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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02559778 Comparator | Sep 2015 → Sep 2030 expected | neuroblastoma | Giselle Sholler | Recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04356118 Background | Jun 2020 → Jun 2023 | malignant leptomeningeal tumor | Hui Bu | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05100134 Background | — | non-small cell lung carcinoma | Novartis Pharmaceuticals | No longer available | No outcome recorded |
Press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-06-29 | Novartis Pharmaceuticals | Novartis receives EU approval for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC) novartis.com ↗ |
| 2017-05-26 | Novartis Pharmaceuticals | 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 | Novartis receives positive CHMP opinion for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC) novartis.com ↗ |
| 2017-02-23 | Novartis Pharmaceuticals | Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC novartis.com ↗ |
| 2016-12-06 | Novartis Pharmaceuticals | Novartis announces Zykadia® first-line study results showing 16.6 month progression-free survival in patients with ALK+ advanced NSCLC novartis.com ↗ |
| 2016-10-09 | Novartis Pharmaceuticals | Novartis ALK+ metastatic NSCLC therapy Zykadia® extends progression-free survival beyond 18 months in Phase II study novartis.com ↗ |
| 2016-09-23 | Novartis Pharmaceuticals | Novartis announces positive top-line results from ASCEND-4, a Phase III trial of Zykadia® in untreated adult ALK+ NSCLC patients novartis.com ↗ |
| 2015-06-01 | Novartis Pharmaceuticals | Novartis presents new data at ASCO for Zykadia® and combination of Tafinlar® and Mekinist® in certain NSCLC patients with unmet needs novartis.com ↗ |
| 2015-05-08 | Novartis Pharmaceuticals | Novartis lung cancer drug Zykadia® gains EU approval, providing new therapy for certain patients with ALK+ NSCLC novartis.com ↗ |
| 2015-02-27 | Novartis Pharmaceuticals | Novartis lung cancer drug Zykadia® recommended for EU approval in patients with ALK+ NSCLC previously treated with crizotinib novartis.com ↗ |
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 ↗ |