Clinical Trials

Multiple clinical trials spanning Phase 1 and unclassified developmental phases evaluate pharmacokinetic responses and dose-dependent management strategies in healthy volunteers and patients with type 2 diabetes. Sponsored by entities including Baxter Healthcare Corporation and the Hospital de Clinicas de Porto Alegre, these studies maintain recruitment statuses ranging from completed to unknown. Together, these records reflect early-stage clinical evaluations across healthy populations and metabolic disease contexts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05309304 COMPLETED
Healthy
Baxter Healthcare Corporation
2022-02-14 PHASE1
NCT03423108 UNKNOWN
Type2 Diabetes
Hospital de Clinicas de Porto Alegre
2018-09-10

(data from https://clinicaltrials.gov, updated on 2022-10-12)

Check the G150 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

G150 selectively binds to human cyclic GMP-AMP synthase (cGAS) with an IC50 of 10.2 nM, potently inhibiting the enzymatic synthesis of 2'3'-cGAMP and preventing downstream STING pathway activation and type I interferon production. By suppressing aberrant cytosolic DNA-driven inflammatory signaling and immune activation, cGAS inhibition by G150 provides a targeted therapeutic strategy relevant to inflammatory and metabolic disorders such as type 2 diabetes evaluated in clinical settings.

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.