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ARO-HIF2

Phase 1

Clear Cell Renal Cell Carcinoma | Small molecule | Oncology |Arrowhead Pharmaceuticals, Inc.|Last Updated: Oct 9, 2025

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04169711Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell CarcinomaPHASE1 COMPLETED 26 — — Aug 17, 2020Jul 22, 2022Oct 9, 20255 United States
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Up to 2 years from first dose
Secondary Endpoints
Pharmacokinetics (PK) of ARO-HIF2: Maximum Observed Plasma Concentration (Cmax)
Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Time to Maximum Plasma Concentration (Tmax)
Up to Week 2: predose and up to 48 hours postdose
PK of ARO-HIF2: Area Under the Plasma Concentration Versus Time Curve from Zero to 4 Hours (AUC0-4)
Up to Week 2: predose and up to 48 hours postdose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARO-HIF2EXPERIMENTAL -
Interventions
NameTypeDescription
ARO-HIF2DRUGMultiple doses of ARO-HIF2 by intravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception * Willing to provide written informed consent and to comply with study requirements * Histologically confirmed locally advanced or metastatic c...

Countries:United States
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