Gemigliptin Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple Phase 1 clinical trials sponsored by LG Chem, currently of unknown recruitment status, evaluate gemigliptin for metabolic indications, specifically type 2 diabetes mellitus and concurrent dyslipidemias. These early-phase investigations assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the compound, as well as potential drug-drug interactions following oral co-administration with dapagliflozin. Together, these studies aim to establish the overall pharmacological profile and therapeutic safety of gemigliptin for managing metabolic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03867942	Unknown status	Diabetes Mellitus Type 2\|Dyslipidemias	LG Chem	2019-03-21	Phase 1
NCT03565458	Unknown status	Type 2 Diabetes Mellitus	LG Chem	2018-04-05	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gemigliptin functions as a potent and selective dipeptidyl peptidase 4 inhibitor, binding the enzyme with high affinity (Ki = 7.25 nM) to prevent the degradation of circulating incretin hormones such as glucagon-like peptide-1. By preserving active incretin levels, the compound enhances glucose-dependent insulin secretion and suppresses glucagon release, thereby improving glycemic control in clinical conditions including type 2 diabetes mellitus and dyslipidemias.

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>).