NL-1 Clinical Trials

Size	Price	Qty
10mg	USD 149
50mg	USD 447

Clinical Trials

A clinical trial sponsored by an industry entity, Two Pi Signalprocessing Applications GmbH, evaluated an in-situ audiometry application for diagnostics and amplification adjustment in mild to moderate sensorineural hearing loss. Operating under an unassigned phase (Phase N/A), this completed study commenced recruitment in May 2013. Overall, the trial demonstrates a targeted investigation into diagnostic and therapeutic management tools for auditory impairment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01877317	COMPLETED	Mild to Moderate Sensorineural Hearing Loss	Two Pi Signalprocessing Applications GmbH	2013-05

(data from https://clinicaltrials.gov, updated on 2016-10-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

NL-1 acts as a mitochondrial mitoNEET inhibitor that selectively binds mitoNEET to disrupt iron-sulfur cluster transfer and cellular redox balance, consequently impairing mitochondrial bioenergetics and reducing cell viability. In the context of clinical investigations studying mild to moderate sensorineural hearing loss, modulating mitoNEET-mediated mitochondrial dynamics provides a prospective mechanism for regulating oxidative stress responses and cellular survival in auditory tissues.

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>).