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Nuplazid (PIMAVANSERIN)
Nuplazid works by blocking the action of a specific chemical messenger in the brain called serotonin.
Nuplazid (Pimavanserin) is a small molecule atypical antipsychotic developed by Acadia Pharmaceuticals Inc. It targets the 5-hydroxytryptamine receptor 2A to treat Parkinson's disease psychosis. Nuplazid is FDA-approved since 2016 and has two generic manufacturers. The commercial status of Nuplazid is not off-patent, and key safety considerations include the risk of falls and hallucinations. As an atypical antipsychotic, Nuplazid has a different mechanism of action compared to typical antipsychotics.
At a glance
| Generic name | PIMAVANSERIN |
|---|---|
| Sponsor | Acadia Pharms Inc |
| Drug class | Atypical Antipsychotic |
| Target | 5-hydroxytryptamine receptor 2A |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2016 |
| Annual revenue | 600 |
Mechanism of action
The mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with Parkinsons disease psychosis is unclear. However, the effect of pimavanserin could be mediated through combination of inverse agonist and antagonist activity at serotonin 5-HT2A receptors and to lesser extent at serotonin 5-HT2C receptors.
Approved indications
- Parkinson's disease
Boxed warnings
- WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia who experience psychosis unless their hallucinations and delusions are related to Parkinson's disease [see Warnings and Precautions (5.1) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning . Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia who experience psychosis unless their hallucinations and delusions are related to Parkinson's disease. ( 5.1 )
Common side effects
- Peripheral edema
- Nausea
- Confusional state
- Constipation
- Gait disturbance
- Hallucination
- Urinary tract infection
- Fatigue
- Rash
- Urticaria
- Angioedema
- Somnolence
Key clinical trials
- Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease. (PHASE2)
- A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis (PHASE3)
- Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder (PHASE2)
- Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder (PHASE2,PHASE3)
- Comparing Antipsychotic Medications in LBD Over Time (PHASE4)
- Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis (PHASE4)
- Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder (PHASE2,PHASE3)
- Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia (PHASE3)
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 |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nuplazid CI brief — competitive landscape report
- Nuplazid updates RSS · CI watch RSS
- Acadia Pharms Inc portfolio CI