Overview
Sinecatechins is a botanical drug product for topical use. It is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg) and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.
Background
Sinecatechins is a botanical drug product for topical use. It is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg) and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.
Indication
For the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
Associated Conditions
- Condylomata Acuminata
- Perianal Warts
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/10/22 | Phase 2 | Recruiting | ECOG-ACRIN Cancer Research Group | ||
2019/08/13 | Phase 3 | Completed | |||
2018/09/24 | Phase 2 | Terminated | GTO Pharmaceutical, LLC | ||
2015/12/04 | Phase 4 | Completed | |||
2014/05/26 | Not Applicable | Completed | |||
2014/01/07 | Phase 2 | Completed | |||
2011/12/12 | Phase 1 | Completed | |||
2011/10/14 | Phase 2 | Terminated | |||
2011/09/13 | Phase 1 | Completed | |||
2010/02/02 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PharmaDerm a division of Fougera Pharmaceuticals Inc. | 10337-450 | TOPICAL | 150 mg in 1 g | 8/12/2021 | |
| ANI Pharmaceuticals, Inc. | 62559-385 | TOPICAL | 150 mg in 1 g | 1/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||