Trelagliptin Clinical Trials

Size	Price	Qty
5mg	USD 247

Clinical Trials

Multiple completed clinical trials sponsored by Takeda have evaluated trelagliptin across Phase 1 and Phase 3 development. These studies investigated bioequivalence following oral administration in healthy volunteers, as well as glycemic response in patients with type 2 diabetes mellitus. All evaluated trials have reached completed status, contributing key clinical data regarding the compound's pharmacokinetic and therapeutic profile.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02512068	Completed	Type 2 Diabetes Mellitus	Takeda	2015-08-07	Phase 3
NCT02372097	Completed	Healthy	Takeda	2015-03	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trelagliptin potently and selectively binds to dipeptidyl peptidase-4 (DPP-4), effectively blocking the enzymatic cleavage and inactivation of endogenous incretin hormones such as glucagon-like peptide-1. By prolonging active incretin signaling to stimulate glucose-dependent insulin secretion and suppress glucagon release, this mechanism helps restore normoglycemia in patients evaluated for 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>).