Carbamazepine
As of the edition of 20 October 2026, Carbamazepine is a small molecule: marketed, first approved in 1963 (CH); 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 2001
- Kind
- Small molecule
- Brand name
- Tegretol
- First approved
- 5 June 1963 (CH)
- Approvals on record
- 21 in 6 regions
- Holder of the most recent approval
- Lundbeck; 7 holders in all
- Registered trials
- 102, 5 stopped early
- Disease areas
- Nervous system; Mental health; Infections; Lungs and airways; Chemically induced; Mouth and teeth
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.
Companies that need a new molecule because of this drug
10 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product10 company-target rows are on route B because of Carbamazepine.
See the 10 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
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 | 12 | 6 | 2 | 1 |
| Phase 1 | 59 | 51 | 6 | 2 |
| Phase 2 | 6 | 5 | 0 | 0 |
| Phase 3 | 8 | 7 | 0 | 1 |
| Phase 4 | 17 | 12 | 0 | 1 |
| All trials | 102 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 1969 to now |
| Takeda | Later holder | 1997 to now |
| Validus Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2005 to now |
| Lundbeck | Later holder and Lead sponsor of trials | 2007 to now |
| GEIGY Pharmaceuticals | Applicant |