MedPath

Ranolazine

Generic Name
Ranolazine
Brand Names
Aspruzyo Sprinkle, Ranexa, Ranexa (previously Latixa)
Drug Type
Small Molecule
Chemical Formula
C24H33N3O4
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

Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)

Phase 3
Completed
Conditions
Coronary Artery Disease
Angina Pectoris
Interventions
Drug: Placebo
First Posted Date
2011-09-28
Last Posted Date
2016-07-15
Lead Sponsor
Gilead Sciences
Target Recruit Count
2651
Registration Number
NCT01442038
Locations
🇺🇸

Tallahassee Research Institute, Tallahassee, Florida, United States

🇺🇸

Union Memorial Hospital, Baltimore, Maryland, United States

🇺🇸

Veterans Administration Medical Center, Pittsburgh, Pennsylvania, United States

and more 205 locations

Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

Phase 4
Completed
Conditions
End-stage Renal Disease
Cardiovascular Disease
Interventions
Procedure: Pharmacokinetic Blood and Dialysate Sampling
Procedure: QT Interval
First Posted Date
2011-09-16
Last Posted Date
2017-10-16
Lead Sponsor
University of Michigan
Target Recruit Count
17
Registration Number
NCT01435174
Locations
🇺🇸

University of Michigan Hospital, Ann Arbor, Michigan, United States

Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina

Phase 4
Completed
Conditions
Angina Pectoris
Type 2 Diabetes Mellitus
Coronary Artery Disease
Interventions
First Posted Date
2011-08-30
Last Posted Date
2014-11-04
Lead Sponsor
Gilead Sciences
Target Recruit Count
949
Registration Number
NCT01425359
Locations
🇷🇺

State Institution of Healthcare Perm Regional Hospital for War Veterans, Perm, Russian Federation

🇺🇸

Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, United States

🇺🇸

Med-Tech Research, Houston, Texas, United States

and more 128 locations

Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Phase 3
Terminated
Conditions
Heart; Dysfunction Postoperative, Cardiac Surgery
Interventions
Drug: Placebo
First Posted Date
2011-05-11
Last Posted Date
2017-01-06
Lead Sponsor
William Beaumont Hospitals
Target Recruit Count
15
Registration Number
NCT01352416
Locations
🇺🇸

William Beaumont Hospital, Troy, Michigan, United States

Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion

Phase 3
Terminated
Conditions
Atrial Fibrillation
Interventions
Drug: Matching placebo
First Posted Date
2011-05-06
Last Posted Date
2017-04-27
Lead Sponsor
University of Oklahoma
Target Recruit Count
10
Registration Number
NCT01349491
Locations
🇺🇸

OU Medical Center, Oklahoma City, Oklahoma, United States

🇺🇸

Oklahoma City VA Medical Center, Oklahoma City, Oklahoma, United States

Ranolazine in Ischemic Cardiomyopathy

Phase 4
Completed
Conditions
Cardiomyopathy
Dyspnea
Chest Pain
Interventions
Drug: Placebo
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
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
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
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
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
© Copyright 2025. All Rights Reserved by MedPath