> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/tezepelumab-8dc36556-e99a-4122-9017-127f366a520e
> Record changed: 2026-10-13

# Tezepelumab

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707229)

Drug type

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707229)

First approval year

2021

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707229)

## Development status

**First approval year**

2021

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707229)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707229)

## Names and chemistry

**Drug type**

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707229)

**Drug name**

Tezepelumab

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707229)

### Brand names (2)

- tezspire
- Tezspire

### Other names (35)

- amg 157
- AMG 157
- AMG-157
- medi 19929
- medi 9929
- MEDI-19929
- MEDI-9929
- medi19929
- MEDI19929
- medi9929
- MEDI9929
- MEDI9929 210 mg
- MEDI9929 280 mg
- MEDI9929 70 mg
- tezepelumab
- Tezepelumab
- Tezepelumab (AI)
- Tezepelumab (APFS)
- tezepelumab (Arm1&Arm2)
- tezepelumab \[INN\]
- TEZEPELUMAB \[JAN\]
- Tezepelumab \[MI\]
- TEZEPELUMAB \[USAN\]
- Tezepelumab \[WHO-DD\]
- tezepelumab ekko

And 10 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- R03DX11

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707229)

**CAS registry numbers**

- 1572943-04-4

**ChEMBL ID**

CHEMBL3707229

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707229)

**FDA ingredient codes (UNII)**

- RJ1IW3B4QX

### RxNorm IDs (RxCUI) (2)

- 2587789
- 2587790

## Regulatory information

### United States

**Applicant**

ASTRAZENECA AB

**Approval date**

17 Dec 2021

**Application number**

BLA761224

### European Union

**Status**

Authorised

**Status date**

19 Sept 2022

**Authorisation date**

19 Sept 2022

**Approved indications**

AsthmaTezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyps (CRSwNP) Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.

**Product number**

EMEA/H/C/005588

**Authorisation holder**

AstraZeneca AB

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

Yes

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Asthma
- Sinusitis

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/tezspire)

### Other regulatory facts

**Patents**

0

**Designations**

4

**First in class**

Yes

**Fast track**

No

**Breakthrough designation**

Yes

**Orphan designation**

No

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

tezepelumab

**Type**

Antibody

**Drug name stem**

\-mab

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Parenteral

### Mechanisms of action (2)

- **Action**  
Binding

**Action type**  
Binding

**Target**  
thymic stromal lymphopoietin

**Gene symbol**  
thymic stromal lymphopoietin

**Affinity units**  
pKd

**Primary target**  
Yes
- **Mechanism**  
Thymic stromal lymphopoietin inhibitor

**Action type**  
Inhibitor

**Target**  
Thymic stromal lymphopoietin

**Protein identifier**  
Q969D9

### Open Targets mechanisms

- **Mechanism**  
Thymic stromal lymphopoietin inhibitor

**Action type**  
Inhibitor

**Target**  
Thymic stromal lymphopoietin

### Investigated indications (7)

- **Condition**  
Dermatitis, Atopic

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000274

**Subject identifier**  
D003876
- **Condition**  
Pulmonary Disease, Chronic Obstructive

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000341

**Subject identifier**  
D029424
- **Condition**  
Eosinophilic Esophagitis

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0004232

**Subject identifier**  
D057765
- **Condition**  
Lung Diseases, Obstructive

**Highest recorded phase**  
4

**Condition identifier**  
HP:0006536

**Subject identifier**  
D008173
- **Condition**  
Asthma

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0004979

**Subject identifier**  
D001249
- **Condition**  
Hypersensitivity

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0005271

**Subject identifier**  
D006967
- **Condition**  
Chronic Urticaria

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0044212

**Subject identifier**  
D000080223

### Open Targets indications (20)

- **Condition identifier**  
EFO\_0000274

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000341

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0004232

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0007425

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0007486
- **Condition identifier**  
EFO\_1002029

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0006536
- **Condition identifier**  
HP\_0006536

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0004784

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004979
- **Condition identifier**  
MONDO\_0004979

