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PIMAVANSERIN TARTRATE
PIMAVANSERIN TARTRATE is a drug. It is currently FDA-approved (first approved 2016).
At a glance
| Generic name | PIMAVANSERIN TARTRATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2016 |
Approved indications
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
- Confusional state
Serious adverse events
- Increased mortality in elderly patients with dementia-related psychosis
- QT interval prolongation
- Hallucination
- Angioedema
- Urticaria
- Rash
- Falls
- Aggression
- Agitation
- Fecal incontinence
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)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PIMAVANSERIN TARTRATE CI brief — competitive landscape report
- PIMAVANSERIN TARTRATE updates RSS · CI watch RSS
Frequently asked questions about PIMAVANSERIN TARTRATE
What is PIMAVANSERIN TARTRATE?
PIMAVANSERIN TARTRATE is a Small molecule drug.
When was PIMAVANSERIN TARTRATE approved?
PIMAVANSERIN TARTRATE was first approved on 2016.
What development phase is PIMAVANSERIN TARTRATE in?
PIMAVANSERIN TARTRATE is FDA-approved (marketed).
What are the side effects of PIMAVANSERIN TARTRATE?
Common side effects of PIMAVANSERIN TARTRATE include Peripheral edema, Confusional state. Serious adverse events: Increased mortality in elderly patients with dementia-related psychosis, QT interval prolongation, Hallucination, Angioedema.