Isosilybin Clinical Trials

Size	Price	Qty
1mg	USD 157

Clinical Trials

Several clinical trials spanning Phases I through IV evaluate silymarin flavanolignans, including isosilybin, across diverse therapeutic applications. Supported by academic, government, and pharmaceutical entities—such as Assiut University, Horus University, and the National Institutes of Health—these studies target dermatological and hepatic disorders, including melasma, fatty liver disease, liver failure, chronic hepatitis C, and oxidative stress, alongside cardioprotection during breast cancer chemotherapy. Trial statuses range from completed pharmacokinetic and liver evaluations to studies of unknown status investigating topical regimens.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05099601	Unknown status	Melasma	Assiut University	2022-05	Phase 4
NCT04434404	Completed	Breast Cancer	Horus University	2018-09-10	Phase 4
NCT03216668	Unknown status	Liver Function Failure	Nhat Nhat Pharmaceutical Company	2017-06-15	Phase 3
NCT02006498	Completed	Non-alcoholic Fatty Liver Disease	University of Malaya\|Rottapharm	2012-06	Phase 2
NCT01018615	Completed	Chronic Hepatitis C\|Oxidative Stress	University of North Carolina Chapel Hill\|National Center for Complementary and Integrative Health (NCCIH)\|National Institutes of Health (NIH)	2009-11	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Isosilybin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isosilybin suppresses CYP3A4 enzyme induction and scavenges reactive oxygen species, thereby mitigating oxidative damage and altering xenobiotic biotransformation in hepatic cellular pathways. This inhibition of oxidative stress and metabolic dysregulation supports its clinical relevance in managing hepatic disorders, including non-alcoholic fatty liver disease and chronic hepatitis C.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).