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
| 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 · 2 met primary | ||||||
| Phase 3 | NCT03168841 | Jun 2017 → Jan 2019 | tinea unguium | Western University of Health Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01007708 | Nov 2009 → Dec 2011 | tinea unguium | Dow Pharmaceutical Sciences | Completed | Met primary |
| Phase 3 | NCT01008033 | Nov 2009 → Nov 2011 | tinea unguium | Dow Pharmaceutical Sciences | Completed | Met primary |
| 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 |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT07382427 Comparator | Mar 2026 → Jan 2028 expected | fungal infection of the toenail | Onyx Axiom | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03110029 Comparator | Sep 2015 → May 2017 | fungal infection of the toenail | University of Alabama at Birmingham | Completed | No outcome recorded |
| — | NCT03022916 Comparator | Sep 2015 → Sep 2017 | — | University of Alabama at Birmingham | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-06-25 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 손∙발톱무좀 치료제 ‘주블리아’ 만 6세 이상 소아 투여 허가 확대 donga-st.com ↗
동아에스티(대표이사 사장 정재훈)는 손∙발톱무좀 치료제 ‘주블리아’가 식품의약품안전처로부터 용법∙용량 변경허가를 받아 투여 대상 연령이 만 6세 이상 소아까지 확대됐다고 25일 밝혔다. |
| 2023-04-26 | Dong-A ST Co., Ltd. | Results 동아ST, 주블리아 임상 4상에서 한국인 대상 높은 치료 효과 확인 donga-st.com ↗
주블리아의 임상 4상에서 완전치료율은 16.7%로 확인됐다. |
| 2017-05-17 | Dong-A ST Co., Ltd. | Regulatory 동아ST, 바르는 손발톱무좀치료제 신약 ‘주블리아’ 식약처 품목허가 획득 donga-st.com ↗
동아에스티(대표이사 사장 민장성)는 지난 16일 바르는 손발톱무좀치료제 신약 ‘주블리아(Jublia)’의 품목허가를 식품의약품안전처로부터 획득했다고 17일 밝혔다. |
| 2013-05-29 | Kaken Pharmaceutical | Regulatory カナダのバリアント社、爪真菌症治療剤「エフィナコナゾール」について米国食品医薬局(FDA)より審査完了通知(Complete Response Letter)を受領 eir-parts.net ↗ |
| 2011-12-19 | Kaken Pharmaceutical | Results バリアント社が、外用の爪真菌症治療剤に関する第III相臨床試験の結果を発表 eir-parts.net ↗ |
All press releases naming this drug 13 releases
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 NCT01008033 ↗ |
| 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 |