Factor IX Inhibitors
3 drugsAbout Factor IX
Factor IX, also known as Christmas factor, is a serine protease essential for the coagulation cascade, the process of blood clot formation. It plays a crucial role in converting factor X to its active form, a key step in the intrinsic pathway of coagulation.
Factor IX is a significant target for drug development in bleeding disorders, despite the lack of direct genetic evidence linking it to specific diseases. Modulating Factor IX activity is essential for managing conditions with impaired or excessive blood clotting.
Currently, one FDA-approved drug, HEMLIBRA (Roche), targets Factor IX. This antibody-based therapy highlights the clinical relevance of Factor IX in treating bleeding disorders.
Top Factor IX Drugs
Roche is the only company with an approved drug targeting Factor IX.
The market is highly concentrated, presenting a high barrier to entry for new competitors.
Factor IX Drug Modality Landscape
Modalities
Routes of Administration
Factor IX requires biologic approaches (gene therapy), likely due to its structure or location.
Exploring alternative modalities like small molecules could provide a competitive advantage.
📈 Modality Evolution
Antibodies pioneered Factor IX targeting (2017), with gene therapies entering more recently (2022).
Factor IX Clinical Trials 28 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on Factor IX. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 2 | 1 | 0 | 1 | 100% |
| Phase 2 | 4 | 1 | 0 | 3 | 100% |
| Phase 3 | 15 | 7 | 5 | 3 | 58% |
| Phase 4 | 7 | 0 | 3 | 4 | 0% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Phase 3 Readout Calendar Pro
2 Phase 3 trials testing approved Factor IX drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting Factor IX. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
Factor IX Drug Approval Timeline (2017 - 2024)
The first and only drug, HEMLIBRA, was approved in 2017.
The approval timeline suggests a potential for market saturation with the current therapeutic approach.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 3 companies competing
- • Market share by company
Full Drug Portfolio
- • All 3 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 3-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 13 (3 companies)
- • 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 IX. A trial counts if an approved drug acting on Factor IX 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.