Ertugliflozin L-pyroglutamic acid Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Multiple clinical trials evaluate the therapeutic profile and pharmacokinetics of ertugliflozin across Phase 1, Phase 3, and Phase 4 studies for conditions including type 2 diabetes mellitus, hepatic impairment, heart failure with nonischemic cardiomyopathy, diabetic kidney disease, and hypertension. Supported by pharmaceutical sponsors such as Merck Sharp & Dohme LLC and Pfizer alongside academic institutions like Yonsei University and Amsterdam UMC, recruitment statuses range from completed pharmacokinetic assessments to planned hemodynamic studies and evaluations of unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05727579	Not yet recruiting	Diabetes Mellitus\|Diabetic Kidney Disease\|Hypertension	Amsterdam UMC location VUmc\|Merck Sharp & Dohme LLC\|University of Colorado Denver	2023-06-01	Phase 4
NCT04490681	Unknown status	Heart Failure With Nonischemic Cardiomyopathy	Yonsei University	2020-08	Phase 3
NCT02115347	Completed	Type 2 Diabetes Mellitus\|Hepatic Impairment	Merck Sharp & Dohme LLC\|Pfizer	2014-09-19	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ertugliflozin L-pyroglutamic acid acts as a potent and selective inhibitor of sodium-dependent glucose cotransporter 2 (SGLT2) with an IC50 of 0.877 nM, blocking renal tubular reabsorption of filtered glucose to promote urinary glucose excretion and reduce circulating blood glucose levels. This targeted inhibition directly supports its therapeutic relevance across clinical study conditions, including type 2 diabetes mellitus, diabetic kidney disease, hypertension, and heart failure.

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>).