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Drug

Tezepelumab

Approved · EMA
Late-stage development

Also known as Tezspire.

RxNorm2587789UNIIRJ1IW3B4QX
15
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-14Primary completion · ClinicalTrials.gov

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

Clinical trial2026-07-10Results expected Q1 2028 · ClinicalTrials.gov

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)

Clinical trial2026-06-26Results expected Q2 2028 · ClinicalTrials.gov

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

Clinical trial2026-06-26Results expected Q3 2028 · ClinicalTrials.gov

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

Clinical trial2026-06-25Results expected Q3 2027 · ClinicalTrials.gov

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

Clinical trial2026-06-24Results expected Q1 2029 · ClinicalTrials.gov

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

Clinical trial2026-06-24Results expected Q1 2029 · ClinicalTrials.gov

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

Clinical trial2026-06-23Completed · ClinicalTrials.gov

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

Clinical trial2026-05-06Results expected Q4 2026 · ClinicalTrials.gov

A RAndomised Placebo Controlled Trial - to Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis

Clinical trial2026-04-29Results expected Q3 2026 · ClinicalTrials.gov

Tezepelumab in the Treatment of Co-morbid Allergic Rhinitis and Allergic Asthma Study (TEZARS) - An Open-Label Exploratory Mechanistic Pilot Study to Evaluate Tezepelumab Efficacy in Asthma and Allergic Rhinitis

Clinical trial2026-01-20Results expected Q4 2026 · ClinicalTrials.gov

Approval: Tezspire (EMA)

Regulatory2022-09-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tezepelumab
Aliases & brands
Tezspire
RxNorm CUI
2587789
UNII
RJ1IW3B4QX
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-09-19
Latest approval
2022-09-19
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-09-19Approval
Approval: Tezspire (EMA)
Indication: 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… Show full indication

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)&nbsp;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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

33 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
33
registered trials across all phases
LATEST COMPLETION 2026
15
Active studies
12
Recruiting
20
Late-stage (III+)
15
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 33
Phase 15Phase 28Phase 317Phase 42Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

Not yet recruitingPH IVUniversity of Albertan=1002026

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)

CompletedPH IVAstraZenecan=2872025

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)

RecruitingPH IIIAstraZenecan=2312030

A Multi-center, Randomised, Double Blind, Active Controlled Phase III Trial to Compare the Efficacy and Safety of QL2302 With Tezspire® in Adults With Uncontrolled Severe Asthma

Not yet recruitingPH IIIQilu Pharmaceutical Co., Ltd.n=6362029

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 recruitingPH IIIUniversity Hospital, Montpelliern=382029

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IIIUniversity Hospital, Montpelliern=902026

A Two-arm, Placebo-controlled, Randomized Clinical Trial to Evaluate the Effect of Tezepelumab on Airway Structure and Function in Patients With Uncontrolled Moderate-to-severe Asthma

CompletedPH IIIMcMaster Universityn=272025

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)

CompletedPH IVAstraZenecan=2872025

A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants With Severe Asthma on High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Long-term Oral Corticosteroid Therapy (WAYFINDER)

CompletedPH IIIAstraZenecan=3052024

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

CompletedPH IIAstraZenecan=3372024

A Phase I, Open-label Study to Evaluate the Pharmacokinetics of Tezepelumab in Children ≥ 5 to 11 Years of Age With Mild, Moderate, or Severe Asthma (TRAILHEAD)

CompletedPH IAstraZenecan=182022
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.