TheraRadar
Data updated: May 26, 2026

PIMAVANSERIN (pimavanserin tartrate)

Trial Activity: Stable 5 active trials
CNS Approved 2024-01-16
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

ACADIA Pharmaceuticals Inc. conducting 15 trials (68%)
17 indications explored (Broad Platform)
→ schizophrenia (4 trials)
→ adjunctive treatment of major depressive disorder (3 trials)
→ irritability associated with autism spectrum disorder (2 trials)
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Discontinued
First Approved
2024-01-16
Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

MSN Aurobindo Pharma ZYDUS Teva
Active Ingredient: PIMAVANSERIN TARTRATE

PIMAVANSERIN Approval History

2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2024 to 2024
Jan 2024 ORIGINAL
Update
FDA Letter

What PIMAVANSERIN Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
📋

Clinical Trial Registry

25 trials
Trial Sponsor ID Phase Status Title
NCT05441280 PIP-II MHBP-001-21F IK2CX002363-01A1 Ph 2 recruiting Pimavanserin for Insomnia in Veterans With PTSD
NCT06068465 TSL-CM-JSSPMFSL-Ⅲ Ph 3 completed A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
NCT05555615 results posted ACP-103-070 Ph 2, Ph 3 terminated Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
NCT05590637 CAMELOT 22-0198H Ph 4 recruiting Comparing Antipsychotic Medications in LBD Over Time
NCT04373317 C-SAPP 2015 Ph 4 recruiting Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
NCT05523895 results posted ACP-103-069 Ph 2, Ph 3 completed Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
NCT03121586 results posted ACP-103-035 2016-003435-38 Ph 3 terminated Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
NCT04531982 ADVANCE-2 results posted ACP-103-064 Ph 3 completed Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
NCT05357612 212028 Ph 4 recruiting Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases
NCT06592833 STUDY-23-00855 Ph 2 recruiting Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
NCT04292223 results posted ACP-103-063 Ph 4 completed Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis
NCT03575052 results posted ACP-103-046 2017-003536-36 Ph 3 completed A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease
NCT03623321 results posted ACP-103-047 2017-004439-36 Ph 3 completed Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
NCT04809116 H-48699 Ph 4 withdrawn Pimavanserin for Insomnia in Veterans With Posttraumatic Stress Disorder: Proof of Concept
NCT04188392 PIP results posted H-45799 Ph 4 completed Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder
NCT04000009 results posted ACP-103-055 2018-003252-20 Ph 3 terminated Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
NCT03968159 results posted ACP-103-054/059 2018-003251-37 Ph 3 completed Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
NCT04164758 results posted ACP-103-056 Ph 2 terminated Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
NCT02970305 results posted ACP-103-038 2016-003436-20 Ph 2 completed Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)
NCT03482882 results posted ACP-103-048 Ph 2 completed Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression
NCT02970292 results posted ACP-103-034 2016-003434-24 Ph 3 completed Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
NCT03118947 results posted ACP-103-033 2016-001128-78 Ph 2 completed A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
NCT03018340 results posted ACP-103-042 Ph 2 completed Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
NCT02035553 results posted ACP-103-019 Ph 2 completed A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis
NCT01174004 results posted ACP-103-020 Ph 3 completed A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PIMAVANSERIN FDA Label Details

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Data Sources

FDA Approval: ANDA214925 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment