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Ensacove (ENSARTINIB)
Ensartinib works by inhibiting a specific protein that drives the growth of cancer cells.
At a glance
| Generic name | ENSARTINIB |
|---|---|
| Sponsor | Xcovery |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2026 |
Mechanism of action
Ensartinib is a kinase inhibitor of anaplastic lymphoma kinase (ALK) and inhibits other kinases including MET and ROS1. In vitro, ensartinib inhibited phosphorylation of ALK and its downstream signaling proteins AKT, ERK, and S6, thereby blocking ALK-mediated signaling pathways and inhibiting proliferation in cell lines harboring ALK fusions and mutations. In vivo, ensartinib showed anti-tumor activity in a mouse xenograft model of human NSCLC harboring an ALK fusion.
Approved indications
- ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)
Common side effects
- Rash
- Musculoskeletal pain
- Constipation
- Pruritus
- Cough
- Nausea
- Edema
- Vomiting
- Fatigue
- Pyrexia
- Increased uric acid
- Decreased lymphocytes
Drug interactions
- Moderate or Strong CYP3A Inhibitors
- Moderate or Strong CYP3A Inducers
- P-gp Inhibitors
- Strong or Moderate CYP3A Inhibitors
- Strong or Moderate CYP3A Inducers
- P-gp Inhibitors
Key clinical trials
- Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial) (PHASE2)
- Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (PHASE2)
- Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors. (PHASE1,PHASE2)
- Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer (PHASE1)
- Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (PHASE2)
- Treating Patients With Melanoma and ALK Alterations With Ensartinib (PHASE2)
- Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC) (PHASE1,PHASE2)
- Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ensacove CI brief — competitive landscape report
- Ensacove updates RSS · CI watch RSS
- Xcovery portfolio CI