Drugs / Ciclopirox
Ciclopirox
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LOPROX | — | 1982-12-30 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05647343 | Mar 2023 → Apr 2024 | — | Atlas Molecular Pharma | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07024316 | Jan 2026 → May 2028 expected | inherited porphyria | Atlas Molecular Pharma | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02961634 | Apr → Aug 2017 | tinea unguium | MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT01014637 | Aug 2009 → Sep 2011 | tinea unguium | Pierre Fabre Dermo Cosmetique | Unknown | No outcome recorded |
| Phase 4 | NCT01646580 | Oct 2008 → Nov 2011 | dermatomycosis | Ferrer Internacional S.A. | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable3 trials | ||||||
| — | NCT06485050 | Apr → Nov 2024 | diabetes mellitus, fungal infection of the toenail | Universidad Complutense de Madrid | Unknown | No outcome recorded |
| — | NCT00804193 | Jun → Dec 2004 | tinea pedis | Padagis LLC | Completed | No outcome recorded |
| — | NCT00382330 | — | vulva cancer | University of Medicine and Dentistry of New Jersey | Withdrawn | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT02644551 Comparator | Nov 2016 → May 2018 | tinea unguium | 9305-9954 Quebec Inc | Unknown | No outcome recorded |
| Phase 3 | NCT02866032 Comparator | Sep 2016 → Jun 2020 | tinea unguium | Moberg Pharma AB | Completed | No outcome recorded |
| Phase 4 | NCT05809297 Comparator | Sep 2023 → Apr 2024 | tinea unguium | Universidad Complutense de Madrid | Unknown | No outcome recorded |
| Phase 4 | NCT02679911 Comparator | Sep 2015 → Jun 2016 | dermatophytosis | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT01419847 Comparator | Mar 2002 → Dec 2005 | tinea unguium | Rady Children's Hospital, San Diego | Completed | No outcome recorded |
| — | NCT00127868 Comparator | Mar 2005 → Apr 2008 | dermatophytosis of scalp or beard | Chen, Catherine, M.D. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2007-09-19 | Perrigo Company | Regulatory Perrigo Company Announces FDA Approval for Ciclopirox Topical Solution perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market Ciclopirox Topical Solution, 8% (Nail Lacquer). |
| 2006-10-02 | Perrigo Company | Regulatory Perrigo Receives Tentative Approval for Ciclopirox Topical Solution perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has been granted tentative approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Ciclopirox Topical Solution, 8% (Nail Lacquer). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2007-09-19 | Perrigo Company | Perrigo Company Announces FDA Approval for Ciclopirox Topical Solution perrigo.com ↗ |
| 2006-10-02 | Perrigo Company | Perrigo Receives Tentative Approval for Ciclopirox Topical Solution perrigo.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ciclopirox | “Initial treatment with RV4104A ointment for 3 weeks, followed by treatment with ciclopiroxolamine 1% cream for 8 weeks and by cyclopirox 8% film-forming solution for 25 weeks.” NCT01014637 ↗12“Daily application of ciclopirox 8% with ethyl acetate, ethanol (96%), ketosteryl alcohol, hydroxypropyl chitosan and purified water.” NCT06485050 ↗ |
| Known as | ATL-001 | “ATL-001 (Ciclopirox oral solution)” NCT07024316 ↗1“ATL-001 (Ciclopirox Olamine)” NCT05647343 ↗ |
| Known as | Ciclopirox NL | “Ciclopirox NL 8% to be applied once daily for 12 weeks on all affected toenails of the opposite foot” NCT02679911 ↗ |
| Known as | Ciclopirox Olamine | “Ciclopirox olamine (Ciclochem®) is a pyridone broad spectrum antifungal drug” NCT01646580 ↗1“ATL-001 (Ciclopirox Olamine)” NCT05647343 ↗ |
| Known as | Cyclopirox | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01014637 ↗ |
| Known as | Penlac | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02644551 ↗ |
| Action | Inhibit | “inhibiting the cellular captation of essential substances needed for the metabolism and growth of the fungi” NCT01646580 ↗ |
| Route | Topical | “randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks.” NCT00127868 ↗ |