Overview
Asthma is a heterogeneous chronic obstructive respiratory disease with both "type 2" (T2) and T2-low endotypes characterized by reduced airflow, chronic inflammation, and airway remodelling. Thymic stromal lymphopoietin (TSLP), an innate pleiotropic IL-2-family cytokine, has emerged as a key upstream regulator of chronic inflammation across asthma endotypes. Blocking the interaction of TSLP with the receptors TSLPR and IL-7Rα improves asthma-associated biomarkers including eosinophil counts and IgE, FeNO, IL-5, and IL-13 levels. As existing asthma treatments such as omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab act on specific downstream mediators of the inflammatory response, they are mostly limited to treating T2 asthma. Conversely, tezepelumab, which targets the upstream master regulator TSLP, has the potential to be effective across asthma endotypes. Tezepelumab is a human monoclonal IgG2λ antibody directed against TSLP produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. It was granted FDA approval on December 17, 2021, and is currently marketed under the trademark TEZSPIRE by Amgen/AstraZeneca. Tezepelumab was also approved by the European Commission on September 19, 2022.
Indication
Tezepelumab is indicated as an add-on maintenance treatment for patients aged 12 years and older with severe asthma. In Europe, it is reserved for patients who are inadequately controlled despite maintenance treatment with high-dose inhaled corticosteroids plus another drug. Tezepelumab is not indicated for the relief of acute bronchospasm or status asthmaticus.
Associated Conditions
- Severe Asthma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/01 | Not Applicable | Not yet recruiting | |||
2025/06/11 | Phase 2 | Not yet recruiting | |||
2025/06/10 | Phase 3 | Not yet recruiting | |||
2025/04/30 | N/A | Not yet recruiting | |||
2025/04/29 | N/A | Recruiting | |||
2025/03/19 | Phase 3 | Recruiting | |||
2025/03/14 | Phase 3 | Recruiting | |||
2024/12/18 | Phase 3 | Not yet recruiting | Dr. Andrew Thamboo, MD | ||
2024/11/26 | Phase 4 | Not yet recruiting | |||
2024/06/12 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amgen Inc | 55513-112 | SUBCUTANEOUS | 210 mg in 1.9 mL | 5/26/2023 | |
| Amgen, Inc | 55513-112 | SUBCUTANEOUS | 210 mg in 1.9 mL | 5/26/2023 | |
| Amgen Inc | 55513-123 | SUBCUTANEOUS | 210 mg in 1.9 mL | 5/26/2023 | |
| Amgen, Inc | 55513-123 | SUBCUTANEOUS | 210 mg in 1.9 mL | 5/26/2023 | |
| Amgen Inc | 55513-100 | SUBCUTANEOUS | 210 mg in 1.9 mL | 5/26/2023 | |
| Amgen, Inc | 55513-100 | SUBCUTANEOUS | 210 mg in 1.9 mL | 5/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/19/2022 | ||
Authorised | 9/19/2022 | ||
Authorised | 9/19/2022 | ||
Authorised | 9/19/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TEZSPIRE SOLUTION FOR INJECTION 210 MG IN PRE-FILLED PEN | SIN16817P | INJECTION, SOLUTION | 210 mg/unit | 7/4/2023 | |
| TEZSPIRE SOLUTION FOR INJECTION 210 MG IN PRE-FILLED SYRINGE | SIN16815P | INJECTION, SOLUTION | 210 mg/unit | 7/4/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Tezspire, tezepelumab 210 mg in 1.91mL solution for Injection prefilled syringe | 427956 | Medicine | A | 3/24/2025 | |
| Tezspire, tezepelumab 210 mg in 1.91mL solution for Injection prefilled pen | 432812 | Medicine | A | 3/24/2025 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TEZSPIRE 210 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1221677001 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
| TEZSPIRE 210 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1221677003 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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