Drugs / Ranolazine
Ranolazine
also known as
Ranexa · Aspruzyo · Aspruzyo sprinkle · CVT-303 · NSC-759100 · Ran d · Ranexa (previously latixa) · Ranolazina · +5 more
Small molecule targets SCN4A, SCN5A via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | RANEXA | — | 2008-11-05 | fda.gov ↗ |
| Approved | EU (EMA) | Ranexa (previously Latixa) | — | 2008-07-08 | europa.eu ↗ |
| Approved | US (FDA) | RANEXA | — | 2006-01-27 | fda.gov ↗ |
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT02817932 | Mar → Jul 2016 | — | A.Menarini Asia-Pacific Holdings Pte Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT02251457 | Aug 2014 → Dec 2017 | myotonic dystrophy type 1, nondystrophic myotonia, paramyotonia congenita of Von Eulenburg | Ohio State University | Completed | No outcome recorded |
| Phase 1 | NCT01873950 | May → Jul 2013 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT01675973 | Jul → Aug 2012 | — | Gilead Sciences | Terminated | No outcome recorded |
| Phase 1 | NCT01546597 | Feb → Mar 2012 | type 2 diabetes mellitus | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01546558 | Feb → Mar 2012 | type 2 diabetes mellitus | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01757808 | Aug 2011 → Jan 2015 | pulmonary arterial hypertension | University of Chicago | Completed | No outcome recorded |
| Phase 215 trials · 1 met primary · 3 missed | ||||||
| Phase 2 | NCT06570473 | Jul 2025 → Aug 2026 overdue | heart failure, pulmonary hypertension | University of Alberta | Recruiting | No outcome recorded |
| Phase 2 | NCT06527222 | Apr 2025 → Jul 2028 expected | amyotrophic lateral sclerosis | Swathy Chandrashekhar, MBBS | Recruiting | No outcome recorded |
| Phase 2 | NCT04456517 | Oct 2022 → Apr 2024 | Crohn disease | Vanderbilt University Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03472950 | Jun 2018 → Dec 2020 | amyotrophic lateral sclerosis | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03953989 | Oct 2016 → Feb 2020 | hypertrophic cardiomyopathy | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 2 | NCT02360397 | Dec 2014 → Dec 2017 | cardiac rhythm disease, myocardial ischemia | Kent Hospital, Rhode Island | Completed | No outcome recorded |
| Phase 2 | NCT02147067 | Sep 2014 → Mar 2018 | coronary microvascular disorder | Emory University | Completed | Missed primary |
| Phase 2 | NCT02133911 | May 2014 → Dec 2015 | dilated cardiomyopathy | University Medical Centre Ljubljana | Completed | No outcome recorded |
| Phase 2 | NCT01728025 | Oct 2012 → Nov 2017 | long QT syndrome 3 | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT01648205 | Sep 2012 → Jul 2018 | long QT syndrome | University of Rochester | Completed | Missed primary |
| Phase 2 | NCT01522651 | Jan 2012 → Mar 2014 | atrial fibrillation | Gilead Sciences | Completed | Met primary |
| Phase 2 | NCT01534962 | Jan 2012 → Oct 2013 | persistent atrial fibrillation | Menarini Group | Completed | Missed primary |
| Phase 2 | NCT01163721 | Jun → Nov 2010 | type 2 diabetes mellitus | Gilead Sciences | Completed | Mixed |
| Phase 2 | NCT01163734 | Apr 2010 → Feb 2011 | diastolic heart failure | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00570089 | Apr 2007 → Dec 2009 | myocardial ischemia | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07380919 | Feb → Jun 2026 overdue | ST-elevation myocardial infarction | Federico II University | Recruiting | No outcome recorded |
| Phase 311 trials · 3 met primary · 4 missed | ||||||
| Phase 3 | NCT01810796 | Dec 2013 → Dec 2016 | coronary artery disorder | Hadassah Medical Organization | Unknown | No outcome recorded |
| Phase 3 | NCT01754259 | Apr 2013 → Oct 2015 | coronary artery disorder, type 1 diabetes mellitus, type 2 diabetes mellitus | Brigham and Women's Hospital | Completed | Missed primary |
