Naftifine
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | NAFTIN | — | 1989-04-05 – 2016-11-10 | fda.gov ↗ |
| Approved | US (FDA) | NAFTIN | — | 1988-02-29 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02335255 | Jun 2014 → May 2018 | tinea pedis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02132260 | Aug 2013 → Feb 2014 | tinea pedis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01580891 | May 2012 → Mar 2013 | tinea pedis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00253305 | Sep 2005 → ? | tinea unguium | MediQuest Therapeutics | Completed | No outcome recorded |
| Phase 35 trials · 3 met primary | ||||||
| Phase 3 | NCT02633813 | Mar → Nov 2015 | tinea pedis | Genzum Life Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01885156 | Aug → Nov 2013 | dermatophytosis of groin and perianal area, tinea pedis | Merz North America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01290341 | Feb → Nov 2011 | tinea pedis | Merz North America, Inc. | Completed | Met primary |
| Phase 3 | NCT00750152 | Sep 2008 → Aug 2009 | dermatophytosis of groin and perianal area, tinea pedis | Merz North America, Inc. | Completed | Met primary |
| Phase 3 | NCT00750139 | Aug 2008 → Aug 2009 | tinea pedis | Merz North America, Inc. | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT02227290 | Aug 2014 → Nov 2015 | tinea corporis | Merz North America, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02466867 | Jan 2014 → Oct 2015 | tinea corporis | Merz North America, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01712360 | Oct 2012 → Nov 2013 | dermatophytosis of groin and perianal area, tinea pedis | Merz North America, Inc. | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT05363449 Comparator | Feb 2022 → Nov 2023 | dermatophytosis of groin and perianal area, tinea pedis | Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02658292 Comparator | ? → Jul 2016 | dermatophytosis of scalp or beard | Merz North America, Inc. | Withdrawn | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-02-25 | Xiromed LLC | Xiromed® LLC Launches Naftifine Hydrochloride Cream USP, 2% xiromed.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | naftifine | “An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis” NCT02466867 ↗7“Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States.” PMID 22052309 ↗ Nov 2011 “naftifine” NCT01712360 ↗ |
| Known as | NAFT-1 | “Naftifine 1% cream (NAFT-1) treatment for four weeks and vehicle were also evaluated as a positive control.” PMID 22052309 ↗ Nov 2011 |
| Known as | NAFT-2 | “Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States.” PMID 22052309 ↗ Nov 2011 |
| Known as | NAFT-500 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00750152 ↗ |
| Known as | NAFT-600 | “NAFT-600 (naftin 2 % gel)” NCT01290341 ↗ |
| Known as | Naftifine HCl | “Naftifine HCl 2% cream (NAFT-2) is a topical allylamine antifungal agent under development in the United States.” PMID 22052309 ↗ Nov 20111“Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.)” NCT01580891 ↗ |
| Known as | naftifine hydrochloride | “The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in...” NCT02227290 ↗5“The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week...” NCT02335255 ↗ “An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis” NCT02466867 ↗ “Naftin® 2% (Naftifine hydrochloride 2%)” NCT02633813 ↗ “Naftin (naftifine hydrochloride) Cream” NCT05363449 ↗ |
| Known as | Naftin | “The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week...” NCT02335255 ↗8“An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis” NCT02466867 ↗ “Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.” NCT02132260 ↗ “Naftin® (Naftifine HCl) Cream 1% (Merz Pharmaceuticals)” NCT01580891 ↗ “Naftin® 2% (Naftifine hydrochloride 2%)” NCT02633813 ↗ |
| Modality | Other / unclassified | “topical allylamine antifungal agent” PMID 22052309 ↗ Nov 2011 |
| Route | Topical | “topical allylamine cream applied once a day for up to 4 weeks” NCT00750139 ↗ |