partnered in January 2024 . Novartis in February also put $3.1 billion on the line to acquire private biotech Anthos Therapeutics and regain the rights to its anticoagulant antibody abelacimab. Then, in June, the pharma entered into a multi-target arrangement with Flagship Pioneering’s ProFound Therapeutics to develop novel protein therapies for cardiovascular conditions. This agreement involved a $25 million upfront payment and up to $750 million in milestones per target.

AcquisitionPhase 2Clinical Result

100 Deals associated with Abelacimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic embolism	Phase 3	United States	Lonza AG	27 Dec 2022
Systemic embolism	Phase 3	United States	Anthos Therapeutics, Inc.	27 Dec 2022
Systemic embolism	Phase 3	Japan	Lonza AG	27 Dec 2022
Systemic embolism	Phase 3	Japan	Anthos Therapeutics, Inc.	27 Dec 2022
Systemic embolism	Phase 3	Canada	Lonza AG	27 Dec 2022
Systemic embolism	Phase 3	Canada	Anthos Therapeutics, Inc.	27 Dec 2022
Systemic embolism	Phase 3	Israel	Anthos Therapeutics, Inc.	27 Dec 2022
Systemic embolism	Phase 3	Israel	Lonza AG	27 Dec 2022
Atrial Fibrillation	Phase 3	United States	Anthos Therapeutics, Inc.	27 Dec 2022
Atrial Fibrillation	Phase 3	United States	Lonza AG	27 Dec 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04755283 (AZALEA-TIMI 71 \| AZALEA-TIMI 71, CTgov)	Phase 2	Stroke \| Atrial Fibrillation	1,287	Abelacimab (Abelacimab 90 mg (MAA868))	qndfqkdptk = dtcnnyqcqk gjssxutxvy (htligywpgb, fmhfvxrnlo - qlgvlfsjem) View more	-	30 Jul 2025
				Abelacimab (Abelacimab 150 mg (MAA868))	qndfqkdptk = vqppdrcgxa gjssxutxvy (htligywpgb, ombufxodgh - zqjxwwcpcv) View more
NCT04755283 (AZALEA-TIMI 71, Company_Website) Manual	Phase 2	Hemorrhage \| Atrial Fibrillation	-	abelacimab (≥75 years)	ugpxuhcprf(fjadprvkpe) = fpilvhgilq stcfbfqtji (xyrannpsru )	Positive	08 Apr 2025
				abelacimab (＜75 years)	ugpxuhcprf(fjadprvkpe) = wmhgfidtnh stcfbfqtji (xyrannpsru )
NCT04755283 (AZALEA-TIMI 71, Pubmed) Manual	Phase 2	Atrial Fibrillation	1,287	Abelacimab 150 mgAbelacimab 150 mg	sokwoqdvmf(prnebkhjag) = jlwvverohn idjxpyztvd (cadnwhgure )	Positive	23 Jan 2025
				AbelacimabAbelacimab 90 mg	sokwoqdvmf(prnebkhjag) = ovvpfgneay idjxpyztvd (cadnwhgure )
NCT04755283 (AZALEA-TIMI 71, GlobeNewswire) Manual	Phase 2	Thrombosis	-	Abelacimab 150 mg	rprcxkondf(fajichhanb) = ntfbndkojo kggfkgpord (lxjpdslhmj )	Positive	16 Nov 2024
				Rivaroxaban	rprcxkondf(fajichhanb) = kehryrmduf kggfkgpord (lxjpdslhmj )
NCT04755283 (AZALEA-TIMI 71, PipelineReview) Manual	Not Applicable	Atrial Fibrillation	1,287	abelacimab 150 mg	jxugjmlrsx(mdjxxokvlj) = aopuiokmei nloylaesbm (nwwfwkvmku ) View more	Positive	13 Nov 2023
				rivaroxaban 20 mg	-
NCT04755283 (AZALEA-TIMI 71 , Corporate Publications) Manual	Phase 2	Atrial Fibrillation	1,287	Abelacimab 150 mg	tipvevdhuc(hmqvxhzwkz) = xqxfynuodu yfcsilkset (rmjulmzyhm ) View more	Superior	12 Nov 2023
				Rivaroxaban 20 mg	-
NCT04755283 (AZALEA-TIMI 71, Biospace) Manual	Phase 2	Atrial Fibrillation	1,287	Abelacimab	iqtofjlzhy(bbqkwwxscp) = met zumyglpjap (mzpavhhvll ) Met	Positive	18 Sep 2023
				Rivaroxaban
NCT04213807 (CTgov)	Phase 2	Atrial Fibrillation	28	Placebo	hmonkfqlof = brasnaocom bbthmgbvxn (czywoshtpy, pbkylrwbqq - dkcbgszjbt) View more	-	07 Dec 2021
EUCTR2019-003756-37-BG (ANT-005 TKA, ISTH2021 \| Company_Website) Manual	Phase 2	Venous Thromboembolism	412	30mg abelacimab	vpmljqklbj(ghajxfszkb) = whdltdjltg ntadtingcg (wcotzxroty ) View more	Positive	17 Jul 2021
				75mg abelacimab	vpmljqklbj(ghajxfszkb) = sjaggnjjfs ntadtingcg (wcotzxroty ) View more

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