Xadago

(Safinamide)

Phase 2Small molecule

Xadago is a small molecule that works as a MAO-B Inhibitor.[2] It is being investigated across 2 indications, with its most advanced program in Phase 2.[1]

Xadago is one of 61 small molecule programs targeting Cognitive impairment. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cognitive ImpairmentActive, not recruiting

Parkinson's DiseaseUnknown

Cognitive ImpairmentPhase 2

Active, not recruiting

Parkinson's DiseasePreclinical

Unknown

Competition

Competitive Landscape

279 competitors in Cognitive Impairment

#DrugCompanyPhaseTrials

Actos

Takeda

Phase 3

3 2

Farxiga

AstraZeneca

Phase 3

1 3

Xarelto

WWim Janssens

Phase 3

1 4

Aquasol E

NNational Eye Institute (NEI)

Phase 3

1 5

Provigil

NNuvo Research GmbH

Phase 3

1 6

Viagra

VViatris Specialty LLC

Phase 3

1 7

Donepezil Hydrochloride

Eisai

Phase 3

3 8

Namenda

AbbVie

Phase 2

5 9

Statins

Sanofi

Phase 3

1 10

Galantamine Hydrobromide

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Parkinson's Disease4 trials

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

Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects

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

Show 1 more trial

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

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 (12 Month Extension)

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

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

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

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

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

6 more indications

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

Interaction1 trial

Safinamide Steady State Interaction With Rosuvastatin

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

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

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[4]

Mar 21, 2017

XADAGO

NDA NDA207145

Sources

References

[1]
ClinicalTrials.gov — 16 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]
Open Targets Platform — Drug–disease associations for Safinamide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA207145). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Xadago. U.S. Food & Drug Administration.
[6]
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]
Highest Phase: Phase 2[1]
Company: SSamson Clinical Operations Pty Ltd

Patent Landscape[5]

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

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Parkinson's Disease4 trials

Idiopathic Parkinson's Disease2 trials

Efficacy1 trial

Imaging1 trial

Parkinson's Disease (PD)1 trial

Adult1 trial

Renal Impairment1 trial

Interaction1 trial

Hepatic Impairment1 trial

Cognitive impairment1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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