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

Effects of Ranolazine and Exercise on Daily Physical Activity Trial

Phase 4

Completed

Conditions: Chronic Stable Angina

Interventions: Behavioral: Aerobic Exercise
Drug: Ranolazine
Drug: Placebo

First Posted Date: 2013-09-23

Last Posted Date: 2017-12-12

Lead Sponsor: Duke University

Target Recruit Count: 38

Registration Number: NCT01948310

Locations: 🇺🇸
Duke Center for Living, Durham, North Carolina, United States

The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

Phase 2

Terminated

Conditions: Atrial Fibrillation
Heart Failure

Interventions: Drug: Placebo
Drug: Ranolazine

First Posted Date: 2013-06-26

Last Posted Date: 2015-07-20

Lead Sponsor: Intermountain Health Care, Inc.

Target Recruit Count: 8

Registration Number: NCT01887353

Locations: 🇺🇸
Intermountain Medical Center, Murray, Utah, United States

Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects

Phase 1

Completed

Conditions: Drug-induced Surface ECG Changes

Interventions: Drug: Placebo
Drug: Ranolazine
Drug: Dofetilide
Drug: Verapamil
Drug: Quinidine sulfate

First Posted Date: 2013-06-10

Last Posted Date: 2018-03-08

Lead Sponsor: Food and Drug Administration (FDA)

Target Recruit Count: 22

Registration Number: NCT01873950

A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Ranolazine
Drug: Placebo
Drug: Exenatide

First Posted Date: 2013-04-30

Last Posted Date: 2014-03-31

Lead Sponsor: Gilead Sciences

Target Recruit Count: 24

Registration Number: NCT01843127

Locations: 🇺🇸
Profil Institute for Clinical Research, Inc., Chula Vista, California, United States
🇺🇸
Translational Research Institute-Florida Hospital, Orlando, Florida, United States
🇺🇸
SeaView Research, Inc, Miami, Florida, United States

Targeting the Right Ventricle in Pulmonary Hypertension

Phase 4

Completed

Conditions: Pulmonary Hypertension

Interventions: Drug: Placebo
Drug: Ranolazine

First Posted Date: 2013-04-24

Last Posted Date: 2019-02-05

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 22

Registration Number: NCT01839110

Locations: 🇺🇸
University of Maryland, Baltimore, Maryland, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States