Betulinic acid Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 370

Clinical Trials

A clinical trial was designed to evaluate a topical ointment formulation of Betulinic acid for the treatment of dysplastic nevus syndrome with moderate to severe dysplasia. Sponsored by the University of Illinois at Chicago, this Phase I/Phase II study was withdrawn prior to subject enrollment. Consequently, no active or completed clinical trials are currently documented for this small-molecule compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00346502	WITHDRAWN	Dysplastic Nevus Syndrome	University of Illinois at Chicago	2006-01	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2021-06-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Betulinic acid targets and inhibits nuclear factor kappa B signaling and viral replication pathways, thereby disrupting downstream pro-survival transcription programs and cellular inflammatory cascades. This molecular inhibition suppresses dysregulated cellular proliferation and triggers apoptotic pathways in dysplastic melanocytes, providing a therapeutic rationale for its investigation in cutaneous pre-malignant conditions such as dysplastic nevus syndrome.

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>).