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Drug

Mexiletine hydrochloride

Approved · EMA
Late-stage development

Also known as Mexitil, mexiletine HCl.

1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mexiletine hydrochloride
Aliases & brands
Mexitilmexiletine HCl
RxNorm CUI
142138
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2018-12-18
Latest approval
2018-12-18
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-12-18Approval
Approval: Namuscla (EMA)

Indication: Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

2 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
2
registered trials across all phases
LATEST COMPLETION 1997
1
Active studies
1
Recruiting
1
Late-stage (III+)
1
Completed
PHASE DISTRIBUTIONn = 2
Phase 21Phase 2 / 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase II/III Double-Blind Study of Amitriptyline and Mexiletine for Painful Neuropathy in HIV Infection

CompletedPH IINational Institute of Allergy and Infectious Diseases (NIAID)n=2401997
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.