Mexiletine
As of the edition of 20 October 2026, Mexiletine is a small molecule: marketed, first approved in 1985 (US); acts on SCN10A, SCN11A and SCN1A and 7 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Mexitil
- First approved
- 30 December 1985 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Lupin; 2 holders in all
- Registered trials
- 18, 0 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Inherited and neonatal; Heart and blood vessels; Eye; Hormones
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| SCN1A | Sodium channel protein type 1 subunit alpha | P35498 |
| SCN4A | Sodium channel protein type 4 subunit alpha | P35499 |
| SCN7A | Sodium channel protein type 7 subunit alpha | Q01118 |
| SCN5A | Sodium channel protein type 5 subunit alpha | Q14524 |
| SCN9A | Sodium channel protein type 9 subunit alpha | Q15858 |
| SCN2A | Sodium channel protein type 2 subunit alpha | Q99250 |
| SCN3A | Sodium channel protein type 3 subunit alpha | Q9NY46 |
| SCN11A | Sodium channel protein type 11 subunit alpha | Q9UI33 |
| SCN8A | Sodium channel protein type 8 subunit alpha | Q9UQD0 |
| SCN10A | Sodium channel protein type 10 subunit alpha | Q9Y5Y9 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 2 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 5 | 5 | 0 | 0 |
| Phase 3 | 6 | 5 | 1 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Applicant | 1985 to now |
| Lupin | Applicant and Lead sponsor of trials | 2018 to now |