APX-3330 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 447

Clinical Trials

Multiple clinical trials have evaluated APX-3330 across oncology and ophthalmology indications, with recruitment now completed across all recorded studies. Apexian Pharmaceuticals, Inc. sponsored a Phase 1 clinical trial in patients with advanced solid tumors. Furthermore, Ocuphire Pharma, Inc. sponsored a Phase 2 clinical trial evaluating orally administered APX-3330 for ocular conditions, including diabetic macular edema as well as non-proliferative and proliferative diabetic retinopathy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04692688	COMPLETED	Diabetic Retinopathy; Diabetic Macular Edema; NPDR - Non Proliferative Diabetic Retinopathy; PDR - Proliferative Diabetic Retinopathy	Ocuphire Pharma, Inc.	2021-04-08	PHASE2
NCT03375086	COMPLETED	Cancer	Apexian Pharmaceuticals, Inc.	2018-01-30	PHASE1
NCT03375086	Completed	Cancer	Apexian Pharmaceuticals Inc.	2018-01-30	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-08)

Check the APX-3330 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

APX-3330 selectively binds to apurinic/apyrimidinic endonuclease 1/redox effector factor 1 (APE1/Ref-1), thereby blocking its redox signaling function and downstream activation of nuclear factor kappa B (NF-κB) DNA-binding activity. This inhibition suppresses pro-inflammatory and pro-angiogenic gene expression, leading to reduced cell survival and pathological vascularization relevant to clinical evaluation in advanced solid tumors and diabetic retinopathy.

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>).