Clinical Trials

Numerous Phase I through Phase IV clinical trials evaluate the therapeutic efficacy of ranolazine across diverse indications. These studies assess cardiovascular conditions—including chronic stable angina, acute myocardial ischemia, atrial fibrillation, and pulmonary hypertension—alongside non-cardiovascular disorders such as diabetic peripheral neuropathic pain, metabolic syndrome, and prostate cancer. Sponsored by pharmaceutical entities like Gilead Sciences, academic institutions, and hospital research foundations, the trials encompass various recruitment statuses, including completed, recruiting, terminated, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06527222 RECRUITING
Amyotrophic Lateral Sclerosis
Swathy Chandrashekhar, MBBS
 2025-04-29 PHASE2
NCT06527222 RECRUITING
Amyotrophic Lateral Sclerosis
Swathy Chandrashekhar, MBBS
 2025-04-29 PHASE2
NCT06570473 RECRUITING
Pulmonary Hypertension; Right Ventricular Dysfunction; Right Heart Failure
University of Alberta
 2025-07-15 PHASE2
NCT06570473 RECRUITING
Pulmonary Hypertension; Right Ventricular Dysfunction; Right Heart Failure
University of Alberta
 2025-07-15 PHASE2
NCT07380919 RECRUITING
STEMI (ST Elevation MI)
Federico II University
 2026-02 PHASE2; PHASE3
NCT07380919 RECRUITING
STEMI (ST Elevation MI)
Federico II University
 2026-02 PHASE2; PHASE3
NCT04456517 TERMINATED
Crohn's Disease; Inflammatory Bowel Disease
Vanderbilt University Medical Center
 2022-10-18 PHASE2
NCT04456517 TERMINATED
Crohn's Disease; Inflammatory Bowel Disease
Vanderbilt University Medical Center
 2022-10-18 PHASE2
NCT03472950 COMPLETED
ALS
University of Kansas Medical Center
 2018-06-11 PHASE2
NCT03472950 COMPLETED
ALS
University of Kansas Medical Center
 2018-06-11 PHASE2
NCT07054255 COMPLETED
Healthy
Haisco Pharmaceutical Group Co., Ltd.
 2020-09-06 PHASE1
NCT07054255 COMPLETED
Healthy
Haisco Pharmaceutical Group Co., Ltd.
 2020-09-06 PHASE1
NCT02687269 WITHDRAWN
Myocardial Stunning
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2019-04-10 PHASE4
NCT02687269 WITHDRAWN
Myocardial Stunning
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2019-04-10 PHASE4
NCT03953989 COMPLETED
HCM - Hypertrophic Non-Obstructive Cardiomyopathy
IRCCS San Raffaele
 2016-10 PHASE2
NCT03953989 COMPLETED
HCM - Hypertrophic Non-Obstructive Cardiomyopathy
IRCCS San Raffaele
 2016-10 PHASE2
NCT03401502 COMPLETED
Angina
TSH Biopharm Corporation Limited
 2018-06-07
NCT03401502 COMPLETED
Angina
TSH Biopharm Corporation Limited
 2018-06-07
NCT02252406 COMPLETED
Stable Angina; Metabolic Syndrome
University of Florida
 2015-09 PHASE4
NCT02252406 COMPLETED
Stable Angina; Metabolic Syndrome
University of Florida
 2015-09 PHASE4
NCT03162120 WITHDRAWN
Atrial Fibrillation; Recurrence
Elpen Pharmaceutical Co. Inc.
 2018-09-01 PHASE2; PHASE3
NCT03162120 WITHDRAWN
Atrial Fibrillation; Recurrence
Elpen Pharmaceutical Co. Inc.
