Metformin Hydrochloride Clinical Trials

Size	Price	Qty
500mg	USD 147
1g	USD 197

Clinical Trials

Multiple clinical trials are currently investigating the therapeutic potential of Metformin Hydrochloride across diverse indications, including Type 2 Diabetes, pulmonary sarcoidosis, and Long COVID-associated fatigue. These studies span Early Phase I through Phase IV stages and are sponsored by academic and institutional entities such as the University of Maryland Baltimore, Purpose Life Sciences, UCSF in collaboration with NIDDK, and UIC. Recruitment statuses for these trials range from not yet recruiting to actively recruiting participants.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05910554	Not yet recruiting	Sarcoidosis Pulmonary	University of Maryland Baltimore	2024-05-01	Phase 2
NCT06120881	Recruiting	Type 2 Diabetes	University of California San Francisco\|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2024-04-01	Early Phase 1
NCT06147050	Not yet recruiting	Long COVID	Purpose Life Sciences	2024-04	Phase 3
NCT06296836	Not yet recruiting	Diabetes Mellitus Type 2	University of Illinois at Chicago\|Emily Hanners\|Dulal Bhaumik\|Avisek Datta\|Peggy Choye\|Hailey Soni\|Annesti Elmasri\|Julie Jun\|Colin Goodman	2024-04-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Metformin Hydrochloride acts as an antihyperglycemic agent by suppressing hepatic gluconeogenesis, decreasing intestinal glucose absorption, and activating the JNK/p38 MAPK signaling pathway to induce apoptosis and promote mitophagy. These biochemical actions improve peripheral insulin sensitivity and reduce systemic cellular stress, providing the mechanistic rationale for its clinical investigation in Type 2 Diabetes, pulmonary sarcoidosis, and Long COVID.

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>).