Drugs / Efinaconazole
Efinaconazole
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | JUBLIA | — | 2020-04-26 | fda.gov ↗ |
| Approved | US (FDA) | JUBLIA | — | 2014-06-06 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00777868 | Oct 2007 → Apr 2009 | tinea unguium | Dow Pharmaceutical Sciences | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03168841 | Jun 2017 → Jan 2019 | tinea unguium | Western University of Health Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01008033 | Nov 2009 → Nov 2011 | tinea unguium | Dow Pharmaceutical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01007708 | Nov 2009 → Dec 2011 | tinea unguium | Dow Pharmaceutical Sciences | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03280927 | Nov 2017 → Jan 2020 | tinea unguium | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT02812771 | Aug 2016 → Jan 2019 | fungal infection of the toenail | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT03098615 | Sep 2015 → May 2017 | tinea unguium | University of Alabama at Birmingham | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07382427 Comparator | Mar 2026 → Jan 2028 expected | fungal infection of the toenail | Onyx Axiom | Not yet recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03110029 Comparator | Sep 2015 → May 2017 | fungal infection of the toenail | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03022916 Comparator | Sep 2015 → Sep 2017 | — | University of Alabama at Birmingham | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Efinaconazole | “Evaluate anti-fungal activity and safety of efinaconazole in patients with mild to moderate toenail onychomycosis caused by dermatophytes that received a 48-week administration...” NCT03280927 ↗ |
| Known as | Clenafin | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103877 ↗ |
| Known as | Efinaconazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103877 ↗ |
| Known as | IDP-108 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01007708 ↗ |
| Known as | Jublia | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103877 ↗ |
| Known as | KP-103 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103877 ↗ |
| Modality | Small molecule | “a novel topical triazole antifungal” PMID 23377392 ↗ Feb 2013 |
| Route | Topical | “applied topically for 36 weeks” PMID 23377392 ↗ Feb 2013 |