TGR5 Receptor Agonist Clinical Trials

Size	Price	Qty
5mg	USD 397
25mg	USD 1,199

Clinical Trials

A clinical trial is currently recruiting participants to evaluate therapeutic interventions for male infertility under a non-applicable trial phase framework. Co-sponsored by GYNOV and Laboratoire Drouot, the study assesses the efficacy of dietary supplementation compared to a placebo. Investigators are primarily evaluating clinical parameters, including sperm DNA fragmentation rates, reflecting an active focus on male reproductive health.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04959864	Recruiting	Male Infertility	GYNOV\|Laboratoire Drouot	2021-07-07	Not Applicable

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

Check the TGR5 Receptor Agonist product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TGR5 Receptor Agonist selectively binds to and activates the G protein-coupled bile acid receptor TGR5, driving downstream intracellular cyclic AMP accumulation and secondary signaling cascades. This biochemical activation regulates cellular metabolic and inflammatory responses, contributing to potential therapeutic management in conditions such as male infertility.

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>).