Drugs / Mexiletine
Mexiletine
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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01717404 | Oct → Nov 2012 | irritable bowel syndrome | Mayo Clinic | Completed | No outcome recorded |
| Phase 25 trials · 2 met primary | ||||||
| Phase 2 | NCT02561702 | Sep 2015 → Dec 2016 | Charcot-Marie-Tooth disease | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT00832000 | Dec 2008 → Mar 2011 | nondystrophic myotonia | Richard Barohn, MD | Completed | Met primary |
| Phase 2 | NCT00001784 | Jul 1998 → Jul 2002 | dystonic disorder | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00383682 | Jul 1997 → Apr 2003 | chronic pain syndrome | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | Met primary |
| Phase 2 | NCT00000793 | ? → Oct 1997 | HIV infectious disease, peripheral nervous system disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06549400 | Sep 2025 → May 2028 expected | myotonic dystrophy | Lupin Ltd. | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT04624750 | Sep 2021 → Jun 2024 | myotonic dystrophy | Lupin Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02336477 | Jun 2011 → Jan 2014 | nondystrophic myotonia, paramyotonia congenita of Von Eulenburg | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT00004647 | Mar 1993 → Feb 1999 | diabetic neuropathy | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 3 | NCT00000464 | Apr 1987 → Dec 1992 | cardiac arrest, myocardial infarction, ventricular fibrillation | University of Washington | Completed | No outcome recorded |
| Phase 3 | NCT00000518 | Jul 1985 → Dec 1992 | sudden cardiac arrest, ventricular fibrillation, ventricular tachycardia | University of Utah | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02260388 | Oct 2014 → Sep 2017 | idiopathic progressive polyneuropathy | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06669299 | Jun 2025 → Dec 2027 expected | ventricular tachycardia | IRCCS Ospedale San Raffaele | Recruiting | No outcome recorded |
| — | NCT05619120 | Jan 2023 → Jun 2025 | — | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| — | NCT04622553 | Nov 2021 → Jun 2026 | myotonic syndrome | Lupin Ltd. | Completed | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT02308748 Comparator | May → Jun 2014 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| 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 2/3 | NCT06862596 Comparator | Feb 2025 → Dec 2027 expected | bulbospinal muscular atrophy | Masahisa Katsuno | Recruiting | No outcome recorded |
| Phase 3 | NCT07097701 Comparator | Sep 2025 → Jan 2027 expected | myotonic syndrome | Lupin Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06523400 Comparator | Feb 2025 → Jun 2027 expected | 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 4 | NCT02114528 Comparator | Oct 2014 → Nov 2015 | ventricular tachycardia | Ottawa Heart Institute Research Corporation | Terminated | No outcome recorded Stop: Enrollment |
| 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 |
News releases announcing trial results or a regulatory action · 6
All press releases naming this drug 7 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 30 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 | 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)” NCT06523400 ↗ |
| 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 ↗ |