Mexitil, Namuscla(mexiletine hydrochloride)
Mexitil, Namuscla (mexiletine hydrochloride) is a small molecule pharmaceutical. Mexiletine hydrochloride was first approved as Mexitil on 1985-12-30. It is used to treat cardiac arrhythmias, diabetic neuropathies, ventricular fibrillation, and ventricular premature complexes in the USA. It has been approved in Europe to treat myotonic disorders.
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mexiletine hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
MEXITIL | Boehringer Ingelheim | N-018873 DISCN | 1985-12-30 | 3 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
mexiletine hydrochloride | ANDA | 2023-06-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
cardiac arrhythmias | EFO_0004269 | D001145 | I49.9 |
diabetic neuropathies | EFO_1000783 | D003929 | — |
ventricular fibrillation | EFO_0004287 | D014693 | I49.01 |
ventricular premature complexes | — | D018879 | I49.3 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
24 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 2 | — | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Myotonic dystrophy | D009223 | G71.11 | — | 2 | 2 | — | 1 | 5 | |
Myotonic disorders | D020967 | Orphanet_606 | G71.1 | — | — | 1 | — | 1 | 2 |
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | — | — | 2 |
Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 2 | — | — | 2 |
Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 2 | — | — | 2 |
Ventricular fibrillation | D014693 | EFO_0004287 | I49.01 | — | — | 2 | — | — | 2 |
Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
Heart arrest | D006323 | EFO_0009492 | I46 | — | — | 1 | — | — | 1 |
Myotonia congenita | D009224 | G71.12 | — | — | 1 | — | — | 1 | |
Ventricular tachycardia | D017180 | I47.2 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Charcot-marie-tooth disease | D002607 | G60.0 | — | 1 | — | — | — | 1 | |
Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
Peripheral nervous system diseases | D010523 | G64 | — | 1 | — | — | — | 1 | |
Myotonia | D009222 | — | 1 | — | — | — | 1 | ||
Surgical amputation | D000671 | — | 1 | — | — | — | 1 | ||
Chronic pain | D059350 | HP_0012532 | — | 1 | — | — | — | 1 | |
Dystonia | D004421 | HP_0001332 | G24 | — | 1 | — | — | — | 1 |
Blepharospasm | D001764 | G24.5 | — | 1 | — | — | — | 1 | |
Spasm | D013035 | M62.83 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
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Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | MEXILETINE HYDROCHLORIDE |
INN | mexiletine |
Description | Mexiletine is an aromatic ether which is 2,6-dimethylphenyl ether of 2-aminopropan-1-ol. It has a role as an anti-arrhythmia drug. It is an aromatic ether and a primary amino compound. |
Classification | Small molecule |
Drug class | — |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Cc1cccc(C)c1OCC(C)N.Cl |
Identifiers
PDB | — |
CAS-ID | 5370-01-4 |
RxCUI | — |
ChEMBL ID | CHEMBL1200606 |
ChEBI ID | 6917 |
PubChem CID | 4178 |
DrugBank | DB00379 |
UNII ID | 1U511HHV4Z (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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722 adverse events reported
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