Ensartinib

Ensartinib
Clinical data
Trade names	Ensacove
Other names	X-396
License data	US DailyMed: Ensartinib;
Routes of; administration	By mouth
ATC code	None;
Legal status
Legal status	US: ℞-only;
Identifiers
CAS Number	1370651-20-9;
PubChem CID	56960363;
DrugBank	DB14860;
ChemSpider	58828042;
UNII	SMA5ZS5B22;
KEGG	D11346;
ChEMBL	ChEMBL4113131;
ECHA InfoCard	100.306.918
Chemical and physical data
Formula	C26H27Cl2FN6O3
Molar mass	561.44 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES 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 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]

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]

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

Legal status

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

Names

Ensartinib is the international nonproprietary name.^[5]

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

References

^ ^a ^b ^c ^d ^e ^f ^g "ENSACOVETM (ensartinib) capsules, for oral use" (PDF). Xcovery Holdings, Inc. U.S. Food and Drug Administration. December 2024.
^ ^a ^b ^c ^d ^e ^f ^g "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. Retrieved 20 December 2024. This article incorporates text from this source, which is in the public domain.
^ ^a ^b ^c "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 20 December 2024.
^ "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.
^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.

External links

"Ensartinib (Code C102754)". NCI Thesaurus.
Clinical trial number NCT02767804 for "eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients" at ClinicalTrials.gov

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[Ensacove_FDA_label-1] ^ ^a ^b ^c ^d ^e ^f ^g "ENSACOVETM (ensartinib) capsules, for oral use" (PDF). Xcovery Holdings, Inc. U.S. Food and Drug Administration. December 2024.

[FDA_20241218-2] ^ ^a ^b ^c ^d ^e ^f ^g "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. Retrieved 20 December 2024. This article incorporates text from this source, which is in the public domain.

[Novel_Drug_Approvals_for_2024-3] "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 20 December 2024.

[4] "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.

[5] 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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