Safinamide

Safinamide
Clinical data
Trade namesXadago, Onstryv
Other namesEMD-1195686, PNU-15774E;
(2S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl] methylamino]propanamide
AHFS/Drugs.comMonograph
Pregnancy
category
  • Fetal malformations in animal studies[1]
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability95%
Protein binding88–90%
MetabolismAmidases, glucuronidation
Elimination half-life20–30 hrs
Excretion76% Kidney, 1.5% faeces
Identifiers
  • N2-{4-[(3-fluorobenzyl)oxy]benzyl}-L-alaninamide
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.120.167 Edit this at Wikidata
Chemical and physical data
FormulaC17H19FN2O2
Molar mass302.349 g·mol−1
3D model (JSmol)
  • O=C(N)[C@@H](NCc2ccc(OCc1cccc(F)c1)cc2)C
  • InChI=1S/C17H19FN2O2/c1-12(17(19)21)20-10-13-5-7-16(8-6-13)22-11-14-3-2-4-15(18)9-14/h2-9,12,20H,10-11H2,1H3,(H2,19,21)/t12-/m0/s1 checkY
  • Key:NEMGRZFTLSKBAP-LBPRGKRZSA-N checkY
 ☒NcheckY (what is this?)  (verify)

Safinamide, sold under the brand name Xadago, is a medication used as treatment for Parkinson's disease with "off" episodes; it has multiple modes of action, including the inhibition of monoamine oxidase B.[4][5][7]

It was approved in the European Union in February 2015,[4] in the United States in March 2017,[5] and in Canada in January 2019.[2]

  1. ^ "Summary of the risk management plan (RMP) for Xadago (safinamide)" (PDF). European Medicines Agency. January 2015.
  2. ^ a b "Onstryv Product information". Health Canada. 25 April 2012. Retrieved 21 July 2019.
  3. ^ "Summary Basis of Decision (SBD) for Onstryv". Health Canada. 23 October 2014. Retrieved 29 May 2022.
  4. ^ a b c "Xadago - Summary of Product Characteristics". UK Electronic Medicines Compendium. 1 February 2017. Retrieved 2 April 2017.
  5. ^ a b c "Safinimide label" (PDF). FDA. March 2017. Retrieved 2 April 2017. See FDA index page for NDA 207145 for updates.
  6. ^ "Xadago EPAR". European Medicines Agency (EMA). 24 February 2015. Retrieved 27 August 2024.
  7. ^ Perez-Lloret S, Rascol O (2016). "The safety and efficacy of safinamide mesylate for the treatment of Parkinson's disease". Expert Review of Neurotherapeutics. 16 (3): 245–258. doi:10.1586/14737175.2016.1150783. hdl:11336/41809. PMID 26849427. S2CID 37787896.