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0004980

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005002

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005271
- **Condition identifier**  
MONDO\_0005271

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005361

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005961

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0011786

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0015943

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0044212

**Highest recorded phase**  
2

### Reported adverse events

- **Event**  
asthma

**Reports**  
5

**Reporting signal score**

14.0619

### Trial references (21)

- NCT00757042  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00757042)
- NCT02525094  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02525094)
- NCT03809663  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03809663)
- NCT01405963  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01405963)
- NCT02054130  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02054130)
- NCT02512900  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02512900)
- NCT02698501  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02698501)
- NCT03347279  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03347279)
- NCT03406078  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03406078)
- NCT03706079  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03706079)
- NCT03927157  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03927157)
- NCT03989544  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03989544)
- NCT04673630  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04673630)
- NCT05062759  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05062759)
- NCT05274815  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05274815)
- NCT05280418  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05280418)
- NCT05651841  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05651841)
- NCT02237196  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02237196)
- NCT04039113  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04039113)
- NCT04833855  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04833855)
- NCT05583227  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05583227)

## Dosing

**Dose**

210 mg

**Route**

Subcutaneous

**How often**

Once every 4 weeks

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences (3)

- **Component**  
Disulfide bridges location

**Sequence**  
22'-87' | 22'''-87''' | 22-96 | 22''-96'' | 136'-195' | 136'''-195''' | 136-213' | 136''-213''' | 149-205 | 149''-205'' | 224-224'' | 225-225'' | 228-228'' | 231-231'' | 262-322 | 262''-322'' | 368-426 | 368''-426''
- **Component**  
Light chain

**Type**  
Protein

**Sequence**  
SYVLTQPPSVSVAPGQTARITCGGNNLGSKSVHWYQQKPGQAPVLVVYDDSDRPSWIPERFSGSNSGNTATLTISRGEAGDEADYYCQVWDSSSDHVVFGGGTKLTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
- **Component**  
Heavy chain

**Type**  
Protein

**Sequence**  
QMQLVESGGGVVQPGRSLRLSCAASGFTFRTYGMHWVRQAPGKGLEWVAVIWYDGSNKHYADSVKGRFTITRDNSKNTLNLQMNSLRAEDTAVYYCARAPQWELVHEAFDIWGQGTMVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPAPIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK

## National Drug Codes

- 55513-112
- 55513-123

## Related records

### Trials (73)

- [A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2302 vs. Tezspire® in Healthy Subjects](https://trialight.com/data/trial/a-comparative-phase-1-study-to-evaluate-the-pharmacokinetic-20cf5c1a-8bb1-42d7-8f40-33c7d8eea1ae.md)
- A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 After Single Administration in Healthy Male Japanese Subjects
- A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer
- A Study to Evaluate the Pharmacokinetics of MEDI9929 (AMG 157) in Adolescents With Mild to Moderate Asthma
- 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
- A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
- A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab
- A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
- A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
- A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
- A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
- Adjuvant AI Combined With Zoladex
- Anti-TSLP (AMG 157) Plus Antigen-Specific Immunotherapy for Induction of Tolerance in Individuals With Cat Allergy
- Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
- Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection
- Clinical Study of Adjuvant Therapy on Post-menopausal Women With Breast Cancer Under the Guidance of the Results of Preoperative Endocrinotherapy
- Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma
- Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
- Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer

### Approved for (2)

- [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md)
- Obstructive lung disease

### In development for (6)

- [Allergic asthma](https://trialight.com/data/condition/allergic-asthma-09fdf0b0-d623-5f2a-9bed-3f05a0ce487a.md) Phase 2
- Allergic disease Phase 1
- [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Phase 2
- Chronic idiopathic urticaria Phase 2
- [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Phase 2
- Eosinophilic esophagitis Phase 3

### Other linked conditions (1)

- Sinusitis

### Targets (1)

- [TSLP](https://trialight.com/data/target/tslp-057bc96b-1ea4-5177-a6e4-25ad3ec5d86e.md) Thymic stromal lymphopoietin inhibitor

---

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