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Nuplazid

(Pimavanserin)

ApprovedSmall molecule

AACADIA Pharmaceuticals Inc.

Pimavanserin is used to treat hallucinations and delusions that occur in people with Parkinson's disease. It helps reduce these psychiatric symptoms without making the movement problems of Parkinson's worse.[2] Nuplazid is currently approved and in use across 7 indications[4].[1]

Nuplazid is one of 156 small molecule programs targeting Alzheimer's Disease. It is currently in Approved.

7

Indications

31

Total Trials

9

Active Trials

155

Competitors

21

FDA Applications

NDA/BLA/ANDA regulatory filings

17

Patents

Pipeline

Status by Indication[4][1]

Indication

Alzheimer's DiseaseApproved

Parkinson DiseaseRecruiting

Neurodegenerative DiseasesRecruiting

MoodRecruiting

PsychosisCompleted

CognitionRecruiting

Neurodegenerative DiseaseCompleted

Alzheimer's DiseaseApproved

Approved

Parkinson DiseaseApproved

Recruiting

Neurodegenerative DiseasesApproved

Recruiting

MoodPreclinical

Recruiting

PsychosisApproved

Completed

CognitionPhase 2

Recruiting

Neurodegenerative DiseaseApproved

Completed

Competition

Competitive Landscape

92 competitors in Parkinson Disease

#DrugCompanyPhaseTrials

Medrol

Brintellix

Aricept

Keppra

Ritalin

Epidiolex

Jazz Pharmaceuticals

Nicorette

Avelox

Nourianz

Kyowa Kirin Co., Ltd.

Actos

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Post-ApprovalRecruiting

Medication

NCT05590637

Q3 2027

Phase 2Recruiting

Insomnia

NCT05441280

ApprovedRecruiting

Neurodegenerative Diseases

NCT05357612

Q1 2028

Phase 2Recruiting

Cognition

NCT05895513

Phase 2Recruiting

Major Depressive Disorder

NCT06592833

Q2 2028

Phase 2Recruiting

Parkinson Disease

NCT06455293

Clinical

Trials by Indication[1]

Major Depressive Disorder4 trials

Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Completed·AACADIA Pharmaceuticals Inc.·Phase 3·NCT03968159·298 enrolled

Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Terminated·AACADIA Pharmaceuticals Inc.·Phase 3·NCT04000009·235 enrolled

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

Completed·AACADIA Pharmaceuticals Inc.·Phase 2·NCT03018340·207 enrolled

Show 1 more trial

Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT06592833·60 enrolled

Schizophrenia4 trials

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

Completed·AACADIA Pharmaceuticals Inc.·Phase 3·NCT02970292·396 enrolled

Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

Terminated·AACADIA Pharmaceuticals Inc.·Phase 3·NCT03121586·995 enrolled

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

Completed·AACADIA Pharmaceuticals Inc.·Phase 3·NCT04531982·454 enrolled

Show 1 more trial

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

Completed·AACADIA Pharmaceuticals Inc.·Phase 2·NCT02970305·403 enrolled

Insomnia3 trials

Pimavanserin for Insomnia in Veterans With PTSD

Recruiting·VVA Office of Research and Development·Phase 2·NCT05441280·60 enrolled

Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder

Completed·—·Phase 4·NCT04188392·6 enrolled

Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept

Withdrawn·—·Phase 4·NCT04809116

Parkinson disease3 trials

Pimavanserin for Sleep in Parkinson Disease

Withdrawn·SState University of New York - Downstate Medical Center·Phase 1·NCT05796167

CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)

Recruiting·VVA Office of Research and Development·Approved·NCT04373317·358 enrolled

The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

Recruiting·JJoshua Woolley, MD, PhD·Phase 2·NCT06455293·60 enrolled

Psychosis2 trials

Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis

Completed·AACADIA Pharmaceuticals Inc.·Phase 4·NCT04292223·29 enrolled

Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis

Completed·AACADIA Pharmaceuticals Inc.·Phase 3·NCT03325556·392 enrolled

11 more indications

Autism Spectrum Disorder2 trials

Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

Completed·AACADIA Pharmaceuticals Inc.·Phase 2/3·NCT05523895·237 enrolled

Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

Terminated·AACADIA Pharmaceuticals Inc.·Phase 2/3·NCT05555615·209 enrolled

Neurodegenerative Disease2 trials

Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Completed·AACADIA Pharmaceuticals Inc.·Phase 3·NCT03623321·595 enrolled

