Drugs / Pimavanserin
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed parkinsonism with polyneuropathy 1 milestone | |||||
| Filed | US (FDA) | NUPLAZID | parkinsonism with polyneuropathy | — | “September submission to the FDA of our New Drug Application for the use of NUPLAZID™ in the treatment of Parkinson’s disease psychosis” acadia.com ↗ “Submitted NDA for NUPLAZID in September 2015, which was accepted for filing with Priority Review by the FDA in October 2015” acadia.com ↗ “the NDA was submitted in September 2015” tonixpharma.com ↗ |
| Filed substance-induced psychosis 2 milestones | |||||
| Rejected (CRL) | US (FDA) | — | substance-induced psychosis | 2021-04-02 | “FDA’s April 2, 2021 Complete Response Letter (CRL) to the sNDA originally submitted for a proposed indication for pimavanserin for the treatment of dementia-related psychosis.” acadia.com ↗ “FDA’s complete response letter (CRL) for the sNDA for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).” acadia.com ↗ |
| Filed | US (FDA) | NUPLAZID | substance-induced psychosis | 2020-06-15 | “the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to support a potential new indication for NUPLAZID® (pimavanserin)” acadia.com ↗ “filed the supplemental NDA for pimavanserin for the treatment of the hallucinations and delusions associated with dementia-related psychosis (DRP).” acadia.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansions (3) | US (FDA) | NUPLAZID | — | 2018-06-28 – 2026-04-27 | fda.gov ↗ |
| Approved | US (FDA) | NUPLAZID | — | 2016-04-29 | fda.gov ↗ |
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05796167 | Jan 2023 → Jun 2024 | Parkinson disease | State University of New York - Downstate Medical Center | Withdrawn | No outcome recorded |
| Phase 0 | NCT04794413 | Nov 2018 → Feb 2021 | Tourette syndrome, tardive dyskinesia | Joseph Jankovic | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07610135 | Oct 2026 → Jun 2028 expected | — | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 216 trials · 4 met primary · 1 missed | ||||||
| Phase 2 | NCT05999240 | Oct 2025 → Oct 2027 expected | autism spectrum disorder | New York State Psychiatric Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT03994965 | Dec 2024 | schizophrenia | Bjorn H. Ebdrup | Withdrawn | No outcome recorded |
| Phase 2 | NCT06455293 | Aug 2024 → Jun 2027 expected | Parkinson disease, depressive disorder | Joshua Woolley, MD, PhD | Recruiting | No outcome recorded |
| Phase 2 | NCT05895513 | Aug 2024 → Jan 2027 expected | intermittent explosive disorder | Ohio State University | Recruiting | No outcome recorded |
| Phase 2 | NCT03947216 | Oct 2020 → Apr 2024 | Parkinson disease | University Hospital, Strasbourg, France | Completed | No outcome recorded |
| Phase 2 | NCT04164758 | Oct 2019 → Sep 2020 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03482882 | Mar 2018 → Jul 2019 | — | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03118947 | Feb 2017 → Feb 2019 | — | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03018340 | Dec 2016 → Sep 2018 | — | ACADIA Pharmaceuticals Inc. | Completed | Met primary |
| Phase 2 | NCT02970305 | Nov 2016 → Oct 2019 | schizophrenia | ACADIA Pharmaceuticals Inc. | Completed | Met primary |
| Phase 2 | NCT02992132 | Nov 2016 → Jan 2018 | — | ACADIA Pharmaceuticals Inc. | Terminated | Missed primary |
| Phase 2 | NCT02035553 | Nov 2013 → Sep 2016 | Alzheimer disease | ACADIA Pharmaceuticals Inc. | Completed | Met primary |
| Phase 2 | NCT00361166 | Aug 2005 → Mar 2007 | schizophrenia | ACADIA Pharmaceuticals Inc. | Completed | Met primary |
| Phase 2 | NCT01518309 | Nov 2004 → May 2013 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00086294 | Jun 2004 → Nov 2007 | Parkinson disease, drug-induced dyskinesia | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00087542 | Mar 2004 → Dec 2005 | Parkinson disease, psychotic disorder | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT05555615 | Nov 2022 → Feb 2025 | autism spectrum disorder | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT05523895 | Aug 2022 → Sep 2024 | autism spectrum disorder | ACADIA Pharmaceuticals Inc. | Completed | Missed primary |
| Phase 312 trials · 2 met primary · 3 missed | ||||||
| Phase 3 | NCT06068465 | Sep 2024 → Feb 2026 | Parkinson disease | Tasly Pharmaceutical Group Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT04531982 | Aug 2020 → Jan 2024 | schizophrenia | ACADIA Pharmaceuticals Inc. | Completed | Missed primary |
