IRAK1 Inhibitors
1 drugsAbout IRAK1
Interleukin-1 receptor-associated kinase 1 (IRAK1) is an intracellular serine/threonine kinase crucial for signaling downstream of Toll-like receptors (TLRs) and interleukin-1 receptors (IL-1Rs). These pathways are key components of the innate immune system, initiating inflammatory responses upon pathogen recognition. As a central mediator of inflammation, IRAK1 is a potential drug target.
IRAK1's involvement in inflammatory signaling makes it relevant to a range of therapeutic areas. Currently, there is no genetic evidence data available linking IRAK1 to specific diseases. The development of drugs targeting IRAK1 holds promise for modulating immune responses and treating diseases where inflammation plays a significant role.
There is one FDA-approved drug, VONJO (SOBI), that targets IRAK1. VONJO is a small molecule approved in 2022 for one indication. SOBI is the only company with an approved IRAK1-targeting drug.
Top IRAK1 Drugs
SOBI is the only company with an approved drug targeting IRAK1.
The market is not yet saturated, but SOBI's first-mover advantage creates a barrier to entry.
IRAK1 Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets IRAK1, using small molecule modality.
Explore opportunities for alternative modalities like antibodies or PROTACs to differentiate from existing therapies.
IRAK1 Clinical Trials 51 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on IRAK1. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 25 | 11 | 6 | 8 | 65% |
| Phase 2 | 21 | 1 | 8 | 12 | 11% |
| Phase 3 | 4 | 1 | 2 | 1 | 33% |
| Phase 4 | 1 | 1 | 0 | 0 | 100% |
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By Modality
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Top Drugs
IRAK1 Drug Approval Timeline (2022 - 2022)
The first and only IRAK1-targeting drug, VONJO, was approved in 2022.
Recent approval suggests growing interest in IRAK1 as a target, but further approvals are needed to confirm this trend.
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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: 28 (5 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 IRAK1. A trial counts if an approved drug acting on IRAK1 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.