Data updated: May 26, 2026
MEXITIL (mexiletine hydrochloride)
Cardiovascular
Approved 1985-12-30
2
Indications
--
Phase 3 Trials
1
Priority Reviews
40
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1985-12-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MEXITIL Approval History
1986
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Original
New Indication
New Form
Label Update
54 FDA actions from 1985 to 2004
Dec 2002 SUPPL Priority
Mfg · Manufacturing (CMC)
Sep 1999 SUPPL Priority
Mfg · Manufacturing (CMC)
May 1996 SUPPL
Label
Sep 1995 SUPPL Priority
Mfg
Jan 1992 SUPPL Priority
Mfg
Oct 1991 SUPPL
Label
Aug 1991 SUPPL Priority
Mfg
Mar 1989 SUPPL Priority
Mfg
Dec 1988 SUPPL Priority
Mfg
Jun 1988 SUPPL
Label
Dec 1987 SUPPL
Label
Sep 1987 SUPPL Priority
Mfg
May 1987 SUPPL Priority
Mfg
Dec 1985 ORIGINAL Priority
New Drug
What MEXITIL Treats
2 FDA approvalsOriginally approved for its first indication in 1985 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Dec 1985) Priority
- • Approved indication (Oct 1991)
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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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.