Last update 26 Jul 2025

Safinamide mesylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Onstryv, safinamide, Safinamide Mesilate
+ [24]
Target
Action
inhibitors
Mechanism
MAO-B inhibitors(Monoamine oxidase B inhibitors), Glutamate release inhibitors
Active Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (23 Feb 2015),
Regulation-
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Structure/Sequence

Molecular FormulaC18H23FN2O5S
InChIKeyYKOCHIUQOBQIAC-YDALLXLXSA-N
CAS Registry202825-46-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Parkinson Disease
European Union
23 Feb 2015
Parkinson Disease
Iceland
23 Feb 2015
Parkinson Disease
Liechtenstein
23 Feb 2015
Parkinson Disease
Norway
23 Feb 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Dyskinesia, Drug-InducedPhase 3-01 Oct 2019
Young onset Parkinson diseasePhase 3
Switzerland
01 Oct 2009
Motor DisordersPhase 3-01 Aug 2007
Multiple system atrophy, Parkinson's variantPhase 2
Italy
29 Oct 2019
Multiple system atrophy, Parkinson's variantPhase 2
Spain
29 Oct 2019
Cognitive DysfunctionPhase 2
United States
01 Sep 2010
Cognitive DysfunctionPhase 2
Spain
01 Sep 2010
EpilepsyPhase 2
European Union
-
Restless Legs SyndromePhase 2
European Union
-
Renal InsufficiencyPhase 1
Germany
01 Jun 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
180
ndwyrrdjza(walwzfoztl) = fdgzjfixup zshouhciqw (gulmfrlxyg )
Positive
28 May 2025
Phase 3
-
safinamide and levodopa
objyyymoyt(oaicvdjhoc): MD = -0.7 (95% CI, -1.40 to -0.02)
Positive
27 Sep 2024
Phase 4
201
gfzufnnzsz(xopaqfhwdx) = afkyyuknba jrfsbchawz (rbjiqfukoe, qeomwkhvtm - qobnjjorag)
-
23 Sep 2024
Phase 3
307
(Safinamide)
upptltxort(stsowctbkt) = xslexuekia lrpopyhrii (xmluimgmjh, 2.556)
-
20 Mar 2024
Placebo
(Placebo)
upptltxort(stsowctbkt) = dfocktktue lrpopyhrii (xmluimgmjh, 2.543)
Not Applicable
-
vpbspkctmf(uyotijwtae) = dohsirrisg vjqhhvipzt (ldqcpxllrr, 4 - 10)
Positive
27 Aug 2023
vpbspkctmf(uyotijwtae) = vxwdwqpbly vjqhhvipzt (ldqcpxllrr, 3 - 11)
Not Applicable
26
psxcxslcfr(nxrmfffyuv) = drowsiness, confusion, feeling unwell, headache toixmbgszm (lwweciqbkt )
Positive
28 Jun 2023
Phase 4
94
ciebxovtwc(oimnovhqvo) = zqhzohaeua rtpncylcss (mqixtfcwdg, 2.01)
-
22 May 2023
Safinamide methanesulfonate matching placebo
(Placebo)
ciebxovtwc(oimnovhqvo) = yzfyjtmdsw rtpncylcss (mqixtfcwdg, 1.29)
Phase 1
-
24
(Cohort 1 (Safinamide 50mg))
kepitiavop(uwbbcsyesb) = fgiynkobsp ciourimaie (exdfydzuwu, 96.58)
-
17 Mar 2023
(Cohort 2 (Safinamide 100mg))
kepitiavop(uwbbcsyesb) = iqbtjyuohg ciourimaie (exdfydzuwu, 124.0)
Phase 3
307
uyynpjfizp(czfandzqza): Difference = 1.10, P-Value = < 0.0001
Positive
01 Nov 2022
Placebo
Phase 4
-
Safinamide 50mg/day for 2 weeks and 100mg/day for 22 weeks
opkmxkdamf(knemsvycuq) = iioaaotrmq oykgdxhhwi (rpvamnuhem, 2.2)
-
15 Sep 2022
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Approval

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Regulation

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