Drugs / Terconazole

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) TERAZOL 7 — 1987-12-31 fda.gov ↗

Trials 4

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01813162 Dec 2013 → Dec 2014 — CONRAD Completed No outcome recorded
Phase 31 trial
Phase 3 NCT01867164 Dec 2007 → Dec 2008 infective vaginitis Janssen-Cilag, S.A. Completed No outcome recorded
Phase 41 trial
Phase 4 NCT02180100 Aug 2013 → Jun 2014 vulvovaginal candidiasis Peking University Shenzhen Hospital Completed No outcome recorded
Phase not applicable1 trial
— NCT00803738 Dec 2002 → Dec 2003 vulvovaginal candidiasis Padagis LLC Completed No outcome recorded
Comparator or background therapy4 trials
Phase 3 NCT03473418 Comparator Apr → Oct 2018 vulvovaginal candidiasis Assiut University Unknown No outcome recorded
Phase 3 NCT02308007 Comparator Jun 2015 → Jun 2018 infective vaginitis Curatek Pharmaceuticals, LLC Completed No outcome recorded
Phase 3 NCT02308046 Comparator Jun 2015 → Jun 2017 infective vaginitis Curatek Pharmaceuticals, LLC Completed No outcome recorded
— NCT04208555 Comparator Jan 2020 → Feb 2021 vulvovaginal candidiasis Hatem AbuHashim Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2006-03-21 Perrigo Company Regulatory Perrigo Company Announces Approval For Terconazole Suppositories perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market terconazole vaginal suppositories, 80 mg.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as Terconazole “One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days.” NCT01867164 ↗
7

“Terconazole 0.4% vaginal cream: once a day for seven days. 1 applicator (5 gm) of terconazole cream contains 20 mg terconazole.” NCT01813162 ↗

NCT02180100 ↗

NCT00803738 ↗

NCT04208555 ↗

NCT02308046 ↗

NCT03473418 ↗

NCT02308007 ↗

Known as Fungistat ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as Gyno-terazol ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as NSC-331942 ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as Panlomyc ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as R 42470 ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as Terazol “Terazol Vaginal Suppository” NCT00803738 ↗
Known as Terazol 3 ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as Terazol 3 suppository “Terazol 3 suppository” NCT00803738 ↗
Known as Terazol 7 ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as Terconazol ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as Tercospor ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as Termayazole ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Known as Triaconazole ChEMBL registry synonym — accepted as the source's own label CHEMBL1714574 ↗
Action Inhibit “inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme” NCT03473418 ↗
Modality Small molecule “Terconazole is a new, broad-spectrum, triazole antifungal agent.” PMID 25877666 ↗ Apr 2015
Route Other “Terconazole 0.4% vaginal cream: once a day for seven days.” NCT01813162 ↗