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ION904

Phase 2

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

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

Clinical trial landscape

ION904 · 2 trials · 2 indications

Phase 2 1Phase 1 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
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Up to Day 85
Severity and dose relationship of TEAE
Up to Day 85
Severity and dose relationship of clinically significant changes in laboratory values
Up to Day 85
Severity and dose relationship of clinically significant changes in ECG
Up to Day 85

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
Changes in the Level of ION904 Target Biomarker
Up to Day 85
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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 StatesCanada
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Frequently asked questions about ION904

What is ION904 used for?

ION904 is an investigational small molecule being developed by Ionis Pharmaceuticals for the treatment of hypertension. It has been studied in healthy volunteers and in participants with uncontrolled hypertension. The drug is administered via subcutaneous injection on a monthly basis.

Who makes ION904?

ION904 is developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety, tolerability, and efficacy of this investigational drug.

What phase is ION904 in?

ION904 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 study assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers. The Phase 2 study evaluated safety, tolerability, and efficacy in participants with uncontrolled hypertension. The drug is not FDA approved and remains investigational.

What clinical trials is ION904 in?

ION904 has been studied in two completed clinical trials. NCT04731623 was a Phase 1 study in healthy volunteers in Canada. NCT05314439 was a Phase 2 study in participants with uncontrolled hypertension in the United States. Both trials were randomized, double-blind, and placebo-controlled.

How is ION904 administered?

ION904 is administered via subcutaneous injection. In the Phase 2 clinical trial, the drug was given on a monthly basis to participants with uncontrolled hypertension. The Phase 1 study in healthy volunteers also evaluated subcutaneous administration of the drug.