Clinical Trials

Multiple clinical trials evaluate interventions for conditions such as insulin resistance, coronary artery disease, acute lung injury, masticatory dysfunction, post-exercise energy intake, and peripheral vasoconstriction disorders. These studies encompass Phase I protocols investigating whole-body glucose metabolism alongside non-phased trials examining tissue perfusion, masticatory performance, and autonomic vagus nerve stimulation. Supported by academic and healthcare institutions including the National Institute on Aging and the Federal University of São Paulo, their recruitment statuses currently include completed, terminated, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07050017 COMPLETED
Appetite; Energy Intake; Post-exercise; Negative Energy Balance
Hacettepe University
2025-05-29
NCT05173259 COMPLETED
Chewing Problem; Mastication Disorder
University of Barcelona
2021-12-01
NCT03753022 UNKNOWN
Coronary Artery Disease; Coronary Artery Bypass Grafting; Acute Lung Injury
Federal University of São Paulo
2012-01
NCT04130893 TERMINATED
Vasoconstriction Disorder of Extremities
Hôpital Européen Marseille
2019-01-17
NCT02518932 UNKNOWN
Insulin Resistance
Elahi, Dariush, PhD
2015-03 PHASE1
NCT02518932 Unknown status
Insulin Resistance
Elahi Dariush PhD|ICON plc|Massachusetts General Hospital|National Institute on Aging (NIA)
2015-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-10-06)

Check the G15 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

G15 functions as a selective, cell-permeable antagonist of G-protein coupled estrogen receptor 1 (GPER/GPR30), binding the receptor with nanomolar affinity to block non-genomic estrogenic signaling cascades and downstream intracellular calcium mobilization. By inhibiting GPER-mediated signal transduction, G15 modulates cellular responses involved in metabolic homeostasis and vascular tone, providing mechanistic relevance to clinical investigations in insulin resistance and cardiovascular disorders.

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>).

Note: Technical data last updated: Sep 1, 2026.