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Ivabradine

Phase 4FDA approved

Postural Orthostatic Tachycardia Syndrome | Small molecule | Cardiovascular |Amgen Inc.|Trials Updated: Jun 29, 2021

Ivabradine development status

FDA approval on record Apr 22, 2019 as Corlanor
Approval holderAmgen Inc
ApplicationNDA209964
Highest phase Phase 4 (NCT03456856)
Phase scored for AMGNPhase 3
Registered trials 14 across 9 sponsors since Jul 2016

Label indication 1. INDICATIONS AND USAGE Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. FDA label

Ivabradine target and mechanism

Molecular targetHCN4
Target classBlocker
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Ivabradine clinical trials

Ivabradine · 1 trial · 1 indication

Phase 3 1
NCT03182725Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia SyndromePostural Orthostatic Tachycardia Syndrome
COMPLETED37 Analytics
PHASE3COMPLETED
Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
Postural Orthostatic Tachycardia SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Heart Rate
Baseline and one month post-treatment

Orthostatic heart rate monitoring will be used to gauge heart rate changes.

Secondary Endpoints

Change in Quality of Life Via SF-36 Survey
Baseline and one month post-treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPatient will consume one placebo pill twice a day for one month.
IvabradineEXPERIMENTALPatient will consume one dose of Ivabradine twice a day for one month.

Interventions

NameTypeDescription
IvabradineDRUGIvabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
PlaceboDRUGA substance that has no therapeutic effect and will act as a control.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects aged 18-65. * Subjects must have POTS diagnosis (Hyperadrenergic Subtype with NE\> 600pg/ml)) * Subjects with no structural heart disease * Subject with no arrhythmias * Subjects with norepinephrine levels greater than 600 pg/ml * Subjects with normal CBC, Metabolic, ...

Countries:United States
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Frequently asked questions about Ivabradine

What is Ivabradine used for in Postural Orthostatic Tachycardia Syndrome?

Ivabradine is being studied as a treatment for Postural Orthostatic Tachycardia Syndrome, a condition marked by an abnormally rapid heart rate upon standing. It is an investigational therapy in this indication and has been evaluated in a Phase 3 clinical trial. Ivabradine is developed by Amgen Inc.

What does Ivabradine target?

Ivabradine targets HCN4, a hyperpolarization-activated cyclic nucleotide-gated channel that helps regulate the heart's pacemaker current. By blocking HCN4, ivabradine reduces heart rate without affecting other cardiac functions. This mechanism underlies its investigation for Postural Orthostatic Tachycardia Syndrome.

Who is developing Ivabradine for Postural Orthostatic Tachycardia Syndrome?

Amgen Inc. (ticker: AMGN) is the developer of ivabradine for Postural Orthostatic Tachycardia Syndrome. Amgen is a biopharmaceutical company focused on cardiovascular and other therapeutic areas.

What phase is Ivabradine in for Postural Orthostatic Tachycardia Syndrome?

Ivabradine is in Phase 3 development for Postural Orthostatic Tachycardia Syndrome. It is an investigational small molecule and has not been approved for this indication. The Phase 3 trial has been completed.

What clinical trials is Ivabradine in for Postural Orthostatic Tachycardia Syndrome?

Ivabradine has been studied in a Phase 3 clinical trial for Postural Orthostatic Tachycardia Syndrome: NCT03182725, titled "Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome." The trial was completed, enrolled 37 participants, and was randomized, double-blind, and placebo-controlled.