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ION904

Phase 2

Hypertension | Small molecule | Cardiovascular |Ionis Pharmaceuticals, Inc.|Last Updated: Dec 22, 2023

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05314439A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled HypertensionPHASE2 COMPLETED 48Apr 29, 2022Feb 15, 2023Dec 22, 20238 United States
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Study Endpoints
Primary Endpoints
Percent Change from Baseline in Plasma Angiotensinogen (AGT)
Baseline up to approximately 15 weeks
Secondary Endpoints
Change from Baseline in Seated Automated Office Systolic Blood Pressure (SBP)
Baseline up to approximately 15 weeks
Change from Baseline in Seated Automated Office Diastolic Blood Pressure (DBP)
Baseline up to approximately 15 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ION904EXPERIMENTALUp to 4 monthly doses of ION904 will be administered by subcutaneous (SC) injection.
PlaceboPLACEBO_COMPARATORUp to 4 monthly doses of placebo will be administered by SC injection.
Interventions
NameTypeDescription
ION904DRUGION904 will be administered by SC injection.
PlaceboDRUGPlacebo will be administered by SC injection.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

General Inclusion Criteria: 1. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she uses a highly effective contraceptive method. Aged 18 - 75 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent...

Countries:United States
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