Amorolfine
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 43 trials | ||||||
| Phase 4 | NCT02812043 | Aug 2016 → Jun 2019 | nail infection | Mahidol University | Completed | No outcome recorded |
| Phase 4 | NCT02705664 | Jan → Sep 2016 | dermatomycosis | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT02679911 | Sep 2015 → Jun 2016 | dermatophytosis | Galderma R&D | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06689852 | Oct 2024 → Jul 2025 overdue | tinea unguium | Oystershell NV | Recruiting | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 2 | NCT01528813 Comparator | Feb 2012 → Dec 2013 | tinea unguium | Brasilia University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02549001 Comparator | Aug 2015 → Sep 2018 | tinea unguium | Polichem S.A. | Completed | No outcome recorded |
| Phase 3 | NCT00459537 Comparator | Mar 2007 → Jan 2009 | tinea unguium | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT01851590 Comparator | Oct 2013 → Oct 2014 | tinea unguium | Helsinki University Central Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01014637 Comparator | Aug 2009 → Sep 2011 | tinea unguium | Pierre Fabre Dermo Cosmetique | Unknown | No outcome recorded |
| — | NCT06254027 Comparator | Mar 2024 → Jun 2025 | tinea unguium | Oystershell NV | Unknown | No outcome recorded |
| — | NCT04961684 Comparator | Feb → Sep 2020 | fungal infection of the toenail | Oystershell NV | Completed | No outcome recorded |
| — | NCT03098342 Comparator | Jun 2017 → Dec 2018 | fungal infection of the toenail | Chulalongkorn University | Completed | No outcome recorded |
| — | NCT03382717 Comparator | Oct 2016 → Aug 2017 | fungal infection of the toenail | Oystershell NV | Completed | No outcome recorded |
| — | NCT03289871 Comparator | Jan → Nov 2015 | tinea unguium | Oystershell NV | Completed | No outcome recorded |
| — | NCT01929187 Comparator | Feb → Dec 2013 | fungal infection of the toenail | National Taiwan University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-06-28 | Galderma R&D | Results WCD 2023: Galderma’s scientific presentations galderma.com ↗
Better penetration profile of the antifungal amorolfine than naftifine and tioconazole in onychomycosis-infected nails quantified by matrix-assisted laser desorption ionization–Fourier transform ion cyclotron resonance imaging (MALDI-FTICR) |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2023-06-28 | Galderma R&D | WCD 2023: Galderma’s scientific presentations galderma.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | amorolfine | “The present study was set up to evaluate the efficacy and safety of a water-based, peelable nail polish (daily application), which acidifies the nail environment, versus a 5%...” PMID 30051298 ↗ Jul 201812“Amorolfine 5% nail lacquer (Loceryl) is a broad-spectrum morpholine antifungal demonstrated 60-75% mycological cure rate in several randomized controlled trials for the...” NCT01929187 ↗ “Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days.” NCT04961684 ↗ “Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%” NCT02705664 ↗ “Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot” NCT02679911 ↗ “the reference product (Loceryl, 5% amorolfine)” NCT06689852 ↗ |
| Known as | Amorolfina | ChEMBL registry synonym — accepted as the source's own label CHEMBL489411 ↗ |
| Known as | Amorolfine (as hydrochloride) | ChEMBL registry synonym — accepted as the source's own label CHEMBL489411 ↗ |
| Known as | amorolfine 5% nail lacquer (Loceryl) | “amorolfine 5% nail lacquer (Loceryl)” NCT01929187 ↗ |
| Known as | Amorolfine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL489411 ↗ |
| Known as | Amorolfine hydrochloride | “Amorolfine hydrochloride NL 5% to be applied once weekly for 12 weeks on all affected toenails of one foot” NCT02679911 ↗1“Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot” NCT02705664 ↗ |
| Known as | Loceryl | “Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days.” NCT04961684 ↗6“Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%” NCT02705664 ↗ “Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.” NCT03098342 ↗ “5% Amorolfine Lacquer is applied once weekly for 9 months (Loceryl®) in toenail onychomycosis.” NCT01851590 ↗ “the reference product (Loceryl, 5% amorolfine)” NCT06689852 ↗ |
| Known as | Loceryl curanail | ChEMBL registry synonym — accepted as the source's own label CHEMBL489411 ↗ |
| Known as | Omicur | ChEMBL registry synonym — accepted as the source's own label CHEMBL489411 ↗ |
| Known as | RO 14-4767/000 | ChEMBL registry synonym — accepted as the source's own label CHEMBL489411 ↗ |
| Action | Inhibit | “inhibits the biosynthesis of the fungal cell membrane” NCT02812043 ↗ |
| Modality | Small molecule | “Amorolfine is a morpholine derivative used in topical anti-fungal” NCT02812043 ↗ |
| Route | Topical | “5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.” NCT00459537 ↗ |