4'-Demethylpodophyllotoxin Clinical Trials

Size	Price	Qty
25mg	USD 157

Clinical Trials

Multiple clinical trials evaluate diverse therapeutic applications across oncology, metabolic conditions, otolaryngology, and respiratory disease, specifically targeting uterine corpus carcinoma, Lynch syndrome, type 2 diabetes mellitus, pediatric acute asthma exacerbations, and vestibular disorders. Conducted across Phase 1/2, Phase 2, and non-applicable classifications by academic, cooperative, and commercial entities—including the Gynecologic Oncology Group, National Cancer Institute, Vanderbilt University Medical Center, Ghent University, and Shanghai HEP Pharmaceutical—these studies are currently either withdrawn or not yet recruiting.

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	--
NCT04662164	Withdrawn	Type 2 Diabetes Patients	Shanghai HEP Pharmaceutical Co. Ltd.	2025-12	Phase 1\|Phase 2
NCT06177132	Not yet recruiting	Vestibular Disorder	University Hospital Ghent\|University Ghent	2025-11	Not Applicable
NCT03277170	Not yet recruiting	Asthma; Status\|Asthma in Children\|Asthma Acute\|Asthma Attack\|Acute Asthma Exacerbation	Vanderbilt University Medical Center	2025-09-01	Phase 2

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

Check the 4'-Demethylpodophyllotoxin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4'-Demethylpodophyllotoxin binds to tubulin heterodimers to disrupt microtubule polymerization dynamics, which halts mitotic spindle formation and triggers apoptotic signaling cascades. This potent cytotoxic action inhibits the proliferation of malignant cells, demonstrating therapeutic relevance for oncological conditions such as uterine corpus carcinoma evaluated in clinical trials.

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>).