EBGLYSS
EBGLYSS (lebrikizumab-lbkz) is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis. It is approved for use in adults and pediatric patients aged 12 years and older who weigh at least 40 kg. The medication is intended for patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It may be administered with or without the concurrent use of topical corticosteroids.
How EBGLYSS Works
Lebrikizumab-lbkz is a monoclonal antibody that binds to interleukin-13 (IL-13), a cytokine that drives the Type 2 inflammation associated with atopic dermatitis. By binding to IL-13, the drug inhibits signaling through the IL-4Rα/IL-13Rα1 receptor complex, which prevents the release of proinflammatory cytokines, chemokines, and IgE. While it blocks this inflammatory signaling, the drug-bound IL-13 can still bind to the IL-13Rα2 receptor to allow for the natural internalization and clearance of the cytokine.
Details
- Status
- Prescription
- First Approved
- 2024-09-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
EBGLYSS Approval History
What EBGLYSS Treats
1 indicationsEBGLYSS is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atopic Dermatitis
EBGLYSS Competitors
Pro1 other drug also targets IL-13. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (IL-13). 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.
EBGLYSS FDA Label Details
ProIndications & Usage
FDA Label (PDF)EBGLYSS is indicated for the treatment of adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids. EBGLYSS ® is an interleukin-13 antagonist indicated for the treatment of adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.