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safinamide

Trade name: xadago

Small moleculeapproved

Approved

Mar 21, 2017

Safinamide (FCE 26743, NW 1015, PNU 151774, PNU 151774E, trade name Xadago) combines potent, selective, and reversible inhibition of MAO-B with blockade of voltage-dependent Na+ and Ca2+ channels and inhibition of glutamate release. Safinamide is under development with Newron, Zambon and Meiji Seika Pharma for the treatment of Parkinson's disease. Safinamide has been launched in the EU, Iceland and Liechtenstein. Safinamide was well tolerated and safe in the clinical development program that demonstrated the amelioration of motor symptoms and OFF phenomena by safinamide when combined with dopamine agonists or levodopa. — NCATS

Clinical trial activity

24 trials · 77 clinical orgs · 9 marketing orgs

Phase 1
6
Phase 2
15
Phase 3
10
Phase 4
4

Earliest trial started Dec 1, 2004 (NCT00643045)

Timeline

2000s

  1. Jan 1, 2004

    Newron Pharmaceuticals — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2009

    Newron Pharmaceuticals — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Newron Pharmaceuticals — Earliest Phase 2 Sponsor(trial)

  2. Mar 21, 2017

    Newron Pharmaceuticals — Earliest FDA Approval

  3. Mar 21, 2017

    Supernus Pharmaceuticals — Marketing Organization

  4. Mar 21, 2017

    US WorldMeds — NDA Secondary Org

  5. Mar 21, 2017

    Newron Pharmaceuticals — NDA Organization

  6. Mar 21, 2017

    Supernus Pharmaceuticals — NDA Secondary Org

2020s

  1. Jan 12, 2023

    OPTIMUS PHARMA PRIVATE LTD — Marketing Organization

  2. May 3, 2023

    Apicore — Marketing Organization

  3. Jun 14, 2023

    Aurobindo Pharma — Marketing Organization

  4. Apr 25, 2024

    Prinston Inc — Marketing Organization

  5. Dec 31, 2024

    MSN Laboratories — Marketing Organization

  6. Jun 13, 2025

    ZENARA — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 21, 2017

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H](NCc1ccc(OCc2cccc(F)c2)cc1)C(N)=O
Mol. weight
302.35 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide
  • emd 1195686
  • emd-1195686
  • emd-1195686
  • emd-1195686
  • emd-1195686
  • fbap methanesulfonate
  • fce 26743
  • fce-26743
  • fce 28073
  • fce-28073
  • nw-1015
  • pnu 151774e
  • pnu-151774e
  • pnu-151774e
  • pnu-151774e
  • (s)-2-((4-(3-fluorobenzoxy)benzyl)amino)propanamide
  • safinamide
  • safinamide
  • safinamide
  • safinamide
  • safinamide
  • safinamide
  • safinamide
  • safinamide
  • safinamide mesilate
  • safinamide mesylate
  • safinamide mesylate
  • safinamide mesylate
  • safinamide mesylate
  • safinamide methanesulfonate
  • safinamide methanesulfonate
  • safinamide methanesulfonate
  • safinimide
  • xadago
  • xadago
  • xadago
  • xadago

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05312632Phase 4Apr 5, 2022Eisai
NCT03987750Phase 3Oct 31, 2019Zambon
NCT03881371Phase 3Aug 1, 2019Zambon
NCT03887221Phase 1Aug 1, 2019Zambon
NCT03753763Phase 2Jul 31, 2019Zambon
NCT03841604Phase 4Feb 28, 2019Zambon
NCT03968744Phase 4Feb 18, 2019Ente Ospedaliero Cantonale
NCT03843944Phase 4May 1, 2018Vita-Salute University of Milano. Italy
NCT03216304Phase 1May 22, 2017Cross Research S.A., Zambon
NCT02495831Phase 1May 1, 2015Cross Research S.A., Zambon
NCT01374113Phase 1Jun 1, 2011Merck Serono, Newron Pharmaceuticals
NCT01264861Phase 2Dec 1, 2010Molecular NeuroImaging, Newron Pharmaceuticals
NCT01211587Phase 2Sep 1, 2010Merck Serono, Newron Pharmaceuticals
NCT01113320Phase 2Apr 1, 2010Merck Serono, Newron Pharmaceuticals
NCT01028586Phase 3Oct 1, 2009Merck Serono, Newron Pharmaceuticals
NCT01026428Phase 1/Phase 2 (Phase 2)Sep 1, 2009Merck KGaA, Newron Pharmaceuticals
NCT01027169Phase 1Apr 1, 2009CRS Clinical Research Services Kiel GmbH, Newron Pharmaceuticals
NCT00865579Phase 3Mar 1, 2009Merck Serono, Newron Pharmaceuticals
NCT00627640Phase 3Feb 1, 2009Merck Serono, Newron Pharmaceuticals
NCT00605683Phase 3Nov 1, 2007Merck Serono, Newron Pharmaceuticals
Showing 20 of 24 trials
Page 1 / 2

Organizations

Research & Development (77)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Newron PharmaceuticalsFor profit141432004
Merck SeronoFor profit7032007
ZambonFor profit7642015
Vita-Salute University of Milano. ItalyAcademic/Hospital3122004
All India Institute of Medical SciencesAcademic/Hospital2012004
Cross Research S.A.For profit2112015
Jaslok Hospital and Research Centre, Mumbai, IndiaAcademic/Hospital2012004
Nizam's Institute of Medical Sciences, Hyderabad, IndiaAcademic/Hospital2012004
Rajiv Gandhi University of Health SciencesAcademic/Hospital2012004
Apollo Hospitals, Chennai, IndiaAcademic/Hospital1012007
Autonomous University of MadridAcademic/Hospital1012004
Baby Memorial Hospital, CalicutAcademic/Hospital1012007
Brain and Mind Institute, NagpurAcademic/Hospital1012007
BYL Nair HospitalAcademic/Hospital1012004
Care Hospital, HyderabadAcademic/Hospital1012007
Chhatrapati Sahuji Maharaj Medical UniversityAcademic/Hospital1012007
colentina Hospital, BucurestiAcademic/Hospital1012007
CRS Clinical Research Services Kiel GmbHFor profit1012009
Cura Villa Margherita, Vicenza, ItalyAcademic/Hospital1012004
D'Annunzio University of Chieti–PescaraAcademic/Hospital1012007
77 organizations
Page 1 / 4

Marketing (10)

OrganizationOrg typeRelationshipDate
ApicoreFor profitMKTGMay 3, 2023
Aurobindo PharmaFor profitMKTGJun 14, 2023
MSN LaboratoriesFor profitMKTGDec 31, 2024
Newron PharmaceuticalsFor profitNDAMar 21, 2017
OPTIMUS PHARMA PRIVATE LTDFor profitMKTGJan 12, 2023
Prinston IncFor profitMKTGApr 25, 2024
Supernus PharmaceuticalsFor profitMKTGMar 21, 2017
Supernus PharmaceuticalsFor profitNDA2Mar 21, 2017
US WorldMedsFor profitNDA2Mar 21, 2017
ZENARAFor profitMKTGJun 13, 2025