 2018-09-01 PHASE2; PHASE3
NCT02611596 WITHDRAWN
Silent Myocardial Ischemia; Type 2 Diabetes
Walter Reed National Military Medical Center
 2016-11
NCT02611596 WITHDRAWN
Silent Myocardial Ischemia; Type 2 Diabetes
Walter Reed National Military Medical Center
 2016-11
NCT03486561 UNKNOWN
Chronic Stable Angina
OBS Pakistan
 2018-04-01 PHASE4
NCT03486561 UNKNOWN
Chronic Stable Angina
OBS Pakistan
 2018-04-01 PHASE4
NCT01648205 COMPLETED
Long QT Syndrome
University of Rochester
 2012-09 PHASE2
NCT01648205 COMPLETED
Long QT Syndrome
University of Rochester
 2012-09 PHASE2
NCT03486561 Unknown status
Chronic Stable Angina
OBS Pakistan
 2018-04-01 Phase 4
NCT02147067 COMPLETED
Microvascular Angina
Emory University
 2014-09 PHASE2
NCT02147067 COMPLETED
Microvascular Angina
Emory University
 2014-09 PHASE2
NCT01839110 COMPLETED
Pulmonary Hypertension
University of Pennsylvania
 2013-07 PHASE4
NCT01839110 COMPLETED
Pulmonary Hypertension
University of Pennsylvania
 2013-07 PHASE4
NCT02360397 COMPLETED
Ventricular Premature Complexes; Myocardial Ischemia
Kent Hospital, Rhode Island
 2014-12 PHASE2
NCT02360397 COMPLETED
Ventricular Premature Complexes; Myocardial Ischemia
Kent Hospital, Rhode Island
 2014-12 PHASE2
NCT02251457 COMPLETED
Myotonia Congenita; Paramyotonia Congenita; Myotonic Dystrophy 1
Ohio State University
 2014-08 PHASE1
NCT02251457 COMPLETED
Myotonia Congenita; Paramyotonia Congenita; Myotonic Dystrophy 1
Ohio State University
 2014-08 PHASE1
NCT02829034 COMPLETED
Pulmonary Hypertension
University of Pennsylvania
 2016-07 PHASE4
NCT02829034 COMPLETED
Pulmonary Hypertension
University of Pennsylvania
 2016-07 PHASE4
NCT01728025 UNKNOWN
Long QT Syndrome Type 3
Tel-Aviv Sourasky Medical Center
 2012-10 PHASE2
NCT01728025 UNKNOWN
Long QT Syndrome Type 3
Tel-Aviv Sourasky Medical Center
 2012-10 PHASE2
NCT03044964 UNKNOWN
Angina
Amit Malhotra, MD
 2017-01-10 PHASE4
NCT03044964 UNKNOWN
Angina
Amit Malhotra, MD
 2017-01-10 PHASE4
NCT03070470 COMPLETED
Drug-induced QT Prolongation; Pharmacokinetics; Pharmacodynamics
Food and Drug Administration (FDA)
 2017-03-14 PHASE1
NCT03070470 COMPLETED
Drug-induced QT Prolongation; Pharmacokinetics; Pharmacodynamics
Food and Drug Administration (FDA)
 2017-03-14 PHASE1
NCT01705509 TERMINATED
Cardiomyopathy
Cardiovascular Institute of the South Clinical Research Corporation
 2012-09
NCT01705509 TERMINATED
Cardiomyopathy
Cardiovascular Institute of the South Clinical Research Corporation
 2012-09
NCT01215253 COMPLETED
Ischemic Cardiomyopathy; Nonischemic Cardiomyopathy; Heart Failure
University of Rochester
 2011-09 PHASE3
NCT01215253 COMPLETED
Ischemic Cardiomyopathy; Nonischemic Cardiomyopathy; Heart Failure
University of Rochester
 2011-09 PHASE3
NCT02156336 TERMINATED
Diabetic Peripheral Neuropathic Pain
Horizons International Peripheral Group
 2014-05 PHASE4
NCT02156336 TERMINATED
Diabetic Peripheral Neuropathic Pain
Horizons International Peripheral Group
 2014-05 PHASE4
NCT03044964 Unknown status
Angina
Amit Malhotra MD|Gilead Sciences|Stern Cardiovascular Foundation Inc.
