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pimavanserin

Generic: PIMAVANSERIN TARTRATE·Brand: NUPLAZID, Nuplazid, PIMAVANSERIN

pimavanserin: developed by 1 company · 22 clinical trials tracked · 2 FDA decisions.

pimavanserin evidence translation

What we can confirm

2 FDA records · 22 tracked trials

What it means

Source-backed records connect pimavanserin to ACAD; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could pimavanserin → ACAD affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence6 indications · 0 study sponsors

Related indications

Parkinson Disease; Schizophrenia; Adjunctive Treatment of Major Depressive DisorderSchizophreniaParkinson's Disease Psychosis; Alzheimer's Disease PsychosisIrritability Associated With Autism Spectrum DisorderNeurodegenerative DiseasesParkinson Disease

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (3)
CompanyPhase
ACADIA PHARMACEUTICALS INC (ACAD)
Parkinson Disease; Schizophrenia; Adjunctive Treatment of Ma…
Phase 4
ACADIA PHARMACEUTICALS INC (ACAD)Approved
ACADIA PHARMACEUTICALS INC (ACAD)
Parkinson's Disease Psychosis; Alzheimer's Disease Psychosis
Phase 4
Clinical Trials (22)showing 10 most recent

Effect of Pimavanserin on Aggression and Social Cognition.

NCT05895513·Phase 2·ACAD
Recruiting

Primary endpoint: Aggressive Responding on the Taylor Aggression Paradigm (TAP)

InterventionalRandomizedquadruple35 targetStarted 2024-08Completion 2028-011 site · United StatesOhio State University

Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study

NCT05796167·Early Phase 1·ACAD
Withdrawn

Primary endpoint: Effect of pimavanserin on sleep fragmentation

Interventionalopen0 targetStarted 2023-01Completion 2024-061 site · United StatesState University of New York - Downstate Medical Center

Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases

NCT05357612·Phase 4
Recruiting

Primary endpoint: Change in 5HT2A receptor density measured using the PET radioligand MH.MZ

Interventionalopen75 targetStarted 2023-01Completion 2027-081 site · United StatesVanderbilt University Medical Center

Open-label Pimavanserin 34mg at Bedtime for 6 Weeks for Insomnia in Veterans With Post-traumatic Stress Disorder: Proof of Concept Study

NCT04809116·Phase 4·ACAD
Withdrawn

Primary endpoint: Recruitment rates

Interventionalopen0 targetStarted 2022-12Completion 2023-121 site · United StatesBaylor College of Medicine

A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD)

NCT05555615·Phase 2/Phase 3·ACAD
Terminated

Primary endpoint: Treatment-emergent Adverse Events

Interventionalopen209 enrolledStarted 2022-11Completion 2025-0248 sites · Australia, France, Hungary, Italy…ACADIA Pharmaceuticals Inc.

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

NCT05523895·Phase 2/Phase 3·ACAD
Completed

Primary endpoint: Change From Baseline at Week 6 in Caregiver-rated Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score

InterventionalRandomizedquadruple237 enrolledStarted 2022-08Completion 2024-0950 sites · Australia, France, Hungary, Italy…ACADIA Pharmaceuticals Inc.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

NCT04531982·Phase 3·ACAD
Completed

Primary endpoint: Negative Symptom Assessment-16 (NSA-16) Total Score - Change From Baseline to Week 26

InterventionalRandomizedquadruple454 enrolledStarted 2020-08Completion 2024-0250 sites · Argentina, Bulgaria, Croatia, Czechia…ACADIA Pharmaceuticals Inc.

A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis

NCT04292223·Phase 4·ACAD
Completed

Primary endpoint: Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score

Interventionalopen29 enrolledStarted 2020-02Completion 2022-0418 sites · United StatesACADIA Pharmaceuticals Inc.

A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

NCT04164758·Phase 2·ACAD
Terminated

Primary endpoint: Treatment-emergent Adverse Events (TEAEs)

InterventionalRandomizedquadruple11 targetStarted 2019-10Completion 2020-0916 sites · United StatesACADIA Pharmaceuticals Inc.

A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

NCT04000009·Phase 3·ACAD
Terminated

Primary endpoint: Treatment-emergent Adverse Events (TEAEs)

Interventionalopen235 targetStarted 2019-06Completion 2021-0250 sites · Finland, Poland, Russia, United StatesACADIA Pharmaceuticals Inc.
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE NUPLAZID ® is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis [ see Clinical Studies (14) ] . NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ( 1 )(ACAD)FDA ↗
NDA210793Type 3 - New Dosage FormStandardOralCapsule
Approval1 INDICATIONS AND USAGE NUPLAZID ® is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis [ see Clinical Studies (14) ] . NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ( 1 )(ACAD)FDA ↗
NDA207318Type 1 - New Molecular EntityPriorityOralTablet

Frequently asked questions

Who is developing pimavanserin?

pimavanserin is being developed by ACADIA PHARMACEUTICALS INC.

How many clinical trials involve pimavanserin?

BioSniper tracks 22 clinical trials involving pimavanserin.

What is pimavanserin's latest FDA decision?

The most recent tracked FDA decision for pimavanserin is Approval for 1 INDICATIONS AND USAGE NUPLAZID ® is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis [ see Clinical Studies (14) ] . NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ( 1 ), dated June 28, 2018.