MEXITIL (mexiletine hydrochloride) · Boehringer Ingelheim
MEXITIL is FDA-approved to treat 2 conditions (same as MEXILETINE HYDROCHLORIDE).
Details
- Status
- Discontinued
- First Approved
- 1985-12-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MEXITIL Approval History
What MEXITIL Treats
2 indicationsMEXITIL is approved for 2 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ventricular Arrhythmia
- Ventricular Tachycardia
Same approved indications as MEXILETINE HYDROCHLORIDE (same active ingredient).
Boehringer Ingelheim's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06862596 Med-SBMA | CAMCR-026 jRCT2041240174 | Ph 2, Ph 3 | recruiting | Clinical Trial of Mexiletine Hydrochloride for Spinal and Bulbar Muscular Atrophy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MEXITIL FDA Label Details
Indications & Usage
MEXITIL is FDA-approved to treat 2 conditions — same approved indications as MEXILETINE HYDROCHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.