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Xadago (SAFINAMIDE)
Xadago works by blocking the enzyme amine oxidase [flavin-containing] B, which breaks down dopamine in the brain.
Xadago (safinamide) is a small molecule monoamine oxidase type B inhibitor developed by Newron Pharma US Inc and currently owned by Mdd Us. It targets the amine oxidase [flavin-containing] B enzyme to treat Parkinson's disease. Xadago was FDA approved in 2017 and is available as a branded and generic medication. The commercial status of Xadago is not fully off-patent, with four generic manufacturers available. Key safety considerations include its potential interactions with other medications.
At a glance
| Generic name | SAFINAMIDE |
|---|---|
| Sponsor | Mdd Us |
| Drug class | Monoamine Oxidase Type B Inhibitor |
| Target | Amine oxidase [flavin-containing] B |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
The precise mechanism by which XADAGO exerts its therapeutic effects in PD is unknown. XADAGO is an inhibitor of monoamine oxidase (MAO-B). Inhibition of MAO-B activity, by blocking the catabolism of dopamine, is thought to result in an increase in dopamine levels and subsequent increase in dopaminergic activity in the brain.
Approved indications
- Parkinson's disease
Common side effects
- Dyskinesia
- Fall
- Nausea
- Insomnia
- Orthostatic hypotension
- Anxiety
- Cough
- Dyspepsia
- Abnormal Laboratory Changes (ALT)
- Abnormal Laboratory Changes (AST)
- Hypersensitivity
- Headache
Key clinical trials
- Effect of Safinamide on Sleep Quality in Patients With Parkinson's Disease (PHASE4)
- Fall Risk Assessment in Parkinson's Disease Using Kinetikos Health
- A Study to Evaluate the Efficacy and Safety of Safinamide Mesilate as Add-on Therapy to Levodopa in Parkinson's Disease Participants With Motor Fluctuation in South Korea (PHASE4)
- An Observational Study on Safinamide, Rasagiline and Other Standard of Care in PD
- Overnight Switch From Rasagiline To Safinamide (PHASE4)
- 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 (PHASE3)
- Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
- Effect of Safinamide on Parkinson's Disease Related Chronic Pain (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xadago CI brief — competitive landscape report
- Xadago updates RSS · CI watch RSS
- Mdd Us portfolio CI