Safinamide Methanesulfonate

Safinamide methanesulfonate was approved by European Medicine Agency (EMA) on Feb 22, 2015. It was developed by Newron and Zambon, then marketed as Xadago® by Zambon in EU.

Safinamide is a unique molecule with a novel dual mechanism of action based on the enhancement of the dopaminergic function (through potent reversible inhibition of MAO-B and of dopamine uptake) and inhibition of the excessive release of glutamate. It is indicated for the treatment of Parkinson's disease (PD).

Xadago® is available as film-coated tablet for oral use, containing Eq. 50 mg/100 mg of free Safinamide. The recommended dose is 50 mg or 100 mg once daily.

General Information

Update Date:2015-09-18

Drug Name:
Safinamide Methanesulfonate
Research Code:
ZP-034; EMD-1195686
Trade Name:
Xadago®
MOA:
MAO-B inhibitor; Sodium channel blocker; Glutamate release inhibitor; Dopamine receptor
Indication:
Parkinson's disease (PD)
Status:
Approved
Company:
Newron (Originator) , Zambon
Sales:
ATC Code:
Approved Countries or Area

Update Date:2015-07-29

Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2015-02-24 First approval Xadago Parkinson's disease (PD) Tablet, Film coated Eq. 50 mg/100 mg Safinamide Zambon
Chemical Structure

Update Date:2015-10-30

Molecular Weight 398.45
Formula C17H19FN2O2 ● CH4O3S
CAS No. 133865-89-1 (Safinamide);
202825-46-5 (Safinamide Mesylate);
Chemical Name Propanamide, 2-[[[4-[(3-fluorophenyl)methoxy]phenyl]methyl]amino]-, (2S)-, methanesulfonate (1:1)
Safinamide (Free Acid/Base)Parameters:
MW HD HA FRB* PSA* cLogP*
302.34 3 4 7 64.3 2.198±0.546
*:Calculated by ACD/Labs software V11.02.
Related Patents

Update Date:2015-10-30

Synthesis & Impurities

Update Date:2016-02-21



Impurity database is being updated!