Drugs / Butenafine
Butenafine
also known as
BAY1896425 · Butenafine HCl · Butenafina · BUTENAFINE HYDROCHLORIDE · KP-363 · Lotrimin Ultra · Mentax · Mentax-tc · +1 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LOTRIMIN ULTRA | — | 2014-12-17 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | MENTAX | — | 1997-11-25 – 2001-06-06 | fda.gov ↗ |
| Approved | US (FDA) | MENTAX | — | 1996-10-18 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01119742 | Jul 2010 → Mar 2011 | tinea pedis | Sun Pharmaceutical Industries, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT00835510 | Jun → Oct 2008 | tinea pedis | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03999437 | Jan → Dec 2019 | tinea pedis | United Laboratories | Unknown | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04531540 | Sep → Oct 2013 | hypersensitivity reaction disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT04531527 | Jun 2013 | phototoxic dermatitis | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT04531813 | Jun → Jul 2013 | hypersensitivity reaction disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT04532164 | Jun → Nov 2013 | photoallergic dermatitis | Bayer | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Butenafine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04531527 ↗ |
| Known as | BAY1896425 | “Butenafine HCl 1% (BAY1896425) - Induction Phase” NCT04532164 ↗3“Butenafine HCl 1% (BAY1896425)” NCT04531527 ↗ “Butenafine HCl 1% (BAY1896425)” NCT04531540 ↗ “Butenafine HCl 1% (BAY1896425)” NCT04531813 ↗ |
| Known as | Butenafina | ChEMBL registry synonym — accepted as the source's own label CHEMBL990 ↗ |
| Known as | Butenafine HCl | “During the Induction Phase, participants received Butenafine HCl 1% on the treated irradiated skin test site followed by UV irradiation” NCT04532164 ↗3“Butenafine HCl 1% (BAY1896425)” NCT04531813 ↗ “Butenafine HCl 1% (BAY1896425)” NCT04531527 ↗ “Butenafine HCl 1% (BAY1896425)” NCT04531540 ↗ |
| Known as | BUTENAFINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL990 ↗ |
| Known as | KP-363 | ChEMBL registry synonym — accepted as the source's own label CHEMBL990 ↗ |
| Known as | Lotrimin Ultra | “Lotrimin Ultra (butenafine) 1%” NCT00835510 ↗ |
| Known as | Mentax | ChEMBL registry synonym — accepted as the source's own label CHEMBL990 ↗ |
| Known as | Mentax-tc | ChEMBL registry synonym — accepted as the source's own label CHEMBL990 ↗ |
| Known as | Volley | ChEMBL registry synonym — accepted as the source's own label CHEMBL990 ↗ |
| Modality | Small molecule | — CHEMBL990 ↗ |
| Route | Topical | “Treatment applied to affected area twice daily for 7 days” NCT00835510 ↗ |