TheraRadar
Data updated: May 26, 2026

RANEXA (ranolazine)

Trial Activity: Declining 4 active trials
Cardiovascular Approved 2006-01-27
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Gilead Sciences conducting 15 trials (27%)
58 indications explored (Broad Platform)
→ type 2 diabetes mellitus (8 trials)
→ coronary artery disease (7 trials)
→ angina (5 trials)
2
Indications
--
Phase 3 Trials
20
Years on Market

Details

Status
Discontinued
First Approved
2006-01-27
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

MENARINI INTL
Active Ingredient: RANOLAZINE

RANEXA Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
34 FDA actions from 2006 to 2019 · 1 indication expansions
Oct 2019 SUPPL
Label · Labeling
FDA Letter Label
Aug 2019 SUPPL
Label · Labeling
FDA Letter Label
Apr 2016 SUPPL
Mfg · Manufacturing (CMC)

What RANEXA Treats

2 FDA approvals

Originally approved for its first indication in 2006 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

53 trials
Trial Sponsor ID Phase Status Title
NCT07380919 INaMICRON 2025-520801-12-00 Ph 2, Ph 3 recruiting Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study
NCT06527222 24-43175 Ph 2 recruiting A Study of Ranolazine in ALS
NCT06570473 CRAVE CRAVE-01 Ph 2 recruiting Feasibility Trial for a Right Ventricular Failure Platform Trial
NCT04456517 REACT results posted 200640 Ph 2 terminated Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy
NCT01345188 results posted IN-US-259-D032 Ph 4 completed Ranolazine in Ischemic Cardiomyopathy
NCT02423265 IN-US-259-0172 Buch ISR UMCIRB 13-001574 Ph 4 withdrawn Efficacy of Ranolazine in Patients With Chronic Total Occlusions of Coronary Arteries
NCT01648205 results posted IN-US-259-0128 Ph 2 completed Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients
NCT02133911 RAMP-DCM AHFTX-UMCLJ-1 Ph 2 completed A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy
NCT02687269 RAN Ph 4 withdrawn Ranolazine a Potential New Therapeutic Application
NCT01522651 HARMONY results posted GS-US-291-0102 2011-001134-42 Ph 2 completed Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation
NCT02252406 IRMA results posted WIRB20141202 Ph 4 completed Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome
NCT02360397 results posted IN-US-259-1341 Ph 2 completed Ranolazine Mediated PVC Reduction in Ischemic Heart Disease
NCT03070470 results posted 16-086D SCR-004 Ph 1 completed CiPA Phase 1 ECG Biomarker Validation Study
NCT02265796 IMWELL results posted 149-2013 Ph 2 completed Ranolazine Among Unrevascularized Chronic Stable Angina Patients
NCT02147834 IMWELL3 results posted 201400100 Ph 2 terminated Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents
NCT02147067 MARINA results posted IRB00072996 Ph 2 completed Microvascular Assessment of Ranolazine in Non-Obstructive Atherosclerosis (MARINA)
NCT02251457 IN-US-259-1605 IN-US-259-1605 Ph 1 completed Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1
NCT02829034 results posted 824808 Ph 4 completed Targeting Right Ventricle in Pulmonary Hypertension Gilead
NCT01839110 results posted 817785 Ph 4 completed Targeting the Right Ventricle in Pulmonary Hypertension
NCT01215253 RAID results posted U01HL096607 Ph 3 completed Ranolazine Implantable Cardioverter-Defibrillator Trial
NCT01174173 results posted STU00030314 Ph 3 completed Ranolazine and Pulmonary Hypertension
NCT01873950 results posted 13-011D SCR-002 Ph 1 completed Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects
NCT01797484 RIMINI-Pilot results posted UHZ-KARD-01-2013 Ph 2, Ph 3 completed Reduction of Ischemic Myocardium With Ranolazine-Treatment in Patients With Acute Myocardial Ischemia
NCT01948310 EREDA results posted Pro00045794 Ph 4 completed Effects of Ranolazine and Exercise on Daily Physical Activity Trial
NCT01435174 results posted IN-US-259-0123, HUM00051141 Ph 4 completed Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
NCT01767987 results posted ISR IN-US-259-0139 Ph 2 terminated Ranolazine Cardioprotection in PCI
NCT01754259 RAND-CFR results posted 2012P002537 Ph 3 completed Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD
NCT02133352 results posted 30217 Ph 4 completed Study of Ranolazine in the Treatment of Pulmonary Hypertension Associated With Diastolic Left Ventricular Dysfunction
NCT02052011 RAMP-ED results posted 1312013144 Ph 4 completed Ranolazine and Microvascular Angina by PET in the Emergency Department
NCT01349491 GILEAD results posted 2399 Ph 3 terminated Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion
NCT01721967 RHYME results posted Pro00039302 3938381 Ph 4 completed Ranolazine for the Treatment of Chest Pain in HCM Patients
NCT01757808 11-0301 Ph 1 completed A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
NCT02156336 HIPG-CLIN-2014-01 Ph 4 terminated Ranolazine for Diabetic Peripheral Neuropathic Pain (DPNP)
NCT01352416 results posted 2009-101, IN-US-259-0114 Ph 3 terminated Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
NCT01442038 RIVER-PCI results posted GS-US-259-0116 2011-002507-15 Ph 3 completed Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI)
NCT02239926 Ranolazine results posted 14-000581 Ph 2, Ph 3 terminated Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D
NCT01887353 RAD HF results posted 1024475 Ph 2 terminated The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
NCT01494987 results posted GS-US-259-0110 Ph 3 completed Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
NCT01425359 TERISA results posted GS-US-259-0133 Ph 4 completed Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina
NCT01472185 results posted GS-US-259-0131 Ph 3 completed Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus
NCT01555164 results posted GS-US-259-0147 2012-001259-37 Ph 3 completed A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone
NCT01221272 results posted GS-US-259-0103 Ph 4 completed Effect of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging
NCT01534962 RAFFAELLO results posted RAF-01 2011-002789-18 Ph 2 completed Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion
NCT00657514 07-PAD-01 Ph 4 withdrawn Ranolazine Versus Placebo Effects on Exercise Tolerance in Patients With Heart Disease and Peripheral Arterial Disease
NCT00832572 results posted CVT 3042 Ph 4 terminated Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy
NCT01843127 GS-US-259-0165 Ph 1 completed A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.
NCT01163721 results posted GS-US-259-0107 Ph 2 completed Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy
NCT01675973 GS-US-259-0112 Ph 1 terminated A Phase 1 Study to Assess the Effect of Severe Renal Impairment on the Pharmacokinetics, as Well as Safety/Tolerability, of Ranolazine
NCT01334203 GS-US-259-0108 Ph 4 withdrawn 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)
NCT01163734 RALI-DHF GS-US-270-0101 Ph 2 completed Ranolazine in Diastolic Heart Failure

Showing 50 of 53 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RANEXA FDA Label Details

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Data Sources

FDA Approval: NDA021526 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment