IL-23 Inhibitors & Biosimilars
13 drugsAbout IL-23
Interleukin-23 (IL-23) is a cytokine that promotes the differentiation, proliferation, and survival of Th17 cells, key drivers in autoimmune diseases. It plays a crucial role in the inflammatory cascade.
Human genetics provide moderate support for IL-23 as a therapeutic target, with variants linked to psoriasis (score 0.38). Loss-of-function variants appear protective, suggesting inhibition is likely beneficial.
IL-23 is targeted by 11 FDA-approved drugs, including SELARSDI, TREMFYA, WEZLANA, STELARA, and SKYRIZI. Most are biologics (9 drugs), with antibodies representing the remaining modalities (2 drugs).
IL-23 Genetic Evidence Moderate
Genetic evidence offers moderate support, with a max score of 0.38 for psoriasis.
Moderate genetic support suggests a reasonable probability of clinical success.
💡 Why inhibition?
- • Loss-of-function variants reduce disease risk (OR < 1)
- • 100% directional consistency across 2 traits
- • Strong signal in immune system disease, integumentary system disease, genetic, familial or congenital disease pathways
Cross-Disease Effects
Trade-off: LowDirection of Effect
100% alignedEvidence Across Diseases
5 totalGWAS and other genetic studies link IL23A to 5 diseases.
Inhibiting this target may be therapeutic
Inhibiting this target may be therapeutic
🔗 Colocalization Evidence 20 strong
max H4: 0.98eQTL/pQTL signals for IL23A colocalize with these GWAS traits, providing causal evidence that gene expression changes drive disease risk.
Understanding these scores
Association Score (0-1): Combines all evidence types (genetic, literature, drugs, animal models). Higher = more evidence linking target to disease. This is a ranking heuristic, not a confidence score.
L2G Score: Open Targets uses a machine learning model (Locus-to-Gene) to predict which gene is causal at each GWAS locus. L2G=0.5 means ~50% probability of being the causal gene. Only associations with L2G > 0.05 are included.
Odds Ratio (OR): From gene burden studies (UK Biobank, AstraZeneca PheWAS). Measures how loss-of-function variants affect disease risk. OR<1 = protective (inhibiting target may help), OR>1 = risk (losing function causes disease).
Beta (β): Effect size for continuous traits. β<0 = protective, β>0 = risk.
Clinical Translation (~1.8x): Based on Nelson et al. 2015: drug targets with genetic evidence have ~2x higher success rates in clinical trials. We estimate: Strong support (score ≥0.7) → ~1.8x, Moderate (0.3-0.7) → ~1.3x, Weak → baseline.
Colocalization (H4): Tests whether a GWAS signal and an eQTL/pQTL signal share the same causal variant. H4 is the posterior probability that both traits are associated AND share a causal variant. H4 > 0.8 = strong evidence that gene expression/protein levels drive disease risk. This links genetic variation → gene expression → disease, supporting the target-disease connection.
Top IL-23 Drugs
Ten companies have approved IL-23 targeting drugs, including SUN PHARMA GLOBAL, ALVOTECH USA INC, Johnson & Johnson, Amgen, and AbbVie.
The presence of multiple players indicates a competitive market with moderate entry barriers.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| STELARA | Johnson & Johnson | 2009 | 4 |
| SELARSDI | ALVOTECH USA INC | 2024 | 4 |
| IMULDOSA | ACCORD BIOPHARMA INC. | 2024 | 4 |
| OTULFI | Fresenius Kabi | 2024 | 4 |
| YESINTEK | BIOCON BIOLOGICS INC | 2024 | 4 |
| STARJEMZA | BIO-THERA SOLUTIONS LTD | 2025 | 4 |
| OMVOH | Eli Lilly | 2023 | 2 |
| ILUMYA | SUN PHARMA GLOBAL | 2018 | 1 |
| ICOTYDE | Johnson & Johnson | 2026 | - |
| STEQEYMA | CELLTRION, INC. | 2024 | - |
IL-23 Drug Modality Landscape
Modalities
Routes of Administration
IL-23 requires biologic approaches (biologic (other)), likely due to its structure or location.
A focus on novel small molecule inhibitors could offer a competitive advantage.
📈 Modality Evolution
Antibodies pioneered IL-23 targeting (2009), with other biologics entering more recently (2018).
IL-23 Clinical Trials 318 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on IL-23. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 64 | 52 | 6 | 6 | 90% |
| Phase 2 | 70 | 44 | 5 | 21 | 90% |
| Phase 3 | 130 | 79 | 15 | 36 | 84% |
| Phase 4 | 54 | 21 | 4 | 29 | 84% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
8 Phase 3 trials testing approved IL-23 drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting IL-23. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
IL-23 Drug Approval Timeline (2009 - 2025)
The first IL-23 targeting drug was approved in 2009 (STELARA), with the most recent in 2025 (STARJEMZA).
The continued approval of new drugs suggests ongoing innovation and market potential.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 11 companies competing
- • Market share by company
Full Drug Portfolio
- • All 13 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 13-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 94 (40 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-23. A trial counts if an approved drug acting on IL-23 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.