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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 12 indications[4].[1]

Nuplazid is one of 281 small molecule programs targeting Neurodegenerative Disease. It is currently in Approved.

12

Indications

29

Total Trials

7

Active Trials

280

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

17

Patents

Pipeline

Status by Indication[4][1]

Indication

Neurodegenerative DiseaseApproved

Parkinson DiseaseActive, not recruiting

InsomniaActive, not recruiting

CognitionActive, not recruiting

PsychosisActive, not recruiting

Autism Spectrum DisorderActive, not recruiting

Alzheimer's DiseaseApproved

Parkinson's DiseaseActive, not recruiting

Major Depressive DisorderActive, not recruiting

SchizophreniaActive, not recruiting

Neurodegenerative DiseaseApproved

Approved

Parkinson DiseasePhase 1

Active, not recruiting

InsomniaPhase 2

Active, not recruiting

CognitionPhase 2

Active, not recruiting

PsychosisApproved

Active, not recruiting

Autism Spectrum DisorderPhase 2/Phase 3

Active, not recruiting

Alzheimer's DiseaseApproved

Approved

Parkinson's DiseasePhase 2

Active, not recruiting

Major Depressive DisorderPhase 3

Active, not recruiting

SchizophreniaPhase 3

Active, not recruiting

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Nuplazid

AACADIA Pharmaceuticals Inc.

Celexa

Inapsine

Alnylam Pharmaceuticals

Ozempic

Depakote

Comtan

Orion Corporation, Orion Pharma

Persantine

Boehringer Ingelheim

Inversine

TTargacept Inc.

Permax

VValeant Pharmaceuticals

Luvox

SSolvay Pharmaceuticals

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Neurodegenerative Disease

NCT05357612

Study completion

NCT07022366

Q1 2027

Post-ApprovalRecruiting

Medication

NCT05590637

Q3 2027

Phase 2Recruiting

Insomnia

NCT05441280

Post-ApprovalRecruiting

Psychosis

NCT04373317

Q1 2028

Phase 2Recruiting

Cognition

NCT05895513

Clinical

Trials by Indication[1]

Schizophrenia4 trials

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

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

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

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

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

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

Show 1 more trial

Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

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

Major Depressive Disorder4 trials

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

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

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

Neurodegenerative Disease3 trials

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

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

Recruiting·VVanderbilt University Medical Center·Phase 4·NCT05357612·75 enrolled

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

Completed·AACADIA Pharmaceuticals Inc.·Phase 3·NCT03623321·595 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: Proof of Concept

Withdrawn·—·Phase 4·NCT04809116

Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder

Completed·—·Phase 4·NCT04188392·6 enrolled

Psychosis3 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

Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis

Recruiting·VVA Office of Research and Development·Phase 4·NCT04373317·358 enrolled

9 more indications

Agitation2 trials

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

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

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

Treatment1 trial

Pimavanserin Treatment in TS

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

Parkinson disease1 trial

Pimavanserin for Sleep in Parkinson Disease

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

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

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

Cognition1 trial

Pimavanserin and Aggression and Social Cognition.

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

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]

Jun 28, 2018

NUPLAZID

NDA NDA210793

Jun 28, 2018

NUPLAZID

NDA NDA207318

Sources

References

[1]
ClinicalTrials.gov — 29 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

Aug 24, 2026

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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