Sinecatechins
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VEREGEN | — | 2007-12-19 | fda.gov ↗ |
| Approved | US (FDA) | VEREGEN | — | 2006-10-31 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT03682601 Comparator | Aug 2018 → Feb 2021 | physiological sexual disorder, postmenopausal atrophic vaginitis, sexual disorder, vulvodynia | GTO Pharmaceutical, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT00596011 Comparator | Nov 2007 → Mar 2014 | benign prostatic hyperplasia | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02147353 Comparator | Sep 2011 → Dec 2012 | anogenital human papillomavirus infection | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sinecatechins | “A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves)...” NCT07137819 ↗7“OBJECTIVE: To estimate the clinical efficacy of topical sinecatechins, a defined green tea extract, in the treatment of external genital and perianal warts.” PMID 18515521 ↗ Jun 2008 “Veregen® (sinecatechins) Ointment, 15%, local application of 250 mg corresponding to 0.5 cm strand of ointment, 3 times daily (total dose of 750 mg/d)” NCT01490008 ↗ |
| Known as | Camellia sinensis catechins | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201723 ↗ |
| Known as | Camellia sinensis leaf catechins | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201723 ↗ |
| Known as | defined green tea catechin extract | “Evaluate the efficacy and safety of defined green tea catechin extract (polyphenon E) in former smokers with abnormal sputum score using stringent, newly developed response...” NCT00573885 ↗1“Polyphenon E, a defined green tea catechin extract” NCT00611650 ↗ |
| Known as | EGCG | “Our results show a significant reduction in serum levels of PSA, HGF, and VEGF in men with prostate cancer after brief treatment with EGCG (Polyphenon E), with no elevation of...” PMID 19542190 ↗ Jun 2009 |
| Known as | Green Tea Extract | “Polyphenon E (Green Tea Extract)” NCT00676793 ↗ |
| Known as | Kunecatechins | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201723 ↗ |
| Known as | Poly E | “I. The primary objective of this study is to demonstrate the safety (i.e., determine the maximum tolerated dose (MTD)) of using Polyphenon E (Poly E) over a six-month period in...” NCT00233935 ↗2“We conducted a phase IB dose escalation trial in women with a history of stage I to III hormone receptor-negative breast cancer of an oral green tea extract, polyphenon E (Poly...” PMID 22827973 ↗ Jul 2012 “whether POLYE (Polyphenon E) treatment is associated with a significant percent decrease” NCT01606124 ↗ |
| Known as | Polyphenon E | “Evaluate the efficacy and safety of defined green tea catechin extract (polyphenon E) in former smokers with abnormal sputum score using stringent, newly developed response...” NCT00573885 ↗16“I. The primary objective of this study is to demonstrate the safety (i.e., determine the maximum tolerated dose (MTD)) of using Polyphenon E (Poly E) over a six-month period in...” NCT00233935 ↗ “Demonstrate the safety of green tea catechin extract (Polyphenon E) in women with a history of hormone receptor-negative breast cancer.” NCT00516243 ↗ “Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily” NCT00942422 ↗ “whether POLYE (Polyphenon E) treatment is associated with a significant percent decrease” NCT01606124 ↗ “Polyphenon E, a defined green tea catechin extract” NCT00611650 ↗ “Polyphenon E” NCT00516243 ↗ |
| Known as | Veregen | “Veregen® (sinecatechins) Ointment, 15%, local application of 250 mg corresponding to 0.5 cm strand of ointment, 3 times daily (total dose of 750 mg/d)” NCT01490008 ↗ |
| Action | Inhibit | “inhibit production of hepatocyte growth factor and vascular endothelial growth factor in vitro” PMID 19542190 ↗ Jun 2009 |
| Route | Oral | “Given orally” NCT00363805 ↗ |