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Lomexin (FENTICONAZOLE)
Lomexin (generic name: FENTICONAZOLE) is a fenticonazole drug. It is currently in Phase 2 development for Candidal vulvovaginitis.
Lomexin works by inhibiting the growth of fungi through interference with the synthesis of ergosterol, a critical component of fungal cell membranes.
Lomexin is a small molecule medication used to treat various vaginal infections, including Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis, and Mixed Vaginal Infections. It is available in different formulations, including EVEGYN A, EVEGYN B, and Gynomax XL Vaginal Ovule, which have been evaluated in clinical studies for efficacy and safety.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | FENTICONAZOLE |
|---|---|
| Drug class | fenticonazole |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's cells have a strong, protective wall. Fungi have a similar wall, but Lomexin blocks the production of a key building block, making it harder for the fungus to grow and multiply.
Approved indications
- Candidal vulvovaginitis
Common side effects
Key clinical trials
- Bioavailability Study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule (PHASE1)
- Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule (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 |
|---|---|
| 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:
- Lomexin CI brief — competitive landscape report
- Lomexin updates RSS · CI watch RSS
Frequently asked questions about Lomexin
What is Lomexin?
How does Lomexin work?
What is Lomexin used for?
What is the generic name of Lomexin?
What drug class is Lomexin in?
What development phase is Lomexin in?
Related
- Drug class: All fenticonazole drugs
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Candidal vulvovaginitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing