NDAORALCAPSULE
Approved
Dec 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
17
Data completeness
4/8 — Partial
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENSACOVE (ensartinib) is an oral small-molecule tyrosine 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. As a newly approved NDA, it enters a growth phase with significant commercial development opportunity ahead.
Growth10.9 years to LOE
Early-stage commercial launch creates hiring demand across sales, marketing, and medical affairs; team expansion likely as market penetration accelerates over next 24–36 months.
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 (17)
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
Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation
Started Aug 2022
47 enrolled
Non-Small Cell Lung Cancer
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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.