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SR-T100 Gel
SR-T100 Gel is a Small molecule drug developed by G&E Herbal Biotechnology Co., LTD. It is currently in Phase 3 development for Cutaneous T-cell lymphoma (mycosis fungoides), Other dermatological conditions (Phase 3 pipeline). Also known as: Solamargine, SR-T100.
SR-T100 is a herbal-based topical gel that modulates immune and inflammatory pathways to treat skin conditions.
SR-T100 Gel is a topical treatment that has been studied for its efficacy in treating Vulvar Intraepithelial Neoplasia, Genital Warts, Actinic Keratosis, Common Wart, and Condyloma Acuminata. The gel contains 2.3% Solanum undatum plant extract, which is the active ingredient in SR-T100.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | SR-T100 Gel |
|---|---|
| Also known as | Solamargine, SR-T100 |
| Sponsor | G&E Herbal Biotechnology Co., LTD |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
SR-T100 is derived from herbal extracts and is designed for topical application to enhance immune response and reduce inflammation in dermatological conditions. The exact molecular targets and mechanisms are proprietary to G&E Herbal Biotechnology, but the formulation is intended to work through natural bioactive compounds present in the herbal preparation.
Approved indications
- Cutaneous T-cell lymphoma (mycosis fungoides)
- Other dermatological conditions (Phase 3 pipeline)
Common side effects
- Local skin irritation
- Application site reactions
Key clinical trials
- Efficacy and Safety of SR-T100 Gel in Common Warts (CW) Patients (PHASE2)
- Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs) (PHASE2)
- Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis (PHASE1)
- Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis (PHASE2)
- Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment (PHASE3)
- Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis (PHASE1)
- SR-T100 Gel Efficacy & Safety Study for Vulva Pre-cancerous Lesions & Cutaneous Condyloma (EARLY_PHASE1)
- Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis (PHASE2)
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:
- SR-T100 Gel CI brief — competitive landscape report
- SR-T100 Gel updates RSS · CI watch RSS
- G&E Herbal Biotechnology Co., LTD portfolio CI
Frequently asked questions about SR-T100 Gel
What is SR-T100 Gel?
How does SR-T100 Gel work?
What is SR-T100 Gel used for?
Who makes SR-T100 Gel?
Is SR-T100 Gel also known as anything else?
What development phase is SR-T100 Gel in?
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Related
- Manufacturer: G&E Herbal Biotechnology Co., LTD — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Cutaneous T-cell lymphoma (mycosis fungoides)
- Indication: Drugs for Other dermatological conditions (Phase 3 pipeline)
- Also known as: Solamargine, SR-T100
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing