Ranexa

(Ranolazine)

ApprovedSmall molecule

MMenarini International Operations Luxembourg SA

Ranolazine is used to treat chronic angina (chest pain) in patients with heart disease, typically when other medications haven't provided enough relief or can't be used.[2] Ranexa is currently approved and in use across 22 indications[4].[1]

Ranexa is one of 478 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

477

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseTerminated

Metabolic SyndromeCompleted

Ischemic CardiomyopathyActive, not recruiting

Neuropathic PainActive, not recruiting

Ventricular EctopyApproved

CardiomyopathyApproved

Long QT Syndrome 3Approved

Angina PectorisActive, not recruiting

Type 2 Diabetes MellitusWithdrawn

Kidney DiseaseApproved

Coronary Artery DiseaseApproved

Terminated

Metabolic SyndromeApproved

Completed

Ischemic CardiomyopathyPreclinical

Active, not recruiting

Neuropathic PainApproved

Active, not recruiting

Ventricular EctopyApproved

Approved

CardiomyopathyApproved

Approved

Long QT Syndrome 3Approved

Approved

Angina PectorisApproved

Active, not recruiting

Type 2 Diabetes MellitusApproved

Withdrawn

Kidney DiseaseApproved

Approved

Showing 10 of 21 indications

Competition

Competitive Landscape

312 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Lupron

EEastern Cooperative Oncology Group

Phase 3

53 2

Ranexa

MMenarini International Operations Luxembourg SA

Approved

1 3

Androgen Deprivation Therapy

Johnson & Johnson

Phase 3

48 4

Orgovyx

Sumitomo Pharma America, Inc.

Phase 3

12 5

Acetylsalicylic Acid

Bayer

Phase 3

2 6

Fluciclovine

UUniversity of Utah

Phase 3

3 7

Piflufolastat F 18

Novartis

Phase 3

1 8

Rhpsma-7.3 (18f)

BBlue Earth Diagnostics

Phase 3

4 9

Trexall

Jazz Pharmaceuticals

Preclinical

—10

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Pulmonary Hypertension

NCT06570473

Clinical

Trials by Indication[1]

Pulmonary Hypertension5 trials

Targeting the Right Ventricle in Pulmonary Hypertension

Completed·UUniversity of Pennsylvania·Phase 4·NCT01839110·22 enrolled

Targeting Right Ventricle in Pulmonary Hypertension Gilead

Completed·UUniversity of Pennsylvania·Phase 4·NCT02829034·22 enrolled

Ranolazine and Pulmonary Hypertension

Completed·NNorthwestern University·Phase 3·NCT01174173·11 enrolled

Show 2 more trials

Study of Ranolazine in the Treatment of Pulmonary Hypertension Associated With Diastolic Left Ventricular Dysfunction

Completed·—·Phase 4·NCT02133352·10 enrolled

Feasibility Trial for the Canadian Right Ventricular AdaptiVE (CRAVE) Platform for Therapies Targeting Right Ventricular Failure

Recruiting·UUniversity of Alberta·Phase 2·NCT06570473·30 enrolled

Atrial Fibrillation4 trials

Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

Terminated·CCorewell Health East·Phase 3·NCT01352416·15 enrolled

Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion

Terminated·UUniversity of Oklahoma·Phase 3·NCT01349491·10 enrolled

Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion

Completed· Menarini logo

Menarini·Phase 2·NCT01534962·241 enrolled

Show 1 more trial

Randomized Double Blind Control Trial on Effects of Ranolazine on New Onset Atrial Fibrillation

Terminated·NNorthwell Health·N/A·NCT01590979·54 enrolled

Type 2 Diabetes Mellitus4 trials

Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

Completed· Gilead logo

Gilead·Phase 3·NCT01472185·465 enrolled

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)

Withdrawn· Gilead logo

Gilead·Phase 4·NCT01334203

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

Completed· Gilead logo

Gilead·Phase 2·NCT01163721·80 enrolled

Show 1 more trial

Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus

Completed· Gilead logo

Gilead·Phase 3·NCT01494987·431 enrolled

Type 2 Diabetes3 trials

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

Completed· Gilead logo

Gilead·Phase 4·NCT01425359·949 enrolled

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

Completed· Gilead logo

Gilead·Phase 1·NCT01843127·24 enrolled

A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone

Completed· Gilead logo

Gilead·Phase 3·NCT01555164·442 enrolled

Myocardial Ischemia3 trials

Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia

Completed·UUniversitätsklinikum Hamburg-Eppendorf·Phase 2/3·NCT01797484·20 enrolled

Impact of Ranolazine on Myocardial Ischemia Detected by High-Field 3T Cardiovascular Magnetic Resonance (CMR) Imaging and P-31 Spectroscopy

Unknown status·WWestside Medical Associates of Los Angeles··NCT01804543·30 enrolled

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

Completed·—·N/A·NCT01342029·142 enrolled

51 more indications

Injury2 trials

Ranolazine Loading to Prevent PCI-induced Myocardial Injury

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT01491061·100 enrolled

Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial

Unknown status·HHadassah Medical Organization·Phase 3·NCT01810796·300 enrolled

Metformin2 trials

Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine

Completed· Gilead logo

Gilead·Phase 1·NCT01546597·24 enrolled

Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg

Completed· Gilead logo

Gilead·Phase 1·NCT01546558·25 enrolled

Metabolic Syndrome2 trials

Ranolazine, Ethnicity and the Metabolic Syndrome

Unknown status·AAtlanta Heart Specialists, LLC·Phase 4·NCT01304095·160 enrolled

Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome

Completed·UUniversity of Florida·Phase 4·NCT02252406·33 enrolled

CAR2 trials

Ranolazine Cardioprotection in PCI

Terminated·HHarvey Hahn·Phase 2·NCT01767987·6 enrolled

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

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT01873950·22 enrolled

Chest pain2 trials

Ranolazine for the Treatment of Chest Pain in HCM Patients

Completed·—·Phase 4·NCT01721967·14 enrolled

Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents

Terminated·NNorth Florida Foundation for Research and Education·Phase 2·NCT02147834·5 enrolled

Diastolic Heart Failure2 trials

Ranolazine in Diastolic Heart Failure

Completed· Gilead logo

Gilead·Phase 2·NCT01163734·20 enrolled

The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure

Terminated·IIntermountain Health Care, Inc.·Phase 2·NCT01887353·8 enrolled

Heart Disease2 trials

Management of Ischemic Heart Disease With Angiwell-XR (Ranolazine)

Unknown status·OOBS Pakistan·Phase 4·NCT03486561·2,000 enrolled

Ranolazine Mediated PVC Reduction in Ischemic Heart Disease

Completed·—·Phase 2·NCT02360397·6 enrolled

Peripheral Arterial Disease1 trial

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

Withdrawn·CColorado Prevention Center·Phase 4·NCT00657514

Exercise1 trial

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

Completed· Gilead logo

Gilead·Phase 4·NCT01221272·81 enrolled

Platelet Reactivity1 trial

Pharmacodynamic Effects of Ranolazine Versus Amlodipine on Platelet Reactivity

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT01490255·100 enrolled

Chronic Total Occlusion1 trial

Efficacy of Ranolazine in Patients With Chronic Total Occlusions of Coronary Arteries

Withdrawn·—·Phase 4·NCT02423265

Ischemic Cardiomyopathy1 trial

The Effects of Ranolazine on CPET Parameters in Ischemic Cardiomyopathy Patients (ERIC)

Terminated·—·N/A·NCT01705509·14 enrolled

Neuropathic Pain1 trial

Ranolazine for Diabetic Peripheral Neuropathic Pain (DPNP)

Terminated·HHorizons International Peripheral Group·Phase 4·NCT02156336·4 enrolled

Physical Activity1 trial

Effects of Ranolazine and Exercise on Daily Physical Activity Trial

Completed·—·Phase 4·NCT01948310·38 enrolled

Intermittent Claudication1 trial

Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities

Terminated·CCorewell Health East·N/A·NCT00914316·29 enrolled

Biomarker1 trial

CiPA Phase 1 ECG Biomarker Validation Study

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT03070470·60 enrolled

Percutaneous Coronary Intervention (PCI)1 trial

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

Completed· Gilead logo

Gilead·Phase 3·NCT01442038·2,651 enrolled

Myotonic Dystrophy Type 11 trial

Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1

Completed·OOhio State University·Phase 1·NCT02251457·35 enrolled

Arrhythmia1 trial

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

Completed·AAspirus Heart and Vascular Institute-Research and Education·Phase 3·NCT00998218·7 enrolled

Diastolic Dysfunction1 trial

Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction

Terminated·UUniversity of California, San Diego·N/A·NCT00574756·14 enrolled

TIA1 trial

Ranolazine a Potential New Therapeutic Application

Withdrawn·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 4·NCT02687269

MPR1 trial

Ranolazine for Improving Symptoms of Palpitations

Unknown status·UUniversity of Roma La Sapienza·Phase 4·NCT01495520·100 enrolled

Chronic1 trial

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)

Completed· Gilead logo

Gilead·Phase 4·NCT00644332·172 enrolled

Speckle Tracking1 trial

RANOLAZINE STUDY: Speckle Tracking Derived Myocardial Strain

Withdrawn·SSaint Thomas Health··NCT03257683

Trial1 trial

Ranolazine Implantable Cardioverter-Defibrillator Trial

Completed·UUniversity of Rochester·Phase 3·NCT01215253·1,012 enrolled

Chronic Stable Angina1 trial

Ranolazine Among Unrevascularized Chronic Stable Angina Patients

Completed·NNorth Florida Foundation for Research and Education·Phase 2·NCT02265796·50 enrolled

Gastrointestinal1 trial

Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D

Terminated·MMayo Clinic·Phase 2/3·NCT02239926·5 enrolled

Heart Failure1 trial

The Effects of Ranolazine on Exercise Capacity in Patients With Heart Failure With Preserved Ejection Fraction

Completed·UUniversity of California, San Diego·N/A·NCT01505179·10 enrolled

Dialysis Patients1 trial

Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

Completed·UUniversity of Michigan·Phase 4·NCT01435174·17 enrolled

ART1 trial

Ranolazine and Microvascular Angina by PET in the Emergency Department

Completed·YYale University·Phase 4·NCT02052011·31 enrolled

Pacemaker1 trial

Effect of Ranolazine on Valvular Disease in Patients With Pacemakers

Unknown status·UUniversity Cardiology·Phase 4·NCT01979965·50 enrolled

Cardiovascular Disease1 trial

Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease

Terminated· Novartis logo

Novartis·Phase 2·NCT01562041·14 enrolled

Amyotrophic Lateral Sclerosis1 trial

Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis

Completed·UUniversity of Kansas Medical Center·Phase 2·NCT03472950·14 enrolled

Long QT Syndrome1 trial

Long Term Prophylactic Therapy of Congenital Long QT Syndrome Type III (LQT3) With Ranolazine

Unknown status·TTel-Aviv Sourasky Medical Center·Phase 2·NCT01728025·10 enrolled

Efficacy1 trial

Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients

Completed·UUniversity of Rochester·Phase 2·NCT01648205·25 enrolled

Atherosclerosis1 trial

Microvascular Assessment of Ranolazine in Non-Obstructive Atherosclerosis (MARINA)

Completed·EEmory University·Phase 2·NCT02147067·26 enrolled

Prostate Cancer1 trial

A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine

Completed·UUniversity of Colorado, Denver·N/A·NCT01992016·11 enrolled

ALS1 trial

A Study of Ranolazine in ALS

Recruiting·—·Phase 2·NCT06527222·72 enrolled

Tics1 trial

A Study of Pharmacokinetics and Safety of Ranolazine PR in Healthy Korean and Caucasian Male Subjects

Unknown status·AA.Menarini Asia-Pacific Holdings Pte Ltd·Phase 1·NCT02817932·120 enrolled

