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

Associated Therapies: -

Clinical Trials

Ranolazine in Ischemic Cardiomyopathy

Phase 4

Completed

Conditions: Cardiomyopathy
Dyspnea
Chest Pain

Interventions: Drug: Placebo
Drug: Ranexa

First Posted Date: 2011-04-29

Last Posted Date: 2024-12-09

Lead Sponsor: Midwest Cardiovascular Research Foundation

Target Recruit Count: 28

Registration Number: NCT01345188

Locations: 🇺🇸
Midwest Cardiovascular Research Foundation, Davenport, Iowa, United States

Treatment With Ranolazine in Microvascular Coronary Dysfunction (MCD): Impact on Angina Myocardial Ischemia

Not Applicable

Completed

Conditions: Microvascular Coronary Dysfunction (MCD)

Interventions: Drug: Placebo
Drug: Ranolazine

First Posted Date: 2011-04-26

Last Posted Date: 2019-04-24

Lead Sponsor: Cedars-Sinai Medical Center

Target Recruit Count: 142

Registration Number: NCT01342029

Locations: 🇺🇸
127 S. San Vicente Blvd, Suite A9303, Los Angeles, California, United States
🇺🇸
University of Florida, Gainesville, Florida, United States

A Study on the Effects of Ranolazine on Exercise Duration in Subjects With Chronic Stable Angina and Coronary Artery Disease (CAD) With Type 2 Diabetes Mellitus (T2DM)

Phase 4

Withdrawn

Conditions: Angina Pectoris
Coronary Artery Disease
Type 2 Diabetes Mellitus

Interventions: Drug: Ranolazine

First Posted Date: 2011-04-13

Last Posted Date: 2012-07-31

Lead Sponsor: Gilead Sciences

Registration Number: NCT01334203

Ranolazine, Ethnicity and the Metabolic Syndrome

Phase 4

Conditions: Coronary Artery Disease
Angina
Metabolic Syndrome

Interventions: Drug: Ranolazine

First Posted Date: 2011-02-25

Last Posted Date: 2013-07-11

Lead Sponsor: Atlanta Heart Specialists, LLC

Target Recruit Count: 160

Registration Number: NCT01304095

Locations: 🇺🇸
Atlanta Heart Specialist, LLC, Cumming, Georgia, United States
🇺🇸
Atlanta Heart Specialists, LLC, Tucker, Georgia, United States

Effect of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging

Phase 4

Completed

Conditions: Myocardial Perfusion Imaging
Myocardial Ischemia

Interventions: Drug: Ranolazine
Drug: Placebo to match ranolazine
Procedure: SPECT MPI
Behavioral: Exercise

First Posted Date: 2010-10-14

Last Posted Date: 2014-09-03

Lead Sponsor: Gilead Sciences

Target Recruit Count: 81

Registration Number: NCT01221272

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States
🇨🇦
Chum Hotel Dieu, Montreal, Quebec, Canada
🇫🇮
Turku University Hospital, Turku, Finland

and more 39 locations

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

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