How many clinical trials are studying Tezepelumab?

8 recruiting trials in our tracked data involve Tezepelumab.

What conditions is Tezepelumab being studied for?

In our tracked recruiting trials, Tezepelumab is being studied in trials for Asthma, COPD, Severe Asthma.

Tezepelumab: clinical trials recruiting now

Q: Is Tezepelumab FDA-approved?

Yes. According to the FDA drug label available through openFDA, Tezepelumab is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Tezepelumab appears in the FDA drug-label database. Marketed as TEZSPIRE.
Drug class: Thymic Stromal Lymphopoietin Blocker (FDA established pharmacologic class)
Mechanism of action: Thymic Stromal Lymphopoietin Blockers (as stated on the FDA label)

FDA-approved use

TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. ( 1.1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. ( 1.1 ) • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). ( 1.2 ) 1.1 Asthma TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use: TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.2 Chronic Rhinosinusitis with Nasal Polyps TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

FDA label via openFDA

Phase breakdown

Phase 2 1 Phase 3 4 Phase 4 1 Not applicable 2

Conditions being studied

Condition	Trials
Asthma · Tezepelumab for Asthma	5
COPD · Tezepelumab for COPD	3
Severe Asthma · Tezepelumab for Severe Asthma	3
Chronic Obstructive Pulmonary Disease (COPD)	2
Airway Disease	1
COPD Bronchitis	1
COPD Exacerbation	1
Cardiovascular Events	1
Heart failure	1
Immune System Disorder	1
MACE	1

Recruiting trials involving Tezepelumab

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
NCT06023589 · Phase: Phase 3 · Ages: 5 Years to 11 Years · Sex: All (male and female) · 147 locations
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)
NCT06883305 · Phase: Phase 3 · Ages: 40 Years to 80 Years · Sex: All (male and female) · 305 locations
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
NCT06878261 · Phase: Phase 3 · Ages: 40 Years to 80 Years · Sex: All (male and female) · 276 locations
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD
NCT05507242 · Phase: Phase 2 · Ages: 40 Years and older · Sex: All (male and female) · 2 locations
Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
NCT07363642 · Phase: Phase 3 · Ages: 12 Years to 80 Years · Sex: All (male and female) · 75 locations
Physical Activity Promotion and Clinical Remission in Severe Asthma
NCT07735494 · Phase: Not applicable (e.g. observational or device study) · Ages: 18 Years to 70 Years · Sex: All (male and female) · 1 location
Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)
NCT06705764 · Phase: Phase 4 · Ages: 18 Years to 55 Years · Sex: All (male and female) · 2 locations
Tezspire Cardiac Events PASS
NCT06951867 · Phase: Not specified · Ages: 12 Years to 130 Years · Sex: All (male and female) · 4 locations

Common questions

Is Tezepelumab FDA-approved?

Yes, marketed as TEZSPIRE.

How many recruiting trials involve Tezepelumab?

8 recruiting trials across 11 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.