Selonsertib (GS-4997) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials evaluate selonsertib (GS-4997) across metabolic, renal, liver, and cardiovascular pathologies, including diabetic kidney disease, nonalcoholic steatohepatitis, alcoholic hepatitis, and pulmonary arterial hypertension. Sponsored by organizations including Gilead Sciences and HepQuant, LLC, these Early Phase 1 through Phase 3 trials—with recruitment statuses listed as completed, terminated, or withdrawn—examine the safety, pharmacokinetics, and therapeutic efficacy of ASK1 inhibition to mitigate tissue inflammation and fibrosis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04026165	COMPLETED	Diabetic Kidney Disease	Gilead Sciences	2019-07-24	PHASE2
NCT03449446	COMPLETED	Nonalcoholic Steatohepatitis	Gilead Sciences	2018-03-21	PHASE2
NCT03053050	TERMINATED	Nonalcoholic Steatohepatitis	Gilead Sciences	2017-02-13	PHASE3
NCT03053063	TERMINATED	Nonalcoholic Steatohepatitis	Gilead Sciences	2017-01-30	PHASE3
NCT02854631	COMPLETED	Alcoholic Hepatitis (AH)	Gilead Sciences	2016-09-01	PHASE2
NCT03087968	WITHDRAWN	Severe Alcoholic Hepatitis	HepQuant, LLC	2016-07-31	EARLY_PHASE1
NCT02466516	COMPLETED	Non-Alcoholic Steatohepatitis (NASH)	Gilead Sciences	2015-06-08	PHASE2
NCT02177786	COMPLETED	Diabetic Kidney Disease	Gilead Sciences	2014-06	PHASE2
NCT02234141	COMPLETED	Pulmonary Arterial Hypertension	Gilead Sciences	2014-11	PHASE2
NCT02509624	COMPLETED	Diabetic Kidney Disease	Gilead Sciences	2015-08-18	PHASE1
NCT02509624	Completed	Diabetic Kidney Disease	Gilead Sciences	2015-08-18	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-12-21)

Check the Selonsertib (GS-4997) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Selonsertib (GS-4997) selectively binds to apoptosis signal-regulating kinase 1 (ASK1), inhibiting its kinase activity and thereby blocking downstream phosphorylation and activation of the p38 mitogen-activated protein kinase and c-Jun N-terminal kinase pathways under oxidative stress. This intracellular pathway blockade suppresses stress-induced apoptosis, pro-inflammatory cytokine secretion, and fibrotic signaling cascades, providing therapeutic relevance for attenuating disease progression in clinical trial conditions such as nonalcoholic steatohepatitis and diabetic kidney disease.

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>).