TEZSPIRE (tezepelumab-ekko)
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-12-17
- Patent Cliff
- 2033
- Revenue
- $474M (Q4-2025)
- 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 Target & Pathway
ProTarget
TEZSPIRE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
Drugs Similar to TEZSPIRE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
30 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06878261 JOURNEY | D5241C00007 | Ph 3 | recruiting | A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007) |
| NCT06883305 EMBARK | D5241C00006 | Ph 3 | recruiting | A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) |
| NCT06705764 TERAA | ESR-22-22102 | Ph 4 | not yet recruiting | Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA) |
| NCT06023589 HORIZON | D5180C00016 | Ph 3 | recruiting | A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma |
| NCT07015996 ZENITH | DAIT ITN097AD | Ph 2 | not yet recruiting | Efficacy of Tezepelumab in Peanut Oral Immunotherapy |
| NCT06230354 RACEMATE | 1007564 21HH7284 | Ph 2 | active not recruiting | Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis |
| NCT07363642 TAPER | D5180L00021 | Ph 3 | recruiting | Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab |
| NCT05583227 CROSSING | D5244C00001 2022-001294-31 | Ph 3 | active not recruiting | Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis |
| NCT07520162 BIFANG | D5242L00001 | Ph 3 | not yet recruiting | A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab |
| NCT06189742 TEZARS | TEZARS-001 | Ph 2 | active not recruiting | Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS) |
| NCT07327697 | QL2302-101 | Ph 1 | not yet recruiting | A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects |
| NCT05280418 | ESR-20-210000 | Ph 3 | completed | Tezepelumab on Airway Structure and Function in Patients With Uncontrolled Moderate-to-severe Asthma |
| NCT05274815 WAYFINDER results posted | D5180C00037 2021-005457-85 | Ph 3 | completed | Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma |
| NCT05329194 PASSAGE | D5180C00032 | Ph 4 | completed | Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States |
| NCT07013123 TEZEPAIT | RECHMPL25_0069 2025-521258-41-00 | Ph 3 | not yet recruiting | Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab |
| NCT05398263 SUNRISE | D5180C00024 05398263, 2023-504648-33 | Ph 3 | terminated | Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma |
| NCT04039113 COURSE results posted | D5241C00001 2019-001363-67 | Ph 2 | completed | Tezepelumab COPD Exacerbation Study |
| NCT06740045 | H24-02151 | Ph 3 | not yet recruiting | Opening the "Black Box" on Tezepelumab's Effect on Chronic Rhinosinusitis With Severe Asthma |
| NCT05507242 UPSTREAM-COPD | UPSTREAM-COPD | Ph 2 | recruiting | Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD |
| NCT05651841 REVERT | RECHMPL22_0123 | Ph 3 | recruiting | REVErsing Airway Remodelling With Tezepelumab |
| NCT04673630 TRAILHEAD results posted | D5180C00025 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma |
| NCT05062759 VECTOR results posted | D5180C00031 | Ph 3 | completed | Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma |
| NCT03706079 DESTINATION results posted | D5180C00018 | Ph 3 | completed | Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma |
| NCT01405963 results posted | 20101183 | Ph 1 | completed | Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma |
| NCT00757042 results posted | 20070620 | Ph 1 | completed | Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis |
| NCT00972179 results posted | 20080390 | Ph 1 | completed | Safety Study of Tezepelumab (AMG 157) in Healthy Adults |
| NCT03809663 results posted | 20170755 2018-001997-52 | Ph 2 | terminated | A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis |
| NCT03688074 CASCADE results posted | D5180C00013 | Ph 2 | completed | Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE) |
| NCT03406078 SOURCE results posted | D5180C00009 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma |
| NCT03989544 PATH-BRIDGE | D5180C00012 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics of Tezepelumab After Being Delivered by an Accessorized Pre Filled Syringe or Autoinjector Compared With Vial and Syringe in Healthy Adult Subjects |
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
Indications & Usage
FDA Label (PDF)TEZSPIRE is indicated for the treatment of Asthma; Chronic Rhinosinusitis.
Pro Intelligence Preview
Deep insights for TEZSPIRE
Revenue Insights
- • Q4-2025: $474M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • Generic/biosimilar risk
Trial Analysis
- • 31 total trials
- • Stage: Expansion
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment