Friday, July 10, 2026

Drug profile · INN

ceritinib

ceritinib (ZYKADIA) is a eml4-alk. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved Antineoplastic and immunomodulating agents (L01) L01XE
US status approved
Patents linked 0
Pipeline programs 5
News articles 0
Drug details — ceritinib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
5
Data quality
0.84

Quick answer

ceritinib (ZYKADIA) is a eml4-alk. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ceritinib
Brand ZYKADIA
Mechanism EML4-ALK
Target ALK tyrosine kinase receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01XE

Mechanism of action

EML4-ALK

Primary target: ALK tyrosine kinase receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved

Pipeline programs

  1. C16-40 Phase 3 · George Institute for · Unresectable locally advanced and/or metastatic soft-tissue
  2. ABP-2019 Phase 2 · George Institute for · locally advanced (stage III) and not suitable for curative t
  3. Ceritinib (LDK378) Phase 2 · Novartis India · Tumors With Aberrations in ALK
  4. CLDK378A2120C Phase 1 · Novartis India · Non-small cell lung cancer
  5. CERITINIB Approved · Novartis India · non small cell lung cancer

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is ceritinib?

ceritinib (ZYKADIA) is a eml4-alk. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ceritinib?

ZYKADIA is a marketed brand name for ceritinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ceritinib?

ceritinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.