| Phase 3 | NCT01555164 | Jun 2012 → Sep 2013 | type 2 diabetes mellitus | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT01349491 | Mar 2012 → Jun 2014 | atrial fibrillation | University of Oklahoma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01494987 | Jan 2012 → Aug 2013 | type 2 diabetes mellitus | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01472185 | Nov 2011 → Oct 2013 | type 2 diabetes mellitus | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01442038 | Oct 2011 → Feb 2015 | coronary artery disorder | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT01174173 | Jun 2010 → Jan 2014 | pulmonary arterial hypertension | Northwestern University | Completed | Mixed |
| Phase 3 | NCT00998218 | Sep 2009 → Dec 2010 | sudden cardiac arrest | Aspirus Heart and Vascular Institute-Research and Education | Completed | No outcome recorded |
| Phase 3 | NCT00099788 | Oct 2004 → Feb 2007 | myocardial ischemia | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT00091429 | Aug 2004 → Feb 2005 | — | Gilead Sciences | Completed | Met primary |
| Phase 413 trials · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT02687269 | Apr 2019 → Sep 2020 | myocardial stunning | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Withdrawn | No outcome recorded |
| Phase 4 | NCT03486561 | Apr → Sep 2018 | intermediate coronary syndrome | OBS Pakistan | Unknown | No outcome recorded |
| Phase 4 | NCT02252406 | Sep 2015 → Dec 2018 | metabolic syndrome X | University of Florida | Completed | No outcome recorded |
| Phase 4 | NCT02052011 | Apr 2014 → Nov 2015 | coronary microvascular disorder | Yale University | Completed | Missed primary |
| Phase 4 | NCT01996618 | Jan 2014 → Jun 2016 | — | Walter Reed National Military Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01721967 | Nov 2012 → Nov 2015 | hypertrophic cardiomyopathy | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT01435174 | Oct 2011 → Mar 2013 | cardiovascular disorder, end stage renal failure | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT01425359 | Sep 2011 → Oct 2012 | coronary artery disorder, type 2 diabetes mellitus | Gilead Sciences | Completed | Met primary |
| Phase 4 | NCT02133352 | Jul 2011 → May 2013 | diastolic heart failure, pulmonary hypertension | Boston University | Completed | No outcome recorded |
| Phase 4 | NCT01334203 | May 2011 → Oct 2012 | coronary artery disorder, type 2 diabetes mellitus | Gilead Sciences | Withdrawn | No outcome recorded |
| Phase 4 | NCT01221272 | Sep 2010 → Sep 2012 | myocardial ischemia | Gilead Sciences | Completed | Missed primary |
| Phase 4 | NCT00832572 | Jan → Jun 2009 | coronary artery disorder, polyneuropathy | Gilead Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00644332 | Nov 2007 → Jan 2011 | — | Gilead Sciences | Completed | No outcome recorded |
| Phase not applicable7 trials · 1 missed | ||||||
| — | NCT03401502 | Jun 2018 → Mar 2019 | — | TSH Biopharm Corporation Limited | Completed | No outcome recorded |
| — | NCT02611596 | Nov 2016 → Nov 2018 | myocardial ischemia, type 2 diabetes mellitus | Walter Reed National Military Medical Center | Withdrawn | No outcome recorded |
| — | NCT01992016 | Apr 2014 → Oct 2016 | malignant soft tissue neoplasm, metastatic carcinoma in the bone, prostate adenocarcinoma | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT01705509 | Sep 2012 → Mar 2017 | cardiomyopathy | Cardiovascular Institute of the South Clinical Research Corporation | Terminated | No outcome recorded |
| — | NCT01815957 | May 2012 → Mar 2016 | coronary artery disorder, coronary microvascular disorder, ischemic disease, myocardial disorder | University of New Mexico | Completed | No outcome recorded |
| — | NCT01342029 | May 2011 → Dec 2016 | coronary microvascular disorder | Cedars-Sinai Medical Center | Completed | Missed primary |
| — | NCT00574756 | Dec 2007 → Mar 2010 | diastolic heart failure | University of California, San Diego | Terminated | No outcome recorded Stop: Business |
| Comparator or background therapy30 trials | ||||||
