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Sinecatechins 15% Ointment
Sinecatechins 15% Ointment is a Small molecule drug developed by Icahn School of Medicine at Mount Sinai. It is currently in Phase 1 development. Also known as: Veregen.
Sinecatechins 15% Ointment is a botanical drug derived from green tea, used to treat significant to severe secondary provoked vestibulodynia in postmenopausal women. It is applied topically to alleviate symptoms associated with this condition.
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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 | Sinecatechins 15% Ointment |
|---|---|
| Also known as | Veregen |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment (PHASE2)
- Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment (NA)
- Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study (PHASE4)
- Systemic Exposure of Catechins From Veregen 15% Ointment in Patients With External Anogenital Warts and From Oral Intake of Green Tea Beverage in Healthy Volunteers (PHASE1)
- Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage (PHASE4)
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:
- Sinecatechins 15% Ointment CI brief — competitive landscape report
- Sinecatechins 15% Ointment updates RSS · CI watch RSS
- Icahn School of Medicine at Mount Sinai portfolio CI
Frequently asked questions about Sinecatechins 15% Ointment
What is Sinecatechins 15% Ointment?
Who makes Sinecatechins 15% Ointment?
Is Sinecatechins 15% Ointment also known as anything else?
What development phase is Sinecatechins 15% Ointment in?
Related
- Manufacturer: Icahn School of Medicine at Mount Sinai — full pipeline
- Also known as: Veregen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing