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ARO-APOC3

Phase 2

Dyslipidemias | Small molecule | Metabolic |Arrowhead Pharmaceuticals, Inc.|Last Updated: May 12, 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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment418
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05413135Study of ARO-APOC3 in Adults With DyslipidemiaPHASE2 COMPLETED 418Jul 7, 2022Sep 22, 2025May 12, 202660 United States, Australia +5
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Study Endpoints
Primary Endpoints
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Through 24 months
Secondary Endpoints
Change from Baseline in Fasting Triglycerides (TG) Over Time
Through 24 months
Percent Change from Baseline in Fasting TG Over Time
Through 24 months
Change from Baseline in Apolipoprotein (Apo) C-III Over Time
Through 24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARO-APOC3EXPERIMENTAL1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months
Interventions
NameTypeDescription
ARO-APOC3DRUGARO-APOC3 Injection
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites60

Inclusion Criteria: * Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study * Able and willing to provide written informed consent * Completed the 48-week study treatment period in the parent study Exclusion Criteria: * Subject was permanently discontinued f...

Countries:United StatesAustraliaCanadaHungaryNetherlandsNew ZealandPoland
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