MedPath

Pimavanserin

Generic Name
Pimavanserin
Brand Names
Nuplazid
Drug Type
Small Molecule
Chemical Formula
C25H34FN3O2
CAS Number
706779-91-1
Unique Ingredient Identifier
JZ963P0DIK
Background

Pimavanserin is an atypical antipsychotic indicated for the treatment of psychiatric disorders. Although the exact mechanism of action is unknown, it is thought that pimavanserin interacts with the serotonin receptors, particularly the 5-HT and HT receptors. Unlike other atypical antipsychotics, pimavanserin lacks inherent dopaminergic activity. In fact, pimavanserin is the first antipsychotic drug without D blocking activity. Therefore, pimavanserin can be used to treat psychotic symptoms without causing extrapyramidal or worsening motor symptoms.

Pimavanserin is marketed under the trade name NUPLAZID and developed by Acadia Pharmaceuticals. It was approved by the FDA in April 2016 for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis thanks to favorable results from a pivotal six-week, randomized, placebo-controlled, parallel-group study. Pimavanserin was also under review as a potential treatment for dementia-related psychosis; however, as of April 2021, FDA approval has not been granted for this indication despite previous breakthrough designation.

Indication

用于伴随帕金森氏病精神病幻觉和妄想的治疗。

Associated Conditions
Delusions, Hallucinations
Associated Therapies
-

Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression

Phase 2
Completed
Conditions
Treatment of Depression in Adults With Parkinson's Disease (PD)
Interventions
First Posted Date
2018-03-29
Last Posted Date
2020-08-31
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
47
Registration Number
NCT03482882
Locations
🇺🇸

Associated Neurologists, P.C., Danbury, Connecticut, United States

🇺🇸

ATP Clinical Research, Inc., Costa Mesa, California, United States

🇺🇸

CNS Network, Torrance, California, United States

and more 17 locations

Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

Phase 3
Terminated
Conditions
Schizophrenia
Interventions
First Posted Date
2017-04-20
Last Posted Date
2024-08-15
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
996
Registration Number
NCT03121586
Locations
🇺🇸

141-Hassman Research Institute, Berlin, New Jersey, United States

🇺🇸

114-Northwestern University, Chicago, Illinois, United States

🇺🇦

582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU, Kharkiv, Ukraine

and more 158 locations

A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

Phase 2
Completed
Conditions
Agitation and Aggression in Alzheimer's Disease
Interventions
First Posted Date
2017-04-18
Last Posted Date
2020-04-09
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
79
Registration Number
NCT03118947
Locations
🇺🇸

Miami Jewish Health Systems, Miami, Florida, United States

🇺🇸

Acadia Hospital, Bangor, Maine, United States

🇨🇱

Especialidades Medicas L y S, Santiago, Chile

and more 25 locations

Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)

Phase 2
Completed
Conditions
Adjunctive Treatment of Major Depressive Disorder
Interventions
Other: Placebo
Drug: Pimavanserin
First Posted Date
2017-01-12
Last Posted Date
2019-11-14
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
207
Registration Number
NCT03018340
Locations
🇺🇸

Carolina Clinical Trials, Inc., Charleston, South Carolina, United States

🇺🇸

Woodland Research Northwest, Rogers, Arkansas, United States

🇺🇸

Altea Research, Las Vegas, Nevada, United States

and more 31 locations

Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)

Phase 3
Completed
Conditions
Schizophrenia
Interventions
Drug: Pimavanserin
Drug: Placebo
First Posted Date
2016-11-22
Last Posted Date
2020-06-17
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
396
Registration Number
NCT02970292

Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)

Phase 2
Completed
Conditions
Schizophrenia
Interventions
Drug: Pimavanserin
Drug: Placebo
First Posted Date
2016-11-22
Last Posted Date
2020-12-22
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Target Recruit Count
403
Registration Number
NCT02970305
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