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MedKoo CAT#: 326805

CAS#: 133865-89-1 (free base)

Description: Safinamide, also known as FCE-26743 and EMD-1195686, is a drug indicated for the treatment of Parkinson's disease with multiple methods of action. Potential additional uses might be restless legs syndrome (RLS) and epilepsy. Safinamide is a reversible and selective monoamine oxidase B inhibitor, reducing degradation of dopamine, and a glutamate release inhibitor. It also inhibits dopamine reuptake. Additionally, safinamide blocks sodium and calcium channels. Safinamide has been approved by the European Medicines Agency for the treatment of adult patients with idiopathic Parkinson’s disease as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD drugs in patients with mid-to-late-stage fluctuating disease.

Chemical Structure

CAS# 133865-89-1 (free base)

Theoretical Analysis

MedKoo Cat#: 326805
Name: Safinamide
CAS#: 133865-89-1 (free base)
Chemical Formula: C17H19FN2O2
Exact Mass: 302.1431
Molecular Weight: 302.35
Elemental Analysis: C, 67.53; H, 6.33; F, 6.28; N, 9.27; O, 10.58

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Related CAS #: 133865-89-1 (free base)   202825-46-5 (mesylate)    

Synonym: FCE-28073; FCE 28073; FCE28073; NW 1015; NW1015; NW-1015; PNU 151774E; PNU-151774E; EMD-1195686; EMD1195686; EMD 1195686; Safinamide, Xadago

IUPAC/Chemical Name: (S)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamide


InChi Code: 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


Appearance: Solid powder

Purity: >98% (or refer to the Certificate of Analysis)

Shipping Condition: Shipped under ambient temperature as non-hazardous chemical. This product is stable enough for a few weeks during ordinary shipping and time spent in Customs.

Storage Condition: Dry, dark and at 0 - 4 C for short term (days to weeks) or -20 C for long term (months to years).

Solubility: Soluble in DMSO

Shelf Life: >2 years if stored properly

Drug Formulation: This drug may be formulated in DMSO

Stock Solution Storage: 0 - 4 C for short term (days to weeks), or -20 C for long term (months).

HS Tariff Code: 2934.99.9001

Preparing Stock Solutions

The following data is based on the product molecular weight 302.35 Batch specific molecular weights may vary from batch to batch due to the degree of hydration, which will affect the solvent volumes required to prepare stock solutions.

Recalculate based on batch purity %
Concentration / Solvent Volume / Mass 1 mg 5 mg 10 mg
1 mM 1.15 mL 5.76 mL 11.51 mL
5 mM 0.23 mL 1.15 mL 2.3 mL
10 mM 0.12 mL 0.58 mL 1.15 mL
50 mM 0.02 mL 0.12 mL 0.23 mL

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1: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Available from PubMed PMID: 31644126.

2: Safinamide for Parkinson's disease. Aust Prescr. 2019 Apr;42(2):78-79. doi: 10.18773/austprescr.2019.021. Epub 2018 Feb 28. Review. PubMed PMID: 31048946; PubMed Central PMCID: PMC6478961.

3: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from PubMed PMID: 30835405.

4: Bette S, Shpiner DS, Singer C, Moore H. Safinamide in the management of patients with Parkinson's disease not stabilized on levodopa: a review of the current clinical evidence. Ther Clin Risk Manag. 2018 Sep 18;14:1737-1745. doi: 10.2147/TCRM.S139545. eCollection 2018. Review. PubMed PMID: 30271159; PubMed Central PMCID: PMC6152599.

5: ▼ Safinamide for Parkinson's disease. Drug Ther Bull. 2018 May;56(5):54-57. doi: 10.1136/dtb.2018.5.0623. Review. PubMed PMID: 29760163.

6: Müller T. Safinamide: an add-on treatment for managing Parkinson's disease. Clin Pharmacol. 2018 Apr 5;10:31-41. doi: 10.2147/CPAA.S137740. eCollection 2018. Review. PubMed PMID: 29670409; PubMed Central PMCID: PMC5896660.

7: Teixeira FG, Gago MF, Marques P, Moreira PS, Magalhães R, Sousa N, Salgado AJ. Safinamide: a new hope for Parkinson's disease? Drug Discov Today. 2018 Mar;23(3):736-744. doi: 10.1016/j.drudis.2018.01.033. Epub 2018 Jan 12. Review. PubMed PMID: 29339106.

8: Baker DE, Kim AP. Formulary Drug Review: Safinamide. Hosp Pharm. 2017 Sep;52(8):532-543. doi: 10.1177/0018578717726046. Epub 2017 Aug 18. Review. PubMed PMID: 29276285; PubMed Central PMCID: PMC5735722.

9: Institute for Quality and Efficiency in Health Care. Safinamide: Benefit Assessment According to §35a Social Code Book V [Internet]. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2015 Aug 13. Available from PubMed PMID: 29144651.

10: Institute for Quality and Efficiency in Health Care. Safinamide (Addendum to Commission A15-18) [Internet]. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2015 Nov 5. Available from PubMed PMID: 29144646.

11: Müller T. Pharmacokinetic drug evaluation of safinamide mesylate for the treatment of mid-to-late stage Parkinson's disease. Expert Opin Drug Metab Toxicol. 2017 Jun;13(6):693-699. doi: 10.1080/17425255.2017.1329418. Review. PubMed PMID: 28537214.

12: deSouza RM, Schapira A. Safinamide for the treatment of Parkinson's disease. Expert Opin Pharmacother. 2017 Jun;18(9):937-943. doi: 10.1080/14656566.2017.1329819. Epub 2017 May 23. Review. PubMed PMID: 28504022.

13: Blair HA, Dhillon S. Safinamide: A Review in Parkinson's Disease. CNS Drugs. 2017 Feb;31(2):169-176. doi: 10.1007/s40263-017-0408-1. Review. PubMed PMID: 28110399.

14: Müller T, Foley P. Clinical Pharmacokinetics and Pharmacodynamics of Safinamide. Clin Pharmacokinet. 2017 Mar;56(3):251-261. doi: 10.1007/s40262-016-0449-5. Review. PubMed PMID: 27665574.

15: Müller T. Emerging approaches in Parkinson's disease - adjunctive role of safinamide. Ther Clin Risk Manag. 2016 Aug 2;12:1151-60. doi: 10.2147/TCRM.S86393. eCollection 2016. Review. PubMed PMID: 27536120; PubMed Central PMCID: PMC4977086.

16: Stocchi F, Torti M. Adjuvant therapies for Parkinson's disease: critical evaluation of safinamide. Drug Des Devel Ther. 2016 Feb 5;10:609-18. doi: 10.2147/DDDT.S77749. eCollection 2016. Review. PubMed PMID: 26917951; PubMed Central PMCID: PMC4751980.

17: Perez-Lloret S, Rascol O. The safety and efficacy of safinamide mesylate for the treatment of Parkinson's disease. Expert Rev Neurother. 2016;16(3):245-58. doi: 10.1586/14737175.2016.1150783. Epub 2016 Feb 19. Review. PubMed PMID: 26849427.

18: Müller T. Safinamide for symptoms of Parkinson's disease. Drugs Today (Barc). 2015 Nov;51(11):653-9. doi: 10.1358/dot.2015.51.11.2414529. Review. PubMed PMID: 26744740.

19: Fabbri M, Rosa MM, Abreu D, Ferreira JJ. Clinical pharmacology review of safinamide for the treatment of Parkinson's disease. Neurodegener Dis Manag. 2015 Dec;5(6):481-96. doi: 10.2217/nmt.15.46. Epub 2015 Nov 20. Review. PubMed PMID: 26587996.

20: Deeks ED. Safinamide: first global approval. Drugs. 2015 Apr;75(6):705-11. doi: 10.1007/s40265-015-0389-7. Review. PubMed PMID: 25851099.