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Tezspire (AMG 157)
Tezspire blocks the action of Thymic Stromal Lymphopoietin (TSLP), a protein that triggers inflammation in the airways.
At a glance
| Generic name | AMG 157 |
|---|---|
| Also known as | MEDI9929/AMG 157, Placebo for AMG157 |
| Sponsor | AstraZeneca |
| Drug class | Thymic Stromal Lymphopoietin Blocker [EPC] |
| Target | Thymic stromal lymphopoietin |
| Modality | Biologic |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2021 |
| Annual revenue | 800 |
Mechanism of action
Tezepelumab-ekko is thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody IgG2 that binds to human TSLP with dissociation constant of 15.8 pM and blocks its interaction with the heterodimeric TSLP receptor. TSLP is cytokine mainly derived from epithelial cells and occupies an upstream position in the asthma inflammatory cascade.Airway inflammation is an important component in the pathogenesis of asthma. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes, ILC2 cells) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in airway inflammation. Blocking TSLP with tezepelumab-ekko reduces biomarkers and cytokines associated with inflammation including blood eosinophils, airway submucosal eosinophils, IgE, FeNO, IL-5, and IL-13; however, the mechanism of tezepelumab-ekko action in asthma has not been definitively established.
Approved indications
- Severe asthma
Common side effects
- Pharyngitis
- Arthralgia
- Back pain
- Injection site reactions
- Injection site erythema
- Injection site swelling
- Injection site pain
- Anti-drug antibodies
- Treatment-emergent antibodies
- Neutralizing antibodies
Key clinical trials
- Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (PHASE3)
- A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma (PHASE3)
- Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States (PHASE4)
- Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria (PHASE2)
- Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma (PHASE1)
- Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis (PHASE1)
- Safety Study of Tezepelumab (AMG 157) in Healthy Adults (PHASE1)
- A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tezspire CI brief — competitive landscape report
- Tezspire updates RSS · CI watch RSS
- AstraZeneca portfolio CI