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Femstat 3 (BUTOCONAZOLE)
Femstat 3 (Butoconazole) is a small molecule azole antifungal medication originally developed by Bayer and currently owned by the same company. It is used to treat candidal vulvovaginitis, a fungal infection of the vagina. The medication is off-patent and has a generic manufacturer. Femstat 3 works by inhibiting the growth of fungi through the disruption of their cell membranes. It was FDA approved in 1995.
At a glance
| Generic name | BUTOCONAZOLE |
|---|---|
| Sponsor | Bayer |
| Drug class | Azole Antifungal |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1995 |
Approved indications
- Candidal vulvovaginitis
Common side effects
- vulvar/vaginal burning
- vulvar/vaginal itching
- vulvar/vaginal soreness
- vulvar/vaginal swelling
- pelvic pain
- abdominal pain
- cramping
Drug interactions
- ciclosporin
Key clinical trials
- A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations (NA)
- Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis. (PHASE2)
- Vaginal Infection Study 2 (PHASE3)
- Vaginal Infection Study (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Femstat 3 CI brief — competitive landscape report
- Femstat 3 updates RSS · CI watch RSS
- Bayer portfolio CI