Tezspire

(Tezepelumab)

Phase 3Monoclonal antibody

Tezspire is a monoclonal antibody that works as a Thymic Stromal Lymphopoietin Inhibitor.[2] It is being investigated across 13 indications, with its most advanced program in Phase 3.[1]

Tezspire is one of 160 biologic programs targeting Airway obstruction. It is currently in Phase 3.

Indications

Total Trials

Active Trials

159

Competitors

Pipeline

Status by Indication[3][1]

Indication

Airway ObstructionUnknown

SinusitisUnknown

Chronic Obstructive Pulmonary Disease (COPD)Recruiting

Allergic Bronchopulmonary AspergillosisNot yet recruiting

Bronchiolitis Obliterans SyndromeRecruiting

Eosinophilic EsophagitisActive, not recruiting

Chronic Rhinosinusitis With Nasal PolypsRecruiting

AsthmaCompleted

Allergic RhinitisActive, not recruiting

Granulomatosis With PolyangiitisEnrolling by invitation

Airway ObstructionPreclinical

Unknown

SinusitisPreclinical

Unknown

Chronic Obstructive Pulmonary Disease (COPD)Phase 3

Recruiting

Allergic Bronchopulmonary AspergillosisPreclinical

Not yet recruiting

Bronchiolitis Obliterans SyndromePhase 2

Recruiting

Eosinophilic EsophagitisPhase 3

Active, not recruiting

Chronic Rhinosinusitis With Nasal PolypsPhase 3

Recruiting

AsthmaPhase 3

Completed

Allergic RhinitisPhase 2

Active, not recruiting

Granulomatosis With PolyangiitisPhase 2

Enrolling by invitation

Showing 10 of 12 indications

Competition

Competitive Landscape

175 competitors in Asthma

#DrugCompanyPhaseTrials

Tezspire

AstraZeneca

Phase 3

14 2

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 3

DUPIXENT

Regeneron

Preclinical

1 4

Paracetamol

GSK

Preclinical

1 5

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 6

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 7

Lexapro

SShirley Ryan AbilityLab

Preclinical

1 8

Biological Drug

UUniversitaire Ziekenhuizen KU Leuven

Preclinical

1 9

Guanidine Hydrochloride

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 10

Rhinovirus

UUniversity of Virginia

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

ApprovedRecruiting

Severe Asthma

NCT06705764

Phase 2Active, not recruiting

Allergic Rhinitis

NCT06189742

Not yet recruiting

Asthma

NCT06438913

Q1 2027

Phase 3Active, not recruiting

Eosinophilic Esophagitis

NCT05583227

Q2 2027

Active, not recruiting

Asthma

NCT06948396

Q4 2027

PreclinicalNot yet recruiting

Allergic Bronchopulmonary Aspergillosis

NCT07757841

Clinical

Trials by Indication[1]

Asthma14 trials

Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab

Not yet recruiting·UUniversity Hospital, Montpellier·Phase 3·NCT07013123·38 enrolled

Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma

Terminated· AstraZeneca logo

AstraZeneca·Phase 3·NCT05398263·125 enrolled

Compare the Efficacy and Safety of QL2302 Versus Tezspire® in Severe Asthma

Not yet recruiting· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT07302516·636 enrolled

Show 11 more trials

Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT03706079·951 enrolled

Tezepelumab Treatment in Korean Severe Asthma Patients

Not yet recruiting·—··NCT06438913·100 enrolled

Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT03406078·150 enrolled

Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT05274815·305 enrolled

Patient Characteristics, Treatment Patterns and Outcomes of Patients With Severe Asthma Treated With Tezepelumab in the Real World; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres

Completed· AstraZeneca logo

AstraZeneca··NCT06455462·352 enrolled

Tezepelumab on Airway Structure and Function in Patients With Uncontrolled Moderate-to-severe Asthma

Completed·MMcMaster University·Phase 3·NCT05280418·27 enrolled

Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04673630·18 enrolled

Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE)

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT03688074·116 enrolled

A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06023589·231 enrolled

IdentiFy attRibutes Of uNcontrolled Severe asThma Patients trEateD With Tezepelumab: Italian Clinical Practice Study With the New bioloGic targEting TSLP

Active, not recruiting· AstraZeneca logo

AstraZeneca··NCT06948396·315 enrolled

A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants With Severe Asthma Including Several Under-Studied Populations in the United States (PASSAGE)

Completed· AstraZeneca logo

AstraZeneca·Approved·NCT05329194·286 enrolled

Chronic Rhinosinusitis With Nasal Polyps3 trials

Effect of Tezepelumab on Barrier Function in Severe Asthmatic Patients With and Without Comorbid Chronic Rhinosinusitis With Nasal Polyps

Not yet recruiting·MMedical University of Vienna·N/A·NCT07046117·20 enrolled

BIFANG: A Multicentre, Single-Arm, Phase 3b Study to Assess Nasal Polyps Score and Symptoms in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07520162·230 enrolled

Tezepelumab CRSwNP Real World Study (CREW Study): Non-interventional Prospective, Observational Study in Patients With CRSwNP Treated by Tezepelumab, Evaluating Patient-reported Outcomes in Japan Real World Practice.

