IL-1ra Inhibitors & Biosimilars
1 drugsAbout IL-1ra
Interleukin-1 receptor antagonist (IL-1ra) is a naturally occurring protein that inhibits the pro-inflammatory effects of interleukin-1 (IL-1) by binding to the IL-1 receptor. This mechanism of action makes IL-1ra an important target for therapeutic intervention in diseases driven by excessive IL-1 activity.
While there is currently no genetic evidence directly linking IL-1ra to specific diseases, the role of IL-1 in inflammatory processes has spurred interest in targeting this pathway. IL-1ra is a therapeutic target for autoimmune diseases and inflammatory conditions.
There is one FDA-approved drug, ARCALYST, a fusion protein developed by KINIKSA PHARMACEUTICALS (UK), LTD. ARCALYST was first approved in 2008 and is approved for use in a single therapeutic area classified as "other".
Top IL-1ra Drugs
KINIKSA PHARMACEUTICALS (UK), LTD. is the only company with an approved drug targeting IL-1ra.
The market is highly concentrated, suggesting high barriers to entry or limited commercial opportunity.
IL-1ra Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets IL-1ra, using fusion protein modality.
The absence of small molecule or antibody drugs represents a whitespace opportunity.
IL-1ra Clinical Trials 17 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on IL-1ra. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 2 | 2 | 0 | 0 | 100% |
| Phase 2 | 8 | 7 | 0 | 1 | 100% |
| Phase 3 | 6 | 5 | 1 | 0 | 83% |
| Phase 4 | 1 | 1 | 0 | 0 | 100% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
IL-1ra Drug Approval Timeline (2008 - 2008)
ARCALYST was first approved in 2008 and remains the only approved drug.
The lack of recent approvals suggests market saturation or challenges in developing new IL-1ra-targeting therapies.
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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: 12 (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 IL-1ra. A trial counts if an approved drug acting on IL-1ra 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.