Terazol 3

(Terconazole)

ApprovedSmall molecule

WWim Janssens

Terazol 3 is one of 7 small molecule programs targeting Vulvovaginal Candidiasis. It is currently in Approved.

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 CandidiasisApproved

Active, not recruiting

Competition

Competitive Landscape

7 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

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Oteseconazole (VT-1161)

MMycovia Pharmaceuticals Inc.

Preclinical

1 7

Azole Antifungal

AAssiut University

Preclinical

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

Clinical

Trials by Indication[1]

Infections2 trials

Multi-Center Study of New Medications to Treat Vaginal Infections

Completed·CCuratek Pharmaceuticals, LLC·Phase 3·NCT02308007·475 enrolled

Multi-Center Study of New Medications to Treat Vaginal Infections

Completed·CCuratek Pharmaceuticals, LLC·Phase 3·NCT02308046·212 enrolled

Vulvovaginal Candidiasis2 trials

Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis

Completed·PPadagis LLC·N/A·NCT00803738·572 enrolled

Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis

Completed·PPeking University Shenzhen Hospital·Phase 4·NCT02180100·140 enrolled

Treatment1 trial

Comparison of Boric Acid vs. Terconazole in Treatment of RVVC

Unknown status·HHatem AbuHashim·N/A·NCT04208555·76 enrolled

Candidiasis1 trial

Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis

Unknown status·—·Phase 3·NCT03473418·69 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 31, 1987

TERAZOL 7

NDA NDA019579

May 24, 1988

TERAZOL 3

NDA NDA019641

Feb 21, 1991

TERAZOL 3

NDA NDA019964

Oct 1, 2004

TERCONAZOLE

NDA NDA021735

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Terconazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Terconazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Terconazole. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021735). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: WWim Janssens

Terazol 3

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Infections2 trials

Vulvovaginal Candidiasis2 trials

Treatment1 trial

Candidiasis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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