 2017-01-10 Phase 4
NCT02423265 WITHDRAWN
Myocardial Ischemia; Coronary Artery Disease; Arteriosclerosis; Chronic Stable Angina
East Carolina University
 2015-06 PHASE4
NCT01810796 UNKNOWN
Coronary Artery Disease,
Hadassah Medical Organization
 2013-12 PHASE3
NCT01342029 COMPLETED
Microvascular Coronary Dysfunction (MCD)
Cedars-Sinai Medical Center
 2011-05
NCT02423265 WITHDRAWN
Myocardial Ischemia; Coronary Artery Disease; Arteriosclerosis; Chronic Stable Angina
East Carolina University
 2015-06 PHASE4
NCT01810796 UNKNOWN
Coronary Artery Disease,
Hadassah Medical Organization
 2013-12 PHASE3
NCT01342029 COMPLETED
Microvascular Coronary Dysfunction (MCD)
Cedars-Sinai Medical Center
 2011-05
NCT01948310 COMPLETED
Chronic Stable Angina
Duke University
 2013-12 PHASE4
NCT01948310 COMPLETED
Chronic Stable Angina
Duke University
 2013-12 PHASE4
NCT01992016 COMPLETED
Adenocarcinoma of the Prostate; Bone Metastases; Soft Tissue Metastases; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer
University of Colorado, Denver
 2014-04-07
NCT01992016 COMPLETED
Adenocarcinoma of the Prostate; Bone Metastases; Soft Tissue Metastases; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer
University of Colorado, Denver
 2014-04-07
NCT02817932 UNKNOWN
Healthy Male Individuals
A.Menarini Asia-Pacific Holdings Pte Ltd
 2016-03 PHASE1
NCT02817932 UNKNOWN
Healthy Male Individuals
A.Menarini Asia-Pacific Holdings Pte Ltd
 2016-03 PHASE1
NCT01996618 UNKNOWN
Premature Ventricular Beats
Walter Reed National Military Medical Center
 2014-01 PHASE4
NCT01996618 UNKNOWN
Premature Ventricular Beats
Walter Reed National Military Medical Center
 2014-01 PHASE4
NCT02265796 COMPLETED
Angina
North Florida Foundation for Research and Education
 2014-09 PHASE2
NCT02265796 COMPLETED
Angina
North Florida Foundation for Research and Education
 2014-09 PHASE2
NCT02147834 TERMINATED
Angina
North Florida Foundation for Research and Education
 2015-08 PHASE2
NCT02147834 TERMINATED
Angina
North Florida Foundation for Research and Education
 2015-08 PHASE2
NCT02133911 COMPLETED
Dilated Cardiomyopathy
University Medical Centre Ljubljana
 2014-05-01 PHASE2
NCT02133911 COMPLETED
Dilated Cardiomyopathy
University Medical Centre Ljubljana
 2014-05-01 PHASE2
NCT01491061 UNKNOWN
Coronary Artery Disease
University of Roma La Sapienza
 2014-01 PHASE4
NCT01491061 UNKNOWN
Coronary Artery Disease
University of Roma La Sapienza
 2014-01 PHASE4
NCT01721967 COMPLETED
Hypertrophic Cardiomyopathy
Duke University
 2012-11 PHASE4
NCT02052011 COMPLETED
Microvascular Angina
Yale University
 2014-04 PHASE4
NCT01721967 COMPLETED
Hypertrophic Cardiomyopathy
Duke University
 2012-11 PHASE4
NCT02052011 COMPLETED
Microvascular Angina
Yale University
 2014-04 PHASE4
NCT01754259 COMPLETED
Diabetes, Type I; Diabetes, Type II; Angina; Coronary Artery Disease
Brigham and Women's Hospital
 2013-04 PHASE3
NCT01754259 COMPLETED
Diabetes, Type I; Diabetes, Type II; Angina; Coronary Artery Disease
Brigham and Women's Hospital
 2013-04 PHASE3
NCT02239926 TERMINATED
Diarrhea Predominant Irritable Bowel Syndrome
Mayo Clinic
 2014-09 PHASE2; PHASE3
NCT02252406 Completed
