Ensacove
(Ensartinib)ApprovedSmall molecule
Ensartinib is used to treat a type of lung cancer (non-small cell lung cancer) in patients whose cancer has a specific genetic change called ALK fusion. It works by blocking a protein that helps cancer cells grow.[2] Ensacove is currently approved and in use across 6 indications[4].[1]
Ensacove is one of 194 small molecule programs targeting Lung Cancer. It is currently in Approved.
6
Indications
25
Total Trials
18
Active Trials
193
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
4
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
1639 competitors in Non-Small Cell Lung Cancer
#DrugCompanyPhaseTrials
1Ensacove
XXcovery Holdings, Inc.
Approved
PORTRAZZA
Eli LillyPreclinical
Imjudo
AstraZenecaPreclinical
Vizimpro
PfizerPreclinical
Immunotherapy
Bristol-Myers SquibbPreclinical
Remeron
OOrganon and Co
Preclinical
PD-1 Inhibitor
Johnson & JohnsonPreclinical
Tyrosine Kinase Inhibitor
PfizerPreclinical
REGN2810
RegeneronPreclinical
Treatment
GSKPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q4 2026
Phase 2Active, not recruiting
Advanced Malignant Solid Neoplasm
NCT03213652
Phase 2Active, not recruiting
Bevacizumab
NCT05491811
Clinical
Trials by Indication[1]
Non-Small Cell Lung Cancer9 trials
Show 6 more trials
Resistance1 trial
Tics1 trial
Lung Cancer1 trial
Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer
Not yet recruiting·NNanjing First Hospital, Nanjing Medical University·Phase 2·NCT06762327·20 enrolled
12 more indications
Bevacizumab1 trial
Patients With Advanced Solid Tumors1 trial
Adjuvant Therapy1 trial
Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations
Not yet recruiting·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 3·NCT06955325·270 enrolled
Lung Adenocarcinoma1 trial
Unresectable1 trial
Regulatory
FDA Approval Timeline[5]
Dec 18, 2024
ENSACOVE
NDA NDA218171
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Ensacove drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Ensartinib. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- ALK Tyrosine Kinase Receptor Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- XXcovery Holdings, Inc.