FcRI Inhibitors
2 drugsAbout FcRI
FcεRI is the high-affinity receptor for IgE, crucial in allergic reactions. When bound by IgE and cross-linked by allergens, it triggers mast cell and basophil activation, releasing mediators that cause allergic disease symptoms.
FcεRI is a significant target in respiratory therapeutic areas, though no genetic evidence directly links it to specific diseases. Its role in the inflammatory cascade associated with asthma and allergic rhinitis makes it therapeutically relevant.
Two FDA-approved drugs, XOLAIR (omalizumab) and OMLYCLO, target FcεRI. These drugs are biologics, including one antibody and one other biologic, developed by Roche and CELLTRION INC for respiratory indications.
Top FcRI Drugs
The competitive landscape includes Roche and CELLTRION INC, each with approved drugs.
Limited number of players suggests opportunity for new entrants with differentiated FcεRI therapies.
FcRI Drug Modality Landscape
Modalities
Routes of Administration
FcRI requires biologic approaches (biologic (other)), likely due to its structure or location.
Consider novel modalities to differentiate from existing antibody and biologic approaches.
📈 Modality Evolution
Antibodies pioneered FcRI targeting (2003), with other biologics entering more recently (2025).
FcRI Clinical Trials 119 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on FcRI. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 27 | 24 | 2 | 1 | 92% |
| Phase 2 | 34 | 25 | 2 | 7 | 93% |
| Phase 3 | 27 | 24 | 1 | 2 | 96% |
| Phase 4 | 31 | 18 | 8 | 5 | 69% |
Top Sponsors
By Modality
FcRI Drug Approval Timeline (2003 - 2025)
The first drug was approved in 2003, with the most recent in 2025, spanning 23 years.
Recent approval suggests continued interest, but increasing saturation warrants innovative strategies.
Pro Intelligence Preview
Deep insights for drug target analysis
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: 61 (19 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 FcRI. A trial counts if an approved drug acting on FcRI 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.