RS-1 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Several clinical trials evaluate RS1 gene-targeting therapies for ocular conditions, predominantly X-linked retinoschisis, focusing on safety, dose escalation, and gene transfer efficacy. Spanning Early Phase 1 to Phase 3, these studies range from completed early-phase protocols to actively recruiting cohorts. Sponsorship is distributed across governmental institutions, such as the National Eye Institute, and industry partners including Zhongmou Therapeutics, Beacon Therapeutics, VegaVect, Inc., and Atsena Therapeutics Inc.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05878860	RECRUITING	X-linked Retinoschisis	Atsena Therapeutics Inc.	2023-08-22	PHASE3
NCT02317887	COMPLETED	Retinoschisis; X-Linked	VegaVect, Inc.	2015-02-11	PHASE1; PHASE2
NCT06066008	Recruiting	X-linked Retinoschisis	Zhongmou Therapeutics	2022-09-25	Early Phase 1
NCT02416622	COMPLETED	X-linked Retinoschisis	Beacon Therapeutics	2015-05	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-21)

Check the RS-1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

RS-1 selectively binds to and stimulates the recombinant human DNA repair protein RAD51, enhancing its DNA-binding affinity and promoting homology-directed repair during double-strand break processing. By boosting host-cell homologous recombination efficiency, this molecular stimulation facilitates precise target gene insertion and repair, holding clinical relevance for gene editing strategies aimed at treating inherited retinal disorders such as X-linked retinoschisis.

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>).