L-Sulforaphane Clinical Trials

Size	Price	Qty
5mg	USD 379
25mg	USD 1,137

Clinical Trials

A clinical trial sponsored by an academic institution, the Universidade Federal Fluminense, is currently evaluating the therapeutic potential of sulforaphane in individuals with chronic kidney disease. This investigator-initiated study lacks a formal phase designation and maintains an active, not recruiting status. Overall, this research highlights focused efforts to explore sulforaphane in renal therapeutic applications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04608903	ACTIVE_NOT_RECRUITING	Chronic Kidney Disease	Universidade Federal Fluminense	2021-12-01

(data from https://clinicaltrials.gov, updated on 2025-04-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-Sulforaphane directly activates the nuclear factor erythroid 2-related factor 2 (Nrf2) signaling cascade by targeting the Keap1/Nrf2/ARE pathway, promoting the nuclear translocation of Nrf2 and subsequent upregulation of antioxidant and carcinogen-detoxifying enzymes. This induction of cytoprotective enzymatic defenses mitigates cellular oxidative stress and tissue damage, underscoring its therapeutic evaluation for improving renal outcomes in chronic kidney disease.

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>).