Phenytoin
As of the edition of 20 October 2026, Phenytoin is a small molecule: marketed, first approved in 1945 (ES); acts on SCN10A, SCN11A and SCN1A and 7 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1988
- Kind
- Small molecule
- Brand name
- Dilantin
- First approved
- 1 February 1945 (ES)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- EFISCIENS (MALTE); 5 holders in all
- Registered trials
- 54, 7 stopped early
- Disease areas
- Nervous system; Immune system; Mental health; Infections; Blood and lymph; Injuries
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
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 | 8 | 5 | 1 | 0 |
| Phase 1 | 22 | 20 | 2 | 0 |
| Phase 2 | 9 | 4 | 1 | 3 |
| Phase 3 | 6 | 4 | 1 | 1 |
| Phase 4 | 9 | 4 | 1 | 3 |
| All trials | 54 |