Efinaconazole
As of the edition of 20 October 2026, Efinaconazole is a small molecule: marketed, first approved in 2013 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Jublia
- First approved
- 2 October 2013 (CA)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Kaken Pharmaceutical; 2 holders in all
- Registered trials
- 7, 0 stopped early
- Disease areas
- Infections; Skin and connective tissue
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Dow Pharmaceutical Sciences | Applicant and Lead sponsor of trials | 2007 to now |
| Bausch Health | Acquired holder and Lead sponsor of trials | 2013 to now |
| Kaken Pharmaceutical | Applicant | 2014 to now |