Drug

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

GeneProteinUniProt
SCN1ASodium channel protein type 1 subunit alphaP35498
SCN4ASodium channel protein type 4 subunit alphaP35499
SCN7ASodium channel protein type 7 subunit alphaQ01118
SCN5ASodium channel protein type 5 subunit alphaQ14524
SCN9ASodium channel protein type 9 subunit alphaQ15858
SCN2ASodium channel protein type 2 subunit alphaQ99250
SCN3ASodium channel protein type 3 subunit alphaQ9NY46
SCN11ASodium channel protein type 11 subunit alphaQ9UI33
SCN8ASodium channel protein type 8 subunit alphaQ9UQD0
SCN10ASodium channel protein type 10 subunit alphaQ9Y5Y9

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated20940
Phase 14300
Phase 25500
Phase 37510
Phase 416824
All trials52

Who has held its approvals

CompanyRoleYears
American GenomicsApplicant and Lead sponsor of trials2020 to now
Thea PharmaAcquired holder2026 to now