Drugs / Mexiletine
Mexiletine
also known as
(rs)-mexiletine · Dl-mexiletine · Katen · KO 1173 CL · KO-1173 · Mexiletina · mexiletine HCl · Mexiletine hydrochloride · +5 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Namuscla | — | 2018-12-18 | europa.eu ↗ |
| Label expansion | US (FDA) | MEXITIL | — | 1991-10-21 | fda.gov ↗ |
| Approved | US (FDA) | MEXITIL | — | 1985-12-30 | fda.gov ↗ |
Trials 16 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02308748 Comparator | May → Jun 2014 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT02781454 Comparator | Oct 2016 → Sep 2018 | sporadic amyotrophic lateral sclerosis | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT02045667 Comparator | Jan 2014 → Jun 2015 | nondystrophic myotonia | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01849770 Comparator | Jul 2013 → Aug 2014 | sporadic amyotrophic lateral sclerosis | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT01406873 Comparator | Jun 2011 → Feb 2017 | myotonic dystrophy | University of Rochester | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06862596 Comparator | Feb 2025 → Dec 2027 expected | bulbospinal muscular atrophy | Masahisa Katsuno | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07097701 Comparator | Sep 2025 → Jan 2027 expected | myotonic syndrome | Lupin Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06523400 Comparator | Feb 2025 → Mar 2026 overdue | myotonic dystrophy | Lupin Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT04700046 Comparator | Sep 2021 → Jul 2024 | myotonic dystrophy | Lupin Ltd. | Withdrawn | No outcome recorded |
| Phase 3 | NCT05017155 Comparator | Aug 2021 → Aug 2023 | nondystrophic myotonia | University College, London | Unknown | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02114528 Comparator | Oct 2014 → Nov 2015 | ventricular tachycardia | Ottawa Heart Institute Research Corporation | Terminated | No outcome recorded |
| Phase 4 | NCT01811355 Comparator | May 2013 → Mar 2016 | amyotrophic lateral sclerosis | Bjorn Oskarsson, MD | Completed | No outcome recorded |
| Phase 4 | NCT00905853 Comparator | May 2009 → Dec 2015 | ventricular tachycardia | John Sapp | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05639257 Comparator | Dec 2022 → Apr 2024 | nondystrophic myotonia | Grete Andersen, MD | Unknown | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mexiletine | “Patients who 'failed' amiodarone (greater or equal to 300mg/day) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day” NCT00905853 ↗28“Either one or more of the following antiarrhythmic drugs: sotalol, mexiletine, procainamide, or amiodarone.” NCT02114528 ↗ |
| Known as | (rs)-mexiletine | ChEMBL registry synonym — accepted as the source's own label CHEMBL558 ↗ |
| Known as | Dl-mexiletine | ChEMBL registry synonym — accepted as the source's own label CHEMBL558 ↗ |
| Known as | Katen | ChEMBL registry synonym — accepted as the source's own label CHEMBL558 ↗ |
| Known as | KO 1173 CL | ChEMBL registry synonym — accepted as the source's own label CHEMBL558 ↗ |
| Known as | KO-1173 | ChEMBL registry synonym — accepted as the source's own label CHEMBL558 ↗ |
| Known as | Mexiletina | ChEMBL registry synonym — accepted as the source's own label CHEMBL558 ↗ |
| Known as | mexiletine HCl | “Mexiletine 167 mg (equivalent to mexiletine HCl 200 mg) immediate release, oral capsules.” NCT04700046 ↗ |
| Known as | Mexiletine hydrochloride | “Mexiletine hydrochloride 300 mg is administered orally divided into three times a day after meals for 12 weeks.” NCT06862596 ↗ |
| Known as | Mexiletine PR | “Mexiletine PR 167 mg (mexiletine HCl 200 mg) Mexiletine PR 333 mg (mexiletine HCl 400 mg) OR Mexiletine PR 500 mg (mexiletine HCl 600 mg)” NCT06523400 ↗ |
| Known as | Mexitil | ChEMBL registry synonym — accepted as the source's own label CHEMBL558 ↗ |
| Known as | Mexitil p.l. | ChEMBL registry synonym — accepted as the source's own label CHEMBL558 ↗ |
| Known as | Namuscla | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05639257 ↗ |
| Known as | NSC-758639 | ChEMBL registry synonym — accepted as the source's own label CHEMBL558 ↗ |
| Action | Restore | “Incubation of cells that expressed this variant with mexiletine restored their sodium current” PMID 24613995 ↗ Mar 2014 |
| Modality | Small molecule | “Mexiletine is a lidocaine-derivate and belongs to the class of 1B antiarrhythmic agents (Vaughan-Williams Classification of Antiarrhytmica).” NCT02045667 ↗ |
| Route | Oral | “can be taken by mouth” NCT00001784 ↗ |