Mexiletine
Mexiletine, Namuscla (mexiletine) is a small molecule pharmaceutical. Mexiletine 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. The pharmaceutical is active against sodium channel protein type 4 subunit alpha.
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Commercial
Trade Name
FDA
EMA
Mexiletine (discontinued: Mexiletine, Mexitil)
Drug Products
FDA
EMA
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 hcl | 2008-04-29 | |
| mexiletine hydrochloride | ANDA | 2024-10-23 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ventricular tachycardia | D017180 | — | I47.2 | — | — | 1 | 2 | 2 | 5 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | — | 1 | 2 | 2 | 5 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 2 | 1 | — | 3 |
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | — | 2 | — | 1 | — | 3 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 2 | — | 1 | — | 3 |
| Sclerosis | D012598 | — | — | — | 2 | — | 1 | — | 3 |
| Muscle cramp | D009120 | HP_0003394 | — | — | 1 | — | 1 | — | 2 |
| Spasm | D013035 | — | M62.83 | — | 1 | — | 1 | — | 2 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myotonic dystrophy | D009223 | — | G71.11 | — | 2 | 4 | — | 1 | 7 |
| Myotonia | D009222 | HP_0002486 | — | — | 2 | 2 | — | 1 | 5 |
| Myotonic disorders | D020967 | Orphanet_606 | G71.1 | — | — | 2 | — | 2 | 4 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 2 | — | — | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 2 | — | — | 2 |
| Ventricular fibrillation | D014693 | HP_0001663 | I49.01 | — | — | 2 | — | — | 2 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | — | 1 | — | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 1 | — | — | 1 |
| Myotonia congenita | D009224 | — | G71.12 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nerve compression syndromes | D009408 | — | — | — | 1 | — | — | — | 1 |
| Tooth diseases | D014076 | — | — | — | 1 | — | — | — | 1 |
| Charcot-marie-tooth disease | D002607 | EFO_0004148 | G60.0 | — | 1 | — | — | — | 1 |
| Hereditary sensory and motor neuropathy | D015417 | — | G60.0 | — | 1 | — | — | — | 1 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | — | 1 | — | — | — | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 1 | — | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | 1 | — | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Pharmacological phenomena | D000069437 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mexiletine |
| 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 |
Identifiers
| PDB | — |
| CAS-ID | 31828-71-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL558 |
| ChEBI ID | 6916 |
| PubChem CID | 4178 |
| DrugBank | DB00379 |
| UNII ID | 1U511HHV4Z (ChemIDplus, GSRS) |
Target
Agency Approved
SCN4A
SCN4A
Organism
Homo sapiens
Gene name
SCN4A
Gene synonyms
NCBI Gene ID
Protein name
sodium channel protein type 4 subunit alpha
Protein synonyms
CTC-264K15.6, skeletal muscle sodium channel alpha subunit, skeletal muscle voltage-dependent sodium channel type IV alpha subunit, SkM1, Sodium channel protein skeletal muscle subunit alpha, Sodium channel protein type IV subunit alpha, sodium channel, voltage-gated, type IV, alpha subunit, Voltage-gated sodium channel subunit alpha Nav1.4
Uniprot ID
Mouse ortholog
Scn4a (110880)
sodium channel protein type 4 subunit alpha (Q9ER60)
Alternate
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Variants
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Financial
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Estimated US medical usage
Mexiletine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,675 documents
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Safety
Black-box Warning
Black-box warning for: Mexiletine hydrochloride
Adverse Events
Top Adverse Reactions
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964 adverse events reported
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