Data updated: May 26, 2026
ASPRUZYO SPRINKLE (ranolazine)
Cardiovascular
Approved 2022-02-28
1
Indication
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2022-02-28
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- GRANULE, EXTENDED RELEASE
ASPRUZYO SPRINKLE Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2022 to 2022
What ASPRUZYO SPRINKLE Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
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Clinical Trial Registry
51 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 |
| NCT02423265 | IN-US-259-0172 Buch ISR UMCIRB 13-001574 | Ph 4 | withdrawn | Efficacy of Ranolazine in Patients With Chronic Total Occlusions of Coronary Arteries |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| NCT02687269 | RAN | Ph 4 | withdrawn | Ranolazine a Potential New Therapeutic Application |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 |
| 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 |
| NCT01546597 | GS-US-259-0137 | Ph 1 | completed | Single Cohort 4-period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine |
| NCT01546558 | GS-US-259-0143 | Ph 1 | completed | Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg |
Showing 50 of 51 trials
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
ASPRUZYO SPRINKLE FDA Label Details
View full patent landscape →
3 OB patents · 1 families ·
7 international docs across 2 countries
ASPRUZYO SPRINKLE Patents & Exclusivity
Latest Patent: Jan 2038
Patents (3 active)
Source: FDA Orange Book
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Patent Timeline
- • Cliff: 2038
- • 8 active patents
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.