Ipragliflozin L-Proline Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Several completed Phase 1 and Phase 3 clinical trials, sponsored by Astellas Pharma Europe B.V. and Astellas Pharma Inc, have evaluated ipragliflozin for Type 2 Diabetes Mellitus and clinical pharmacology assessment. Early-phase studies focused on evaluating glucose homeostasis, pharmacokinetics, bioavailability, and drug interactions in healthy volunteers and diabetic cohorts. Additionally, Phase 3 research investigated the therapeutic efficacy and safety of ipragliflozin combined with metformin for managing glycemic control in patients with type 2 diabetes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02794792	Completed	Type 2 Diabetes Mellitus	Astellas Pharma Europe B.V.\|Astellas Pharma Inc	2016-05-11	Phase 3
NCT01611363	Completed	Type 2 Diabetes Mellitus	Astellas Pharma Europe B.V.\|Astellas Pharma Inc	2011-10-27	Phase 1
NCT01611415	Completed	Healthy Subjects\|Pharmacokinetics of Ipragliflozin	Astellas Pharma Europe B.V.\|Astellas Pharma Inc	2011-07	Phase 1
NCT01611428	Completed	Bioavailability of Ipragliflozin\|Healthy Subjects	Astellas Pharma Europe B.V.\|Astellas Pharma Inc	2011-06	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ipragliflozin L-Proline is a highly potent and selective inhibitor of sodium-glucose cotransporter 2 (SGLT2) that binds to SGLT2 in the renal proximal tubules, thereby blocking active luminal glucose reabsorption back into systemic circulation. By suppressing renal glucose reuptake, the compound enhances urinary glucose excretion and lowers plasma glucose levels, providing a targeted therapeutic approach to improve glycemic control in patients with type 2 diabetes mellitus.

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>).