Selnoflast Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Selnoflast is currently being evaluated in a multicenter Phase 2 clinical trial sponsored by Genentech, Inc. Currently recruiting subjects, this Phase IIa study investigates the molecule for the treatment of atherosclerosis, evaluating its safety, efficacy, pharmacodynamics, and pharmacokinetics. This clinical evaluation represents a significant stage of targeted development aiming to modulate inflammatory pathways in arterial disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07448038	RECRUITING	Atherosclerosis	Genentech, Inc.	2026-06-05	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Selnoflast acts as a selective and reversible small-molecule inhibitor that directly binds to the NLRP3 inflammasome, thereby blocking its oligomerization and the downstream maturation of pro-inflammatory cytokines. By inhibiting NLRP3-mediated cellular inflammatory cascades and pyroptotic signaling, this molecular targeted intervention reduces chronic arterial vascular inflammation, directly underpinning its investigation in clinical trials for atherosclerosis.

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>).