Wednesday, July 8, 2026

Drug profile · INN

mexiletine hydrochloride

mexiletine hydrochloride (MEXILETINE HYDROCHLORIDE) is a sodium channel alpha subunit blocker. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — mexiletine hydrochloride
US status
approved
Class
Route
ORAL
Patents
0
Programs
2
Data quality
0.89

Quick answer

mexiletine hydrochloride (MEXILETINE HYDROCHLORIDE) is a sodium channel alpha subunit blocker. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN mexiletine hydrochloride
Brand MEXILETINE HYDROCHLORIDE
Mechanism Sodium channel alpha subunit blocker
Target Sodium channel alpha subunit
Route ORAL
Formulation CAPSULE

Mechanism of action

Sodium channel alpha subunit blocker

Primary target: Sodium channel alpha subunit

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. MEX-DM-303 Phase 3 · Lupin (Europe) · Myotonic Dystrophy type 1 and type 2 (DM1/DM2)
  2. mexiletine Phase 3 · Ultragenyx UK · Pain

Related & competitor drugs

  1. carbamazepine Sodium channel alpha subunit blocker
  2. disopyramide phosphate Sodium channel alpha subunit blocker
  3. eslicarbazepine acetate Nervous system (N03)
  4. fosphenytoin sodium Sodium channel alpha subunit blocker
  5. lacosamide Nervous system (N03)
  6. lamotrigine Sodium channel alpha subunit blocker

Frequently asked questions

What is mexiletine hydrochloride?

mexiletine hydrochloride (MEXILETINE HYDROCHLORIDE) is a sodium channel alpha subunit blocker. Associated with Teva Pharma GmbH. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for mexiletine hydrochloride?

MEXILETINE HYDROCHLORIDE is a marketed brand name for mexiletine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of mexiletine hydrochloride?

mexiletine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.