Overview
Chronic angina is a common cardiovascular condition affecting millions worldwide and causes significant disability while interfering with daily activities. Ranolazine is a well-tolerated piperazine derivative used for the management of this condition, offering relief from uncomfortable and debilitating symptoms. With a mechanism of action different from drugs used to treat the same condition, ranolazine is a promising anti-anginal therapy. It was originally approved by the FDA in 2006.
Indication
Ranolazine is indicated for the treatment of chronic angina. It can be used alone or in conjunction with nitrates, beta-blockers, angiotensin receptor blockers, anti-platelet drugs, calcium channel blockers, lipid-lowering drugs, and ACE inhibitors. Ranolazine has also been used off-label for the treatment of certain arrhythmias, including ventricular tachycardia, however, this use is not strongly supported by scientific evidence. Ranolazine has also been studied for the treatment of acute coronary syndrome, microvascular coronary dysfunction, arrhythmia, and glycemic control, which are not yet approved indications.
Associated Conditions
- Chronic Angina
- Ventricular Arrhythmia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/26 | Phase 2 | Recruiting | |||
2024/07/30 | Phase 2 | Recruiting | Swathy Chandrashekhar, MD | ||
2020/07/02 | Phase 2 | Terminated | |||
2019/05/17 | Phase 2 | Completed | |||
2018/04/03 | Phase 4 | UNKNOWN | |||
2018/03/21 | Phase 2 | Completed | |||
2018/01/17 | Not Applicable | Completed | |||
2017/08/22 | N/A | Withdrawn | |||
2017/05/22 | Phase 2 | Withdrawn | |||
2017/03/03 | Phase 1 | Completed | Food and Drug Administration (FDA) |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Actavis Pharma, Inc. | 45963-418 | ORAL | 500 mg in 1 1 | 9/30/2022 | |
| Aurobindo Pharma Limited | 59651-010 | ORAL | 1000 mg in 1 1 | 2/15/2024 | |
| SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-624 | ORAL | 500 mg in 1 1 | 3/2/2022 | |
| Micro Labs Limited | 42571-325 | ORAL | 1000 mg in 1 1 | 11/23/2021 | |
| SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-625 | ORAL | 1000 mg in 1 1 | 3/2/2022 | |
| Lifestar Pharma LLC | 70756-703 | ORAL | 500 mg in 1 1 | 5/15/2021 | |
| Slate Run Pharmaceuticals | 70436-104 | ORAL | 1000 mg in 1 1 | 7/25/2023 | |
| ScieGen Pharmaceuticals, Inc | 50228-424 | ORAL | 1000 mg in 1 1 | 11/24/2019 | |
| i3 Pharmaceuticals, LLC | 72319-021 | ORAL | 500 mg in 1 1 | 5/4/2022 | |
| Aurobindo Pharma Limited | 59651-009 | ORAL | 500 mg in 1 1 | 2/15/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/8/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| RANEXA PROLONGED-RELEASE TABLET 750 MG | SIN14863P | TABLET, FILM COATED, EXTENDED RELEASE | 750 mg | 10/6/2015 | |
| RANEXA PROLONGED-RELEASE TABLET 500 MG | SIN14862P | TABLET, FILM COATED, EXTENDED RELEASE | 500 mg | 10/6/2015 | |
| RANEXA PROLONGED-RELEASE TABLET 375 MG | SIN14861P | TABLET, FILM COATED, EXTENDED RELEASE | 375 mg | 10/6/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dosmalfate Tablets | 国药准字H20052435 | 化学药品 | 片剂 | 8/4/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RANEXA ranolazine 375mg modified release tablet blister pack | 236110 | A Menarini Australia Pty Ltd | Medicine | A | 10/13/2017 |
| RANEXA ranolazine 750mg modified release tablet blister pack | 236108 | A Menarini Australia Pty Ltd | Medicine | A | 10/13/2017 |
| RANEXA ranolazine 500mg modified release tablet blister pack | 236109 | A Menarini Australia Pty Ltd | Medicine | A | 10/13/2017 |
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