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ARO-C3

Phase 1

C3 Glomerulopathy | Small molecule | Nephrology |Arrowhead Pharmaceuticals, Inc.|Last Updated: May 22, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

ARO-C3 · 1 trial · 2 indications

Phase 1 1
NCT05083364Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal DiseaseC3 Glomerulopathy
COMPLETED62 Analytics
PHASE1COMPLETED
Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease
C3 GlomerulopathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) at Day 169
up to day 169 (End of Study [EOS])

Secondary Endpoints

Pharmacokinetics (PK) of ARO-C3: Maximum Observed Plasma Concentration (Cmax)
up to 48 hours post-dose
PK of ARO-C3: Area under the Plasma Concentration Versus Time Curve from Zero to 24Hours (AUC0-24)
up to 48 hours post-dose
PK of ARO-C3: Area Under the Plasma Versus Time Concentration Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast)
up to 48 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARO-C3 (Healthy Volunteers)EXPERIMENTAL1 or 2 doses of ARO-C3 by subcutaneous (sc) injection
Placebo (Healthy Volunteers)PLACEBO_COMPARATORplacebo calculated volume to match active treatment by sc injection
ARO-C3 (Adult Patients with C3G or IgAN)EXPERIMENTAL3 doses of ARO-C3 by sc injection

Interventions

NameTypeDescription
ARO-C3DRUGARO-C3 for sc injection
PlaceboDRUGsterile normal saline (0.9% NaCl) for sc injection
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites16

Inclusion Criteria (All Participants): * Willing to provide written informed consent and to comply with study requirements * Female participants must be non-pregnant/non-lactating * Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. C3G and IgAN parti...

Countries:AustraliaGeorgiaGermanyNew ZealandSouth KoreaThailandUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMJun 22, 2026NCT05083364TRIAL_REMOVED: changed
MEDIUMJun 22, 2026NCT05083364TRIAL_REMOVED: changed
MEDIUMJun 22, 2026NCT05083364TRIAL_REMOVED: changed

Frequently asked questions about ARO-C3

What is ARO-C3 used for?

ARO-C3 is an investigational small molecule being developed for C3 Glomerulopathy, a rare kidney disease. It is also being studied in IgA Nephropathy, another complement-mediated renal condition. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ARO-C3?

ARO-C3 is being developed by Arrowhead Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARWR. The company is conducting clinical trials to evaluate the safety and efficacy of ARO-C3 in patients with complement-mediated renal diseases.

What phase is ARO-C3 in?

ARO-C3 is in Phase 1 clinical development. A Phase 1 study has been completed, involving 62 participants, including healthy volunteers and patients with complement-mediated renal disease. The drug is investigational and has not yet received FDA approval.

What clinical trials is ARO-C3 in?

ARO-C3 has been studied in a Phase 1 clinical trial with the identifier NCT05083364. This trial, titled 'Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease,' was completed and enrolled 62 participants across multiple countries including Australia, Georgia, Germany, New Zealand, South Korea, Thailand, and the United Kingdom.

Is ARO-C3 the same as any other drug?

ARO-C3 is the primary name for this investigational drug. No alternative names have been reported for ARO-C3. It is a distinct asset being developed by Arrowhead Pharmaceuticals for the treatment of complement-mediated renal diseases.