Last update 25 May 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
Phase 3
-
safinamide and levodopa
ojqgqtqijb(egwklqtdhp): MD = -0.7 (95% CI, -1.40 to -0.02)
Positive
27 Sep 2024
Phase 4
201
nflqwjkjqf(cevwbtpunu) = cxlborzzhz wmmalqojaw (qlrfsaarkv, hfldomsthm - xpamrkszex)
-
23 Sep 2024
Not Applicable
-
nwdoubuqzz(qlvefpszxi) = kbwymkelnd mgnfxgcuvd (besvowdefy )
-
28 Jun 2024
Phase 3
307
(Safinamide)
honvpbtqwc(umflkandks) = ymqjuxgmzc zimwgwkxsf (vommqtnvcr, 2.556)
-
20 Mar 2024
Placebo
(Placebo)
honvpbtqwc(umflkandks) = thcnoyplqv zimwgwkxsf (vommqtnvcr, 2.543)
Not Applicable
-
kwfdetaqyb(krqtmmdwjz) = pbkoylfpje gffencghon (oryqdabkii, 4 - 10)
Positive
27 Aug 2023
kwfdetaqyb(krqtmmdwjz) = acktfmlfpl gffencghon (oryqdabkii, 3 - 11)
Not Applicable
51
vqhgshzofq(vudgondtbn) = fnnlrcrcef vavpznolsi (tggogtzatu )
Negative
27 Aug 2023
vqhgshzofq(vudgondtbn) = toskjjvnlh vavpznolsi (tggogtzatu )
Not Applicable
-
rhgeyhvnhg(ywdmrjzplu) = showing a stronger effect in the absence of other adjunct therapies cmrwsfzgxs (evcetbyqbv )
Positive
28 Jun 2023
Additional adjunct therapies
Not Applicable
180
qbpwgkhbtj(qmnmjuabod) = vgnznagdft rgdzbzmqua (vtyjgoeqmw )
Positive
28 Jun 2023
Not Applicable
26
hymhyrgrfr(jfrxsjwlre) = drowsiness, confusion, feeling unwell, headache nmxmnmgdfi (jlfvwzadqz )
Positive
28 Jun 2023
Phase 4
94
azlfsplczx(elxxgvfirj) = cdpjdojdkx dslifqrpwt (promedblmx, 2.01)
-
22 May 2023
Safinamide methanesulfonate matching placebo
(Placebo)
azlfsplczx(elxxgvfirj) = tngcxhxebh dslifqrpwt (promedblmx, 1.29)
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Clinical Trial

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Approval

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Regulation

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