ALK Inhibitors
7 drugsAbout ALK
Anaplastic Lymphoma Kinase (ALK) is a receptor tyrosine kinase involved in cell growth and differentiation. It is activated by ligand binding, leading to downstream signaling cascades that promote cell survival and proliferation.
ALK is strongly validated as a therapeutic target by human genetics, with a max score of 0.97 linking it to neuroblastoma. Gain-of-function mutations are associated with increased disease risk, suggesting that inhibition is likely beneficial.
ALK is targeted by 7 FDA-approved small molecule drugs, including XALKORI, ROZLYTREK, and ALUNBRIG, primarily in oncology. The first drug was approved in 2011, with the most recent approval in 2024.
Strategic Insights
ℹ️ How we calculate- Validated target with strong trial activity and 80% attractiveness score.
- White space opportunity in Recurrent Malignant Solid Neoplasm with only 4 trials.
- phase2 represents biological uncertainty with 55% completion.
ALK Genetic Evidence Strong
ALK has strong genetic support with a score of 0.97, linking it to neuroblastoma.
Strong genetic support suggests a higher probability of clinical trial success for ALK-targeting therapies.
💡 Why inhibition?
- • Gain-of-function variants increase disease risk — blocking overactivity may help
- • 100% directional consistency across 1 traits
- • Strong signal in nervous system disease, cancer or benign tumor pathways
Cross-Disease Effects
Trade-off: LowDirection of Effect
100% alignedEvidence Across Diseases
15 totalGWAS and other genetic studies link ALK to 15 diseases.
Gain-of-function causes disease; inhibition may help
🔗 Colocalization Evidence 1 strong
max H4: 0.99eQTL/pQTL signals for ALK 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 ALK Drugs
Six companies have approved ALK-targeting drugs, including Roche, Takeda, and Novartis.
The presence of multiple established players indicates a moderately competitive market with potential entry barriers.
ALK Drug Modality Landscape
Modalities
Routes of Administration
ALK is amenable to small molecule drugs, with oral options available for convenient dosing.
Exploring alternative modalities like antibodies or PROTACs could provide a competitive advantage.
ALK Clinical Trials 237 trials
Completion by Phase
| Phase | Total | Completed | Failed | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 95 | 57 | 17 | 21 | 77% |
| Phase 2 | 104 | 28 | 23 | 53 | 55% |
| Phase 3 | 26 | 9 | 0 | 17 | 100% |
| Phase 4 | 12 | 2 | 2 | 8 | 50% |
Top Sponsors
By Modality
Top Conditions
Phase 3 Readout Calendar Pro
5 Phase 3 trials testing approved ALK drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting ALK. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
ALK Drug Approval Timeline (2011 - 2024)
ALK has seen approvals spanning 14 years, from 2011 to 2024.
The continued approvals suggest sustained interest and potential for further development in ALK-targeted therapies.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 6 companies competing
- • Market share by company
Full Drug Portfolio
- • All 7 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 7-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Competition: High (15 sponsors)
- • White space: 9 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 209 clinical trials targeting ALK.
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