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ION904

Phase 2

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

ION904 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Feb 2021

ION904 target and mechanism

Molecular targetAGT
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

ION904 clinical trials

ION904 · 1 trial · 1 indication

Phase 2 1
NCT05314439A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled HypertensionHypertension
COMPLETED48 Analytics
PHASE2COMPLETED
A Study to Assess the Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of ION904 in Participants With Uncontrolled Hypertension
HypertensionUnlock trial analytics

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 to 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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Frequently asked questions about ION904

What is ION904 used for?

ION904 is an investigational medicine being developed for the treatment of hypertension, or high blood pressure. It is designed for patients whose blood pressure is not adequately controlled. Ionis Pharmaceuticals is studying it as a monthly subcutaneous injection in adults 18 years and older.

What does ION904 target?

ION904 targets angiotensinogen, abbreviated AGT. Angiotensinogen is the precursor protein at the start of the renin-angiotensin system, the hormonal pathway that regulates blood pressure. By targeting AGT, ION904 aims to reduce production of the angiotensin peptides that raise blood pressure.

Who is developing ION904?

ION904 is being developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol IONS. Ionis is the sponsor of the clinical program evaluating the drug in hypertension.

What phase is ION904 in?

ION904 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 study of ION904 in uncontrolled hypertension has been completed, and the program remains in clinical development.

What clinical trials is ION904 in?

ION904 has been evaluated in one clinical trial, NCT05314439, titled a study to assess the safety, tolerability, and efficacy of monthly subcutaneous administration of ION904 in participants with uncontrolled hypertension. That Phase 2 trial enrolled 48 participants in the United States, was randomized, double-blind, and placebo-controlled, and is now completed.

How is ION904 given to patients?

ION904 is administered as a monthly subcutaneous injection. The completed Phase 2 trial, NCT05314439, evaluated monthly subcutaneous dosing of ION904 in participants with uncontrolled hypertension, with 48 adults enrolled in the United States.