TEZSPIRE
TEZSPIRE (tezepelumab-ekko) is a thymic stromal lymphopoietin (TSLP) blocker indicated as an add-on maintenance treatment for patients aged 12 years and older. It is used to treat severe asthma and inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The medication is not indicated for the relief of acute bronchospasm or status asthmaticus. It functions as a maintenance therapy to address the airway and mucosal inflammation associated with these chronic respiratory conditions.
How TEZSPIRE Works
Tezepelumab-ekko is a human monoclonal antibody that binds to human TSLP and blocks its interaction with the TSLP receptor. TSLP is an epithelial-derived cytokine that occupies an upstream position in inflammatory cascades, influencing multiple cell types and mediators involved in airway and mucosal inflammation. By blocking this interaction, the drug reduces various biomarkers and cytokines associated with inflammation, including blood eosinophils, IgE, FeNO, IL-5, and IL-13. This mechanism targets the underlying inflammatory processes that contribute to the pathogenesis of asthma and nasal polyps.
Details
- Status
- Prescription
- First Approved
- 2021-12-17
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
TEZSPIRE Approval History
What TEZSPIRE Treats
2 indicationsTEZSPIRE is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Chronic Rhinosinusitis
TEZSPIRE Competitors
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Competitors share the same molecular target (IL-5). 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.
TEZSPIRE FDA Label Details
ProIndications & Usage
FDA Label (PDF)TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). 1.1 Asthma TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.