NDAORALCAPSULE
Approved
Dec 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
18
Data completeness
4/8 — Partial
Drug data last refreshed 8h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENSACOVE (ensartinib) is a novel oral small-molecule kinase inhibitor approved by the FDA on December 18, 2024. The specific indication and mechanism of action are not detailed in available data, but it represents a new therapeutic option in Xcovery's oncology portfolio. Patient population and clinical context will depend on final approved indication.
Growth10.6 years to LOE
As a newly approved product in growth phase with no current Part D spending data, this presents a launch-stage opportunity with potential for rapid team expansion in commercial and medical affairs roles.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC
Started Jul 2026
80 enrolled
ALK-positive, Locally Advanced or Metastatic (TNM Stage IIIB-IV) Non-small Cell Lung Cancer That Has Developed Resistance to Prior Treatment With Lorlatinib
Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.
Started Jan 2026
164 enrolled
Solid Advanced Tumor
Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study
Started Feb 2025
30 enrolled
ALK-positive Advanced NSCLCALK-positive Non-small Cell Lung Cancer (NSCLC)MPR+1 more
Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD
Started Jan 2025
70 enrolled
NSCLC, Stage I, II, IIIA, IIIB
A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers
Started Jul 2024
36 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.