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Safinamide (as add-on therapy)
Safinamide is a monoamine oxidase B (MAO-B) inhibitor that also has a weak inhibitory effect on monoamine oxidase A (MAO-A).
Safinamide is a monoamine oxidase B (MAO-B) inhibitor that also has a weak inhibitory effect on monoamine oxidase A (MAO-A). Used for Parkinson's disease, Major depressive disorder.
At a glance
| Generic name | Safinamide (as add-on therapy) |
|---|---|
| Also known as | Apokyn, Parlodel, Mirapex, Requip, Cabergoline (not approved in US) |
| Sponsor | Newron Pharmaceuticals SPA |
| Drug class | MAO-B inhibitor |
| Target | MAO-B |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting MAO-B, Safinamide increases the levels of dopamine in the brain, which can help alleviate symptoms of Parkinson's disease. Additionally, its weak inhibitory effect on MAO-A may contribute to its therapeutic effects.
Approved indications
- Parkinson's disease
- Major depressive disorder
Common side effects
- Dizziness
- Nausea
- Headache
- Fatigue
- Insomnia
Key clinical trials
- 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
- 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)
- Effect of Safinamide on Parkinson's Disease Related Chronic Pain (PHASE4)
- Safinamide for Multiple System Atrophy (MSA) (PHASE2)
- MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist (PHASE3)
- MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918) (PHASE3)
- Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa (PHASE3)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Safinamide (as add-on therapy) CI brief — competitive landscape report
- Safinamide (as add-on therapy) updates RSS · CI watch RSS
- Newron Pharmaceuticals SPA portfolio CI