Withaferin A (WFA) Clinical Trials

Size	Price	Qty
1mg	USD 127
5mg	USD 390

Clinical Trials

Several clinical trials evaluate Withaferin A across conditions such as recurrent ovarian cancer, graft-versus-host disease in hematological malignancies, portal hypertension in liver cirrhosis, and uterine corpus carcinoma. Spanning Phase I, Phase II, Phase IV, and non-interventional designs, these studies are sponsored by entities including the National Cancer Institute, GOG Foundation, Tata Memorial Centre, and Shanghai Changzheng Hospital. Active recruitment is ongoing for clinical trials testing combination therapy in ovarian cancer and treatment for steroid-refractory acute graft-versus-host disease, while other trials are withdrawn or in planning.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01199250	Not yet recruiting	Lynch Syndrome\|Recurrent Uterine Corpus Carcinoma\|Stage I Uterine Corpus Cancer\|Stage II Uterine Corpus Cancer\|Stage III Uterine Corpus Cancer\|Stage IV Uterine Corpus Cancer	Gynecologic Oncology Group\|National Cancer Institute (NCI)\|GOG Foundation	2100-01	--
NCT04432610	Withdrawn	Nebivolol Adverse Reaction	Clinical Hospital Center Zemun	2030-01	Phase 4
NCT07724873	RECRUITING	Hematopoietic Stem Cell Transplant (HSCT); GVHD - Graft-Versus-Host Disease; Hematological Malignancy	Tata Memorial Centre	2025-01-28	PHASE1; PHASE2
NCT07708987	RECRUITING	Hematological Malignancy; GVHD - Graft-Versus-Host Disease; Steriod Refractory	Tata Memorial Centre	2023-09-23	PHASE2
NCT05610735	RECRUITING	Recurrent Ovarian Cancer	Sham Sunder Kakar	2024-09-25	PHASE1; PHASE2
NCT06376812	Not yet recruiting	Elevated Blood Pressure\|Perimenopause	The University of Texas Medical Branch Galveston	2026-05	Not Applicable

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

Check the Withaferin A (WFA) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Withaferin A directly targets the intermediate filament protein vimentin and inhibits tumor necrosis factor-induced activation of IκB kinase β through a redox-sensitive mechanism, suppressing NF-κB survival signaling and inducing apoptotic pathways. This cellular disruption inhibits tumor cell proliferation and moderates immune response mechanisms, providing a clear biological rationale for its clinical evaluation in conditions such as recurrent ovarian cancer and graft-versus-host disease.

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>).