Amorolfine

Trade name: loceryl

Small moleculeexperimental

Amorolfine, is a morpholine antifungal drug that inhibits Δ14-sterol reductase and cholestenol Δ-isomerase, which depletes ergosterol and causes ignosterol to accumulate in the fungal cytoplasmic cell membranes. Marketed as Curanail, Loceryl, Locetar, and Odenil, amorolfine is commonly available in the form of a nail lacquer, containing 5% amorolfine hydrochloride as the active ingredient. It is used to treat onychomycosis. Amorolfine 5% nail lacquer in once-weekly or twice-weekly applications was shown in two decades-old studies to be between 60% and 71% effective in treating toenail onychomycosis; complete cure rates three months after stopping treatment were 38% and 46%. However, full experimental details of these trials were not available, and since they were first reported in 1992 there have been no subsequent trials. — Wikipedia

Clinical trial activity

16 trials · 16 clinical orgs · 0 marketing orgs

Phase 1
0
Phase 2
3
Phase 3
2
Phase 4
6

Earliest trial started Mar 1, 2007 (NCT00459537)

Timeline

2000s

  1. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Mechanism of action

Chemistry & pharmacology

Loading structure…

SMILES

CCC(C)(C)c1ccc(CC(C)CN2C[C@@H](C)O[C@@H](C)C2)cc1
Mol. weight
317.52 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • allphar brand of amorolfine hydrochloride
  • amorolfine
  • amorolfine
  • amorolfine
  • amorolfine
  • amorolfine
  • amorolfine
  • amorolfine
  • amorolfine hcl
  • amorolfine hcl
  • amorolfine hcl
  • amorolfine hydrochloride
  • amorolfine hydrochloride
  • amorolfin hydrochloride
  • galderma brand of amorolfine hydrochloride
  • isdin brand of amorolfine hydrochloride
  • loceryl
  • loceryl
  • loceryl
  • loceryl
  • loceryl
  • locéryl
  • loceryl curanail
  • locetar
  • odenil
  • omicur
  • ro-144767000
  • ro-144767000
  • ro 14-4767-002
  • ro-14-4767-002
  • roche brand of amorolfine hydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06689852N/ANov 30, 2024Eurofins, Oystershell NV
NCT06254027N/AMar 31, 2024Eurofins, Oystershell NV
NCT04961684N/AFeb 10, 2020Eurofins, Oystershell NV
NCT03098342N/AJun 1, 2017Chulalongkorn University
NCT03382717N/AOct 26, 2016Oystershell NV, Principal Instruction military hospital of Tunis
NCT02812043Phase 4Aug 1, 2016Mahidol University
NCT02705664Phase 4Jan 1, 2016Cutis Ehf, Galderma
NCT02679911Phase 4Sep 1, 2015Galderma
NCT02549001Phase 3Aug 20, 2015Polichem S.A.
NCT03289871N/AJan 31, 2015Oystershell NV, Principal Instruction military hospital of Tunis
NCT02321098Phase 4Feb 1, 2014Galderma
NCT01851590Phase 4Oct 1, 2013Repolar Ltd., University of Helsinki
NCT01929187N/AFeb 1, 2013National Taiwan University
NCT01528813Phase 2Feb 1, 2012University of Brasilia
NCT01014637Phase 4Aug 1, 2009Hopital Purpan, Pierre Fabre, QuantaBio
NCT00459537Phase 3Mar 1, 2007Novartis
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (16)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Oystershell NVFor profit5512015
EurofinsFor profit3012020
GaldermaFor profit3312014
Principal Instruction military hospital of TunisGovernment2012015
Chulalongkorn UniversityAcademic/Hospital1112017
Cutis EhfAcademic/Hospital1012016
Hopital PurpanAcademic/Hospital1012009
Mahidol UniversityAcademic/Hospital1112016
National Taiwan UniversityAcademic/Hospital1112013
NovartisFor profit1112007
Pierre FabreFor profit1112009
Polichem S.A.For profit1112015
QuantaBioFor profit1012009
Repolar Ltd.For profit1012013
University of BrasiliaAcademic/Hospital1112012
University of HelsinkiAcademic/Hospital1112013
16 organizations
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