Quinaglute, Nuedexta(quinidine gluconate)
Cardioquin, Nuedexta, Quinidine (quinidine gluconate) is a small molecule pharmaceutical. Quinidine gluconate was first approved as Quinaglute on 1982-01-01. It is used to treat atrial fibrillation, atrial flutter, and cardiac arrhythmias in the USA. It has been approved in Europe to treat neurobehavioral manifestations.
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Commercial
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Combinations
Nuedexta (generic drugs available since 1982-01-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dextromethorphan hydrobromide
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Quinidine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NUEDEXTA | Avanir Pharmaceuticals | N-021879 RX | 2010-10-29 | 1 products, RLD, RS |
Quinidine gluconate
Quinidine polygalacturonate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CARDIOQUIN | Pharmaceutical Research Associates Inc | N-011642 DISCN | 1982-01-01 | 1 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nuedexta | New Drug Application | 2023-12-01 |
| quinidine gluconate | ANDA | 2024-08-27 |
| quinidine sulfate | ANDA | 2023-11-08 |
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Agency Specific
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Clinical
Clinical Trials
65 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 7 | 1 | 1 | 10 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 6 | 1 | 1 | 8 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | 3 | 1 | 2 | 7 |
| Brain injuries | D001930 | — | S06.9 | — | 1 | 1 | 1 | 1 | 4 |
| Pseudobulbar palsy | D020828 | EFO_1001131 | — | — | — | 1 | 3 | — | 4 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 1 | 1 | 1 | — | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 1 | 1 | — | 2 |
| Metabolic clearance rate | D008657 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psychomotor agitation | D011595 | — | — | — | 2 | 6 | — | — | 8 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | 1 | 4 | — | 2 | 6 |
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | 1 | 2 | 2 | — | — | 4 |
| Sclerosis | D012598 | — | — | — | 2 | 2 | — | — | 4 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | 2 | 1 | — | — | 3 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | 1 | — | 1 | 3 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 3 | — | — | 3 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 3 | — | — | 3 |
| Ventricular fibrillation | D014693 | HP_0001663 | I49.01 | — | 1 | 2 | — | — | 3 |
| Syndrome | D013577 | — | — | — | 1 | 2 | — | 1 | 3 |
Show 19 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 2 | — | — | — | 3 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | 2 | — | — | — | 3 |
| Depression | D003863 | — | F33.9 | — | 2 | — | — | — | 2 |
| Malaria | D008288 | EFO_0001068 | B54 | — | 1 | — | — | — | 1 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | — | — | — | 1 |
| Disease progression | D018450 | — | — | — | 1 | — | — | — | 1 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | 1 | — | — | — | 1 |
| Dyskinesias | D020820 | HP_0002310 | G24 | — | 1 | — | — | — | 1 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | — | 1 | — | — | — | 1 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | — | — | — | — | 10 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
| Hepatitis b | D006509 | — | — | 1 | — | — | — | — | 1 |
| Respiratory syncytial virus infections | D018357 | EFO_1001413 | — | 1 | — | — | — | — | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | — | — | — | — | 1 |
| Constipation | D003248 | HP_0002019 | K59.0 | 1 | — | — | — | — | 1 |
| Covid-19 | D000086382 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | HP_0001903 | D64.9 | — | — | — | — | 1 | 1 |
| Vascular dementia | D015140 | — | F01 | — | — | — | — | 1 | 1 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | — | — | — | — | 1 | 1 |
| Lewy body disease | D020961 | EFO_0006792 | G31.83 | — | — | — | — | 1 | 1 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | — | — | — | 1 | 1 |
| Hyperhomocysteinemia | D020138 | — | — | — | — | — | — | 1 | 1 |
| Vitamin b 12 deficiency | D014806 | EFO_0000734 | E53.8 | — | — | — | — | 1 | 1 |
| Tauopathies | D024801 | — | — | — | — | — | — | 1 | 1 |
| Frontotemporal dementia | D057180 | HP_0002145 | G31.0 | — | — | — | — | 1 | 1 |
| Tdp-43 proteinopathies | D057177 | — | — | — | — | — | — | 1 | 1 |
Show 4 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Quinidine gluconate |
| INN | — |
| Description | Quinidine is a cinchona alkaloid consisting of cinchonine with the hydrogen at the 6-position of the quinoline ring substituted by methoxy. It has a role as an alpha-adrenergic antagonist, an antimalarial, an anti-arrhythmia drug, a sodium channel blocker, a muscarinic antagonist, a potassium channel blocker, a P450 inhibitor, an EC 1.14.13.181 (13-deoxydaunorubicin hydroxylase) inhibitor, an EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor and a drug allergen. It derives from a hydride of a cinchonan. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=C[C@H]1CN2CC[C@H]1C[C@@H]2[C@@H](O)c1ccnc2ccc(OC)cc12.O=C(O)[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO |
Identifiers
| PDB | — |
| CAS-ID | 56-54-2 |
| RxCUI | 9068 |
| ChEMBL ID | CHEMBL1200437 |
| ChEBI ID | 27502 |
| PubChem CID | 441074 |
| DrugBank | DB00908 |
| UNII ID | — |
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5,247 adverse events reported
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