Not yet recruiting· AstraZeneca logo

AstraZeneca··NCT07790198·100 enrolled

Severe Asthma3 trials

TAPER: A Prospective, Interventional, Multicentre, Single-Arm, Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Asthma Treated With Tezepelumab

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07363642·400 enrolled

Impact of Physical Activity Promotion on Clinical Remission in Adults With Severe Asthma Receiving Tezepelumab: A Multicentre, Open Label, Randomised Controlled Trial

Recruiting·UUniversity of Leeds·Preclinical·NCT07735494·140 enrolled

Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA): A Phase 4 Double-Blinded, Parallel-Group, Randomized Control Trial With an Open Label Extension

Recruiting·UUniversity of Alberta·Approved·NCT06705764·100 enrolled

Atopic Dermatitis2 trials

A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis

Terminated· Amgen logo

Amgen·Phase 2·NCT03809663·251 enrolled

Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis

Completed· Amgen logo

Amgen·Phase 1·NCT00757042·78 enrolled

Chronic Obstructive Pulmonary Disease (COPD)2 trials

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06883305·990 enrolled

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06878261·990 enrolled

18 more indications

Adult1 trial

Safety Study of Tezepelumab (AMG 157) in Healthy Adults

Completed· Amgen logo

Amgen·Phase 1·NCT00972179·49 enrolled

Granulomatosis with Polyangiitis1 trial

Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis

Enrolling by invitation·IImperial College London·Phase 2·NCT06230354·66 enrolled

Allergic Rhinitis1 trial

Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS)

Active, not recruiting·—·Phase 2·NCT06189742·19 enrolled

Chronic Spontaneous Urticaria1 trial

Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria

Completed· Amgen logo

Amgen·Phase 2·NCT04833855·183 enrolled

Chronic Rhinosinusitis1 trial

Opening the "Black Box" on Tezepelumab's Effect on Chronic Rhinosinusitis With Severe Asthma

Not yet recruiting·—·Phase 3·NCT06740045·10 enrolled

Inflammation1 trial

Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD

Recruiting·AAsger Sverrild·Phase 2·NCT05507242·80 enrolled

Influenza1 trial

Study to Assess the Effect of Tezepelumab on the Immune Response to Influenza Vaccination in Participants With Asthma

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT05062759·70 enrolled

COPD Exacerbation1 trial

Tezepelumab COPD Exacerbation Study

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT04039113·337 enrolled

Allergic Asthma1 trial

Tezepelumab and Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma

Unknown status·MMcMaster University·Phase 2·NCT05740748·34 enrolled

Atopic Asthma1 trial

Double-blind, Multiple Dose Study of Tezepelumab (AMG 157) in Adults With Mild Atopic Asthma

Completed· Amgen logo

Amgen·Phase 1·NCT01405963·31 enrolled

Adult Subject1 trial

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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03989544·315 enrolled

Cardiovascular Events1 trial

An Observational Multi-Country Post-Authorisation Safety Study to Evaluate the Risk of Serious Adverse Cardiovascular Events in Adolescent and Adult Patients With Severe Asthma Taking Tezepelumab

Recruiting· AstraZeneca logo

AstraZeneca··NCT06951867·16,640 enrolled

Peanut Allergy1 trial

Efficacy of Tezepelumab in Peanut Oral Immunotherapy: a Double-Blind, Randomized, Placebo-Controlled Trial

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT07015996·62 enrolled

Bronchiolitis Obliterans Syndrome1 trial

Efficacy of an Anti-TSLP Monoclonal Antibody in the Management of Chronic Bronchial Disease Induced by Bronchiolitis Obliterans Syndrome in Allogeneic Hematopoietic Stem Cells Transplantation Recipients

Recruiting·HHopital Foch·Phase 2·NCT07771855·36 enrolled

Allergic Bronchopulmonary Aspergillosis1 trial

Effectiveness and Safety of Tezepelumab in Allergic Bronchopulmonary Aspergillosis (ABPA): a Prospective Study of Real-world Experience

Not yet recruiting·QQianfoshan Hospital·Preclinical·NCT07757841·10 enrolled

Eosinophilic Esophagitis1 trial

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING).

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05583227·368 enrolled

Airway Remodelling, Asthmatic1 trial

REVErsing Airway Remodelling With Tezepelumab : a Protocol for a Double-blind Randomized Controlled Trial for Patients With Asthma

Completed·UUniversity Hospital, Montpellier·Phase 3·NCT05651841·90 enrolled

Unspecified1 trial

Tezepelumab Home Use Study

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT03968978·216 enrolled

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Tezepelumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tezepelumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tezepelumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thymic Stromal Lymphopoietin Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

Tezspire

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Asthma14 trials

Chronic Rhinosinusitis With Nasal Polyps3 trials

Severe Asthma3 trials

Atopic Dermatitis2 trials

Chronic Obstructive Pulmonary Disease (COPD)2 trials

Adult1 trial

Granulomatosis with Polyangiitis1 trial

Allergic Rhinitis1 trial

Chronic Spontaneous Urticaria1 trial

Chronic Rhinosinusitis1 trial

Inflammation1 trial

Influenza1 trial

COPD Exacerbation1 trial

Allergic Asthma1 trial

Atopic Asthma1 trial

Adult Subject1 trial

Cardiovascular Events1 trial

Peanut Allergy1 trial

Bronchiolitis Obliterans Syndrome1 trial

Allergic Bronchopulmonary Aspergillosis1 trial

Eosinophilic Esophagitis1 trial

Airway Remodelling, Asthmatic1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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