SCR7 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

A clinical trial sponsored by Astellas Pharma Inc has evaluated this therapeutic candidate. This completed Phase 2, randomized, double-blind, placebo-controlled study served as a proof-of-concept evaluation to assess the compound's safety and efficacy in mitigating renal damage in patients at risk for acute kidney injury (AKI). Currently, no other clinical studies for this molecule are on record across additional indications or development phases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03941483	Completed	Acute Kidney Injury (AKI)	Astellas Pharma Inc	2019-11-01	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the SCR7 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SCR7 selectively binds to and inhibits DNA Ligase IV, which blocks the non-homologous end joining pathway and prevents the enzymatic ligation of double-strand DNA breaks in mammalian cells. This blockade alters cellular DNA repair responses, providing therapeutic potential to mitigate cellular injury and tissue damage in clinical conditions such as acute kidney injury.

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>).