Drugs / Luliconazole

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Luliconazole ClinicalTrials.gov intervention name — accepted as the source's own label NCT07333170
7

NCT05110638

NCT02394340

NCT01431820

NCT02767271

NCT02767947

NCT01044381

NCT00869336

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