ENSACOVE (ensartinib hydrochloride)
Ensacove is a kinase inhibitor used for adults with a specific type of lung cancer known as ALK-positive non-small cell lung cancer. It helps patients with advanced or metastatic disease who have not previously been treated with an ALK-inhibitor. This medication is prescribed after a specialized test confirms the presence of the ALK biomarker in the patient's tumor.
How ENSACOVE Works
This drug works by blocking the activity of anaplastic lymphoma kinase (ALK) and other proteins like MET and ROS1. By inhibiting these kinases, it stops the signaling pathways that drive the growth and spread of cancer cells. This process prevents the phosphorylation of downstream proteins, which effectively inhibits the proliferation of tumors harboring ALK mutations.
Details
- Status
- Prescription
- First Approved
- 2024-12-18
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ENSACOVE Approval History
What ENSACOVE Treats
1 indicationsENSACOVE is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Small Cell Lung Cancer
ENSACOVE Target & Pathway
ProTarget
A receptor tyrosine kinase that, when mutated or rearranged, drives cancer cell growth. ALK rearrangements occur in about 5% of non-small cell lung cancers. Inhibiting ALK blocks aberrant signaling that promotes tumor survival and proliferation.
ENSACOVE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ENSACOVE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ENSACOVE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ENSACOVE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05665283 | XCV-X396-ONC-103 | Ph 1 | completed | A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ENSACOVE FDA Label Details
Indications & Usage
FDA Label (PDF)ENSACOVE is indicated for the treatment of Non-Small Cell Lung Cancer.
ENSACOVE Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ENSACOVE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 16 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.