Safinamide Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials across Phase 1 and Phase 4 evaluate safinamide in healthy adult volunteers, individuals with late-stage idiopathic Parkinson's disease, and subjects with renal impairment. Sponsored by commercial and academic entities including Zambon SpA, Newron Pharmaceuticals SPA, and Ente Ospedaliero Cantonale, these completed and actively recruiting studies evaluate pharmacokinetic profiles, safety margins, and specialized outcomes like sleep quality. Together, these findings define the drug's safety, pharmacokinetics, and clinical applicability across diverse patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03887221	Completed	Healthy	Zambon SpA	2021-06-21	Phase 1
NCT03968744	Recruiting	Idiopathic Parkinson''s Disease (at Later Stage)	Alain Kaelin\|Clinical Trial Unit Ente Ospedaliero Cantonale\|Ente Ospedaliero Cantonale Bellinzona	2019-02-18	Phase 4
NCT01374113	Completed	Renal Impairment	Newron Pharmaceuticals SPA	2011-06	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Safinamide selectively and reversibly binds monoamine oxidase-B with an IC50 of 98 nM, inhibiting dopamine breakdown and elevating synaptic dopamine availability within the central nervous system. This enhancement of dopaminergic pathways, combined with non-dopaminergic glutamatergic modulation, reduces motor impairment and improves clinical outcomes in patients evaluated for conditions such as idiopathic 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>).