Zykadia

(ceritinib)

ApprovedSmall molecule

Ceritinib is used to treat a specific type of lung cancer (non-small cell lung cancer) in patients whose cancer cells have an ALK gene mutation. It works by blocking a protein that helps cancer cells grow.[2] Zykadia is currently approved and in use across 8 indications[4].[1]

Zykadia is one of 186 small molecule programs targeting ALK Positive Malignancies. It is currently in Approved.

Indications

Total Trials

Active Trials

185

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

ALK Positive MalignanciesActive, not recruiting

Inflammatory Myofibroblastic TumorApproved

Liver DiseaseApproved

CholangiocarcinomaApproved

Pancreatic Ductal CarcinomaRecruiting

Advanced Soft-Tissue SarcomaActive, not recruiting

Non-Small Cell Lung CancerCompleted

Advanced NSCLCActive, not recruiting

ALK Positive MalignanciesApproved

Active, not recruiting

Inflammatory Myofibroblastic TumorApproved

Approved

Liver DiseaseApproved

Approved

CholangiocarcinomaApproved

Approved

Pancreatic Ductal CarcinomaPhase 2

Recruiting

Advanced Soft-Tissue SarcomaPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Completed

Advanced NSCLCPhase 1

Active, not recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Zykadia

Novartis

Approved

8 2

Oleclumab

AstraZeneca

Phase 3

7 3

Remeron

OOrganon and Co

Preclinical

1 4

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 5

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—6

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—7

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 9

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

2 10

Pyrotinib Maleate

AstraZeneca

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Non-Small Cell Lung Cancer

NCT02321501

Q1 2027

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT03737994

Q2 2027

Phase 1Active, not recruiting

ALK Positive

NCT02393625

ApprovedActive, not recruiting

ALK Positive Malignancies

NCT02584933

Q1 2028

Phase 2Recruiting

Pancreatic Ductal Carcinoma

NCT06813079

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer8 trials

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Completed· Pfizer logo

Pfizer··NCT05834348·5,279 enrolled

A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors

Completed· Takeda logo

Takeda··NCT03546894·111 enrolled

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)

Completed· Novartis logo

Novartis·Phase 1·NCT02299505·306 enrolled

Show 5 more trials

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT01828099·376 enrolled

Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Terminated·UUniversity of California, San Francisco·Phase 1·NCT03087448·9 enrolled

Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.

Completed· Novartis logo

Novartis·Phase 1·NCT02292550·27 enrolled

Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT02321501·37 enrolled

Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03737994·10 enrolled

Melanoma2 trials

Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03501368·27 enrolled

Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma

Terminated·UUniversity of California, San Francisco·Phase 2·NCT02587650·1 enrolled

Tumors2 trials

Ceritinib Rare Indications Study in ALK+ Tumors

Terminated· Novartis logo

Novartis·Phase 2·NCT02465528·22 enrolled

Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)

Terminated· Novartis logo

Novartis·Phase 2·NCT02186821·47 enrolled

Neuroblastoma2 trials

Next Generation Personalized Neuroblastoma Therapy

Terminated·YYael P Mosse·Phase 1·NCT02780128·66 enrolled

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 Newly Diagnosed High-Risk Neuroblastoma

Recruiting·GGiselle Sholler·Phase 2·NCT02559778·500 enrolled

Pancreatic Cancer1 trial

Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer

Completed·RRoswell Park Cancer Institute·Phase 1·NCT02227940·38 enrolled

17 more indications

Tyrosine Kinase Inhibitor1 trial

Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Completed· Pfizer logo

Pfizer··NCT04647110·549 enrolled

Anaplastic Large Cell Lymphoma1 trial

Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma

Withdrawn·UUniversity of Washington·Phase 1/2·NCT02729961

Efficacy and Safety1 trial

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

Completed· Novartis logo

Novartis·Phase 2·NCT02336451·156 enrolled

Interaction1 trial

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

Completed· Novartis logo

Novartis·Phase 1·NCT02422589·33 enrolled

Glioblastoma Multiforme1 trial

Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis

Completed·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 1·NCT02605746·10 enrolled

Aged1 trial

Managed Access Programs for LDK378, Ceritinib

Available· Novartis logo

Novartis··NCT05100134

Advanced NSCLC1 trial

Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03611738·21 enrolled

Chemotherapy1 trial

LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

Completed· Novartis logo

Novartis·Phase 3·NCT01828112·231 enrolled

Gastrointestinal1 trial

Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies

Terminated·CCriterium, Inc.·Phase 2·NCT02638909·4 enrolled

Advanced Soft-tissue Sarcoma1 trial

Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT03784014·603 enrolled

Lung Adenocarcinoma1 trial

Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT02513667·14 enrolled

Lymphoma1 trial

Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

Completed· Novartis logo

Novartis·Phase 1·NCT01742286·83 enrolled

Thyroid Cancer1 trial

Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT02289144

Malignancies1 trial

Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies

Withdrawn·—·Phase 2·NCT02343679

ALK Positive1 trial

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)

Active, not recruiting· Novartis logo

Novartis·Phase 1·NCT02393625·57 enrolled

ALK Positive Malignancies1 trial

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 recruiting· Novartis logo

Novartis·Approved·NCT02584933·233 enrolled

Pancreatic Ductal Carcinoma1 trial

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

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06813079·25 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 29, 2014

ZYKADIA

NDA NDA205755

Mar 18, 2019

ZYKADIA

NDA NDA211225

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for ceritinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zykadia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — ceritinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for ceritinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211225). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Zykadia. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: NPM/ALK (nucleophosmin/alk Tyrosine Kinase Receptor) Inhibitor; ALK Tyrosine Kinase Receptor Inhibitor; EML4-ALK Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Nov 20, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7893074Apr 25, 2026

8399450Nov 20, 2027

8377921Nov 20, 2027

7964592Apr 29, 2028

8039479Jun 29, 2030

3 more patents

9309229Jan 18, 2032

8703787Feb 2, 2032

12357630Dec 13, 2037

Zykadia

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q1 2028

Trials by Indication[1]

Non-Small Cell Lung Cancer8 trials

Melanoma2 trials

Tumors2 trials

Neuroblastoma2 trials

Pancreatic Cancer1 trial

Tyrosine Kinase Inhibitor1 trial

Anaplastic Large Cell Lymphoma1 trial

Efficacy and Safety1 trial

Interaction1 trial

Glioblastoma Multiforme1 trial

Aged1 trial

Advanced NSCLC1 trial

Chemotherapy1 trial

Gastrointestinal1 trial

Advanced Soft-tissue Sarcoma1 trial

Lung Adenocarcinoma1 trial

Lymphoma1 trial

Thyroid Cancer1 trial

Malignancies1 trial

ALK Positive1 trial

ALK Positive Malignancies1 trial

Pancreatic Ductal Carcinoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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