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ceritinib

Trade name: zykadia

Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Apr 29, 2014

Ceritinib is a selective inhibitor of ALK1, a target found in metastatic non-small cell lung cancer (NSCLC). Ceritinib is approved by FDA and is indicated for the treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer. Ceritinib also targets insulin-like growth factor 1 receptor (IGF-1R), insulin receptor (InsR), and ROS1. — NCATS

Clinical trial activity

42 trials · 33 clinical orgs · 1 marketing orgs

Phase 1
17
Phase 2
26
Phase 3
3
Phase 4
1

Earliest trial started Jan 1, 2011 (NCT01283516)

Timeline

2010s

  1. Jan 1, 2011

    Novartis — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Novartis — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2013

    Novartis — Earliest Phase 3 Sponsor(trial)

  4. Sep 27, 2013

    Orphan Drug Designation

  5. Apr 29, 2014

    Novartis — Earliest FDA Approval

  6. Apr 29, 2014

    Novartis — NDA Organization

  7. Apr 29, 2014

    Novartis — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughApr 29, 2014

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)OC1=CC(C2CCNCC2)=C(C)C=C1NC3=NC=C(Cl)C(NC4=CC=CC=C4S(=O)(=O)C(C)C)=N3
Mol. weight
558.135 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 5-chloro-n2-(2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl)-n4-(2-(isopropylsulfonyl)phenyl)pyrimidine-2,4-diamine
  • ceritinib
  • ceritinib
  • ceritinib
  • ceritinib
  • ceritinib
  • ceritinib
  • ceritinib
  • ceritinib
  • ceritinib
  • ceritinib
  • céritinib
  • céritinib
  • ldk378
  • ldk378
  • ldk378
  • ldk378
  • n-{2-[(5-chloro-2-{[2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl]amino}pyrimidin-4-yl)amino]phenyl}propane-2-sulfonamide
  • n-{2-[(5-chloro-2-{[2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl]amino}pyrimidin-4-yl)amino]phenyl}propane-2-sulfonamide
  • nvp-ldk378-nx
  • nvp-ldk378-nx
  • nvp-ldk378-nx
  • nvp-ldk378-nx
  • nvp-ldk378-nx
  • zykadia
  • zykadia
  • zykadia
  • zykadia

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06813079Phase 2Feb 17, 2025University of Toronto
NCT05489887Phase 2Sep 14, 2022Medical University of South Carolina, Wake Forest University
NCT03737994Phase 2Apr 1, 2019National Cancer Institute (NCI), NRG Oncology
NCT03784014Phase 3Mar 31, 2019Commissariat A L'energie Atomique, Hôpital Européen Georges-Pompidou, Institut Bergonié, Institut National de la Santé Et de la Recherche Médicale, France
NCT03611738Phase 1Oct 31, 2018University of South Florida
NCT03501368Phase 2Jun 18, 2018Novartis, University of South Florida
NCT03399487Phase 2Jan 31, 2018Yonsei University
NCT02729961Phase 1/Phase 2 (Phase 2)Jun 1, 2017National Cancer Institute (NCI), University of Washington
NCT03087448Phase 1/Phase 2 (Phase 2)Jun 1, 2017Novartis, University of California, Davis, University of California, Irvine, University of California, Los Angeles, University of California, San Diego, University of California, San Francisco
NCT02780128Phase 1Jul 1, 2016Children's Hospital of Philadelphia, Foundation Medicine, Novartis, University of Pennsylvania
NCT02321501Phase 1Jun 1, 2016Novartis, University of Texas at Houston
NCT02465528Phase 2May 6, 2016Novartis
NCT02587650Phase 2May 1, 2016University of California, San Francisco
NCT02638909Phase 2Dec 1, 2015Criterium, Inc., Novartis, University of Colorado, Denver
NCT02584933Phase 4Dec 1, 2015Novartis
NCT02605746Early Phase 1 (Phase 1)Nov 1, 2015Barrow Neurological Institute, Novartis, University of Arizona, Wayne State University
NCT02513667Phase 2Nov 1, 2015Novartis, The University of Texas, Dallas
NCT02422589Phase 1Oct 23, 2015Novartis
NCT02450903Phase 2Aug 21, 2015Novartis
NCT02289144Phase 2Jun 1, 2015Novartis, The University of Texas, Dallas
Showing 20 of 42 trials
Page 1 / 3

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit312252011
National Cancer Institute (NCI)Government3122015
The University of Texas, DallasAcademic/Hospital2212015
University of California, San FranciscoAcademic/Hospital2212016
University of South FloridaAcademic/Hospital2222018
Yonsei UniversityAcademic/Hospital2212013
Barrow Neurological InstituteAcademic/Hospital1012015
Children's Hospital of PhiladelphiaAcademic/Hospital1112016
Commissariat A L'energie AtomiqueGovernment1012019
Criterium, Inc.For profit1112015
Duke UniversityAcademic/Hospital1112015
Foundation MedicineFor profit1012016
Government of TaiwanGovernment1112015
Hôpital Européen Georges-PompidouAcademic/Hospital1012019
Institut BergoniéAcademic/Hospital1012019
Institut National de la Santé Et de la Recherche Médicale, FranceAcademic/Hospital1112019
Medical University of South CarolinaAcademic/Hospital1012022
National Cheng Kung UniversityAcademic/Hospital1012015
National Taiwan UniversityAcademic/Hospital1012015
NRG OncologyAcademic/Hospital1012019
33 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
NovartisFor profitNDAApr 29, 2014
NovartisFor profitMKTGApr 29, 2014