Butoconazole Nitrate

(butoconazole nitrate)

Phase 2Small molecule

Butoconazole Nitrate is one of 18 small molecule programs targeting Vulvovaginal Candidiasis. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Vulvovaginal CandidiasisActive, not recruiting

Vulvovaginal CandidiasisPhase 2

Active, not recruiting

Competition

Competitive Landscape

33 competitors in Vulvovaginal Candidiasis

#DrugCompanyPhaseTrials

Lotrimin

Bayer

Approved

4 2

Diflucan

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

15 3

Nizoral

Terazol 3

2 5

Canesten

AAVVA Pharmaceuticals Ltd.

Approved

1 6

Peridex

MMedline Industries

Phase 2

1 7

Vaccine

Pfizer

Phase 2

1 8

Brexafemme

GGlaxo Dba Glaxosmithkline

Phase 3

4 9

Boric Acid

MMansoura University

Phase 3

1 10

SHR8008

JJiangsu HengRui Medicine Co., Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Infection2 trials

Vaginal Infection Study 2

Completed·LLumara Health, Inc.·Phase 3·NCT00694928·843 enrolled

Vaginal Infection Study

Completed·LLumara Health, Inc.·Phase 3·NCT00616330·1,443 enrolled

Vulvovaginal Candidiasis1 trial

Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.

Withdrawn·EEMS·Phase 2·NCT05031481

Randomized1 trial

A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations

Completed·PPadagis LLC·N/A·NCT01039584·611 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 25, 1985

FEMSTAT

NDA NDA019215

Nov 25, 1985

FEMSTAT

NDA NDA019359

Dec 21, 1995

FEMSTAT 3

NDA NDA020421

Feb 7, 1997

BUTOCONAZOLE NITRATE

NDA NDA019881

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for butoconazole nitrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — butoconazole nitrate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for butoconazole nitrate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA019881). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Roche

Butoconazole Nitrate

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Infection2 trials

Vulvovaginal Candidiasis1 trial

Randomized1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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