Skip to main content

Ensacove FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 28, 2024.

FDA Approved: Yes (First approved December 18, 2024)
Brand name: Ensacove
Generic name: ensartinib
Dosage form: Capsules
Company: Xcovery Holdings, Inc.
Treatment for: Non Small Cell Lung Cancer

Ensacove (ensartinib) is an anaplastic lymphoma kinase (ALK) inhibitor used for the treatment of ALK-positive non-small cell lung cancer.

Development timeline for Ensacove

DateArticle
Dec 18, 2024Approval FDA Approves Ensacove (ensartinib) for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Mar 13, 2024U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib
Feb  7, 2018Xcovery Announces Initiation of Phase 2 Clinical Trial for Ensartinib in Melanoma Patients with ALK Alternations

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.