Brefeldin A (BFA chemical) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials sponsored by academic and governmental medical institutions evaluate BFA interventions for pain management, specifically targeting chronic musculoskeletal pain, knee osteoarthritis, fibromyalgia, and cancer-related pain. Lacking formal phase designations, these studies encompass recruitment statuses ranging from completed and active to not yet recruiting or unknown. The protocols assess these non-pharmacologic interventions in patient populations such as veterans, individuals with chronic pain, and post-procedural recovery cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date
NCT02979574	ACTIVE_NOT_RECRUITING	Chronic Pain; Musculoskeletal Pain; Fibromyalgia; Pain Management	Memorial Sloan Kettering Cancer Center	2016-11
NCT05969353	UNKNOWN	Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study	Bnai Zion Medical Center	2023-07-23
NCT06783556	NOT_YET_RECRUITING	Percutaneous Nephrolithotomy	Indonesia University	2025-01-20
NCT06115330	COMPLETED	Gynecologycal Cancer; Cancer Related Pain; Cancer Pain	Indonesia University	2023-08-30
NCT05417724	COMPLETED	Acupuncture; Homelessness; Pain; Veterans	Edith Nourse Rogers Memorial Veterans Hospital	2022-03-28
NCT03456011	UNKNOWN	Knee Osteoarthritis	Brooke Army Medical Center	2018-02-23

(data from https://clinicaltrials.gov, updated on 2025-12-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brefeldin A acts as a lactone antibiotic that inhibits ATPase activity and blocks protein transport, thereby impairing downstream vesicular trafficking, autophagy, and mitophagy. This biochemical blockade induces cancer cell differentiation and apoptosis with an IC50 of 0.2 μM in HCT 116 cells, demonstrating therapeutic relevance for oncological conditions such as gynecological cancer and cancer-related pain.

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>).