Clinical Trials

Multiple clinical trials have evaluated rasagiline across neurological and psychiatric indications, including Parkinson's disease, amyotrophic lateral sclerosis, major depressive disorder, and treatment-resistant depression. Ranging from Phase 1 through Phase 4 alongside non-applicable phase investigations such as brain occupancy studies, these studies include both completed and terminated evaluations. Research sponsors encompass academic institutions, such as the University of Ulm, as well as industry sponsors including H. Lundbeck A/S and Teva Branded Pharmaceutical Products R&D Inc.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rasagiline selectively and irreversibly binds to monoamine oxidase B (MAO-B), preventing the oxidative deamination of central dopamine. This enzymatic inhibition elevates extracellular dopamine levels and suppresses reactive oxygen species generation, ultimately mitigating motor fluctuations and depressive symptoms in clinical indications such as Parkinson's disease and major depressive disorder.

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>).

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Note: Technical data last updated: Sep 1, 2026.