Xadago

(Safinamide)

Small molecule

SSamson Clinical Operations Pty Ltd

Xadago is a small molecule that works as a MAO-B Inhibitor.[2]

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

PARKINSON DISEASE (disorder)

NCT07761936

Clinical

Trials by Indication[1]

Parkinson's Disease4 trials

Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease

Completed·NNewron Pharmaceuticals SPA·Phase 3·NCT01187966·669 enrolled

Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease

Terminated·AAlain Kaelin·Phase 4·NCT03968744·11 enrolled

Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients

Terminated·NNewron Pharmaceuticals SPA·Phase 3·NCT00865579·964 enrolled

Show 1 more trial

Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects

Completed·NNewron Pharmaceuticals SPA·Phase 2·NCT01113320·26 enrolled

Idiopathic Parkinson's Disease2 trials

Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

Completed·NNewron Pharmaceuticals SPA·Phase 3·NCT00643045·269 enrolled

Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)

Completed·NNewron Pharmaceuticals SPA·Phase 3·NCT00642889·227 enrolled

Adult1 trial

A Single and Multiple Dose Study to Assess How the Drug Enters, Moves Through and Exits the Body, Safety and Tolerability of Safinamide in Healthy Adult Chinese Volunteers

Completed·ZZambon SpA·Phase 1·NCT03887221·24 enrolled

Renal Impairment1 trial

Safinamide Renal Impairment Trial

Completed·NNewron Pharmaceuticals SPA·Phase 1·NCT01374113·24 enrolled

Imaging1 trial

A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain Imaging

Terminated·NNewron Pharmaceuticals SPA·Phase 2·NCT01264861·5 enrolled

7 more indications

Interaction1 trial

Safinamide Steady State Interaction With Rosuvastatin

Completed·CCross Research S.A.·Phase 1·NCT03216304·24 enrolled

Parkinson's Disease (PD)1 trial

A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa

Completed·ZZambon SpA·Phase 3·NCT03881371·307 enrolled

Cognitive impairment1 trial

A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's Disease

Completed·NNewron Pharmaceuticals SPA·Phase 2·NCT01211587·103 enrolled

Efficacy1 trial

18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

Completed·NNewron Pharmaceuticals SPA·Phase 3·NCT01286935·544 enrolled

Hepatic Impairment1 trial

A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics

Completed·NNewron Pharmaceuticals SPA·Phase 1·NCT01027169·24 enrolled

PARKINSON DISEASE (Disorder)1 trial

Effects of Safinamide Versus Placebo on Pain in Patients With Parkinson's Disease With Motor Fluctuations: A Randomized, Controlled, Double-Blind Clinical Trial

Recruiting·UUniversita di Verona·Phase 3·NCT07761936·60 enrolled

Unspecified2 trials

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

Completed·NNewron Pharmaceuticals SPA·Phase 3·NCT00605683·679 enrolled

Overnight Switch From Rasagiline To Safinamide

Completed·IIRCCS San Raffaele Roma·Phase 4·NCT03843944·20 enrolled

Regulatory

FDA Approval Timeline[3]

Mar 21, 2017

XADAGO

NDA NDA207145

Jun 16, 2017

XADAGO

NDA NDA207145

Nov 25, 2019

XADAGO

NDA NDA207145

Aug 6, 2021

XADAGO

NDA NDA207145

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Safinamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Safinamide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA207145). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Xadago. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Samson Clinical Operations Pty Ltd company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: MAO-B Inhibitor[2]
Modality: Small molecule[2]
Company: SSamson Clinical Operations Pty Ltd

Patent Landscape[4]

Patent Cliff

Jun 8, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8278485Jun 8, 2027

8076515Dec 10, 2028

8283380Mar 21, 2031

Xadago

Expected Milestones

Q4 2027

Trials by Indication[1]

Parkinson's Disease4 trials

Idiopathic Parkinson's Disease2 trials

Adult1 trial

Renal Impairment1 trial

Imaging1 trial

Interaction1 trial

Parkinson's Disease (PD)1 trial

Cognitive impairment1 trial

Efficacy1 trial

Hepatic Impairment1 trial

PARKINSON DISEASE (Disorder)1 trial

Unspecified2 trials

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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