Clinical Trials

Several clinical trials evaluate conditions including peptic ulcer hemorrhage, coronary artery disease, acute lung injury, primary hypercholesterolemia, and mixed dyslipidemia across Phase 3, Phase 4, and unassigned phase protocols. Sponsored by academic and institutional centers such as the McGill University Health Centre and the Federal University of São Paulo, as well as pharmaceutical sponsors like Merck Sharp & Dohme LLC, these studies encompass completed, terminated, and unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03753022 UNKNOWN
Coronary Artery Disease; Coronary Artery Bypass Grafting; Acute Lung Injury
Federal University of São Paulo
2012-01
NCT01335997 TERMINATED
Primary Hypercholesterolemia; Mixed Dyslipidemia
Merck Sharp & Dohme LLC
2011-05-01 PHASE3
NCT00840008 Completed
Peptic Ulcer Hemorrhage
McGill University Health Centre/Research Institute of the McGill University Health Centre|Horizon Health Network|Queen Elizabeth II Health Sciences Centre|St-Johns Health Sciences Centre|Centre hospitalier de l''Université de Montréal (CHUM)|Jewish General Hospital|Montreal General Hospital|Royal Victoria Hospital Canada|Maisonneuve-Rosemont Hospital|St Mary''s Hospital London|Centre Hospitalier Pierre Boucher|Cité de la Santé Hospital|Centre Hospitalier Anna Laberge|Hotel Dieu Hospital|CHAUQ - Hopital Saint Sacrement and Hopital Enfant Jesus|CISSS de Chaudière-Appalaches|Hamilton Health Sciences Corporation|Unity Health Toronto|Sunnybrook Health Sciences Centre|Toronto General Hospital|York Central Hospital Ontario|Lakeridge Health Corporation|Guelph General Hospital|London Health Sciences Centre|The Ottawa Hospital|Queen''s University|Scarborough General Hospital|Matsqui-Sumas-Abbotsford General Hospital and Mission Memorial Hospital|Vancouver General Hospital|Peter Lougheed Centre/The Calgary General Hospital|Foothills Medical Centre|Rockyview General Hospital|Grey Nuns Hospital|University of Alberta|Royal Alexandra Hospital|Misericordia|Royal University Hospital Foundation|Regina General Hospital|University of Manitoba
2008-09 Phase 4

(data from https://clinicaltrials.gov, updated on 2018-11-29)

Check the G10 (STING agonist-1) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

G10 selectively binds to and activates the stimulator of interferon genes protein, triggering downstream activation of interferon regulatory factor 3 and type I interferon transcriptional pathways to induce cellular antiviral immune responses. By stimulating type I interferon signaling and regulating host innate immune responses, this pathway modulates viral replication and inflammatory cascades relevant to study conditions such as acute lung injury.

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.