Polyphyllin B (Formosanin C) Clinical Trials

Size	Price	Qty
1mg	USD 147

Clinical Trials

Multiple clinical trials evaluate diverse conditions, including gastrointestinal disorders such as Crohn's disease, chronic heart failure, pulmonary arterial hypertension, and pediatric nutritional deficiency. Sponsored by academic institutions, university hospitals, and pharmaceutical organizations—including AstraZeneca, Duke University, and Brigham and Women's Hospital—these Phase 2, Phase 4, and unclassified studies span various operational stages. Currently, the portfolio consists predominantly of studies classified as not yet recruiting or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06211400	Not yet recruiting	Crohn Disease	University of Hertfordshire\|University of Central Lancashire\|Anglia Ruskin University\|Royal Veterinary College	2024-07-01	Not Applicable
NCT06299826	Not yet recruiting	Chronic Heart Failure	AstraZeneca	2024-06-10	Phase 2
NCT06104228	Not yet recruiting	Pulmonary Arterial Hypertension\|Idiopathic Pulmonary Arterial Hypertension\|Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder)\|Connective Tissue Diseases	Bastiaan Driehuys\|American Heart Association\|Duke University	2024-05-01	Phase 2
NCT05901766	Not yet recruiting	Iodine Deficiency\|Nutrition Poor\|Development Infant\|Breastfeeding	Brigham and Women''s Hospital	2024-05	Phase 4
NCT06353633	Not yet recruiting	Inflammatory Bowel Diseases	National Nutrition and Food Technology Institute	2024-04-10	Not Applicable
NCT06122922	Withdrawn	Pulmonary Artery Hypertension	Bastiaan Driehuys\|Regeneron Pharmaceuticals\|Duke University	2024-03-15	Phase 2

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

Check the Polyphyllin B (Formosanin C) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a plant-derived diosgenin saponin, Polyphyllin B interacts with cellular membrane lipid domains and modulates intracellular signaling pathways, thereby inhibiting downstream pro-inflammatory enzyme cascades and triggering apoptotic signaling events. Consequently, this cell-death induction and anti-inflammatory activity suppress aberrant tissue proliferation and cellular inflammation, providing a potential therapeutic mechanism relevant to inflammatory bowel diseases, Crohn's disease, and vascular conditions such as pulmonary arterial hypertension.

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>).