Articaine
As of the edition of 20 October 2026, Articaine is a small molecule: marketed, first approved in 1979 (ES); acts on SCN10A, SCN11A and SCN1A and 7 more; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Septocaine
- First approved
- 1 June 1979 (ES)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Thea Pharma; 7 holders in all
- Registered trials
- 52, 4 stopped early
- Disease areas
- Mouth and teeth; Inherited and neonatal; Nervous system; Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Thea Pharma holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original 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 | 20 | 9 | 4 | 0 |
| Phase 1 | 4 | 3 | 0 | 0 |
| Phase 2 | 5 | 5 | 0 | 0 |
| Phase 3 | 7 | 5 | 1 | 0 |
| Phase 4 | 16 | 8 | 2 | 4 |
| All trials | 52 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| American Genomics | Applicant and Lead sponsor of trials | 2020 to now |
| Thea Pharma | Acquired holder | 2026 to now |