Mexitil

(mexiletine)

ApprovedSmall molecule

Mexiletine is used to treat abnormal heart rhythms (arrhythmias) by helping the heart maintain a regular beat. It works by stabilizing electrical activity in the heart muscle.[2] Mexitil is currently approved and in use across 14 indications[4].[1]

Mexitil is one of 222 small molecule programs targeting Charcot-Marie-Tooth disease. It is currently in Approved.

Indications

Total Trials

Active Trials

221

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Charcot-Marie-Tooth DiseaseApproved

Cardiac ArrhythmiaActive, not recruiting

Cardiac ArrestActive, not recruiting

Ventricular TachycardiaActive, not recruiting

Focal DystoniaActive, not recruiting

Myotonic Dystrophy Type 1Active, not recruiting

Myotonic DystrophyApproved

Sporadic Amyotrophic Lateral SclerosisActive, not recruiting

Tooth DiseaseActive, not recruiting

Steinert Myotonic DystrophyApproved

Charcot-Marie-Tooth DiseaseApproved

Approved

Cardiac ArrhythmiaApproved

Active, not recruiting

Cardiac ArrestPhase 3

Active, not recruiting

Ventricular TachycardiaApproved

Active, not recruiting

Focal DystoniaPhase 2

Active, not recruiting

Myotonic Dystrophy Type 1Phase 3

Active, not recruiting

Myotonic DystrophyApproved

Approved

Sporadic Amyotrophic Lateral SclerosisPhase 2

Active, not recruiting

Tooth DiseasePhase 2

Active, not recruiting

Steinert Myotonic DystrophyApproved

Approved

Showing 10 of 14 indications

Competition

Competitive Landscape

185 competitors in Irritable Bowel Syndrome

#DrugCompanyPhaseTrials

Mexitil

Boehringer Ingelheim

Approved

1 2

Lialda

Takeda

Phase 3

2 3

Xifaxan

SSalix

Phase 3

10 4

Zofran

Novartis

Phase 3

1 5

Amitiza

SSucampo Pharma Americas, LLC

Phase 3

5 6

Circadin

NNeurim Pharmaceuticals Ltd.

Phase 3

1 7

Zarontin

PParkedale

Phase 3

1 8

Mesalazine

Ferring

Phase 3

4 9

Saccharomyces Boulardii

BBiocodex

Phase 3

3 10

Trulance

SSalix

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Efficacy and Safety

NCT07097701

Q1 2028

Recruiting

Observational Study

NCT07154654

Clinical

Trials by Indication[1]

Myotonia3 trials

MExiletine Versus Lamotrigine in Non-Dystrophic Myotonias

Unknown status·UUniversity College, London·Phase 3·NCT05017155·60 enrolled

Mexiletine and Non Dystrophic Myotonias

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02336477·24 enrolled

Combined N-of-1 Trials Mexiletine vs Placebo in Patients With Non-Dystrophic Myotonia (NDM)

Completed·RRadboud University Medical Center·Phase 2·NCT02045667·30 enrolled

Myotonic Dystrophy Type 12 trials

Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2

Withdrawn·LLupin Ltd.·Phase 3·NCT04700046

Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1

Completed·UUniversity of Rochester·Phase 2·NCT01406873·42 enrolled

Sporadic Amyotrophic Lateral Sclerosis2 trials

Mexiletine in Sporadic Amyotrophic Lateral Sclerosis (SALS)

Completed·UUniversity of Washington·Phase 2·NCT01849770·75 enrolled

Mexiletine in Sporadic Amyotrophic Lateral Sclerosis

Completed·UUniversity of Washington·Phase 2·NCT02781454·20 enrolled

Effectiveness1 trial

Effectiveness of Mexiletine for Treating People With Non-Dystrophic Myotonia

Completed·—·Phase 2·NCT00832000·59 enrolled

Diabetic Neuropathy1 trial

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004647·40 enrolled

13 more indications

Focal Dystonia1 trial

Mexiletine for the Treatment of Focal Dystonia

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT00001784·24 enrolled

Irritable Bowel Syndrome1 trial

Effects of Mexiletine on Colonic Transit in a Patient With Irritable Bowel Syndrome - Constipation (IBS-C)

Completed·MMayo Clinic·Phase 1·NCT01717404·1 enrolled

CAR1 trial

Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)

Completed·UUniversity of Utah·Phase 3·NCT00000518

Tooth Disease1 trial

Mexiletine for Muscle Cramps in Charcot Marie Tooth Disease

Completed·UUniversity of Rochester·Phase 2·NCT02561702·4 enrolled

Efficacy and Safety1 trial

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR

Recruiting·LLupin Ltd.·Phase 3·NCT07097701·24 enrolled

Cardiac Arrest1 trial

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)

Completed·UUniversity of Washington·Phase 3·NCT00000464

Myotonic Disorders1 trial

Open Label Study in Adolescents and Children With Myotonic Disorders

Completed·LLupin Ltd.·Phase 3·NCT04624750·12 enrolled

Muscle Cramp1 trial

Mexiletine for the Treatment of Muscle Cramps in ALS

Completed·—·Phase 4·NCT01811355·23 enrolled

Observational Study1 trial

Prospective, Long Term, Observational Study (Patient Registry) of Paediatric Myotonic Disorders

Recruiting·LLupin Ltd.··NCT07154654·10 enrolled

Neuropathy1 trial

Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations

Completed·UUniversity of Kansas Medical Center·Phase 4·NCT02260388·402 enrolled

TED1 trial

Open-label Extension Study in Paediatric Patients Who Have Completed the MEX-NM-301 Study.

Active, not recruiting·LLupin Ltd.·N/A·NCT04622553·14 enrolled

Myotonic Dystrophy1 trial

An Observational Study to Describe the Long-term Safety and Effectiveness of Namuscla in the Symptomatic Management of Myotonia in Adult Patients With Non-dystrophic Myotonic Disorders

Completed·LLupin Ltd.··NCT04616807·53 enrolled

Unspecified2 trials

The Effect of Late Na Current Blocker Mexiletine on Giant T-wave Electrical Alternans(STOP-TWA)

Recruiting·FFirst Affiliated Hospital Xi'an Jiaotong University·N/A·NCT05619120·50 enrolled

Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02308748·22 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 30, 1985

MEXITIL

NDA NDA018873

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for mexiletine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Mexitil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — mexiletine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for mexiletine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018873). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Alpha Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Boehringer Ingelheim

Mexitil

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2028

Trials by Indication[1]

Myotonia3 trials

Myotonic Dystrophy Type 12 trials

Sporadic Amyotrophic Lateral Sclerosis2 trials

Effectiveness1 trial

Diabetic Neuropathy1 trial

Focal Dystonia1 trial

Irritable Bowel Syndrome1 trial

CAR1 trial

Tooth Disease1 trial

Efficacy and Safety1 trial

Cardiac Arrest1 trial

Myotonic Disorders1 trial

Muscle Cramp1 trial

Observational Study1 trial

Neuropathy1 trial

TED1 trial

Myotonic Dystrophy1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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