Drugs / Safinamide
Safinamide
also known as
(S)-(+)-2-\[4-(3-fluorobenzyloxy) benzylamino\] propanamide methanesulfonate · EMD 1195686 · NW 1015 · PNU 151774E · Safinamida · Safinamide Mesilate · SAFINAMIDE MESYLATE · Safinamide methanesulfonate · +2 more
Small molecule targets MAOB via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | XADAGO | — | 2017-03-21 | fda.gov ↗ |
| Approved | EU (EMA) | Xadago | — | 2015-02-23 | europa.eu ↗ |
Trials 20 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03887221 | Jun → Aug 2021 | — | Zambon SpA | Completed | No outcome recorded |
| Phase 1 | NCT03216304 | May → Jul 2017 | — | Cross Research S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01374113 | Jun → Oct 2011 | impaired renal function disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 1 | NCT01027169 | Apr → Oct 2009 | — | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01026428 | Sep 2009 → Jul 2010 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03753763 | Oct 2019 → Jan 2021 | multiple system atrophy | Zambon SpA | Completed | No outcome recorded |
| Phase 2 | NCT01264861 | Mar 2011 → Jan 2012 | Parkinson disease | Newron Pharmaceuticals SPA | Terminated | No outcome recorded |
| Phase 2 | NCT01211587 | Sep 2010 → Apr 2012 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT03987750 | Oct 2019 → Apr 2021 | Parkinson disease, drug-induced dyskinesia | Zambon SpA | Withdrawn | No outcome recorded |
| Phase 3 | NCT03881371 | Aug 2019 → Aug 2021 | Parkinson disease | Zambon SpA | Completed | No outcome recorded |
| Phase 3 | NCT00865579 | Apr 2009 → Jun 2012 | Parkinson disease | Newron Pharmaceuticals SPA | Terminated | No outcome recorded |
| Phase 3 | NCT00627640 | Feb 2009 → Jan 2012 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 3 | NCT01286935 | Aug 2007 → Apr 2010 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 3 | NCT01187966 | Jan 2007 → Oct 2008 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 3 | NCT00642889 | Jun 2005 → Jan 2007 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 3 | NCT00643045 | Dec 2004 → Jan 2006 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05312632 | Apr 2022 → May 2023 | Parkinson disease | Eisai Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT03841604 | Apr 2019 → Apr 2021 | Parkinson disease | Zambon SpA | Completed | No outcome recorded |
| Phase 4 | NCT03968744 | Feb 2019 → Feb 2026 | Parkinson disease | Alain Kaelin | Terminated | No outcome recorded |
| Phase 4 | NCT03843944 | May 2018 → Mar 2019 | Parkinson disease | IRCCS San Raffaele Roma | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02495831 Comparator | May 2015 | — | Zambon SpA | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01113320 Comparator | Apr 2010 → Nov 2011 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01028586 Comparator | Oct 2009 → May 2012 | Parkinson disease | Newron Pharmaceuticals SPA | Terminated | No outcome recorded |
| Phase 3 | NCT00605683 Comparator | Nov 2007 → Jan 2012 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Safinamide | “Safinamide is an inhibitor of MAO-B.” NCT00627640 ↗ |
| Known as | (S)-(+)-2-\[4-(3-fluorobenzyloxy) benzylamino\] propanamide methanesulfonate | “Safinamide, (S)-(+)-2-\[4-(3-fluorobenzyloxy) benzylamino\] propanamide methanesulfonate, is an a-aminoamide derivative” NCT00605683 ↗ |
| Known as | EMD 1195686 | ChEMBL registry synonym — accepted as the source's own label CHEMBL396778 ↗ |
| Known as | NW 1015 | ChEMBL registry synonym — accepted as the source's own label CHEMBL396778 ↗ |
| Known as | PNU 151774E | ChEMBL registry synonym — accepted as the source's own label CHEMBL396778 ↗ |
| Known as | Safinamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL396778 ↗ |
| Known as | Safinamide Mesilate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05312632 ↗ |
| Known as | SAFINAMIDE MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL396778 ↗ |
| Known as | Safinamide methanesulfonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL396778 ↗ |
| Known as | Safinamide methansulfonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL396778 ↗ |
| Known as | Xadago | “According to Xadago™ SmPC, safinamide may transiently inhibit BCRP, therefore a time interval of 5 h should be kept between dosing of safinamide and medicinal products that are...” NCT02495831 ↗ |
| Action | Inhibit | “Safinamide is an inhibitor of MAO-B.” NCT00627640 ↗1“Monoamine oxidase B inhibitor” CHEMBL396778 ↗ |
| Modality | Small molecule | “is an a-aminoamide derivative” NCT00605683 ↗ |
| Route | Oral | “50 and 100 mg p.o. q.a.m.” NCT00605683 ↗ |
| Target | MAOB | “Monoamine oxidase B inhibitor” CHEMBL396778 ↗ |