Factor XI Inhibitors in Development
What are factor XI inhibitors?
Factor XI inhibitors are blood thinners (anticoagulants) that block clotting factor XI or its active form, factor XIa. People born with factor XI deficiency usually bleed only after injury or surgery, yet have fewer ischemic strokes than expected, which suggested that blocking factor XI could prevent clots with less bleeding than current blood thinners. The first, asundexian (Sunharbo), was approved by the FDA on November 9, 2026.
Factor XI inhibitors in clinical trials in 2026
TheraRadar tracks 12 factor XI inhibitors with recent clinical activity (1 approved) in 76 registered trials, and 5 have reached Phase 3 or later. Among them are asundexian (Bayer, approved), milvexian (Johnson & Johnson), cenvacibart (Regeneron) and amrecibart (Regeneron). Venous thromboembolism has the most factor XI inhibitors in trials (7), followed by atrial fibrillation (6) and kidney failure on dialysis (5). The next Phase 3 readouts, by the estimated completion date on ClinicalTrials.gov: milvexian (LIBREXIA-AF, Dec 2026), cenvacibart (ROXI-APEX, Feb 2027) and abelacimab (LILAC-TIMI 76, Dec 2027).
10 programs in this class span 9 indications (33 drug–indication pairs mapped). The most contested indication is Atrial Fibrillation (13 programs).
Forward catalysts next 18 months⏰ 6 due ≤6 mo
primaryCompletionDate — a timing proxy, not a confirmed action date). Red = due within 6 months.Drug × Indication
Atrial Fibrillation | Venous Thromboembolism | Kidney Failure on Dialysis | Catheter-Related Thrombosis | Stroke (secondary prevention) | Peripheral Artery Disease | Coronary Artery Disease | Acute Coronary Syndrome | Hypertension | |
|---|---|---|---|---|---|---|---|---|---|
| cenvacibartRegeneronFactor XI | |||||||||
| milvexianJohnson & JohnsonFactor XIa | |||||||||
| amrecibartRegeneronFactor XI | |||||||||
| abelacimabNovartisFactor XI | |||||||||
| asundexianBayerFactor XIa | |||||||||
| KN060Suzhou AlphamabFactor XI / XIa | |||||||||
| gruticibartAronoraFactor XI | |||||||||
| vortosiranRibocure PharmaceuticalsFactor XI | |||||||||
| SRSD107Sirius TherapeuticsFactor XI | |||||||||
| RBD1119Ribocure PharmaceuticalsFactor XI |
Beyond the grid Beta
White-space indications — a single asset 1 found
Active programs — indication not yet mapped (2) — in-scope assets whose trials we haven’t yet resolved to an indication column
| Phase | Mechanism | Company | Modality | Readout | Trial |
|---|---|---|---|---|---|
| Phase 1 | CITY-FXI — Factor XIunclassified | City Therapeutics | 1Q28 | NCT07430397 | |
| Phase 1 | FXI-GalNAc-siRNA — Factor XIunclassified | Sirnaomics | ⏰ 2Q27 | NCT05844293 |
Small-molecule factor XIa inhibitors
2 active programs, most advanced first.
| Drug | Targets | Sponsor | Phase | Main indications | Trials |
|---|---|---|---|---|---|
| asundexian | Factor XIa | Bayer | Approved | Stroke (secondary prevention) · Atrial Fibrillation · Acute Coronary Syndrome | 7 |
| milvexian | Factor XIa | Johnson & Johnson Janssen Research & Development is the registry sponsor; Bristol Myers Squibb is listed as collaborator and co-funder. | Phase 3 | Stroke (secondary prevention) · Kidney Failure on Dialysis · Atrial Fibrillation | 26 |
Antibodies against factor XI
5 active programs, most advanced first.
| Drug | Targets | Sponsor | Phase | Main indications | Trials |
|---|---|---|---|---|---|
| abelacimab | Factor XI | Novartis Developed by Anthos Therapeutics, which Novartis acquired in 2025 (Novartis results filing). Anthos remains the registry sponsor of the core trials. | Phase 3 | Atrial Fibrillation · Venous Thromboembolism | 6 |
| amrecibart | Factor XI | Regeneron | Phase 3 | Atrial Fibrillation · Catheter-Related Thrombosis · Peripheral Artery Disease | 9 |
| cenvacibart | Factor XI | Regeneron | Phase 3 | Venous Thromboembolism · Atrial Fibrillation · Catheter-Related Thrombosis | 16 |
| gruticibart | Factor XI | Aronora | Phase 2 | Catheter-Related Thrombosis · Kidney Failure on Dialysis | 4 |
| KN060 | Factor XI / XIa | Suzhou Alphamab | Phase 2 | Kidney Failure on Dialysis · Venous Thromboembolism · Hypertension | 3 |
RNA drugs that lower factor XI
5 active programs, most advanced first.
