Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 4 have evaluated the safety, pharmacokinetics, and efficacy of Safinamide Mesylate across central nervous system disorders, primarily Parkinson's disease, drug-induced dyskinesia, cognitive impairments, and renal or hepatic impairment. Sponsored by pharmaceutical companies including Newron Pharmaceuticals SPA and Zambon SpA as well as research institutions like IRCCS San Raffaele Roma, these studies display varying recruitment statuses, ranging from completed trials to terminated or withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07761936 RECRUITING
PARKINSON DISEASE (Disorder); Pain; Pain Management; Parkinson Disease (PD)
Universita di Verona
 2026-04-28 PHASE3
NCT03968744 TERMINATED
Idiopathic Parkinson's Disease (at Later Stage)
Alain Kaelin
 2019-02-18 PHASE4
NCT05312632 COMPLETED
Parkinson Disease
Eisai Korea Inc.
 2022-04-05 PHASE4
NCT03881371 COMPLETED
Parkinson Disease
Zambon SpA
 2019-08-01 PHASE3
NCT03887221 COMPLETED
Healthy
Zambon SpA
 2021-06-21 PHASE1
NCT03841604 COMPLETED
Idiopathic Parkinson Disease
Zambon SpA
 2019-04-09 PHASE4
NCT03987750 WITHDRAWN
Dyskinesia, Drug-Induced; Parkinson Disease
Zambon SpA
 2019-10 PHASE3
NCT03753763 COMPLETED
Multiple System Atrophy
Zambon SpA
 2019-10-29 PHASE2
NCT03843944 COMPLETED
Parkinson Disease
IRCCS San Raffaele Roma
 2018-05-01 PHASE4
NCT03216304 COMPLETED
Healthy
Cross Research S.A.
 2017-05-22 PHASE1
NCT02495831 COMPLETED
Healthy
Zambon SpA
 2015-05 PHASE1
NCT00865579 TERMINATED
Parkinson's Disease
Newron Pharmaceuticals SPA
 2009-04 PHASE3
NCT01028586 TERMINATED
Idiopathic Parkinson's Disease
Newron Pharmaceuticals SPA
 2009-10 PHASE3
NCT01211587 COMPLETED
Parkinson's Disease With Cognitive Impairments
Newron Pharmaceuticals SPA
 2010-09 PHASE2
NCT01264861 TERMINATED
Parkinson Disease
Newron Pharmaceuticals SPA
 2011-03 PHASE2
NCT00605683 COMPLETED
Idiopathic Parkinson's Disease
Newron Pharmaceuticals SPA
 2007-11 PHASE3
NCT00627640 COMPLETED
Idiopathic Parkinson's Disease
Newron Pharmaceuticals SPA
 2009-02 PHASE3
NCT01113320 COMPLETED
Parkinson's Disease
Newron Pharmaceuticals SPA
 2010-04 PHASE2
NCT01374113 COMPLETED
Renal Impairment
Newron Pharmaceuticals SPA
 2011-06 PHASE1
NCT01026428 COMPLETED
Idiopathic Parkinson's Disease
Newron Pharmaceuticals SPA
 2009-09 PHASE1; PHASE2
NCT01286935 COMPLETED
Parkinson's Disease
Newron Pharmaceuticals SPA
 2007-08 PHASE3
NCT01027169 COMPLETED
Hepatic Impairment
Newron Pharmaceuticals SPA
 2009-04 PHASE1
NCT01187966 COMPLETED
Parkinson's Disease
Newron Pharmaceuticals SPA
 2007-01 PHASE3
NCT00642889 COMPLETED
Parkinson's Disease
Newron Pharmaceuticals SPA
 2005-06 PHASE3
NCT00643045 COMPLETED
Idiopathic Parkinson's Disease
Newron Pharmaceuticals SPA
 2004-12 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Safinamide mesylate selectively and reversibly inhibits monoamine oxidase B to prevent central dopamine degradation, while additionally blocking voltage-gated sodium and calcium channels to inhibit presynaptic glutamate release. This multi-target mechanism restores synaptic dopamine levels and attenuates excitotoxic signaling, thereby providing clinical efficacy in reducing motor fluctuations in patients with Parkinson's disease.

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.