Tofogliflozin(CSG 452) Clinical Trials

Size	Price	Qty
5mg	USD 147
1g	USD 2,990

Clinical Trials

Multiple clinical trials spanning Phase 1, Phase 2, and Phase 4 evaluate the therapeutic profile of tofogliflozin in healthy volunteers and patients with type 2 diabetes mellitus, diabetic kidney disease, and non-alcoholic fatty liver disease. Sponsored by industry entities like Sanofi and Kowa alongside academic institutions such as Shinshu University and Kanazawa University, these studies focus on bioequivalence, safety, and metabolic outcomes. Although most trials are completed, recruitment continues for a Phase 2 clinical trial examining urinary albumin-to-creatinine ratios in diabetic renal disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05469659	RECRUITING	T2DM (Type 2 Diabetes Mellitus); Metformin; SGLT2-Inhibitors	Shinshu University	2021-09-22	PHASE2
NCT05722262	Completed	Healthy	Kowa Research Institute Inc.	2023-02-24	Phase 1
NCT02649465	COMPLETED	Non-alcoholic Fatty Liver Disease	Kanazawa University	2015-11-11	PHASE4
NCT02537834	COMPLETED	Type 2 Diabetes Mellitus	Kowa Company, Ltd.	2015-08	PHASE4
NCT02201004	COMPLETED	Type 2 Diabetes Mellitus	Sanofi	2014-06	PHASE4

(data from https://clinicaltrials.gov, updated on 2022-07-22)

Check the Tofogliflozin(CSG 452) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tofogliflozin selectively binds to human sodium-glucose co-transporter 2 (hSGLT2), blocking renal glucose reabsorption in the proximal tubules and inducing urinary glucose excretion. This reduced glycemic load lowers plasma glucose levels and ameliorates metabolic stress, underpinning its clinical utility in treating conditions such as type 2 diabetes mellitus, diabetic kidney disease, and non-alcoholic fatty liver disease.

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>).