| Phase 1 | NCT03070470 Comparator | Mar → Jun 2017 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT01843127 Comparator | Apr → Sep 2013 | type 2 diabetes mellitus | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02147834 Comparator | Aug 2015 → Mar 2016 | intermediate coronary syndrome | North Florida Foundation for Research and Education | Terminated | No outcome recorded |
| Phase 2 | NCT02265796 Comparator | Sep 2014 → May 2016 | intermediate coronary syndrome | North Florida Foundation for Research and Education | Completed | No outcome recorded |
| Phase 2 | NCT01887353 Comparator | Jun 2013 → Feb 2014 | atrial fibrillation, heart failure | Intermountain Health Care, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01767987 Comparator | Nov 2012 → Apr 2014 | acute coronary syndrome | Harvey Hahn | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01562041 Background | Mar 2012 → Jan 2014 | coronary atherosclerosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2/3 | NCT03162120 Comparator | Sep → Dec 2018 | atrial fibrillation | Elpen Pharmaceutical Co. Inc. | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT02239926 Comparator | Sep 2014 → Sep 2015 | irritable bowel syndrome | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT01797484 Comparator | Aug 2013 → Jun 2015 | coronary artery disorder, myocardial ischemia | University Medical Center Hamburg-Eppendorf | Completed | No outcome recorded |
| Phase 3 | NCT01215253 Comparator | Sep 2011 → Feb 2017 | cardiomyopathy, heart failure | University of Rochester | Completed | No outcome recorded |
| Phase 3 | NCT01352416 Comparator | Sep 2010 → Nov 2012 | postoperative ventricular dysfunction | Corewell Health East | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03044964 Comparator | Jan → Oct 2017 | — | Amit Malhotra, MD | Unknown | No outcome recorded |
| Phase 4 | NCT02829034 Comparator | Jul 2016 → Dec 2017 | pulmonary hypertension | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT02423265 Comparator | Jun 2015 → Dec 2016 | arteriosclerosis disorder, intermediate coronary syndrome, myocardial ischemia | East Carolina University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02156336 Comparator | May 2014 → Feb 2017 | diabetic polyneuropathy | Horizons International Peripheral Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01491061 Comparator | Jan 2014 → Dec 2015 | coronary artery disorder | University of Roma La Sapienza | Unknown | No outcome recorded |
| Phase 4 | NCT01495520 Comparator | Jan → Dec 2014 | ischemic disease | University of Roma La Sapienza | Unknown | No outcome recorded |
| Phase 4 | NCT01948310 Comparator | Dec 2013 → Oct 2016 | intermediate coronary syndrome | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT01979965 Comparator | Nov 2013 → May 2014 | mitral valve insufficiency | University Cardiology | Unknown | No outcome recorded |
| Phase 4 | NCT01839110 Comparator | Jul 2013 → Jan 2018 | pulmonary hypertension | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT01490255 Comparator | Jan 2012 → Jun 2014 | coronary artery disorder | University of Roma La Sapienza | Unknown | No outcome recorded |
| Phase 4 | NCT01558830 Comparator | Jan 2012 → Apr 2013 | atrial fibrillation, intermediate coronary syndrome, ventricular tachycardia | Cardiovascular Consultants of Nevada | Unknown | No outcome recorded |
| Phase 4 | NCT01345188 Comparator | Apr 2011 → Apr 2014 | cardiomyopathy, intermediate coronary syndrome | Midwest Cardiovascular Research Foundation | Completed | No outcome recorded |
| Phase 4 | NCT01304095 Comparator | Jan 2011 → Jul 2013 | coronary artery disorder, metabolic syndrome X | Atlanta Heart Specialists, LLC | Unknown | No outcome recorded |
| Phase 4 | NCT00657514 Comparator | May 2008 → Jun 2009 | peripheral arterial disease | Colorado Prevention Center | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01590979 Comparator | Apr 2012 → Jun 2015 | atrial fibrillation, hemorrhagic disease, ventricular tachycardia | Northwell Health | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01480336 Comparator | Feb 2011 → Jan 2013 | cardiac rhythm disease | Hartford Hospital | Completed | No outcome recorded |
