Ranolazine

Generic Name: Ranolazine

Brand Names: Aspruzyo Sprinkle, Ranexa, Ranexa (previously Latixa)

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₃₃N_₃O_₄

CAS Number: 95635-55-5

Unique Ingredient Identifier: A6IEZ5M406

Background: Chronic angina is a common cardiovascular condition affecting millions worldwide and causes significant disability while interfering with daily activities. Ranolazine is a well-tolerated piperazine derivative used for the management of this condition, offering relief from uncomfortable and debilitating symptoms. With a mechanism of action different from drugs used to treat the same condition, ranolazine is a promising anti-anginal therapy. It was originally approved by the FDA in 2006.

Indication: Ranolazine is indicated for the treatment of chronic angina. It can be used alone or in conjunction with nitrates, beta-blockers, angiotensin receptor blockers, anti-platelet drugs, calcium channel blockers, lipid-lowering drugs, and ACE inhibitors.

Ranolazine has also been used off-label for the treatment of certain arrhythmias, including ventricular tachycardia, however, this use is not strongly supported by scientific evidence. Ranolazine has also been studied for the treatment of acute coronary syndrome, microvascular coronary dysfunction, arrhythmia, and glycemic control, which are not yet approved indications.

Associated Conditions: Chronic Angina, Ventricular Arrhythmia

Clinical Trials

Ranolazine Implantable Cardioverter-Defibrillator Trial

Phase 3

Completed

Conditions: Ischemic Cardiomyopathy
Nonischemic Cardiomyopathy
Heart Failure

Interventions: Drug: Ranolazine

First Posted Date: 2010-10-06

Last Posted Date: 2018-08-27

Lead Sponsor: University of Rochester

Target Recruit Count: 1012

Registration Number: NCT01215253

Locations: 🇺🇸
University of Arizona, Tucson, Arizona, United States
🇺🇸
Hartford Hospital, Hartford, Connecticut, United States
🇺🇸
University of Mississippi Medical Center, Jackson, Mississippi, United States

and more 87 locations

Ranolazine and Pulmonary Hypertension

Phase 3

Completed

Conditions: Pulmonary Arterial Hypertension
Angina

Interventions: Drug: Ranolazine

First Posted Date: 2010-08-03

Last Posted Date: 2018-05-11

Lead Sponsor: Northwestern University

Target Recruit Count: 11

Registration Number: NCT01174173

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

Ranolazine in Diastolic Heart Failure

Phase 2

Completed

Conditions: Diastolic Heart Failure

Interventions: Other: Saline 0.9% and placebo tablet
Drug: Ranolazine

First Posted Date: 2010-07-16

Last Posted Date: 2012-07-12

Lead Sponsor: Gilead Sciences

Target Recruit Count: 20

Registration Number: NCT01163734

Locations: 🇩🇪
University Medicine Goettingen (UMG), Goettingen, Germany

Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Ranolazine

First Posted Date: 2010-07-16

Last Posted Date: 2013-09-23

Lead Sponsor: Gilead Sciences

Target Recruit Count: 80

Registration Number: NCT01163721

Locations: 🇺🇸
National Research Institute (NRI), Los Angeles, California, United States
🇺🇸
Vince and Associates Clinical Research, Overland Park, Kansas, United States
🇺🇸
Cetero Research, San Antonio, Texas, United States

and more 6 locations

Effect of Ranolazine on Arrhythmias and Microvolt T- Wave Alternans (MVTWA) Patients With LV Dysfunction

Phase 3

Completed

Conditions: Sudden Cardiac Death
Ventricular Arrythmias

Interventions: Drug: Placebo
Drug: Ranolazine

First Posted Date: 2009-10-20

Last Posted Date: 2012-02-09

Lead Sponsor: Aspirus Heart and Vascular Institute-Research and Education

Target Recruit Count: 7

Registration Number: NCT00998218

Locations: 🇺🇸
Aspirus Wausau Hospital, Wausau, Wisconsin, United States

Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities

Not Applicable

Terminated

Conditions: Peripheral Arterial Disease

Interventions: Drug: Ranolazine
Drug: Placebo

First Posted Date: 2009-06-04

Last Posted Date: 2017-08-09

Lead Sponsor: William Beaumont Hospitals

Target Recruit Count: 29

Registration Number: NCT00914316

Locations: 🇺🇸
William Beaumont Hospital, Royal Oak, Michigan, United States

Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy

Phase 4

Terminated

Conditions: Coronary Artery Disease
Polyneuropathy
Pain
Peripheral Nervous System Diseases

Interventions: Drug: Ranolazine
Drug: Placebo

First Posted Date: 2009-01-30

Last Posted Date: 2014-06-30

Lead Sponsor: Gilead Sciences

Target Recruit Count: 5

Registration Number: NCT00832572

Locations: 🇺🇸
Cardiovascular Institute of the South Clinical Research Corporation, Houma, Louisiana, United States

Ranolazine Versus Placebo Effects on Exercise Tolerance in Patients With Heart Disease and Peripheral Arterial Disease

Phase 4

Withdrawn

Conditions: Angina
Peripheral Arterial Disease

Interventions: Drug: Placebo
Drug: Ranolazine

First Posted Date: 2008-04-14

Last Posted Date: 2014-08-15

Lead Sponsor: Colorado Prevention Center

Registration Number: NCT00657514

Locations: 🇺🇸
University of Colorado at Denver, Aurora, Colorado, United States
🇺🇸
Denver Health and Hospital Authority (DHHA), Denver, Colorado, United States
🇺🇸
Department of Veteran Affairs Medical Center, Denver, Colorado, United States

An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)

Phase 4

Completed

Conditions: Chronic Angina

First Posted Date: 2008-03-26

Last Posted Date: 2012-07-02

Lead Sponsor: Gilead Sciences

Target Recruit Count: 172

Registration Number: NCT00644332

Locations: 🇺🇸
Total Heart Care, PC, New York, New York, United States
🇺🇸
South Denver Cardiology Associates, PC, Littleton, Colorado, United States
🇺🇸
Jacksonville Center for Clinical Research, Jacksonville, Florida, United States

and more 24 locations

Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Not Applicable

Terminated

Conditions: Echocardiography
Ranolazine
Diastolic Heart Failure
Tissue Doppler Ultrasound

Interventions: Drug: ranolazine

First Posted Date: 2007-12-17

Last Posted Date: 2019-08-02

Lead Sponsor: University of California, San Diego

Target Recruit Count: 14

Registration Number: NCT00574756

Locations: 🇺🇸
UCSD Medical Center, San Diego, California, United States

Drug Development Updates

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