Drugs / Luliconazole
Luliconazole
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LUZU | — | 2018-02-20 | fda.gov ↗ |
| Approved | US (FDA) | LUZU | — | 2013-11-14 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05110638 | Sep 2021 → Dec 2022 | fungal infection of the toenail | SATO Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01044381 | Dec 2010 → May 2011 | tinea unguium | Topica Pharmaceuticals | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00869336 | Mar → Sep 2009 | tinea pedis | Tinea Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01431820 | May 2012 → Jun 2014 | — | Topica Pharmaceuticals | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07333170 | Feb → Jul 2026 overdue | pityriasis versicolor | PAEC General Hospital, Islamabad | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT02767947 | Feb → Jun 2016 | tinea corporis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02767271 | Dec 2015 → Apr 2016 | dermatophytosis of groin and perianal area, tinea pedis | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02394340 | Feb → Apr 2015 | dermatophytosis of groin and perianal area, tinea pedis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2016-01-22 | SATO Pharmaceutical Co., Ltd. | Regulatory 爪白癬治療剤「ルコナック®爪外用液５％」
製造販売承認取得のお知らせ sato-seiyaku.co.jp ↗
佐藤製薬株式会社（本社：東京都港区、社長：【佐藤誠一】）は、2016年1月22日付で有効成分ルリコナゾールを含有した爪白癬治療剤「ルコナック®爪外用液５％」の製造販売承認を取得しましたので、お知らせいたします。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-07-01 | SATO Pharmaceutical Co., Ltd. | シンガポールにおける 「LUCONAC®, External Solution for Nails 5% w/w (Luliconazole Solution)」の 発売のお知らせ sato-seiyaku.co.jp ↗ |
| 2016-01-22 | SATO Pharmaceutical Co., Ltd. | 爪白癬治療剤「ルコナック®爪外用液５％」 製造販売承認取得のお知らせ sato-seiyaku.co.jp ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Luliconazole | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02394340 ↗ |
| Known as | Lulicon | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105689 ↗ |
| Known as | Luliconazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105689 ↗ |
| Known as | Luzu | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105689 ↗ |
| Known as | NND-502 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105689 ↗ |
| Known as | PR-2699 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105689 ↗ |
| Known as | SKX-16 | “SKX-16 (Luliconazole 10% Solution)” NCT05110638 ↗ |
| Modality | Small molecule | — CHEMBL2105689 ↗ |
| Route | Topical | “Topical cream applied daily for 2 weeks” NCT00869336 ↗ |