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Statins

Phase 3

Intracerebral Hemorrhage | Small molecule | Other |Arrowhead Pharmaceuticals, Inc.|Last Updated: Apr 21, 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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,456
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03936361Statins In Intracerbral HemorrhagePHASE3 RECRUITING 1,456Jun 10, 2020Dec 1, 2029Apr 21, 20261 United States
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Study Endpoints
Primary Endpoints
Recurrent symptomatic ICH
within 24 months
Secondary Endpoints
Major Adverse Cerebro- and Cardio-Vascular Events
Within 24 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
StatinACTIVE_COMPARATORThe same statin agent and dose that subjects were using at the time of ICH onset.
No-statinNO_INTERVENTIONSubjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects.
Interventions
NameTypeDescription
StatinsDRUGStatin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age ≥ 50 years. 2. Spontaneous lobar ICH confirmed by CT or MRI scan 3. Patient was taking a statin drug at the onset of the qualifying/index ICH 4. Randomization can be carried out within 7 days of the onset of the qualifying ICH 5. Patient or legally authorized representati...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT03936361studyFirstPostDate: changed