Factor XIIa Inhibitors
1 drugsAbout Factor XIIa
Factor XIIa (FXIIa) is a serine protease involved in the intrinsic coagulation pathway, initiating blood clotting through the contact activation system. While its in vitro role is clear, its in vivo function is more nuanced, making it a target for drug development.
FXIIa inhibition offers a potential route to prevent thrombosis without increasing bleeding risk, as Factor XII deficiencies do not typically cause bleeding disorders. Currently, there is no genetic evidence available linking Factor XIIa to specific diseases.
ANDEMBRY (CSL BEHRING LLC) is the only FDA-approved drug targeting Factor XIIa, approved in 2025. It is a biologic (other) modality, representing 100% of the drugs in this space.
Top Factor XIIa Drugs
CSL BEHRING LLC is the only company with an approved drug targeting Factor XIIa.
The single-player competitive landscape presents a high barrier to entry but also a first-mover advantage.
Factor XIIa Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets Factor XIIa, using biologic (other) modality.
The lack of modality diversity suggests an opportunity for small molecule or antibody-based FXIIa inhibitors.
Factor XIIa Clinical Trials 3 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Factor XIIa. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 2 | 2 | 2 | 0 | 0 | 100% |
| Phase 4 | 1 | 1 | 0 | 0 | 100% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Factor XIIa Drug Approval Timeline (2025 - 2025)
The first and only drug, ANDEMBRY, was approved in 2025.
The recent approval suggests a growing interest in FXIIa as a therapeutic target, but market saturation is low.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 1 companies competing
- • Market share by company
Full Drug Portfolio
- • All 1 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 1-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 1 (1 company)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on Factor XIIa. A trial counts if an approved drug acting on Factor XIIa is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.