RI-1 Clinical Trials

Size	Price	Qty
10mg	USD 197
50mg	USD 570

Clinical Trials

A Phase 3 clinical trial is currently recruiting to evaluate an investigational therapeutic intervention associated with this compound designation. Sponsored by pharmaceutical industry sponsor Aerogen Pharma Limited, the study is designed to assess safety and clinical efficacy in pre-term infants suffering from respiratory distress syndrome. This active investigation reflects a targeted research focus on specialized neonatal respiratory conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06776783	RECRUITING	Respiratory Distress Syndrome; Pre-term Infants	Aerogen Pharma Limited	2025-09-24	PHASE3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

RI-1 selectively binds to the RAD51 recombinase protein to inhibit homooligomerization, thereby blocking homologous recombination pathways and disrupting cellular DNA double-strand break repair. By impairing DNA repair mechanisms and regulating cell survival, this molecular action provides the biological context for clinical trials evaluating treatments for pre-term infants with respiratory distress syndrome.

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>).