| — | NCT01505179 Comparator | Feb 2011 → Dec 2014 | diastolic heart failure | University of California, San Diego | Completed | No outcome recorded |
| — | NCT00914316 Comparator | May 2009 → Mar 2013 | peripheral arterial disease | Corewell Health East | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2019-08-21 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Ranolazine Extended-Release Tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Ranolazine Extended-Release Tablets (US RLD - Ranexa ®), 500 mg and 1,000 mg. |
| 2019-07-09 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals receives ANDA approval for Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg |
| 2014-05-10 | Gilead Sciences | Results Gilead Announces Results from Phase 2 Study Showing Reduction in Atrial Fibrillation Burden with the Investigational Combination of Ranolazine and Low-Dose Dronedarone gilead.com ↗
In HARMONY, the combination of ranolazine and low-dose dronedarone provided greater reductions in AFB from baseline than either therapy used alone. |
| 2013-03-10 | Gilead Sciences | Results Gilead’s Ranexa® Reduces Angina Frequency in Study of Chronic Angina Patients With Type 2 Diabetes gilead.com ↗ |
| 2010-06-10 | Gilead Sciences | Regulatory Gilead Sciences Announces Notification of ANDA Filing for Ranexa(R) gilead.com ↗
In the Notice Letter, Lupin alleges that all 10 patents associated with Ranexa are invalid, unenforceable and/or will not be infringed by Lupin's manufacture, use or sale of the product described in its ANDA submission. |
All press releases naming this drug 9 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 89 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ranolazine | “The purpose of this study is to assess the effect of severe renal impairment on the steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects...” NCT01675973 ↗82“Ranolazine improves angina in women with evidence of myocardial ischemia but no obstructive coronary artery disease.” PMID 21565740 ↗ May 2011 “After enrollment in the study, participants will initiate Ranolazine for 4 weeks.” NCT01815957 ↗ |
| Known as | Aspruzyo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | Aspruzyo sprinkle | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | CVT-303 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | NSC-759100 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | Ran d | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | Ranexa | “ranolazine (Ranexa)” NCT02133352 ↗ |
| Known as | Ranexa (previously latixa) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | Ranolazina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | Ranolazine dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | Ranolazine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | RANOLAZINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | RS-43285 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Known as | RS-43285-003 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1404 ↗ |
| Action | Inhibit | “Sodium channel protein type IV alpha subunit blocker” CHEMBL1404 ↗1“inhibiting the late sodium current” PMID 21538388 ↗ Apr 2011 |
| Modality | Small molecule | “Ranolazine, a piperazine derivative with anti-ischemic effects” PMID 26059896 ↗ Jun 2015 |
| Route | Intravenous | “initiated intravenously and followed by oral ranolazine extended-release 1000 mg twice daily” PMID 17456819 ↗ Apr 2007 |
| Route | Oral | “initiated intravenously and followed by oral ranolazine extended-release 1000 mg twice daily” PMID 17456819 ↗ Apr 2007 |
| Target | SCN4A | “Sodium channel protein type IV alpha subunit blocker” CHEMBL1404 ↗ |
| Target | SCN5A | “Ranolazine exerted a concentration-dependent block of INaL of the SCN5A-D1790G channel” PMID 27733495 ↗ Oct 2016 |