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Vivjoa (OTESECONAZOLE)
Vivjoa works by inhibiting the enzyme Cytochrome P450 3A4, which is involved in the synthesis of ergosterol, a critical component of fungal cell membranes.
At a glance
| Generic name | OTESECONAZOLE |
|---|---|
| Sponsor | Mycovia Pharms |
| Drug class | Azole Antifungal [EPC] |
| Target | Cytochrome P450 3A4 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
Oteseconazole is an antifungal drug [see Microbiology (12.4)].
Approved indications
- Recurrent vulvovaginal candidiasis (RVVC)
Common side effects
- Headache
- Nausea
- Allergic dermatitis
- Elevations in Creatine Phosphokinase
- Dyspepsia
- Hot flush
- Dysuria
- Menorrhagia
- Metrorrhagia
- Vulvovaginal irritation
Key clinical trials
- A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (PHASE3)
- A Study of Oral Oteseconazole (VT-1161) for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection) (PHASE3)
- Platform Trial For Cryptococcal Meningitis (PHASE2,PHASE3)
- Oteseconazole in the Treatment of Adults With Vulvovaginal Candidiasis（VVC）
- Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vivjoa CI brief — competitive landscape report
- Vivjoa updates RSS · CI watch RSS
- Mycovia Pharms portfolio CI