Pimavanserin tartrate has been evaluated in numerous clinical trials across all development stages, from Early Phase 1 through Phase 4. Sponsored by industry, academic, and government entities, these studies assess therapeutic utility in neuropsychiatric conditions, including Parkinson's disease psychosis, schizophrenia, Alzheimer's disease psychosis, and irritability associated with autism spectrum disorder. The trials encompass various recruitment statuses, incorporating active, completed, and expanded access protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07610135 | RECRUITING | Mood (Psychological Function); Well Being; Mood; Healthy |
Johns Hopkins University |
2026-09-30 | PHASE1; PHASE2 |
| NCT06592833 | RECRUITING | Major Depressive Disorder |
Icahn School of Medicine at Mount Sinai |
2025-02-25 | PHASE2 |
| NCT05999240 | RECRUITING | Autism Spectrum Disorder |
New York State Psychiatric Institute |
2025-10-01 | PHASE2 |
| NCT04373317 | RECRUITING | Parkinson's Disease Psychosis |
VA Office of Research and Development |
2022-10-24 | PHASE4 |
| NCT05441280 | RECRUITING | Post-traumatic Stress Disorder; Insomnia |
VA Office of Research and Development |
2023-12-28 | PHASE2 |
| NCT05357612 | RECRUITING | Neurodegenerative Diseases; Parkinson Disease; Parkinson Disease Psychosis |
Vanderbilt University Medical Center |
2023-01-23 | PHASE4 |
| NCT06455293 | RECRUITING | Parkinson Disease; Depression |
Joshua Woolley, MD, PhD |
2024-08-19 | PHASE2 |
| NCT05895513 | RECRUITING | Intermittent Explosive Disorder |
Ohio State University |
2024-08-01 | PHASE2 |
| NCT05590637 | RECRUITING | Parkinson's Disease Psychosis; Dementia With Lewy Bodies |
The University of Texas Health Science Center at San Antonio |
2022-04-22 | PHASE4 |
| NCT07022366 | RECRUITING | Healthy |
University of Oxford |
2025-02-10 | |
| NCT06068465 | COMPLETED | Parkinson's Disease Psychosis |
Tasly Pharmaceutical Group Co., Ltd |
2024-09-27 | PHASE3 |
| NCT05555615 | TERMINATED | Irritability Associated With Autism Spectrum Disorder |
ACADIA Pharmaceuticals Inc. |
2022-11-02 | PHASE2; PHASE3 |
| NCT03994965 | WITHDRAWN | Schizophrenia; Psychosis |
Bjorn H. Ebdrup |
2024-12-01 | PHASE2 |
| NCT05523895 | COMPLETED | Irritability Associated With Autism Spectrum Disorder |
ACADIA Pharmaceuticals Inc. |
2022-08-09 | PHASE2; PHASE3 |
| NCT05796167 | WITHDRAWN | Parkinson Disease |
State University of New York - Downstate Medical Center |
2023-01-27 | EARLY_PHASE1 |
| NCT03121586 | TERMINATED | Schizophrenia |
ACADIA Pharmaceuticals Inc. |
2017-01 | PHASE3 |
| NCT03947216 | COMPLETED | Parkinson Disease |
University Hospital, Strasbourg, France |
2020-10-23 | PHASE2 |
| NCT05796167 | Recruiting | Parkinson Disease |
State University of New York - Downstate Medical Center|ACADIA Pharmaceuticals Inc. |
2024-04-04 | Early Phase 1 |
| NCT04531982 | COMPLETED | Schizophrenia |
ACADIA Pharmaceuticals Inc. |
2020-08-05 | PHASE3 |
| NCT06450184 | COMPLETED | Parkinson Disease Psychosis |
Humanis Saglık Anonim Sirketi |
2024-01-11 | PHASE1 |
| NCT04809116 | WITHDRAWN | Insomnia Chronic; Posttraumatic Stress Disorder |
Baylor College of Medicine |
2022-12-15 | PHASE4 |
| NCT03623321 | COMPLETED | Neuropsychiatric Symptoms Related to Neurodegenerative Disease |
ACADIA Pharmaceuticals Inc. |
2018-07-17 | PHASE3 |