A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Completed·AACADIA Pharmaceuticals Inc.·Phase 3·NCT03575052·784 enrolled

Agitation2 trials

Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

Terminated·AACADIA Pharmaceuticals Inc.·Phase 2·NCT02992132·111 enrolled

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

Completed·AACADIA Pharmaceuticals Inc.·Phase 2·NCT03118947·79 enrolled

Cognition1 trial

Pimavanserin and Aggression and Social Cognition.

Recruiting·OOhio State University·Phase 2·NCT05895513·35 enrolled

Parkinson's Disease1 trial

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

Completed·AACADIA Pharmaceuticals Inc.·Phase 2·NCT03482882·47 enrolled

Medication1 trial

Comparing Antipsychotic Medications in LBD Over Time

Recruiting·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT05590637·94 enrolled

Sedation1 trial

Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

Terminated·AACADIA Pharmaceuticals Inc.·Phase 2·NCT04164758·11 enrolled

Treatment1 trial

Pimavanserin Treatment in TS

Completed·JJoseph Jankovic·Phase 1·NCT04794413·10 enrolled

Mood1 trial

PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Recruiting·JJohns Hopkins University·Preclinical·NCT07610135·20 enrolled

Neurodegenerative Diseases1 trial

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

Recruiting·VVanderbilt University Medical Center·Approved·NCT05357612·75 enrolled

Unspecified2 trials

Investigating the Neuropsychological Effects of 5-HT2a Antagonism

Recruiting·UUniversity of Oxford·N/A·NCT07022366·80 enrolled

Bioequivalence Study of Pimavanserin 34 mg Capsule

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT06450184·32 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 29, 2016

NUPLAZID

NDA NDA207318

Mar 4, 2018

NUPLAZID

NDA NDA207318

Mar 4, 2018

NUPLAZID

NDA NDA207318

Jun 6, 2018

NUPLAZID

NDA NDA207318

Jun 28, 2018

NUPLAZID

NDA NDA207318

Jun 28, 2018

NUPLAZID

NDA NDA210793

Jun 28, 2018

NUPLAZID

NDA NDA207318

Mar 4, 2019

NUPLAZID

NDA NDA210793

Mar 4, 2019

NUPLAZID

NDA NDA207318

May 10, 2019

NUPLAZID

NDA NDA210793

May 10, 2019

NUPLAZID

NDA NDA207318

Sep 27, 2019

NUPLAZID

NDA NDA207318

Sep 27, 2019

NUPLAZID

NDA NDA210793

Nov 23, 2020

NUPLAZID

NDA NDA207318

Nov 23, 2020

NUPLAZID

NDA NDA210793

Sep 15, 2023

NUPLAZID

NDA NDA210793

Sep 15, 2023

NUPLAZID

NDA NDA207318

Jan 22, 2025

NUPLAZID

NDA NDA210793

Jan 22, 2025

NUPLAZID

NDA NDA207318

Apr 27, 2026

NUPLAZID

NDA NDA210793

Apr 27, 2026

NUPLAZID

NDA NDA207318

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Pimavanserin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nuplazid drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Pimavanserin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Pimavanserin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210793). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Nuplazid. U.S. Food & Drug Administration.
[7]
SEC EDGAR — ACADIA Pharmaceuticals Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: 5-HT2A Inverse Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AACADIA Pharmaceuticals Inc.

Patent Landscape[6]

Patent Cliff

Jun 3, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7659285Aug 24, 2026

7732615Jun 3, 2028

7732615*PEDDec 3, 2028

7601740Apr 29, 2030

7601740*PEDOct 29, 2030

12 more patents

10517860Mar 23, 2037

10953000Mar 23, 2037

10517860*PEDSep 23, 2037

10953000*PEDSep 23, 2037

10449185Aug 27, 2038

11452721Aug 27, 2038

10849891Aug 27, 2038

10646480Aug 27, 2038

10849891*PEDFeb 27, 2039

11452721*PEDFeb 27, 2039

10449185*PEDFeb 27, 2039

10646480*PEDFeb 27, 2039

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