Tezepelumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Tezepelumab
- tezspire
- Tezspire
- 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.
- ATC classification codes
- R03DX11
Sources for recorded values
- CAS registry numbers
- 1572943-04-4
- ChEMBL ID
- CHEMBL3707229
- FDA ingredient codes (UNII)
- RJ1IW3B4QX
- 2587789
- 2587790
- Applicant
- ASTRAZENECA AB
- Approval date
- 17 Dec 2021
- Application number
- BLA761224
- 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
- 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 name
- tezepelumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- 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
- 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
- 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
- NCT00757042
- NCT02525094
- NCT03809663
- NCT01405963
- NCT02054130
- NCT02512900
- NCT02698501
- NCT03347279
- NCT03406078
- NCT03706079
- NCT03927157
- NCT03989544
- NCT04673630
- NCT05062759
- NCT05274815
- NCT05280418
- NCT05651841
- NCT02237196
- NCT04039113
- NCT04833855
- NCT05583227
- Dose
- 210 mg
- Route
- Subcutaneous
- How often
- Once every 4 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 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
- 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
- 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
- Obstructive lung disease
In development for (6)
- Allergic asthma Phase 2
- Allergic disease Phase 1
- Atopic eczema Phase 2
- Chronic idiopathic urticaria Phase 2
- Chronic obstructive pulmonary disease Phase 2
- Eosinophilic esophagitis Phase 3
Other linked conditions (1)
- Sinusitis
Targets (1)
- TSLP Thymic stromal lymphopoietin inhibitor