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ARO-RAGE

Phase 2

Asthma | Small molecule | Respiratory |Arrowhead Pharmaceuticals, Inc.|Last Updated: May 28, 2026

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment206
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07241546Study of Inhaled ARO-RAGE in Allergen-induced Mild AsthmaPHASE2 RECRUITING 36Mar 30, 2026Apr 1, 2028May 28, 20262 Canada
NCT05533294Study of ARO-RAGE in Healthy SubjectsPHASE1 COMPLETED 43Nov 29, 2022Feb 8, 2024Mar 29, 20241 New Zealand
NCT05276570Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung DiseasePHASE1 COMPLETED 127Jun 29, 2022Apr 16, 2025Apr 9, 20268 Australia, New Zealand +3
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Study Endpoints
Primary Endpoints
Change from Baseline Over Time in Maximum Area of Reactance
Baseline through Day 58
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
From first dose of study drug through the end of study (EOS; up to 113 days or until serum soluble receptor for advance glycation end products [SRAGE] is ≥70% of baseline value, whichever is later)
Secondary Endpoints
Change from Baseline Over Time in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve
Baseline through Day 58
Change from Baseline Over Time in Maximum Change in Small Airway Reactance
Baseline through Day 58
Number of Participants with Treatment-Emergent Adverse Events
Up to Day 113 (End of Study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARO-RAGEEXPERIMENTALARO-RAGE inhalation
PlaceboPLACEBO_COMPARATORNormal saline (0.9%)
Interventions
NameTypeDescription
ARO-RAGEDRUGInhalation of nebulized solution
PlaceboDRUGCalculated volume to match active treatment by inhalation of nebulized solution
ARO-RAGE InjectionDRUGARO-RAGE injection for sc administration
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Clinically stable, mild atopic asthma (FEV1 ≥70% predicted) * Established allergy confirmed by positive skin prick test at screening * Willing and able to perform lung function tests and other study-related procedures * Participants of childbearing potential must consent to us...

Countries:CanadaNew ZealandAustraliaPolandSpainThailand
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07241546lastUpdatePostDate: changed
LOWMay 29, 2026NCT07241546lastUpdatePostDate: changed
LOWMay 29, 2026NCT07241546lastUpdatePostDate: changed
LOWMay 26, 2026NCT07241546Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07241546studyFirstPostDate: changed