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ARO-RAGE

Phase 2

Asthma | Small molecule | Respiratory |Arrowhead Pharmaceuticals, Inc.|Last Updated: Jun 23, 2026

Target and mechanism

Molecular targetRAGE
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment206

FDA Designations

No designations recorded

Clinical trial landscape

ARO-RAGE · 3 trials · 1 indication

Phase 2 1Phase 1 2
NCT07241546Study of Inhaled ARO-RAGE in Allergen-induced Mild AsthmaAsthma
RECRUITING36 Analytics
PHASE2RECRUITING
Study of Inhaled ARO-RAGE in Allergen-induced Mild Asthma
AsthmaUnlock trial analytics

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 to 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

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)

LOWJun 23, 2026NCT07241546lastUpdatePostDate: changed
LOWJun 23, 2026NCT07241546lastUpdatePostDate: changed

Frequently asked questions about ARO-RAGE

What is ARO-RAGE used for in asthma?

ARO-RAGE is an investigational inhaled therapy being developed for asthma. It is currently in Phase 2 clinical development, with studies evaluating its effect in patients with allergen-induced mild asthma. The drug is designed to target the receptor for advanced glycation end products, or RAGE, which is implicated in inflammatory lung disease.

What does ARO-RAGE target?

ARO-RAGE targets RAGE, the receptor for advanced glycation end products. RAGE is involved in inflammatory signaling pathways relevant to respiratory conditions. By targeting this receptor, ARO-RAGE aims to modulate the inflammatory response associated with asthma and other inflammatory lung diseases.

Who makes ARO-RAGE?

ARO-RAGE is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARWR. Arrowhead is conducting clinical trials of ARO-RAGE as an inhaled therapy for asthma and related inflammatory lung conditions.

What phase is ARO-RAGE in?

ARO-RAGE is in Phase 2 clinical development for asthma. The Phase 2 trial is currently recruiting participants with allergen-induced mild asthma. Two earlier Phase 1 studies have been completed, including one in healthy subjects and another in healthy subjects and patients with inflammatory lung disease.

What clinical trials is ARO-RAGE in?

ARO-RAGE has three clinical trials listed. The active Phase 2 trial, NCT07241546, is recruiting 36 participants with allergen-induced mild asthma in Canada. Two Phase 1 trials are completed: NCT05533294 enrolled 43 healthy subjects in New Zealand, and NCT05276570 enrolled 127 healthy subjects and patients with inflammatory lung disease across Australia, New Zealand, Poland, Spain, and Thailand.

Is ARO-RAGE FDA approved?

ARO-RAGE is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for asthma. The therapy is being studied in clinical trials to evaluate its safety and efficacy, but it has not yet received regulatory approval for any indication.