IL-12 Inhibitors & Biosimilars
8 drugsAbout IL-12
Interleukin 12 (IL-12) is a key cytokine in the immune system that drives cell-mediated immunity by influencing the differentiation and activation of immune cells.
Human genetic studies provide strong validation for IL-12 as a therapeutic target, with variants linked to primary biliary cirrhosis (score 0.81), multiple sclerosis (score 0.75), and celiac disease (score 0.68). Loss-of-function variants are protective, suggesting inhibition is likely beneficial.
IL-12 is targeted by 7 FDA-approved drugs, including SELARSDI, WEZLANA, and STELARA. These drugs are primarily biologics (6 drugs) and antibodies (1 drug) for immunology indications.
IL-12 Genetic Evidence Strong
IL-12 has strong genetic support with a max score of 0.81 linking it to primary biliary cirrhosis.
Strong genetic support suggests that clinical trials targeting IL-12 have an increased probability of success.
💡 Why inhibition?
- • Loss-of-function variants reduce disease risk (OR < 1)
- • 100% directional consistency across 2 traits
- • Strong signal in gastrointestinal disease, genetic, familial or congenital disease, endocrine system disease pathways
Cross-Disease Effects
Trade-off: LowDirection of Effect
100% alignedEvidence Across Diseases
20 totalGWAS and other genetic studies link IL12A to 31 diseases.
Inhibiting this target may be therapeutic
Inhibiting this target may be therapeutic
🔗 Colocalization Evidence 20 strong
max H4: 1.00eQTL/pQTL signals for IL12A 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-12 Drugs
Seven companies have approved drugs targeting IL-12, including ALVOTECH USA INC, Amgen, and Johnson & Johnson.
The presence of multiple companies indicates a competitive market with moderate barriers to entry.
| Drug | Company | Approved | Indications |
|---|---|---|---|
| IMULDOSA | ACCORD BIOPHARMA INC. | 2024 | 4 |
| OTULFI | Fresenius Kabi | 2024 | 4 |
| YESINTEK | BIOCON BIOLOGICS INC | 2024 | 4 |
| STARJEMZA | BIO-THERA SOLUTIONS LTD | 2025 | 4 |
| STEQEYMA | CELLTRION, INC. | 2024 | - |
IL-12 Drug Modality Landscape
Modalities
Routes of Administration
IL-12 requires biologic approaches (biologic (other)), likely due to its structure or location.
The dominance of biologics suggests a whitespace opportunity for small molecule IL-12 inhibitors.
📈 Modality Evolution
Antibodies pioneered IL-12 targeting (2009), with other biologics entering more recently (2023).
IL-12 Clinical Trials 134 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on IL-12. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 24 | 19 | 3 | 2 | 86% |
| Phase 2 | 33 | 22 | 3 | 8 | 88% |
| Phase 3 | 61 | 42 | 12 | 7 | 78% |
| Phase 4 | 16 | 7 | 1 | 8 | 88% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
5 Phase 3 trials testing approved IL-12 drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting IL-12. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
IL-12 Drug Approval Timeline (2009 - 2025)
The first IL-12 targeting drug was approved in 2009 (STELARA), with the most recent approval in 2025 (STARJEMZA).
The 17-year span of approvals suggests a sustained interest in IL-12 as a drug target.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 8 companies competing
- • Market share by company
Full Drug Portfolio
- • All 8 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 8-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 63 (29 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-12. A trial counts if an approved drug acting on IL-12 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.