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Drug

Ranolazine

Approved · EMA
Emerging researchLate-stage developmentRising momentum

Also known as Aspruzyo, Aspruzyo Sprinkle, Ranexa, Ranolazina.

RxNorm35829ChEMBLCHEMBL1404UNIIA6IEZ5M406
4
Research papers
3
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Ranolazine in ALS: Safety, and Effect on Cramps, Function and Quality of Life.

Clinical trial2026-06-08Results expected Q3 2028 · ClinicalTrials.gov

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

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Recall (Class II): RANOLAZINE

Regulatory2025-03-13FDA

Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study

Clinical trial2024-12-09Results posted · ClinicalTrials.gov

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

Clinical trial2024-12-09Results posted · ClinicalTrials.gov

REACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated Diarrhea

Clinical trial2024-04-11Terminated · ClinicalTrials.gov

Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial.

Research2015-11-10Circulation

Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial.

Research2015-10-22Lancet (London, England)

Comprehensive T wave morphology assessment in a randomized clinical study of dofetilide, quinidine, ranolazine, and verapamil.

Research2015-04-13Journal of the American Heart Association

Differentiating drug-induced multichannel block on the electrocardiogram: randomized study of dofetilide, quinidine, ranolazine, and verapamil.

Research2014-07-23Clinical pharmacology and therapeutics

Approval: Ranexa (previously Latixa) (EMA)

Regulatory2008-07-08EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ranolazine
Aliases & brands
AspruzyoAspruzyo SprinkleRanexaRanolazina
RxNorm CUI
35829
ChEMBL ID
CHEMBL1404
UNII
A6IEZ5M406
Regulatory jurisdictions
fdaema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2008-07-08
Latest approval
2008-07-08
Authorities
FDA · EMA
Total events
2
fdaU.S. Food and Drug Administration· 1 event
2025-03-13RecallSafety
Recall (Class II): RANOLAZINE
Evidence ↗
emaEuropean Medicines Agency· 1 event
2008-07-08Approval
Approval: Ranexa (previously Latixa) (EMA)
Indication: Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line… Show full indication

Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

80 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
80
registered trials across all phases
LATEST COMPLETION 2022
3
Active studies
3
Recruiting
52
Late-stage (III+)
45
Completed
32
Discontinued
PHASE DISTRIBUTIONn = 80
Phase 19Phase 219Phase 2 / 33Phase 313Phase 427Phase N / A9

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Ranolazine Myocardial Protection in Complete Coronary Artery Bypass Grafting: A Randomized-controlled Trial

WithdrawnPH IVFondazione Policlinico Universitario Agostino Gemelli IRCCS2020

Impact of Ranolazine on Inflammatory, Thrombogenic, Lipogenic, Biomarkers in Women With Angina and Metabolic Syndrome.

CompletedPH IVUniversity of Floridan=332019

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

Unknown statusPH IVKey trialOBS Pakistann=2,0002018

A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine on Outcomes in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Accompanied by a Comparative Study of Cellular Metabolism in Subjects With Pulmonary Hypertension With and Without Right Ventricular Dysfunction

CompletedPH IVUniversity of Pennsylvanian=222018

A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Using Cardiovascular MRI

CompletedPH IVUniversity of Pennsylvanian=222018

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IIUniversity of Kansas Medical Centern=142022

Impact of Ranolazine on Inflammatory, Thrombogenic, Lipogenic, Biomarkers in Women With Angina and Metabolic Syndrome.

CompletedPH IVUniversity of Floridan=332019

A TSHRN1201 Sub-study-To Evaluate the Effects of add-on Ranolazine on Exercise Tolerance and Angina Frequency in Patients With Stable Angina Pectoris.

CompletedN/ATSH Biopharm Corporation Limitedn=202019

Efficacy of Ranolazine in LQT3 Patients

CompletedPH IIUniversity of Rochestern=252018

Microvascular Assessment of Ranolazine in Non-Obstructive Atherosclerosis

CompletedPH IIEmory Universityn=262018

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

CompletedN/AUniversity of Colorado, Denvern=112018

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20142016
Most influential

Differentiating drug-induced multichannel block on the electrocardiogram: randomized study of dofetilide, quinidine, ranolazine, and verapamil.

Clinical pharmacology and therapeutics · 2014 · 185 cites

Comprehensive T wave morphology assessment in a randomized clinical study of dofetilide, quinidine, ranolazine, and verapamil.

Journal of the American Heart Association · 2015 · 92 cites

Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial.

Lancet (London, England) · 2016 · 75 cites

Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial.

Circulation · 2016 · 41 cites
Recent papers

Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial.

Lancet (London, England) · 2016 · 75 cites

Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial.

Circulation · 2016 · 41 cites

Comprehensive T wave morphology assessment in a randomized clinical study of dofetilide, quinidine, ranolazine, and verapamil.

Journal of the American Heart Association · 2015 · 92 cites

Differentiating drug-induced multichannel block on the electrocardiogram: randomized study of dofetilide, quinidine, ranolazine, and verapamil.

Clinical pharmacology and therapeutics · 2014 · 185 cites
Major research themes2
Percutaneous Coronary Intervention1Quality of Life1
Journals, researchers & institutions
Top journals
  • Circulation1
  • Clinical pharmacology and therapeutics1
  • Journal of the American Heart Association1
  • Lancet (London, England)1
Leading researchers
  • Alexander KP2
  • Ben-Yehuda O2
  • Farzaneh-Far R2
  • James S2
  • Johannesen L2
  • Mason JW2
  • Ohman EM2
  • Osmukhina A2
Leading institutions
free-text, unnormalised
  • Office of Science and Engineering Laboratories2
  • Spaulding Clinical Research2
  • 1] Office of Science and Engineering Laboratories1
  • Cardiovascular Research Foundation1
  • Center for Drug Evaluation and Research1
  • Chaim Sheba Medical Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.