Rasagiline Mesylate Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential and pharmacokinetic profile of rasagiline mesylate across neurodegenerative and psychiatric indications, including Parkinson's disease, amyotrophic lateral sclerosis, major depressive disorder, and depressive symptoms associated with Parkinson's disease. Spanning Phase 1 through Phase 4 as well as unassigned studies, these completed and terminated protocols are sponsored by academic institutions and industry partners including H. Lundbeck A/S, Teva Branded Pharmaceutical Products R&D Inc., and the Centre for Addiction and Mental Health. Representative research includes Phase 2 studies in amyotrophic lateral sclerosis and Phase 3 studies in levodopa-treated Parkinson's disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04841798	Completed	Major Depressive Disorder\|Treatment Resistant Depression	Centre for Addiction and Mental Health	2021-04-15	Not Applicable
NCT01879241	Completed	Amyotrophic Lateral Sclerosis	University of Ulm	2013-06	Phase 2
NCT01652313	Completed	Parkinson''s Disease	H. Lundbeck A/S	2012-05	Phase 1
NCT01736891	Completed	Parkinson´s Disease	Chongqing Fortune Pharmaceutical Co. Ltd.\|Beijing Bionovo Medicine Development Co. Ltd.	2011-11	Phase 3
NCT01178047	Terminated	Parkinson''s Disease	University of Zurich\|H. Lundbeck A/S	2011-09	Phase 4
NCT01055379	Completed	Depressive Symptoms\|Parkinson''s Disease	Lundbeck Italia S.p.A.\|Teva Branded Pharmaceutical Products R&D Inc.	2010-03	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rasagiline mesylate selectively and irreversibly binds to monoamine oxidase B (MAO-B), thereby blocking the enzymatic catabolism of striatal dopamine. This inhibition elevates synaptic dopamine availability and restores central dopaminergic signaling, directly contributing to symptomatic relief in clinical conditions such as Parkinson's disease and associated depressive disorders.

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>).