| Drug | Targets | Sponsor | Phase | Main indications | Trials |
|---|---|---|---|---|---|
| RBD1119 | Factor XI | Ribocure Pharmaceuticals | Phase 2 | Coronary Artery Disease | 2 |
| SRSD107 | Factor XI | Sirius Therapeutics | Phase 2 | Coronary Artery Disease · Peripheral Artery Disease · Venous Thromboembolism | 4 |
| vortosiran | Factor XI | Ribocure Pharmaceuticals | Phase 2 | Venous Thromboembolism · Atrial Fibrillation · Coronary Artery Disease | 4 |
| CITY-FXI | Factor XI | City Therapeutics | Phase 1 | 1 | |
| FXI-GalNAc-siRNA | Factor XI | Sirnaomics | Phase 1 | 1 |
No recent activity
Programs whose trials ended or went quiet without an announced decision. Their status is unknown, not necessarily stopped.
| Drug | Targets | Sponsor | Status |
|---|---|---|---|
| frunexian | Factor XIa | eXIthera Pharmaceuticals | Its Phase 2, in continuous renal replacement therapy (NCT05602129, Haisco), has an unknown registry status and was last updated in 2022. A COVID-19 Phase 2 (NCT05040776) was withdrawn before enrolling. |
| SHR2285 | Factor XIa | Jiangsu Hengrui | Its only Phase 2 (NCT05203705) was terminated; the registry reason is "Adjustment of the sponsor's R&D strategy". No active trial on ClinicalTrials.gov as of 2026-11-13. |
| ONO-7684 | Factor XIa | Ono Pharmaceutical | No active trial on ClinicalTrials.gov as of 2026-11-12. |
| SHR-2004 | Factor XI | Beijing Suncadia Pharmaceuticals | Phase 3 after knee replacement (NCT06825416, China) is completed with no results posted. No active trial on ClinicalTrials.gov as of 2026-11-12. |
| osocimab | Factor XIa | Bayer | No active trial on ClinicalTrials.gov as of 2026-11-12. |
| MK-2060 | Factor XI | Merck | No active trial on ClinicalTrials.gov as of 2026-11-12. |
| fesomersen | Factor XI | Bayer | No active trial on ClinicalTrials.gov as of 2026-11-12. |
How this list was built
Programs were identified by searching ClinicalTrials.gov by drug name, code name and class, and each has at least one primary source: a paper, the FDA announcement, or the drug's own registry record. Trials are matched to a program by exact drug name or code. Drugs whose records do not state the target are left out, so early programs are probably undercounted. Trials whose registry status is unknown or withdrawn are not shown. Indications are the clinical setting each trial was run in, set from its registry conditions and title.
Frequently asked
Common questions about the Factor XI / XIa inhibitors landscape
- What drugs are in the Factor XI / XIa inhibitors class?
- 12 active programs in the Factor XI / XIa inhibitors class are tracked in this platform view (19 listed in all, with those that have no recent activity shown separately), including cenvacibart, milvexian, and amrecibart. The heatmap maps every drug against the indications it is being developed for.
- What conditions are Factor XI / XIa inhibitors being developed for?
- Factor XI / XIa inhibitors are in clinical development across 9 indications, including Atrial Fibrillation, Venous Thromboembolism, Kidney Failure on Dialysis, Catheter-Related Thrombosis, and Stroke (secondary prevention).
- How many Factor XI / XIa inhibitors are in late-stage trials?
- Of the 12 tracked assets in the Factor XI / XIa inhibitors class, 5 are at Phase 3 or later, developed by 10 sponsors, across 76 mapped trials.
- What are the upcoming Factor XI / XIa inhibitors catalysts?
- Near-term catalysts in this class include milvexian (data readout, Oct '26); milvexian (data readout, Dec '26); KN060 (data readout, Dec '26). Dates combine estimated trial readouts and confirmed FDA decision dates.
- How is the Factor XI / XIa inhibitors platform compiled?
- Programs were identified by searching ClinicalTrials.gov by drug name, code name and class, and each has at least one primary source: a paper, the FDA announcement, or the drug's own registry record. Trials are matched to a program by exact drug name or code. Drugs whose records do not state the target are left out, so early programs are probably undercounted. Trials whose registry status is unknown or withdrawn are not shown. Indications are the clinical setting each trial was run in, set from its registry conditions and title. Each cell links to the underlying trial records.
- Is the Factor XI / XIa inhibitors heatmap free to use?
- Yes — viewing and searching the Factor XI / XIa inhibitors heatmap is free. A TheraRadar Pro subscription adds advanced filters, row/column selection, and one-click export to PowerPoint, PDF, and CSV.
Data: ClinicalTrials.gov · Curated program roster · Trials registered 2008 onwards.