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).
Strategic Insights
ℹ️ How we calculate- Validated target with strong trial activity and 80% attractiveness score.
- White space opportunity in Arthritis, Juvenile with only 3 trials.
- Emerging modalities (Antibody) signal innovation opportunity.
Human 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 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 |
|---|---|---|---|
| SKYRIZI | AbbVie | 2019 | 4 |
| IMULDOSA | ACCORD BIOPHARMA INC. | 2024 | 4 |
| STARJEMZA | BIO-THERA SOLUTIONS LTD | 2025 | 4 |
| STELARA | Johnson & Johnson | 2009 | 4 |
| SELARSDI | ALVOTECH USA INC | 2024 | 4 |
| OTULFI | Fresenius Kabi | 2024 | 4 |
| OMVOH | Eli Lilly | 2023 | 2 |
| ILUMYA | SUN PHARMA GLOBAL | 2018 | 1 |
| STEQEYMA | CELLTRION, INC. | 2024 | - |
| ICOTYDE | Johnson & Johnson | 2026 | - |
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).
Clinical Trials 356 trials
Completion by Phase
| Phase | Total | Completed | Failed | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 82 | 66 | 6 | 10 | 92% |
| Phase 2 | 80 | 53 | 5 | 22 | 91% |
| Phase 3 | 144 | 81 | 17 | 46 | 83% |
| Phase 4 | 50 | 21 | 5 | 24 | 81% |
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.
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
- • Competition: High (15 sponsors)
- • White space: 8 underexplored indications
- • Success rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Calculate These Metrics
Target Attractiveness Score
A 0-100 score based on trial activity, sponsor diversity, and completion rates. Calculated from 301 clinical trials targeting IL-23.
Completion rate: Percentage of trials that reached their planned endpoint. Trials terminated early, withdrawn, or suspended are not counted—these often indicate safety issues, lack of efficacy, or strategic pivots.
- Highly Attractive (80+): High trial activity, many sponsors, strong completion rates
- Attractive (60-79): Good trial activity and validation
- Moderate (40-59): Moderate interest from sponsors
- Low (under 40): Limited trial activity or validation concerns
Strategic Insights
Auto-generated insights based on trial analytics including competition intensity, white space opportunities, modality shifts, and failure patterns. We analyze trial sponsors, phases, indications, and outcomes.
Risk Signals
- High Competition: Many sponsors competing for this target (may reduce market opportunity)
- High Failure Risk: Low trial completion rates suggest development challenges
- Low Validation: Limited trial activity or poor outcomes indicate uncertain viability
- White Space Available: Underexplored indications present opportunities