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Drugs in development · updated 11 November 2026
Mexiletine: clinical trials and development status
Other names and codes: Namuscla
As of 11 November 2026 Mexiletine is in 4 active clinical trials (recruiting or ongoing, phases I–III) for 3 diseases. The most advanced phase is III.
Authorisation
- EU yes, since 18 Dec 2018 (EMA)
- Italy yes, Namuscla (AIFA register)
- Germany yes (EU authorisation)
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
A local anesthetic and antiarrhythmic (Class IB) agent structurally related to lidocaine. Mexiletine exerts its antiarrhythmic effect by inhibiting the inward sodium current in cardiac cells, thereby reducing the rate of rise of the cardiac action potential (phase 0) and decreases automaticity in the Purkinje fibers. This slows nerve impulses in the heart and stabilizes the heartbeat. Mexiletine's anesthetic activity is due to its ability to block sodium influx in peripheral nerves, thereby reducing the rate and intensity of pain impulses reaching the central nervous system.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Myotonic dystrophy | III | 2 | NCT06523400 |
| Bulbo-Spinal Atrophy, X-Linked | II–III | 1 | NCT06862596 |
| Myotonia | III | 1 | NCT07097701 |
Sites in Europe
8 sites of the active trials in 6 European countries, 8 recruiting.
- Belgium2
- United Kingdom2
- Denmark1
- Germany1
- Italy1
- Spain1
Sites declared by the sponsors on ClinicalTrials.gov; region worked out by Phuturdex from the geographic point. The list of sites with city and recruitment status is in the app. See the sites →
Everything on Mexiletine
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 11 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.