Anagliptin Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 590

Clinical Trials

Multiple clinical trials evaluate the therapeutic efficacy and safety of the compound for metabolic and cardiovascular conditions, including type 2 diabetes mellitus, coronary disease, and elevated LDL cholesterol and glycosylated hemoglobin levels. Spanning Phase 3, Phase 4, and observational designs, these evaluations are sponsored by organizations such as JW Pharmaceutical and the Institute for Clinical Effectiveness, Japan. Recruitment statuses across these studies vary, encompassing both completed and actively recruiting trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07442006	RECRUITING	Type 2 Diabetes Mellitus (T2DM)	JW Pharmaceutical	2025-10-29	PHASE4
NCT04810507	COMPLETED	Type 2 Diabetes	JW Pharmaceutical	2018-11-09	PHASE4
NCT02330406	COMPLETED	Dipeptidyl-Peptidase 4 Inhibitors; LDL Cholesterol; Glycosylated Hemoglobin; Diabetes Mellitus; Coronary Disease	Institute for Clinical Effectiveness, Japan	2015-04	PHASE4
NCT01529541	COMPLETED	Type 2 Diabetes Mellitus	JW Pharmaceutical	2011-05	PHASE3
NCT01529528	COMPLETED	Type 2 Diabetes Mellitus	JW Pharmaceutical	2011-05	PHASE3

(data from https://clinicaltrials.gov, updated on 2026-03-02)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Anagliptin functions as a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor that suppresses downstream NF-κB pathway activation, thereby mitigating inflammatory responses in macrophages, adipocytes, and hepatic tissues. This inhibition of DPP-4 activity regulates incretin degradation and glycemic fluctuations, addressing key metabolic pathologies in patients with type 2 diabetes mellitus and associated coronary 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>).