RGX-202 Clinical Trials

Size	Price	Qty
5mg	USD 79
25mg	USD 237

Clinical Trials

Multiple clinical trials sponsored by industry entities including Inspirna, Inc. and REGENXBIO Inc. evaluate the therapeutic application of RGX-202 across Phase 1 through Phase 3 evaluations. These studies target oncological conditions—such as gastrointestinal malignancies, metastatic colorectal carcinoma, gastric cancer, and KRAS mutation-related tumors—alongside neuromuscular disorders like Duchenne muscular dystrophy. Current trial recruitment statuses range from recruiting and enrolling by invitation to active not recruiting, completed, and temporarily unavailable.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05693142	ACTIVE_NOT_RECRUITING	Duchenne Muscular Dystrophy	REGENXBIO Inc.	2023-01-04	PHASE2; PHASE3
NCT03597581	COMPLETED	Gastrointestinal Cancer; Gastrointestinal Neoplasms; Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Gastric Cancer; Gastric Neoplasm; KRAS Mutation-Related Tumors; CRC; Colorectal Cancer Metastatic	Inspirna, Inc.	2018-06-05	PHASE1
NCT03597581	Recruiting	Gastrointestinal Cancer\|Gastrointestinal Neoplasms\|Colorectal Cancer\|Colorectal Neoplasms\|Colorectal Carcinoma\|Gastric Cancer\|Gastric Neoplasm\|KRAS Mutation-Related Tumors\|CRC\|Colorectal Cancer Metastatic	Inspirna Inc.	2018-06-05	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-21)

Check the RGX-202 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

RGX-202 functions as a selective inhibitor of the solute carrier family 6 member 8 (SLC6A8) transporter, effectively blocking cellular creatine import and consequently depleting intracellular phosphocreatine and adenosine triphosphate levels. This acute bioenergetic disruption induces tumor cell apoptosis, providing a mechanistic basis for inhibiting tumor growth in gastrointestinal malignancies, including colorectal and gastric cancers evaluated in clinical trials.

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>).