Stable Angina|Metabolic Syndrome
University of Florida
 2015-09 Phase 4
NCT02239926 TERMINATED
Diarrhea Predominant Irritable Bowel Syndrome
Mayo Clinic
 2014-09 PHASE2; PHASE3
NCT01590979 TERMINATED
Atrial Fibrillation New Onset; Hemorrhage; Prolonged QTc Interval; Ventricular Tachycardia; Medical Care; Complications, Late Effect of Complications
Northwell Health
 2012-04
NCT01797484 COMPLETED
Coronary Artery Disease; Acute Myocardial Ischemia
Universitätsklinikum Hamburg-Eppendorf
 2013-08 PHASE2; PHASE3
NCT01590979 TERMINATED
Atrial Fibrillation New Onset; Hemorrhage; Prolonged QTc Interval; Ventricular Tachycardia; Medical Care; Complications, Late Effect of Complications
Northwell Health
 2012-04
NCT01797484 COMPLETED
Coronary Artery Disease; Acute Myocardial Ischemia
Universitätsklinikum Hamburg-Eppendorf
 2013-08 PHASE2; PHASE3
NCT01442038 COMPLETED
Coronary Artery Disease; Angina Pectoris
Gilead Sciences
 2011-10 PHASE3
NCT01442038 COMPLETED
Coronary Artery Disease; Angina Pectoris
Gilead Sciences
 2011-10 PHASE3
NCT01757808 COMPLETED
Pulmonary Arterial Hypertension
University of Chicago
 2011-08 PHASE1
NCT01757808 COMPLETED
Pulmonary Arterial Hypertension
University of Chicago
 2011-08 PHASE1
NCT01495520 UNKNOWN
Ischemic Heart Disease
University of Roma La Sapienza
 2014-01 PHASE4
NCT01495520 UNKNOWN
Ischemic Heart Disease
University of Roma La Sapienza
 2014-01 PHASE4
NCT01505179 COMPLETED
Heart Failure With Preserved Ejection Fraction
University of California, San Diego
 2011-02
NCT01505179 COMPLETED
Heart Failure With Preserved Ejection Fraction
University of California, San Diego
 2011-02
NCT02360397 Completed
Ventricular Premature Complexes|Myocardial Ischemia
Kent Hospital Rhode Island|Gilead Sciences
 2014-12 Phase 2
NCT01490255 UNKNOWN
Coronary Artery Disease
University of Roma La Sapienza
 2012-01 PHASE4
NCT01490255 UNKNOWN
Coronary Artery Disease
University of Roma La Sapienza
 2012-01 PHASE4
NCT01349491 TERMINATED
Atrial Fibrillation
University of Oklahoma
 2012-03 PHASE3
NCT01349491 TERMINATED
Atrial Fibrillation
University of Oklahoma
 2012-03 PHASE3
NCT01979965 UNKNOWN
Ischemic Mitral Regurgitation
University Cardiology
 2013-11 PHASE4
NCT01979965 UNKNOWN
Ischemic Mitral Regurgitation
University Cardiology
 2013-11 PHASE4
NCT02156336 Terminated
Diabetic Peripheral Neuropathic Pain
Horizons International Peripheral Group|Gilead Sciences
 2014-05 Phase 4
NCT01345188 COMPLETED
Cardiomyopathy; Chest Pain; Dyspnea
Midwest Cardiovascular Research Foundation
 2011-04 PHASE4
NCT01767987 TERMINATED
Acute Coronary Syndrome
Harvey Hahn
 2012-11 PHASE2
NCT01345188 COMPLETED
Cardiomyopathy; Chest Pain; Dyspnea
Midwest Cardiovascular Research Foundation
 2011-04 PHASE4
NCT01767987 TERMINATED
Acute Coronary Syndrome
Harvey Hahn
 2012-11 PHASE2
NCT01522651 COMPLETED
Atrial Fibrillation
Gilead Sciences
 2012-01-24 PHASE2
NCT01522651 COMPLETED
Atrial Fibrillation
Gilead Sciences
 2012-01-24 PHASE2
NCT01887353 TERMINATED
Atrial Fibrillation; Heart Failure
Intermountain Health Care, Inc.
 2013-06 PHASE2
NCT01887353 TERMINATED
Atrial Fibrillation; Heart Failure
Intermountain Health Care, Inc.
