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ARO-RAGE

Phase 2

Asthma | Small molecule | Respiratory |Arrowhead Pharmaceuticals, Inc.|Trials Updated: Oct 1, 2026

ARO-RAGE development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Mar 2022

ARO-RAGE target and mechanism

Molecular targetRAGE
ModalitySmall molecule

Also known as ARO-RAGE Injection

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

ARO-RAGE clinical trials

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 Sites6

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)

LOWOct 1, 2026NCT07241546lastUpdatePostDate: changed
LOWOct 1, 2026NCT07241546lastUpdatePostDate: changed

Frequently asked questions about ARO-RAGE

What is ARO-RAGE used for?

ARO-RAGE is an investigational medicine being developed for the treatment of asthma, a respiratory condition. It is administered as an inhaled therapy and is currently in Phase 2 clinical development. It has not been approved for commercial use, and its safety and efficacy in asthma are still being evaluated in clinical trials.

What does ARO-RAGE target?

ARO-RAGE targets RAGE, the receptor for advanced glycation end products. By targeting this receptor in the lung, the therapy is designed to reduce RAGE-mediated inflammatory signaling associated with asthma. RAGE is the molecular target named for this inhaled investigational candidate, which is being studied in allergen-induced mild asthma.

Who makes ARO-RAGE?

ARO-RAGE is being developed by Arrowhead Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ARWR. The company is the sponsor of the clinical program evaluating the inhaled candidate in asthma. Arrowhead Pharmaceuticals is responsible for the ongoing Phase 2 study and the completed Phase 1 studies of ARO-RAGE.

What phase is ARO-RAGE in?

ARO-RAGE is in Phase 2 clinical development for asthma. It is an investigational therapy and has not been approved by the FDA or any other regulatory authority. Two earlier Phase 1 studies have been completed, and a Phase 2 study in allergen-induced mild asthma is currently recruiting participants.

What clinical trials is ARO-RAGE in?

ARO-RAGE has been studied in three clinical trials. The recruiting Phase 2 trial is NCT07241546, a study of inhaled ARO-RAGE in allergen-induced mild asthma. Completed Phase 1 trials include NCT05533294 in healthy subjects and NCT05276570 in healthy subjects and patients with inflammatory lung disease. Total enrollment across these trials is 206 participants.

Is ARO-RAGE the same as ARO-RAGE Injection?

ARO-RAGE Injection is another name used for ARO-RAGE, the investigational asthma therapy developed by Arrowhead Pharmaceuticals. Both names refer to the same candidate, which targets RAGE and is being evaluated in Phase 2 clinical development. Searches for either name point to the same drug program.