Ensartinib

Last updated

Ensartinib
Ensartinib.svg
Clinical data
Trade names Ensacove
Other namesX-396
License data
Routes of
administration 		By mouth
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
ECHA InfoCard 100.306.918 OOjs UI icon edit-ltr-progressive.svg
Chemical and physical data
Formula C26H27Cl2FN6O3
Molar mass 561.44 g·mol−1
3D model (JSmol)
  • C[C@@H](OC1=C(N)N=NC(=C1)C(=O)NC2=CC=C(C=C2)C(=O)N3C[C@H](C)N[C@H](C)C3)C4=C(Cl)C(F)=CC=C4Cl
  • InChI=1S/C26H27Cl2FN6O3/c1-13-11-35(12-14(2)31-13)26(37)16-4-6-17(7-5-16)32-25(36)20-10-21(24(30)34-33-20)38-15(3)22-18(27)8-9-19(29)23(22)28/h4-10,13-15,31H,11-12H2,1-3H3,(H2,30,34)(H,32,36)/t13-,14+,15-/m1/s1
  • Key:GLYMPHUVMRFTFV-QLFBSQMISA-N

Ensartinib, sold under the brand name Ensacove, is an anti-cancer medication used for the treatment of non-small cell lung cancer. [1] Ensartinib is an Anaplastic lymphoma kinase (ALK) inhibitor used as the salt ensartinib hydrochloride. [1] It is taken by mouth. [1]

Contents

The most common adverse reactions include rash, musculoskeletal pain, constipation, cough, pruritis, nausea, edema, pyrexia, and fatigue. [2]

Ensartinib was approved for medical use in the United States in December 2024. [1] [2] [3] [4]

Medical uses

Ensartinib is indicated for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor. [1] [2]

History

Efficacy was evaluated in eXALT3 (NCT02767804), an open-label, randomized, active-controlled, multicenter trial in 290 participants with locally advanced or metastatic ALK-positive non-small cell lung cancer who had not previously received an ALK-targeted therapy. [2] Participants were randomized 1:1 to receive ensartinib or crizotinib. [2]

Society and culture

Ensartinib was approved for medical use in the United States in December 2024. [2] [3] [5]

Names

Ensartinib is the international nonproprietary name. [6]

Ensartinib is sold under the brand name Ensacove. [1] [2] [3]

References

  1. 1 2 3 4 5 6 7 "Ensacove- ensartinib capsule". DailyMed. 26 December 2024. Retrieved 24 June 2025.
  2. 1 2 3 4 5 6 7 "FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer". U.S. Food and Drug Administration (FDA). 18 December 2024. Archived from the original on 18 December 2024. Retrieved 20 December 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. 1 2 3 "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 19 April 2024. Retrieved 20 December 2024.
  4. ↑ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  5. ↑ "FDA Approval of Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)" (Press release). Xcovery Holdings. 19 December 2024. Retrieved 20 December 2024– via Business Wire.
  6. ↑ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl: 10665/330984 .
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