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Terazol Vaginal Suppository
Terazol Vaginal Suppository is a Small molecule drug developed by Padagis LLC. It is currently in Phase 1 development. Also known as: Terazol 3 suppository.
Terazol Vaginal Suppository is a small molecule that inhibits the cytochrome P450 51 enzyme, specifically targeting lanosterol 14-alpha demethylase. It is used to treat vulvovaginal candidiasis, a fungal infection.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Terazol Vaginal Suppository |
|---|---|
| Also known as | Terazol 3 suppository |
| Sponsor | Padagis LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis (NA)
- Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis (PHASE4)
- Comparison of Boric Acid vs. Terconazole in Treatment of RVVC (NA)
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:
- Terazol Vaginal Suppository CI brief — competitive landscape report
- Terazol Vaginal Suppository updates RSS · CI watch RSS
- Padagis LLC portfolio CI
Frequently asked questions about Terazol Vaginal Suppository
What is Terazol Vaginal Suppository?
Who makes Terazol Vaginal Suppository?
Is Terazol Vaginal Suppository also known as anything else?
What development phase is Terazol Vaginal Suppository in?
Related
- Manufacturer: Padagis LLC — full pipeline
- Also known as: Terazol 3 suppository
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing