MedPath

Tezepelumab

Generic Name
Tezepelumab
Brand Names
Tezspire
Drug Type
Biotech
CAS Number
1572943-04-4
Unique Ingredient Identifier
RJ1IW3B4QX

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
TEZSPIRE
astrazeneca canada inc
02529556
Solution - Subcutaneous
110 MG / ML
10/19/2022
TEZSPIRE
astrazeneca canada inc
02529548
Solution - Subcutaneous
110 MG / ML
10/19/2022

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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