Fosphenytoin
As of the edition of 20 October 2026, Fosphenytoin is a small molecule: marketed, first approved in 1996 (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 2011
- Kind
- Small molecule
- Brand name
- Cerebyx
- First approved
- 5 August 1996 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Lupin; 3 holders in all
- Registered trials
- 4, 1 stopped early
- Disease areas
- Nervous system; Heart and blood vessels; Injuries; Mouth and teeth
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 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 4 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator and Applicant | 1996 to now |
| Nobelpharma | Applicant and Lead sponsor of trials | 2009 to now |
| Lupin | Acquired holder | 2022 to now |