Isuzinaxib (APX-115 free base) Clinical Trials

Size	Price	Qty
5mg	USD 157
25mg	USD 507

Clinical Trials

Multiple clinical trials sponsored by Aptabio Therapeutics, Inc. evaluate the therapeutic efficacy and safety of Isuzinaxib (APX-115) for renal and metabolic disorders. This clinical program encompasses Phase 2 and Phase 2b studies—including completed and active, recruiting protocols—investigating diabetic nephropathies, type 2 diabetes mellitus, and diabetic kidney disease. Additionally, a clinical trial evaluated the compound's potential protective effects in subjects experiencing contrast-induced acute kidney injury.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06962098	RECRUITING	Diabetic Kidney Disease (DKD)	Aptabio Therapeutics, Inc.	2025-05-26	PHASE2
NCT05758896	COMPLETED	Contrast Induced Acute Kidney Injury	Aptabio Therapeutics, Inc.	2023-12-27	PHASE2
NCT04534439	Completed	Diabetic Nephropathies\|Diabetes Mellitus Type 2\|Nephropathy Diabetic	Aptabio Therapeutics Inc.	2020-08-24	Phase 2

(data from https://clinicaltrials.gov, updated on 2025-07-18)

Check the Isuzinaxib (APX-115 free base) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isuzinaxib acts as a potent pan-NADPH oxidase inhibitor by directly binding to Nox1, Nox2, and Nox4 isoforms, thereby blocking downstream production of reactive oxygen species and suppressing the cellular expression of key inflammatory mediators such as MCP-1, IL-6, and TNFα. By attenuating oxidative stress and cellular inflammatory responses in the kidney, Isuzinaxib offers therapeutic relevance for renal pathologies including diabetic nephropathy and contrast-induced acute kidney 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>).