Drugs / Ceritinib
Ceritinib
also known as
LDK378 · CERITINIB (LDK378) · ceritinib(Zykadia) · CERITINIB[MI] · CPD 15 · LKD378 · NVP-LDK-378-NX · ZYKADIA
Small molecule targets ALK, ROS1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ZYKADIA | — | 2017-05-26 – 2017-12-21 | fda.gov ↗ |
| Approved | EU (EMA) | Zykadia | — | 2015-05-06 | europa.eu ↗ |
| Approved | US (FDA) | ZYKADIA | — | 2014-04-29 | fda.gov ↗ |
Trials 43
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02605746 | Feb 2016 → Nov 2018 | glioblastoma, metastatic malignant neoplasm in the brain | St. Joseph's Hospital and Medical Center, Phoenix | Completed | No outcome recorded |
| Phase 115 trials | ||||||
| Phase 1 | NCT03611738 | Feb 2019 → Apr 2025 overdue | non-small cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03501368 | Jun 2018 → Oct 2022 | melanoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT03087448 | Sep 2017 → Apr 2022 | non-small cell lung carcinoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02780128 | Jul 2016 → Aug 2022 | cancer, neuroblastoma | Yael P Mosse | Terminated | No outcome recorded |
| Phase 1 | NCT02321501 | Jun 2016 → Dec 2026 expected | metastatic malignant neoplasm, non-small cell lung carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02422589 | Oct 2015 → Dec 2017 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02393625 | May 2015 → Apr 2027 expected | non-small cell lung carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02292550 | May 2015 → Sep 2018 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02299505 | Apr 2015 → Jun 2016 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02227940 | Jan 2015 → Dec 2018 | pancreatic adenocarcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01950481 | Jan 2014 → Sep 2016 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01742286 | Aug 2013 → Apr 2019 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01772797 | Jun 2013 → Jan 2016 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01634763 | Jun 2012 → Jan 2016 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01283516 | Jan 2011 → May 2016 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02729961 | Jan 2018 → Jul 2023 | ALK-positive anaplastic large cell lymphoma | University of Washington | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02040870 | Mar 2014 → Jul 2017 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT06813079 | Apr 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT02645149 | Nov 2021 → Nov 2025 | melanoma | Melanoma Institute Australia | Completed | No outcome recorded |
| Phase 2 | NCT04817956 | Apr 2021 → Mar 2040 expected | metastatic malignant neoplasm | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03737994 | Jul 2019 → Jul 2021 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03399487 | Jul 2018 → May 2020 | lung cancer | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT02465528 | May 2016 → Aug 2018 | anaplastic large cell lymphoma, glioblastoma, inflammatory myofibroblastic tumor | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02638909 | Dec 2015 → Mar 2018 | cholangiocarcinoma, colorectal adenocarcinoma, esophageal adenocarcinoma, gastric adenocarcinoma +2 | Criterium, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02513667 | Nov 2015 → May 2020 | non-small cell lung carcinoma | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT02450903 | Aug 2015 → Jul 2017 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02289144 | Jun 2015 → Jan 2019 | thyroid gland undifferentiated (anaplastic) carcinoma | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT02343679 | May 2015 → Oct 2020 | hematopoietic and lymphoid system neoplasm | Anne Beaven, MD | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02336451 | Apr 2015 → Feb 2019 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02587650 | Mar 2015 → Jul 2018 | NTRK fusion positive cancer, RET fusion positive cancer, cutaneous melanoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02374489 | Mar 2015 → Jan 2018 | cholangiocarcinoma | National Health Research Institutes, Taiwan | Terminated | No outcome recorded |
| Phase 2 | NCT02276027 | Jan 2015 → Oct 2019 | lung adenocarcinoma, squamous cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02186821 | Sep 2014 → Dec 2017 | — | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01964157 | Sep 2013 → Jan 2026 | non-small cell lung carcinoma | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT01685138 | Dec 2012 → Jan 2018 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01685060 | Nov 2012 → Mar 2016 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT03784014 | Oct 2019 → Dec 2023 | soft tissue sarcoma | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 3 | NCT01828099 | Jul 2013 → Jun 2016 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01828112 | Jun 2013 → Jan 2016 | non-small cell lung carcinoma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT02584933 | Dec 2015 → Jun 2027 expected | neoplastic disease or syndrome | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01947608 | — | non-small cell lung carcinoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT02559778 Comparator | Sep 2015 → Sep 2030 expected | neuroblastoma | Giselle Sholler | Recruiting | No outcome recorded |
