Metyrosine Clinical Trials

Size	Price	Qty
25mg	USD 157

Clinical Trials

Several Phase 2 clinical trials evaluate the therapeutic application of metyrosine across psychiatric and oncological indications, specifically velo-cardio-facial syndrome, psychosis, Ewing sarcoma, and general sarcoma. Conducted by sponsors such as Bausch Health Americas Inc. and the Sarcoma Oncology Research Center, LLC, these investigations demonstrate varied operational outcomes, with recruitment statuses currently listed as terminated or active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03778996	ACTIVE_NOT_RECRUITING	Sarcoma, Ewing; Sarcoma	Sarcoma Oncology Research Center, LLC	2020-01-03	PHASE2
NCT01127503	TERMINATED	Velo-cardio-facial Syndrome; Psychosis	Bausch Health Americas, Inc.	2010-06	PHASE2
NCT01127503	Terminated	Velo-cardio-facial Syndrome\|Psychosis	Bausch Health Americas Inc.	2010-06	Phase 2

(data from https://clinicaltrials.gov, updated on 2025-02-24)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Metyrosine competitively inhibits tyrosine hydroxylase, the rate-limiting enzyme in catecholamine synthesis, thereby blocking the conversion of L-tyrosine to L-DOPA and reducing cellular levels of dopamine, norepinephrine, and epinephrine. This inhibition of catecholamine production suppresses hyperadrenergic signaling, offering clinical relevance in managing hypertension as well as evaluated trial conditions such as psychosis and sarcoma.

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>).