Ranexa, Ranexa (previously latixa)(ranolazine)
Aspruzyo, Latixa, Ranexa (ranolazine) is a small molecule pharmaceutical. Ranolazine was first approved as Ranexa on 2006-01-27. It is used to treat angina pectoris in the USA. It has been approved in Europe to treat angina pectoris.
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Commercial
Trade Name
FDA
EMA
Aspruzyo (generic drugs available since 2013-07-29, discontinued: Ranexa)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ranolazine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ASPRUZYO SPRINKLE | Sun Pharmaceuticals | N-216018 RX | 2022-02-28 | 2 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aspruzyo sprinkle | New Drug Application | 2022-03-02 |
| ranexa | New Drug Application | 2020-12-01 |
| ranolazine | ANDA | 2023-05-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| angina pectoris | EFO_0003913 | D000787 | I20 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
82 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary artery disease | D003324 | I25.1 | — | 1 | 4 | 8 | 1 | 13 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 1 | 4 | 2 | 1 | 11 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 3 | 2 | 3 | 1 | 8 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 4 | 2 | 1 | 1 | 7 |
| Stable angina | D060050 | I20.8 | — | — | — | 5 | — | 5 | |
| Angina pectoris | D000787 | EFO_0003913 | I20 | — | — | 1 | 2 | — | 3 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | — | 3 | — | 3 |
| Microvascular angina | D017566 | — | 1 | — | 1 | — | 2 | ||
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | 2 | — | 2 |
| Ventricular tachycardia | D017180 | I47.2 | — | — | — | 1 | 1 | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | 1 | — | 1 | 3 |
| Pulmonary arterial hypertension | D000081029 | 1 | — | 1 | — | — | 2 | ||
| Recurrence | D012008 | — | 1 | 1 | — | — | 1 | ||
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 1 | 1 | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | 1 | — | — | 1 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | 1 | — | — | 1 | 2 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | — | — | — | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 1 | — | — | — | 1 | |
| Dilated cardiomyopathy | D002311 | EFO_0000407 | I42.0 | — | 1 | — | — | — | 1 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | 1 | — | — | — | 1 | |
| Romano-ward syndrome | D029597 | Orphanet_101016 | I45.8 | — | 1 | — | — | — | 1 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | — | — | 1 | 1 |
| Echocardiography | D004452 | — | — | — | — | 1 | 1 | ||
| Prostatic neoplasms | D011471 | C61 | — | — | — | — | 1 | 1 | |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | RANOLAZINE |
| INN | ranolazine |
| Description | N-(2,6-dimethylphenyl)-2-{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl}acetamide is an aromatic amide obtained by formal condensation of the carboxy group of 2-{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl}acetic acid with the amino group of 2,6-dimethylaniline. It is a monocarboxylic acid amide, an aromatic amide, a N-alkylpiperazine, a secondary alcohol and a monomethoxybenzene. |
| Classification | Small molecule |
| Drug class | antiarrhythmic/antianginal/antihypertensive agents, phthalazine like structure |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 95635-55-5 |
| RxCUI | 35829 |
| ChEMBL ID | CHEMBL1404 |
| ChEBI ID | 87690 |
| PubChem CID | 56959 |
| DrugBank | DB00243 |
| UNII ID | A6IEZ5M406 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Ranexa - Gilead Sciences
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,012 adverse events reported
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