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ARO-ATXN2

Phase 1

Spinocerebellar Ataxia Type 2 | Small molecule | Neurology |Arrowhead Pharmaceuticals, Inc.|Last Updated: Jun 29, 2026

Target and mechanism

ModalitySmall molecule

Also known as ARO-ATXN2 Injection

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

ARO-ATXN2 · 1 trial · 1 indication

Phase 1 1
NCT06672445Study of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2Spinocerebellar Ataxia Type 2
ACTIVE NOT_RECRUITING39 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2
Spinocerebellar Ataxia Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Treatment -Emergent Adverse Events (TEAEs) Over Time
Through End of Study (EOS), Day 253

Secondary Endpoints

Pharmacokinetics (PK) of ARO-ATXN2: Maximum Observed Plasma Concentration (Cmax)
Through 24 hours post-dose
PK of ARO-ATXN2: Time to Maximum Observed Plasma Concentration (Tmax)
Through 24 hours post-dose
PK of ARO-ATXN2: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Through 24 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARO-ATXN2EXPERIMENTALARO-ATXN2 Injection
PlaceboPLACEBO_COMPARATOR(0.9% NaCl)

Interventions

NameTypeDescription
ARO-ATXN2 InjectionDRUGsingle dose of ARO-ATXN2 by intrathecal (IT) administration
PlaceboDRUGcalculated volume to match active treatment by IT administration
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Non-pregnant, non-lactating * Diagnosis of symptomatic SCA2 and ≥33 CAG repeats in the ATXN2 gene based on source verifiable medical records or genetic testing at Screening * Scale of Assessment and Rating of Ataxia (SARA) score ≤14 * Subjects of childbearing potential must ag...

Countries:AustraliaCanadaFranceGermanyItalyNew ZealandSpainTaiwan
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Recent Changes (Last 90 Days)

MEDIUMJun 29, 2026NCT06672445Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 29, 2026NCT06672445Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about ARO-ATXN2

What is ARO-ATXN2 used for?

ARO-ATXN2 is an investigational small molecule being developed for the treatment of Spinocerebellar Ataxia Type 2, a rare inherited neurological disorder. It is administered by injection and is currently in Phase 1 clinical development. The drug is not yet approved by regulatory authorities.

Who makes ARO-ATXN2?

ARO-ATXN2 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARWR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Spinocerebellar Ataxia Type 2.

What phase is ARO-ATXN2 in?

ARO-ATXN2 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is active but not recruiting participants, indicating that enrollment has been completed.

What clinical trials is ARO-ATXN2 in?

ARO-ATXN2 is being studied in a Phase 1 clinical trial with the identifier NCT06672445. This randomized, double-blind, placebo-controlled study enrolls approximately 39 adults with Spinocerebellar Ataxia Type 2. The trial is active but not recruiting and is being conducted in multiple countries including Australia, Canada, France, Germany, Italy, New Zealand, Spain, and Taiwan.

Is ARO-ATXN2 the same as ARO-ATXN2 Injection?

Yes, ARO-ATXN2 is also known as ARO-ATXN2 Injection. The drug is administered via injection, and this alternative name reflects its route of administration. Both names refer to the same investigational drug being developed by Arrowhead Pharmaceuticals for Spinocerebellar Ataxia Type 2.