luliconazole

Trade name: luzu

Small moleculeapproved

Approved

Nov 14, 2013

Luliconazole (trade names Luzu, Lulicon) is an imidazole antifungal drug. As a 1% topical cream, It is indicated for the treatment of athlete's foot, jock itch, and ringworm caused by dermatophytes such as Trichophyton rubrum, Microsporum gypseum and Epidermophyton floccosum. Luliconazole is an antifungal that belongs to the azole class. Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol. Pharmacokinetic and safety results from phase 1 studies in patients with onychomycosis have demonstrated high concentrations of luliconazole within the nail plates of the great toe and have shown that this agent is well tolerated when administered as a 10% solution. — NCATS

Clinical trial activity

10 trials · 5 clinical orgs · 2 marketing orgs

Phase 1
2
Phase 2
6
Phase 3
5
Phase 4
2

Earliest trial started Mar 1, 2009 (NCT00869336)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2011

    Medicis — Earliest Phase 3 Sponsor(trial)

  3. Nov 14, 2013

    Medicis — Earliest FDA Approval

  4. Nov 14, 2013

    Bausch Health Companies — Marketing Organization

  5. Nov 14, 2013

    Medicis — NDA Organization

  6. Nov 14, 2013

    Bausch Health Companies — NDA Secondary Org

Indications

Approved for

Mechanism of action

Approval history

  • approvedNov 14, 2013

Chemistry & pharmacology

Loading structure…

SMILES

ClC1=CC(Cl)=C(C=C1)[C@@H]2CS\C(S2)=C(\C#N)N3C=CN=C3
Mol. weight
354.277 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 33525
  • 4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene-1-imidazolylacetonitrile
  • lulicon
  • luliconazole
  • luliconazole
  • luliconazole
  • luliconazole
  • luliconazole
  • luliconazole
  • luliconazole
  • luliconazole
  • luliconazole
  • luliconazole
  • luliconazole
  • luzu
  • luzu
  • luzu
  • nnd502
  • nnd 502
  • nnd-502
  • nnd-502
  • nnd-502
  • nnd-502
  • pr-2699
  • pr-2699
  • pr-2699
  • product 33525

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05110638Phase 1Sep 13, 2021J&S Studies Inc., Sato Pharmaceutical
NCT02767947Phase 4Feb 8, 2016Bausch Health Companies
NCT02767271Phase 4Dec 14, 2015Bausch Health Companies
NCT01431820Phase 2/Phase 3 (Phase 3)May 1, 2012Tinea Pharmaceuticals
NCT01396811Phase 3Jul 1, 2011Medicis
NCT01396785Phase 3Jul 1, 2011Medicis
NCT01349998Phase 3May 1, 2011Tinea Pharmaceuticals
NCT01342315Phase 3May 1, 2011Medicis
NCT01044381Phase 1/Phase 2 (Phase 2)Dec 1, 2010J&S Studies Inc., Tinea Pharmaceuticals
NCT00869336Phase 2Mar 1, 2009Tinea Pharmaceuticals
Showing 10 of 10 trials
Page 1 / 1

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Tinea PharmaceuticalsFor profit4422009
MedicisFor profit3312011
Bausch Health CompaniesFor profit2212015
J&S Studies Inc.For profit2022010
Sato PharmaceuticalFor profit1112021
5 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Bausch Health CompaniesFor profitMKTGNov 14, 2013
Bausch Health CompaniesFor profitNDA2Nov 14, 2013
MedicisFor profitNDANov 14, 2013