ENSACOVE
Details
- Status
- Prescription
- First Approved
- 2024-12-18
- 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 Competitors
Pro6 other drugs also target ALK. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (ALK). Earlier expiry dates signal biosimilar/generic opportunities.
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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
ProIndications & Usage
FDA Label (PDF)ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ] who have not previously received an ALK-inhibitor. ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor.
ENSACOVE Patents & Exclusivity
Patents (16 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.