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Biological: Experimental: Tezepelumab

Phase 3

Severe Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jun 1, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04048343Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe AsthmaPHASE3 COMPLETED 65Jun 10, 2019Mar 18, 2021Jun 1, 20225 Japan
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Study Endpoints
Primary Endpoints
Number of Subjects With Adverse Events
From first dose of study drug until last study visit at Week 64

The number of subjects who experienced an AE during on-treatment period was summarised.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TezepelumabEXPERIMENTALTezepelumab: Tezepelumab subcutaneous injection
Interventions
NameTypeDescription
Biological: Experimental: TezepelumabDRUGTezepelumab subcutaneous injection every 4 weeks
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Eligibility Criteria
Age Range12 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: Age. 12-80 Documented physician-diagnosed asthma for at least 12 months Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months. Documented treatment with a total daily dose of either medium or high dose...

Countries:Japan
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