TFPI Inhibitors
2 drugsAbout TFPI
Tissue Factor Pathway Inhibitor (TFPI) regulates blood coagulation by inhibiting Factor Xa and Tissue Factor/Factor VIIa complex. These are key components in the coagulation cascade, making TFPI a crucial regulator of hemostasis.
Currently, there is no genetic evidence directly linking TFPI to specific diseases. However, its role in hemostasis has led to the development of therapies modulating TFPI activity.
TFPI is targeted by two FDA-approved biologic drugs, HYMPAVZI (Pfizer) and ALHEMO (Novo Nordisk), both approved in 2024 for rare diseases. These drugs highlight the therapeutic potential of modulating TFPI activity.
Top TFPI Drugs
The competitive landscape consists of Pfizer and Novo Nordisk, each with an approved TFPI-targeting drug.
The market is highly concentrated, suggesting high barriers to entry or limited commercial opportunity beyond rare diseases.
TFPI Drug Modality Landscape
Modalities
Routes of Administration
TFPI requires biologic approaches (biologic (other)), likely due to its structure or location.
The absence of small molecule or antibody drugs targeting TFPI may represent a whitespace opportunity for novel modalities.
TFPI Clinical Trials 9 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on TFPI. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 3 | 1 | 1 | 1 | 50% |
| Phase 2 | 2 | 2 | 0 | 0 | 100% |
| Phase 3 | 4 | 0 | 0 | 4 | - |
Top Sponsors
By Modality
Top Conditions
TFPI Drug Approval Timeline (2024 - 2024)
The first TFPI-targeting drug, HYMPAVZI, was approved in 2024, with ALHEMO following in the same year.
The recent approvals suggest renewed interest in TFPI as a drug target, but it is too early to assess market saturation.
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Competitive Landscape
- • 2 companies competing
- • Market share by company
Full Drug Portfolio
- • All 2 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 2-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 2 (2 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 TFPI. A trial counts if an approved drug acting on TFPI 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.