| NCT05555615 | Recruiting | Irritability Associated With Autism Spectrum Disorder |
ACADIA Pharmaceuticals Inc. |
2022-11-02 | Phase 2|Phase 3 |
| NCT03575052 | COMPLETED | Neuropsychiatric Symptoms Related to Neurodegenerative Disease |
ACADIA Pharmaceuticals Inc. |
2018-05-21 | PHASE3 |
| NCT04292223 | COMPLETED | Parkinson Disease Psychosis |
ACADIA Pharmaceuticals Inc. |
2020-02-10 | PHASE4 |
| NCT04188392 | COMPLETED | Post-traumatic Stress Disorder; Insomnia |
Baylor College of Medicine |
2020-01-06 | PHASE4 |
| NCT04794413 | COMPLETED | Tourette Syndrome; Tardive Dyskinesia |
Joseph Jankovic |
2018-11-12 | EARLY_PHASE1 |
| NCT04000009 | TERMINATED | Adjunctive Treatment of Major Depressive Disorder |
ACADIA Pharmaceuticals Inc. |
2019-06-06 | PHASE3 |
| NCT04164758 | TERMINATED | Parkinson's Disease |
ACADIA Pharmaceuticals Inc. |
2019-10-23 | PHASE2 |
| NCT03968159 | COMPLETED | Adjunctive Treatment of Major Depressive Disorder |
ACADIA Pharmaceuticals Inc. |
2019-04-25 | PHASE3 |
| NCT02970305 | COMPLETED | Schizophrenia |
ACADIA Pharmaceuticals Inc. |
2016-11-04 | PHASE2 |
| NCT03325556 | COMPLETED | Dementia-related Psychosis |
ACADIA Pharmaceuticals Inc. |
2017-09-27 | PHASE3 |
| NCT03482882 | COMPLETED | Treatment of Depression in Adults With Parkinson's Disease (PD) |
ACADIA Pharmaceuticals Inc. |
2018-03-09 | PHASE2 |
| NCT02970292 | COMPLETED | Schizophrenia |
ACADIA Pharmaceuticals Inc. |
2016-10-26 | PHASE3 |
| NCT03118947 | COMPLETED | Agitation and Aggression in Alzheimer's Disease |
ACADIA Pharmaceuticals Inc. |
2017-02-23 | PHASE2 |
| NCT04794413 | Completed | Tourette Syndrome|Tardive Dyskinesia |
Joseph Jankovic|Andrew Billnitzer MD|Baylor College of Medicine |
2018-11-12 | Early Phase 1 |
| NCT03018340 | COMPLETED | Adjunctive Treatment of Major Depressive Disorder |
ACADIA Pharmaceuticals Inc. |
2016-12 | PHASE2 |
| NCT00550238 | COMPLETED | Parkinson's Disease Psychosis |
ACADIA Pharmaceuticals Inc. |
2007-07 | PHASE3 |
| NCT02992132 | TERMINATED | Agitation and Aggression in Alzheimer's Disease |
ACADIA Pharmaceuticals Inc. |
2016-11 | PHASE2 |
| NCT03121586 | Active not recruiting | Schizophrenia |
ACADIA Pharmaceuticals Inc. |
2017-01 | Phase 3 |
| NCT02035553 | COMPLETED | Alzheimer's Disease Psychosis |
ACADIA Pharmaceuticals Inc. |
2013-11 | PHASE2 |
| NCT01518309 | COMPLETED | Parkinson's Disease Psychosis |
ACADIA Pharmaceuticals Inc. |
2004-11-17 | PHASE2 |
| NCT01174004 | COMPLETED | Parkinson's Disease Psychosis |
ACADIA Pharmaceuticals Inc. |
2010-07 | PHASE3 |
| NCT00658567 | COMPLETED | Parkinson's Disease Psychosis |
ACADIA Pharmaceuticals Inc. |
2008-03 | PHASE3 |
| NCT00477672 | COMPLETED | Parkinson's Disease Psychosis |
ACADIA Pharmaceuticals Inc. |
2007-06 | PHASE3 |
| NCT00087542 | Completed | Hallucinations|Psychoses|Parkinson''s Disease |
ACADIA Pharmaceuticals Inc. |
2004-03 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2026-08-31)
Check the
Pimavanserin tartrate
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Pimavanserin tartrate Solubility in DMSO
- Pimavanserin tartrate Stock Solution
- Pimavanserin tartrate Storage
- Pimavanserin tartrate Stability
- Pimavanserin tartrate Molecular Weight
- Pimavanserin tartrate SMILES
- Pimavanserin tartrate CAS Number
- Pimavanserin tartrate Chemical Structure (2D and 3D)
- Pimavanserin tartrate SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.