 2013-06 PHASE2
NCT01562041 TERMINATED
Atherosclerotic Coronary Vascular Disease
Novartis Pharmaceuticals
 2012-03-09 PHASE2
NCT01562041 TERMINATED
Atherosclerotic Coronary Vascular Disease
Novartis Pharmaceuticals
 2012-03-09 PHASE2
NCT01174173 COMPLETED
Angina; Pulmonary Arterial Hypertension
Northwestern University
 2010-06 PHASE3
NCT01174173 COMPLETED
Angina; Pulmonary Arterial Hypertension
Northwestern University
 2010-06 PHASE3
NCT01472185 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2011-11 PHASE3
NCT01472185 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2011-11 PHASE3
NCT01534962 COMPLETED
Persistent Atrial Fibrillation
Menarini Group
 2012-01 PHASE2
NCT01534962 COMPLETED
Persistent Atrial Fibrillation
Menarini Group
 2012-01 PHASE2
NCT01843127 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2013-04 PHASE1
NCT01555164 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2012-06 PHASE3
NCT01843127 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2013-04 PHASE1
NCT01555164 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2012-06 PHASE3
NCT01494987 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2012-01 PHASE3
NCT01494987 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2012-01 PHASE3
NCT01304095 UNKNOWN
Coronary Artery Disease; Angina; Metabolic Syndrome
Atlanta Heart Specialists, LLC
 2011-01 PHASE4
NCT01304095 UNKNOWN
Coronary Artery Disease; Angina; Metabolic Syndrome
Atlanta Heart Specialists, LLC
 2011-01 PHASE4
NCT01873950 COMPLETED
Drug-induced Surface ECG Changes
Food and Drug Administration (FDA)
 2013-05 PHASE1
NCT01873950 COMPLETED
Drug-induced Surface ECG Changes
Food and Drug Administration (FDA)
 2013-05 PHASE1
NCT02133352 COMPLETED
Pulmonary Hypertension; Diastolic Left Ventricular Dysfunction
Boston University
 2011-07 PHASE4
NCT02133352 COMPLETED
Pulmonary Hypertension; Diastolic Left Ventricular Dysfunction
Boston University
 2011-07 PHASE4
NCT01558830 UNKNOWN
Chronic Stable Angina; Coronary Artery Disease; Atrial Fibrillation; Ventricular Tachycardia
Cardiovascular Consultants of Nevada
 2012-01 PHASE4
NCT01558830 UNKNOWN
Chronic Stable Angina; Coronary Artery Disease; Atrial Fibrillation; Ventricular Tachycardia
Cardiovascular Consultants of Nevada
 2012-01 PHASE4
NCT00914316 TERMINATED
Peripheral Arterial Disease
Corewell Health East
 2009-05
NCT01435174 COMPLETED
End-stage Renal Disease; Cardiovascular Disease
University of Michigan
 2011-10 PHASE4
NCT00914316 TERMINATED
Peripheral Arterial Disease
Corewell Health East
 2009-05
NCT01435174 COMPLETED
End-stage Renal Disease; Cardiovascular Disease
University of Michigan
 2011-10 PHASE4
NCT01480336 COMPLETED
Arrhythmia
Hartford Hospital
 2011-02
NCT01480336 COMPLETED
Arrhythmia
Hartford Hospital
 2011-02
NCT01352416 TERMINATED
Heart; Dysfunction Postoperative, Cardiac Surgery
Corewell Health East
 2010-09 PHASE3
NCT01352416 TERMINATED
Heart; Dysfunction Postoperative, Cardiac Surgery
Corewell Health East
 2010-09 PHASE3
NCT01425359 COMPLETED
Angina Pectoris; Coronary Artery Disease; Type 2 Diabetes Mellitus
Gilead Sciences
 2011-09 PHASE4
NCT01334203 WITHDRAWN
Angina Pectoris; Coronary Artery Disease; Type 2 Diabetes Mellitus
Gilead Sciences
 2011-05 PHASE4
NCT01425359 COMPLETED
Angina Pectoris; Coronary Artery Disease; Type 2 Diabetes Mellitus
Gilead Sciences
 2011-09 PHASE4
NCT01334203 WITHDRAWN
