3-Nitro-L-tyrosine Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple clinical trials are currently evaluating conditions such as amyotrophic lateral sclerosis and COVID-19 across Phase 2, combined Phase 2/3, and unphased biomarker protocols. Sponsored by academic institutions, charitable organizations—including the Mario Negri Institute for Pharmacological Research, FightMND, and the ALS Association—and corporate entities like Ocugen and Mitsubishi Tanabe Pharma America, these studies maintain diverse recruitment statuses ranging from completed and active to currently or not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06126315	Not yet recruiting	Amyotrophic Lateral Sclerosis	Mario Negri Institute for Pharmacological Research\|University of Sydney\|FightMND	2024-06	Phase 2\|Phase 3
NCT05258669	Recruiting	COVID-19	Ocugen	2022-02-20	Phase 2\|Phase 3
NCT04259255	Active not recruiting	Amyotrophic Lateral Sclerosis\|ALS	Mitsubishi Tanabe Pharma America Inc.\|Massachusetts General Hospital	2019-10-21	--
NCT03456882	Completed	Amyotrophic Lateral Sclerosis	Mario Negri Institute for Pharmacological Research\|ALS Association\|Get out ONLUS	2017-05-30	Phase 2

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

Check the 3-Nitro-L-tyrosine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Formed by the reaction of peroxynitrite with L-tyrosine, 3-Nitro-L-tyrosine inhibits alpha 1-adrenoceptor-mediated events, which blunts downstream angiotensin II signaling and attenuates vascular contractile responses. This suppression of adrenoceptor activation and reduction of oxidative cell signaling offer critical insights into disease mechanisms and biomarker monitoring for neurodegenerative and inflammatory disorders, including amyotrophic lateral sclerosis and COVID-19.

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>).