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Drug ReportsMexiletine hcl
Mexitil, Namuscla(mexiletine hydrochloride)
Mexiletine, 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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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
cardiovascular diseasesD002318
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
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
MEXITILBoehringer IngelheimN-018873 DISCN1985-12-30
3 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
mexiletine hcl2008-04-29
mexiletine hydrochlorideANDA2024-08-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myotonic disordersOrphanet_606D020967G71.1
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01B: Antiarrhythmics, class i and iii
— C01BB: Antiarrhythmics, class ib
— C01BB02: Mexiletine
HCPCS
No data
Clinical
Clinical Trials
30 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 tachycardiaD017180—I47.2——1214
TachycardiaD013610HP_0001649R00.0——1214
Cardiac arrhythmiasD001145EFO_0004269I49.9——21—3
Amyotrophic lateral sclerosisD000690HP_0007354G12.21—2—1—3
Motor neuron diseaseD016472EFO_0003782G12.2—2—1—3
SclerosisD012598———2—1—3
Muscle crampD009120HP_0003394——1—1—2
SpasmD013035—M62.83—1—1—2
PolyneuropathiesD011115EFO_0009562A69.22———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myotonic dystrophyD009223—G71.11—24—17
MyotoniaD009222HP_0002486——22—15
Myotonic disordersD020967Orphanet_606G71.1——2—24
Cardiovascular diseasesD002318HP_0001626———2——2
Heart diseasesD006331EFO_0003777I51.9——2——2
Ventricular fibrillationD014693HP_0001663I49.01——2——2
Myocardial infarctionD009203EFO_0000612I21——1——1
Heart arrestD006323EFO_0009492I46——1——1
InfarctionD007238EFO_0009463———1——1
Myotonia congenitaD009224—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 syndromesD009408———1———1
Tooth diseasesD014076———1———1
Charcot-marie-tooth diseaseD002607EFO_0004148G60.0—1———1
Hereditary sensory and motor neuropathyD015417—G60.0—1———1
InfectionsD007239EFO_0000544——1———1
Hiv infectionsD015658EFO_0000764B20—1———1
Peripheral nervous system diseasesD010523HP_0009830G64—1———1
Acquired immunodeficiency syndromeD000163EFO_0000765B20—1———1
Communicable diseasesD003141———1———1
Nervous system diseasesD009422—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 syndromeD008133HP_0001657I45.811————1
PharmacokineticsD010599——1————1
Pharmacological phenomenaD000069437——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 reactionsD064420—T88.7————11
Drug interactionsD004347——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMexiletine hydrochloride
INNmexiletine
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—
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Structure (InChI/SMILES or Protein Sequence)
Cc1cccc(C)c1OCC(C)N.Cl
Identifiers
PDB—
CAS-ID5370-01-4
RxCUI—
ChEMBL IDCHEMBL1200606
ChEBI ID6917
PubChem CID4178
DrugBankDB00379
UNII ID1U511HHV4Z (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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965 adverse events reported
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