Angina Pectoris; Coronary Artery Disease; Type 2 Diabetes Mellitus
Gilead Sciences
 2011-05 PHASE4
NCT01221272 COMPLETED
Myocardial Perfusion Imaging; Myocardial Ischemia
Gilead Sciences
 2010-09 PHASE4
NCT01221272 COMPLETED
Myocardial Perfusion Imaging; Myocardial Ischemia
Gilead Sciences
 2010-09 PHASE4
NCT01675973 TERMINATED
Severe Renal Impairment
Gilead Sciences
 2012-07 PHASE1
NCT01675973 TERMINATED
Severe Renal Impairment
Gilead Sciences
 2012-07 PHASE1
NCT01546558 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2012-02 PHASE1
NCT01546597 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2012-02 PHASE1
NCT01546558 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2012-02 PHASE1
NCT01546597 COMPLETED
Type 2 Diabetes Mellitus
Gilead Sciences
 2012-02 PHASE1
NCT01163734 COMPLETED
Diastolic Heart Failure
Gilead Sciences
 2010-04 PHASE2
NCT01163734 COMPLETED
Diastolic Heart Failure
Gilead Sciences
 2010-04 PHASE2
NCT00644332 COMPLETED
Chronic Angina
Gilead Sciences
 2007-11 PHASE4
NCT00644332 COMPLETED
Chronic Angina
Gilead Sciences
 2007-11 PHASE4
NCT00998218 COMPLETED
Sudden Cardiac Death; Ventricular Arrythmias
Aspirus Heart and Vascular Institute-Research and Education
 2009-09 PHASE3
NCT00998218 COMPLETED
Sudden Cardiac Death; Ventricular Arrythmias
Aspirus Heart and Vascular Institute-Research and Education
 2009-09 PHASE3
NCT01163721 COMPLETED
Diabetes Mellitus, Type 2
Gilead Sciences
 2010-06 PHASE2
NCT01163721 COMPLETED
Diabetes Mellitus, Type 2
Gilead Sciences
 2010-06 PHASE2
NCT00574756 TERMINATED
Ranolazine; Diastolic Heart Failure; Tissue Doppler Ultrasound; Echocardiography
University of California, San Diego
 2007-12
NCT00574756 TERMINATED
Ranolazine; Diastolic Heart Failure; Tissue Doppler Ultrasound; Echocardiography
University of California, San Diego
 2007-12
NCT00570089 COMPLETED
Myocardial Ischemia
Cedars-Sinai Medical Center
 2007-04 PHASE2
NCT00570089 COMPLETED
Myocardial Ischemia
Cedars-Sinai Medical Center
 2007-04 PHASE2
NCT00657514 WITHDRAWN
Peripheral Arterial Disease; Angina
Colorado Prevention Center
 2008-05 PHASE4
NCT00832572 TERMINATED
Coronary Artery Disease; Pain; Peripheral Nervous System Diseases; Polyneuropathy
Gilead Sciences
 2009-01 PHASE4
NCT00657514 WITHDRAWN
Peripheral Arterial Disease; Angina
Colorado Prevention Center
 2008-05 PHASE4
NCT00832572 TERMINATED
Coronary Artery Disease; Pain; Peripheral Nervous System Diseases; Polyneuropathy
Gilead Sciences
 2009-01 PHASE4
NCT00099788 COMPLETED
Myocardial Ischemia
Gilead Sciences
 2004-10 PHASE3
NCT00099788 COMPLETED
Myocardial Ischemia
Gilead Sciences
 2004-10 PHASE3
NCT00091429 COMPLETED
Angina
Gilead Sciences
 2004-08 PHASE3
NCT00091429 COMPLETED
Angina
Gilead Sciences
 2004-08 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-08)

Check the Ranolazine 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ranolazine selectively inhibits the late inward sodium current, thereby suppressing intracellular sodium accumulation and preventing subsequent sodium-dependent intracellular calcium overload in ischemic cardiomyocytes. By reducing ionic imbalance and cardiac wall tension, this mechanism improves myocardial relaxation and oxygen balance, directly mitigating symptoms in patients evaluated for chronic stable angina and myocardial ischemia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.