ZYKADIA (ceritinib)
ZYKADIA is indicated for the treatment of Non-Small Cell Lung Cancer.
How ZYKADIA Works
Ceritinib is a kinase inhibitor that targets ALK, insulin-like growth factor 1 receptor (IGF-1R), insulin receptor (InsR), and ROS1, with the highest potency against ALK. It inhibits ALK autophosphorylation and the subsequent ALK-mediated phosphorylation of the downstream signaling protein STAT3, thereby suppressing the proliferation of ALK-dependent cancer cells. Notably, ceritinib demonstrates anti-tumor activity in cases with demonstrated resistance to crizotinib at clinically relevant concentrations.
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2014-04-29
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
ZYKADIA Approval History
What ZYKADIA Treats
1 indicationsZYKADIA is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
ZYKADIA Target & Pathway
ProTarget
ZYKADIA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZYKADIA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZYKADIA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZYKADIA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03784014 MULTISARC | C16-40 2024-514873-22-00, 2017-002851-27 | Ph 3 | completed | Molecular Profiling of Advanced Soft-tissue Sarcomas |
| NCT02559778 PEDS-PLAN | NMTRC012 | Ph 2 | recruiting | Pediatric Precision Laboratory Advanced Neuroblastoma Therapy |
| NCT03737994 results posted | NCI-2018-02486 NCI-2018-02486, NRG-LU003 | Ph 2 | terminated | Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer |
| NCT02584933 | CLDK378A2X01B 2024-511040-58-00 | Ph 4 | active not recruiting | Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study |
| NCT02780128 NEPENTHE | 14-011071 | Ph 1 | terminated | Next Generation Personalized Neuroblastoma Therapy |
| NCT03501368 | MCC-19475 | Ph 1 | completed | Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma |
| NCT03611738 | MCC-19656 | Ph 1 | active not recruiting | Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC |
| NCT02321501 | 2014-0890 NCI-2015-00062, 2014-0890 | Ph 1 | active not recruiting | Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer |
| NCT06813079 | ADOPT 24-5059 | Ph 2 | not yet recruiting | Using Tumor Models to Determine Treatments |
| NCT01828112 results posted | CLDK378A2303 2012-005637-36 | Ph 3 | completed | LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib |
| NCT01828099 results posted | CLDK378A2301 2013-000319-26 | Ph 3 | completed | LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer |
| NCT02513667 results posted | STU 042015-076 | Ph 2 | terminated | Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma |
| NCT03087448 | 166512 NCI-2017-01318 | Ph 1 | terminated | Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) |
| NCT02227940 | I 248813 NCI-2014-01766, I 248813 | Ph 1 | completed | Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer |
| NCT02299505 | CLDK378A2112 2014-004001-32 | Ph 1 | completed | Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC) |
| NCT02186821 SIGNATURE results posted | CLDK378AUS23 | Ph 2 | terminated | Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) |
| NCT02422589 | CLDK378A2103 2014-003741-95 | Ph 1 | completed | A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors |
| NCT02292550 | CLEE011X2110C | Ph 1 | completed | Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer. |
| NCT01742286 results posted | CLDK378X2103 2012-002074-31 | Ph 1 | completed | Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) |
| NCT02336451 Ascend-7 results posted | CLDK378A2205 2014-000578-20 | Ph 2 | completed | A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges |
| NCT02587650 results posted | 14859 NCI-2017-01421 | Ph 2 | terminated | Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma |
| NCT02729961 | 9522 NCI-2016-00396, 9522 | Ph 1, Ph 2 | withdrawn | Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma |
| NCT02289144 | STU 082014-029 | Ph 2 | withdrawn | Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer |
| NCT02638909 | NOV-ALK-01 | Ph 2 | terminated | Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies |
| NCT02343679 | Pro00056623 | Ph 2 | withdrawn | Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYKADIA FDA Label Details
Indications & Usage
FDA Label (PDF)ZYKADIA is indicated for the treatment of Non-Small Cell Lung Cancer.
Pro Intelligence Preview
Deep insights for ZYKADIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 15 active patents
Trial Analysis
- • 25 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment