Drug · Small Molecule

Ceritinib

CI-DRUG-00000147Explore in graph →NCIt C115112 CHEMBL2403108 CIViC Approved

Regulatory

Approvals (3)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory3 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as ZYKADIA (DIN 02436779) under ATC L01ED02 CERITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 29, 2015	health-canada-dpd
EU EMA	—	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.	approved	May 6, 2015	ema
US FDA	—	ZYKADIA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)] . ZYKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )	approved	Mar 18, 2019	openfda

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	6	2	3	39	3	CA, EU, US	Apr 29, 2015	Jan 24, 2011
Malignant Lung Neoplasm	Phase3	Phase 3	2	0	2	18	0	—	—	Jan 24, 2011
Cutaneous Melanoma	Phase2	Phase 2	0	0	0	1	0	—	—	Mar 26, 2015
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	0	0	0	2	0

Curated evidence

Clinical evidence (40)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–40 of 40 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ALK F1174L + ALK Fusion1
Ceritinib	Anaplastic Large Cell Lymphoma

Clinical trials

Trials with this intervention (44)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–44 of 44 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02393625	Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer	active not recruiting	Phase 1	57	Novartis PharmaceuticalsINDUSTRY	8	Sep 17, 2026	clinicaltrials
NCT02584933	Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study	active not recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: ALK tyrosine kinase receptor inhibitor; EML4-ALK inhibitor; NPM/ALK (Nucleophosmin/ALK tyrosine kinase receptor) inhibitor
Targets: 3 genes
UNII: K418KG2GET
Aliases: 2,4-Pyrimidinediamine, 5-chloro-N4-(2-((1-methylethyl)sulfonyl)phenyl)-N2-(5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl)-, 4MK, Ceritinib, CERITINIB (LDK378), Ceritinib[mi], CPD 15, LDK 378, LDK-378, LDK378, NVP-LDK-378-NX, NVP-LDK378-NX, Zykadia, ZYKADIA

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (5)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01ED02	CERITINIB
ATC (WHO)	L01XE	Antineoplastic agents

ALK Fusion7
Ceritinib	Anaplastic Large Cell Lymphoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID7546 In a phase I study of the efficacy of ceritinib in ALK fusion positive cancer, a single patient with anaplastic large cell lymphoma was treated with 750mg daily ceritinb and had a partial response. Du… (full text at CIViC) PMID 24670165 · Shaw et al., 2014 · Open in CIViC	civic
〃	Inflammatory Myofibroblastic Tumor	Predictive	B	Supports Sensitivity Response	3	submitted	EID11291 In this phase 1 study, oral ceritinib was administered to 59 patients in doses of 50 - 750 mg once daily to patients with advanced cancers harbouring genetic alterations in ALK. A total of 130 patient… (full text at CIViC) PMID 24670165 · Shaw et al., 2014 · Open in CIViC	civic
〃	Inflammatory Myofibroblastic Tumor	Predictive	C	Supports Sensitivity Response	3	submitted	EID7547 In a phase I study of the efficacy of ceritinib in ALK fusion positive cancer, a single patient with inflammatory myofibroblastic tumor was treated with 750mg daily ceritinb and showed a partial respo… (full text at CIViC) PMID 24670165 · Shaw et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID7285 In a phase 3 trial, patients with previously treatmented NSCLC with ALK fusion were randomly assigned to ceritinib or chemotherapy. Ceritinib showed a significant improvement in median PFS compared w… (full text at CIViC) PMID 28602779 · Shaw et al., 2017 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	submitted	EID11190 In a phase 3 trial (ASCEND-4, NCT01828099), a comparison of the selective ALK inhibitor ceritinib (750 mg daily) to chemotherapy (cisplatin or carboplatin plus pemetrexed) in 376 untreated ALK-fusion… (full text at CIViC) PMID 28126333 · Soria et al., 2017 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID1175 Updated results from ASCEND-1 trial assessing safety and activity of ceritinib in ALK rearranged locally advanced or metastatic NSCLC. 255 patients were enrolled and received at least one dose of ceri… (full text at CIViC) PMID 26973324 · Kim et al., 2016 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	submitted	EID7535 This dose escalation phase 1 study examined the safety and efficacy of ceritinib in 122 NSCLC patients harboring ALK rearrangements (determined by break-apart FISH). Maximum tolerated dose (MTD) was d… (full text at CIViC) PMID 24670165 · Shaw et al., 2014 · Open in CIViC	civic

ALK G1269A + ALK Fusion2
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1342 The NSCLC cell line MGH021-4, harboring SQSTM1-ALK G1269A, was 6 times more sensitive to ceritinib (80nM GI50) than crizotinib (500 nM) in proliferation assays and caused notable reductions in phospho… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID1355 EML4-ALK with G1269A mutation was tested for sensitivity to ceritinib via transduction into Ba/F3 cells and generation of survival curves varying ceritinib concentration. IC50 of 33 nM was seen, which… (full text at CIViC) PMID 25727400 · Fontana et al., 2015 · Open in CIViC	civic

ALK I11713
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	4	accepted	EID1284 The MGH056-1 cell line was derived from an NSCLC patient with ALK-rearrangement who had progressed on crizotinib and then on alectinib. the cell line was also resistant to crizotinib and alectinib, an… (full text at CIViC) PMID 25228534 · Katayama et al., 2014 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID1368 A 51 year old female never smoker was diagnosed with stage IV NSCLC with liver metastases, and had adverse response to crizotinib treatment, after which she responded to alectinib until disease progre… (full text at CIViC) PMID 25736571 · Ou et al., 2015 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID1344 Ba/F3 cells expressing EML4-ALK variant 3 with ALK I1171T mutation were treated with ceritinib, and survival IC50 of 2.6 nM was observed, which compares favorably with highly ceritinib sensitive EML4-… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic

ALK C1156Y + ALK Fusion2
Ceritinib + Crizotinib + LuminespibSequential	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID841 In this case report, a patient with metastatic, ALK-rearranged NSCLC with C1156Y mutation had tumor progression under sequential treatment with first crizotinib, then ceritinib and finally AUY922. Sub… (full text at CIViC) PMID 26698910 · Shaw et al., 2016 · Open in CIViC	civic
Alectinib + Brigatinib + Ceritinib + LorlatinibSubstitutes	Malignant NeoplasmALIAS	Predictive	D	Does Not Support Resistance	4	submitted	EID7609 In vitro experiments showed that cells expressing EML4-ALK with the resistance mutation C1156Y were sensitive to second and third generation ALK inhibitors. In cell survival assays Ba/F3 cells with C1… (full text at CIViC) PMID 26698910 · Shaw et al., 2016 · Open in CIViC	civic

ALK L1196M + ALK Fusion2
Ceritinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID1341 The crizotinib-resistant MGH045 cell line with EML4-ALK L1196M was treated with crizotinib or ceritinib. In nude mice with MGH045 xenografts, tumor response to crizotinib did not differ appreciably fr… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic
Alectinib + Brigatinib + Ceritinib + LorlatinibSubstitutes	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	4	submitted	EID7597 Ba/F3 cells expressing EML4-ALK variant 1 (E13; A20) or variant 3 (E6a; A20) with the L1196M resistance mutation were sensitive to second and third generation ALK inhibitors. Cell viability assays sho… (full text at CIViC) PMID 29650534 · Yoda et al., 2018 · Open in CIViC	civic