Phenformin HCl Clinical Trials

Size	Price	Qty
50mg	USD 147
250mg	USD 297

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of phenformin hydrochloride for novel applications in oncology and infectious disease. A completed Phase 1 trial sponsored by Memorial Sloan Kettering Cancer Center investigated phenformin combined with targeted BRAF and MEK inhibitors for BRAF-mutated melanoma. Additionally, an investigator-sponsored Phase 1/2 trial of unknown recruitment status was initiated to evaluate aerosolized phenformin alongside adjunctive therapies for severe COVID-19.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03026517	COMPLETED	Melanoma	Memorial Sloan Kettering Cancer Center	2017-01	PHASE1
NCT05003492	UNKNOWN	COVID-19	Amr kamel khalil Ahmed	2021-09	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-01-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phenformin hydrochloride disrupts mitochondrial energy production to elevate cytosolic AMP levels, which directly triggers the phosphorylation and activation of AMP-activated protein kinase (AMPK). This metabolic activation alters cellular energy homeostasis and inhibits proliferative cell signaling, providing a rational biological basis for clinical evaluations in melanoma and COVID-19.

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>).