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Drug

Ceritinib

Established medicine
ClassALK tyrosine kinase receptor inhibitorResearchOngoing clinical research

Also known as Zykadia, Ceritinibum.

RxNorm1535457ChEMBLCHEMBL2403108ATCL01ED02UNIIK418KG2GET
6
Active clinical trials
3
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

Clinical trial2026-06-23Results expected Q1 2028 · ClinicalTrials.gov

A Multi-center, Open-label Study to Assess the Safety and Efficacy of Combination Ceritinib (LDK378) and Nivolumab in Adult Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC)

Clinical trial2026-06-11Results expected Q2 2027 · ClinicalTrials.gov

An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib

Clinical trial2026-06-11Results expected Q2 2027 · ClinicalTrials.gov

A Phase I/Ib Dose Escalation and Biomarker Study of Ceritinib (LDK378) in Combination With Everolimus in Patients With Locally Advanced or Metastatic Solid Tumors With an Expansion in NSCLC Characterized by Abnormalities in Anaplastic Lymphoma Kinase (ALK) Expression

Clinical trial2026-05-20Results expected Q4 2026 · ClinicalTrials.gov

A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Clinical trial2026-04-28Results expected Q3 2030 · ClinicalTrials.gov

A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Protocol

Clinical trial2026-03-17Terminated · ClinicalTrials.gov

Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

Clinical trial2026-01-20Completed · ClinicalTrials.gov

Phase I Study of Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC

Clinical trial2025-04-28Primary completion · ClinicalTrials.gov

A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

Clinical trial2025-02-07Results posted · ClinicalTrials.gov

A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

Clinical trial2025-01-16Results posted · ClinicalTrials.gov

Phase 1 Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma

Clinical trial2024-12-30Completed · ClinicalTrials.gov

Approval: Zykadia (EMA)

Regulatory2015-05-06EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ceritinib
Aliases & brands
ZykadiaCeritinibum
RxNorm CUI
1535457
ChEMBL ID
CHEMBL2403108
ATC codes
L01ED02
UNII
K418KG2GET
Primary mechanism
ALK tyrosine kinase receptor inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

ALK tyrosine kinase receptor
ALK · Q9UM73
INHIBITORALK tyrosine kinase receptor inhibitor
Echinoderm microtubule-associated protein-like 4
EML4 · Q9HC35
INHIBITOREML4-ALK inhibitor
Nucleophosmin
NPM1 · P06748
INHIBITORNPM/ALK (Nucleophosmin/ALK tyrosine kinase receptor) inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2015-05-06
Latest approval
2015-05-06
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2015-05-06Approval
Approval: Zykadia (EMA)
Indication: Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with… Show full indication

Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

28 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
28
registered trials across all phases
LATEST COMPLETION 2026
6
Active studies
2
Recruiting
4
Late-stage (III+)
11
Completed
11
Discontinued
PHASE DISTRIBUTIONn = 28
Early Phase 11Phase 111Phase 1 / 21Phase 211Phase 33Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib

Active, not recruitingPH IVNovartis Pharmaceuticalsn=2332027

Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

CompletedPH IIIInstitut National de la Santé Et de la Recherche Médicale, Francen=6032026

A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

CompletedPH IIINovartis Pharmaceuticalsn=3762024

A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

CompletedPH IIINovartis Pharmaceuticalsn=2312023

Recent completions

Trials that read out recently, adding to the completed evidence base.

Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

CompletedPH IIIInstitut National de la Santé Et de la Recherche Médicale, Francen=6032026

Phase 1 Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma

CompletedPH IH. Lee Moffitt Cancer Center and Research Instituten=272024

A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

CompletedPH IIINovartis Pharmaceuticalsn=3762024

A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

CompletedPH IIINovartis Pharmaceuticalsn=2312023

A Multi-center, Randomized Open Label Study to Assess the Systemic Exposure, Effiacy, and Safety of 450 mg Ceritinib Taken With a Low-fat Meal and 600 mg Ceritinib Taken With a Low-fat Meal as Compared With That of 750 mg Ceritinib Taken in the Fasted State in Adult Patients With ALK Rearranged (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

CompletedPH INovartis Pharmaceuticalsn=3062020

A Phase 0/II Study of Ceritinib (LDK378) in Preoperative Glioblastoma Multiforme (GBM) and CNS Metastasis Patients Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration

CompletedPH ISt. Joseph's Hospital and Medical Center, Phoenixn=102019
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.