Bufalin Clinical Trials

Size	Price	Qty
5mg	USD 177
25mg	USD 570

Clinical Trials

Several clinical trials are currently evaluating interventions associated with this compound or related frameworks across conditions including breast cancer, chronic obstructive pulmonary disease, sexual health, loneliness, and psychological well-being. Actively recruiting participants, these studies assess interventions such as exercise prehabilitation and respiratory quality-of-life metrics, with trial phases documented as unassigned or not applicable. Sponsorship is led by academic, hospital, and regional research institutes, including the Institut Nacional d'Educacio Fisica de Catalunya, Hospital Clinic of Barcelona, and Vejle Hospital.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06360809	Recruiting	Breast Cancer	Institut Nacional d''Educacio Fisica de Catalunya\|ICFO - The Institute of Photonics Sciences\|Hospital Clinic of Barcelona\|Institut d''Investigacions Biomèdiques August Pi i Sunyer\|Universidad San Jorge	2024-03-22	Not Applicable
NCT06240078	Recruiting	Pulmonary Disease Chronic Obstructive\|Sexual Health\|Loneliness\|Well-Being Psychological	Vejle Hospital\|Region of Southern Denmark	2024-02-20	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bufalin potently binds to the α1, α2, and α3 subunits of Na+/K+-ATPase while inhibiting steroid receptor coactivators SRC-1 and SRC-3, thereby disrupting intracellular ion homeostasis and coactivator-dependent transcriptional cascades. This blockade induces cell cycle arrest and apoptosis, ultimately suppressing aberrant cell proliferation in clinical contexts such as breast cancer.

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>).