tezepelumab
tezepelumab: sourced relationships with 1 company · 13 clinical trials tracked · 1 FDA decision.
tezepelumab evidence translation
What we can confirm
1 FDA record · 13 tracked trials
What it means
What to watch
Prepared research question
How could tezepelumab → AZN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| ASTRAZENECA PLC (AZN) Reported 2021-12-17 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (13)showing 10 most recent
Efficacy of Tezepelumab in Peanut Oral Immunotherapy: a Double-Blind, Randomized, Placebo-Controlled Trial
Primary endpoint: Consumption of a cumulative dose of 4000 mg of peanut protein without dose-limiting symptoms during the open Oral Food Challenge (OFC)
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
Primary endpoint: Proportion of patients who have moderate and severe exacerbations of asthma
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
Primary endpoint: To describe changes from baseline in nasal polyp score (NPS)
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
Primary endpoint: To assess the potential for Tezepelumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population while maintaining asthma control
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
Primary endpoint: composite outcome MACE
IdentiFy attRibutes Of uNcontrolled Severe asThma Patients trEateD With Tezepelumab: Italian Clinical Practice Study With the New bioloGic targEting TSLP
Primary endpoint: Demographic and Clinic characterization
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
Primary endpoint: Annualised rate of moderate or severe COPD exacerbations
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
Primary endpoint: Annualised rate of moderate or severe COPD exacerbations
A RAndomised Placebo Controlled Trial - to Explore the Efficacy and Mechanism of Action of Tezepelumab in Eosinophilic Granulomatosis With Polyangiitis
Primary endpoint: Proportion of participants who are in remission at week 24
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)
Primary endpoint: Annualized severe asthma exacerbation rate (AAER)
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with tezepelumab?
tezepelumab has dated SEC/FDA relationship records for ASTRAZENECA PLC.
How many clinical trials involve tezepelumab?
BioSniper tracks 13 clinical trials involving tezepelumab.
What is tezepelumab's latest FDA decision?
The most recent tracked FDA decision for tezepelumab is Approval for 1 INDICATIONS AND USAGE 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)., dated December 17, 2021.