| Phase 4 | NCT04356118 Background | Jun 2020 → Jun 2023 | malignant leptomeningeal tumor | Hui Bu | Unknown | No outcome recorded |
| — | NCT05100134 Background | — | non-small cell lung carcinoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2017-06-29 | Novartis Pharmaceuticals | Regulatory Novartis receives EU approval for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC) novartis.com ↗
Novartis today announced the European Commission approved expanding the use of Zykadia ® (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. |
| 2017-05-26 | Novartis Pharmaceuticals | Regulatory Novartis receives FDA approval for expanded use of Zykadia® in first-line ALK-positive metastatic non-small cell lung cancer (NSCLC) novartis.com ↗ |
| 2017-05-19 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC) novartis.com ↗
Basel, May 19, 2017 - Novartis today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of expanding the use of Zykadia® (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. |
| 2017-02-23 | Novartis Pharmaceuticals | Regulatory Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC novartis.com ↗ |
| 2016-12-06 | Novartis Pharmaceuticals | Results Novartis announces Zykadia® first-line study results showing 16.6 month progression-free survival in patients with ALK+ advanced NSCLC novartis.com ↗
Results were presented during the Presidential Symposium at the 17 th World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer (IASLC), in Vienna. |
| 2016-10-09 | Novartis Pharmaceuticals | Results Novartis ALK+ metastatic NSCLC therapy Zykadia® extends progression-free survival beyond 18 months in Phase II study novartis.com ↗
Median PFS by BIRC for Zykadia and chemotherapy were 5.4 months (95% CI: 4.1-6.9) vs. 1.6 months (95% CI: 1.4-2.8), respectively[4]. |
| 2016-09-23 | Novartis Pharmaceuticals | Results Novartis announces positive top-line results from ASCEND-4, a Phase III trial of Zykadia® in untreated adult ALK+ NSCLC patients novartis.com ↗
The multicenter, randomized trial (NCT01828099), which assessed the efficacy and safety of Zykadia in previously untreated adult patients, met its primary endpoint, demonstrating clinically significant improvement in progression free survival (PFS) compared to standard chemotherapy, including maintenance. |
| 2015-06-01 | Novartis Pharmaceuticals | Results Novartis presents new data at ASCO for Zykadia® and combination of Tafinlar® and Mekinist® in certain NSCLC patients with unmet needs novartis.com ↗
Overall response rates (ORR) seen in these trials were 38.6% and 63.7%, respectively, based upon investigator assessment. |
| 2015-05-08 | Novartis Pharmaceuticals | Regulatory Novartis lung cancer drug Zykadia® gains EU approval, providing new therapy for certain patients with ALK+ NSCLC novartis.com ↗
Basel, May 8, 2015 - Novartis announced today that the European Commission has approved Zykadia ® (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib[1]. |
| 2015-02-27 | Novartis Pharmaceuticals | Regulatory Novartis lung cancer drug Zykadia® recommended for EU approval in patients with ALK+ NSCLC previously treated with crizotinib novartis.com ↗
Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Zykadia ® (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib[2]. |
All press releases naming this drug 10 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ceritinib | “Ceritinib (LDK378) is a new ALK inhibitor that has shown greater antitumor potency than crizotinib in preclinical studies.” PMID 24670165 ↗ Mar 201435“After disease progression with ASP3026 treatment, LDK378 (ceritinib) was initiated at a dose of 750mg once daily.” PMID 27565932 ↗ Jul 2016 “ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib” NCT04356118 ↗ “Carfilzomib Ceritinib Cladribine” NCT02551718 ↗ “LDK378(Ceritinib)” NCT03399487 ↗ “ALK - Ceritinib” NCT02645149 ↗ “Ceritinib” NCT04817956 ↗ |
| Known as | CERITINIB (LDK378) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403108 ↗ |
| Known as | ceritinib(Zykadia) | “ceritinib(Zykadia)” NCT02374489 ↗ |
| Known as | CERITINIB[MI] | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403108 ↗ |
| Known as | CPD 15 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403108 ↗ |
| Known as | LDK378 | “Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)” NCT02186821 ↗16“Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis” NCT02605746 ↗ “Drug: Ceritinib (LDK378)” NCT02393625 ↗ “Ceritinib (LDK378)” NCT02465528 ↗ |
| Known as | LKD378 | “This study is being done to learn about a new drug, Ceritinib (LKD378).” NCT02605746 ↗ |
| Known as | NVP-LDK-378-NX | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403108 ↗ |
| Known as | ZYKADIA | “The main purpose of this study is to determine the risks and benefits of ceritinib (ZYKADIA) given in combination with trametinib (MEKINIST) in patients who have progressed on...” NCT03501368 ↗ |
| Action | Inhibit | “LDK378 is a selective and a potent inhibitor of anaplastic lymphoma kinase (ALK) activity” NCT01283516 ↗ |
| Modality | Small molecule | “ceritinib (novel, potent and selective small molecule anaplastic lymphoma kinase [ALK] inhibitor)” NCT02321501 ↗ |
| Route | Oral | “is administered orally.” NCT01283516 ↗ |
| Target | ALK | “LDK378 is a selective and a potent inhibitor of anaplastic lymphoma kinase (ALK) activity” NCT01283516 ↗ |