Biomarkers1 trial

Does Ranolazine Decrease Biomarkers of Myocardial Damage in Diabetics

Withdrawn·WWalter Reed National Military Medical Center·N/A·NCT02611596

Paroxysmal atrial fibrillation1 trial

Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation

Completed· Gilead logo

Gilead·Phase 2·NCT01522651·134 enrolled

Acute Coronary Syndrome1 trial

Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes

Completed· Gilead logo

Gilead·Phase 3·NCT00099788·6,560 enrolled

Dilated Cardiomyopathy1 trial

A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy

Completed·UUniversity Medical Centre Ljubljana·Phase 2·NCT02133911·10 enrolled

Coronary Artery Disease1 trial

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

Terminated· Gilead logo

Gilead·Phase 4·NCT00832572·5 enrolled

Pulmonary Arterial Hypertension1 trial

A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension

Completed·UUniversity of Chicago·Phase 1·NCT01757808·12 enrolled

Myocardial Infarction1 trial

Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study

Recruiting·FFederico II University·Phase 2/3·NCT07380919·100 enrolled

Diarrhea1 trial

Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy

Terminated·VVanderbilt University Medical Center·Phase 2·NCT04456517·4 enrolled

Coronary Disease1 trial

Microvascular Coronary Disease In Women: Impact Of Ranolazine

Completed·—·Phase 2·NCT00570089·20 enrolled

Tolerance1 trial

A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency

Completed·TTSH Biopharm Corporation Limited·N/A·NCT03401502·20 enrolled

Treatment1 trial

Ranolazine SR in Patients With Chronic Angina Who Remain Symptomatic Despite Maximal Treatment With Amlodipine

Completed· Gilead logo

Gilead·Phase 3·NCT00091429·500 enrolled

Unspecified4 trials

Safety of Amiodarone and Ranolazine Together in Patients With Angina

Unknown status·CCardiovascular Consultants of Nevada·Phase 4·NCT01558830·50 enrolled

Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD

Completed·—·Phase 3·NCT01754259·47 enrolled

Effect of Ranolazine on Activity Level in Patients With Angina After FFR Based Deferred Intervention (REPTAR)

Unknown status·—·Phase 4·NCT03044964·40 enrolled

Show 1 more trial

Study to Reduce Symptoms of Premature Beats With Ranolazine

Unknown status·WWalter Reed National Military Medical Center·Phase 4·NCT01996618·72 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 12, 2007

RANEXA

NDA NDA021526

Feb 28, 2022

ASPRUZYO SPRINKLE

NDA NDA216018

Sources

References

[1]
ClinicalTrials.gov — 80 trial records for Ranolazine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ranexa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ranolazine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ranolazine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216018). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ranexa. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Menarini International Operations Luxembourg SA company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Protein Type V Alpha Subunit Blocker; Sodium Channel Protein Type IV Alpha Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMenarini International Operations Luxembourg SA

Patent Landscape[6]

Patent Cliff

Jan 24, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11510878Jan 24, 2038

12161761Jan 24, 2038

10898444Jan 24, 2038

Ranexa

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Pulmonary Hypertension5 trials

Atrial Fibrillation4 trials

Type 2 Diabetes Mellitus4 trials

Type 2 Diabetes3 trials

Myocardial Ischemia3 trials

Injury2 trials

Metformin2 trials

Metabolic Syndrome2 trials

CAR2 trials

Chest pain2 trials

Diastolic Heart Failure2 trials

Heart Disease2 trials

Peripheral Arterial Disease1 trial

Exercise1 trial

Platelet Reactivity1 trial

Chronic Total Occlusion1 trial

Ischemic Cardiomyopathy1 trial

Neuropathic Pain1 trial

Physical Activity1 trial

Intermittent Claudication1 trial

Biomarker1 trial

Percutaneous Coronary Intervention (PCI)1 trial

Myotonic Dystrophy Type 11 trial

Arrhythmia1 trial

Diastolic Dysfunction1 trial

TIA1 trial

MPR1 trial

Chronic1 trial

Speckle Tracking1 trial

Trial1 trial

Chronic Stable Angina1 trial

Gastrointestinal1 trial

Heart Failure1 trial

Dialysis Patients1 trial

ART1 trial

Pacemaker1 trial

Cardiovascular Disease1 trial

Amyotrophic Lateral Sclerosis1 trial

Long QT Syndrome1 trial

Efficacy1 trial

Atherosclerosis1 trial

Prostate Cancer1 trial

ALS1 trial

Tics1 trial

Biomarkers1 trial

Paroxysmal atrial fibrillation1 trial

Acute Coronary Syndrome1 trial

Dilated Cardiomyopathy1 trial

Coronary Artery Disease1 trial

Pulmonary Arterial Hypertension1 trial

Myocardial Infarction1 trial

Diarrhea1 trial

Coronary Disease1 trial

Tolerance1 trial

Treatment1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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