Abequolixron (RGX-104) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 227

Clinical Trials

Multiple early-stage clinical trials have evaluated abequolixron (RGX-104) in oncology, focusing on advanced solid malignancies such as recurrent or metastatic non-small cell lung cancer and endometrial cancer. A completed Phase 1 trial sponsored by Inspirna, Inc., assessed RGX-104 as both monotherapy and combination therapy. Additionally, a pilot study sponsored by the UNC Lineberger Comprehensive Cancer Center explored abequolixron combined with chemo-immunotherapy for non-small cell lung cancer, though this trial was ultimately terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02922764	COMPLETED	Endometrial Cancer; Endometrial Cancer Recurrent; Lung Cancer Recurrent; Lung Cancer; Non-small Cell Lung Cancer Metastatic; Non-small Cell Carcinoma	Inspirna, Inc.	2016-11-01	PHASE1
NCT05911308	TERMINATED	Non-Small Cell Lung Cancer	UNC Lineberger Comprehensive Cancer Center	2024-04-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-03-26)

Check the Abequolixron (RGX-104) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Abequolixron acts as an orally bioavailable agonist of the liver X receptor, driving the transcriptional activation of apolipoprotein E to modulate innate immune responses within the tumor microenvironment. By enhancing apolipoprotein E-mediated depletion of myeloid-derived suppressor cells, this targeted immunostimulatory mechanism restores anti-tumor immunity to suppress growth in advanced malignancies such as non-small cell lung cancer and endometrial cancer.

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>).