| Phase 3 | NCT04000009 | Jun 2019 → Feb 2021 | — | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03968159 | Apr 2019 → Apr 2020 | — | ACADIA Pharmaceuticals Inc. | Completed | Missed primary |
| Phase 3 | NCT03623321 | Jul 2018 → May 2023 | neurodegenerative disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03575052 | May 2018 → May 2022 | neurodegenerative disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03325556 | Sep 2017 → Jul 2019 | psychotic disorder | ACADIA Pharmaceuticals Inc. | Completed | Met primary |
| Phase 3 | NCT03121586 | Jan 2017 → Apr 2024 | schizophrenia | ACADIA Pharmaceuticals Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02970292 | Oct 2016 → May 2019 | schizophrenia | ACADIA Pharmaceuticals Inc. | Completed | Missed primary |
| Phase 3 | NCT01174004 | Jul 2010 → Nov 2012 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | Met primary |
| Phase 3 | NCT00550238 | Jul 2007 → May 2018 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00477672 | Jun 2007 → Jun 2009 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT05357612 | Jan 2023 → Jun 2027 expected | Parkinson disease, neurodegenerative disease | Vanderbilt University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT04809116 | Dec 2022 → Dec 2023 | insomnia, post-traumatic stress disorder | Baylor College of Medicine | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04292223 | Feb 2020 → Apr 2022 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | Met primary |
| Phase 4 | NCT04188392 | Jan 2020 → Oct 2021 | insomnia, post-traumatic stress disorder | Baylor College of Medicine | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07022366 | Feb 2025 → Jun 2026 overdue | — | University of Oxford | Recruiting | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1/2 | NCT05350215 Comparator | Jun 2022 → Dec 2026 expected | obstructive sleep apnea syndrome | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06592833 Comparator | Feb 2025 → Mar 2028 expected | major depressive disorder | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 2 | NCT05441280 Comparator | Dec 2023 → Jul 2027 expected | insomnia, post-traumatic stress disorder | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 3 | NCT00658567 Comparator | Mar 2008 → Dec 2009 | Parkinson disease | ACADIA Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04373317 Comparator | Oct 2022 → Oct 2026 expected | Parkinson disease | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 4 | NCT05590637 Comparator | Apr 2022 → Aug 2026 overdue | Lewy body dementia, Parkinson disease | The University of Texas Health Science Center at San Antonio | Recruiting | No outcome recorded |
| — | NCT02762591 Background | — | Parkinson disease | ACADIA Pharmaceuticals Inc. | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 63
| Date | Issuer | Release |
|---|---|---|
| 2024-03-11 | ACADIA Pharmaceuticals Inc. | Results Acadia Pharmaceuticals Announces Top-Line Results from Phase 3 ADVANCE-2 Trial of Pimavanserin in Negative Symptoms of Schizophrenia acadia.com ↗
Pimavanserin did not demonstrate a statistically significant improvement over placebo on the study’s primary endpoint, the change from baseline to week 26 on the Negative Symptom Assessment-16 (NSA-16) total score (-11.8 vs. -11.1; p=0.4825; effect size=0.07). |
| 2024-01-17 | Zydus Lifesciences Limited | Regulatory Zydus receives Final Approvals from the USFDA for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approvals from the United States Food and Drug Administration (USFDA) to manufacture and market Pimavanserin Capsules, 34 mg (USRLD: Nuplazid® Capsules) and Pimavanserin Tablets, 10 mg (USRLD: Nuplazid® Tablets), respectively. |
| 2023-09-18 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces Label Update for NUPLAZID® (pimavanserin) acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has made two changes to the NUPLAZID label that clarify its use in patients with Parkinson’s disease-related hallucinations and delusions, with or without dementia. |
| 2023-01-03 | ACADIA Pharmaceuticals Inc. | Results Newly Published Retrospective Analysis Showed Lower All-Cause Mortality Risk Among Parkinson’s Disease Psychosis Patients Treated with NUPLAZID® (pimavanserin) Compared to Those Treated with Other Atypical Antipsychotics acadia.com ↗ |
| 2022-08-05 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Receives Complete Response Letter from U.S. FDA for Supplemental New Drug Application for Pimavanserin for the Treatment of Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). |
| 2022-06-18 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces Outcome of FDA Advisory Committee for NUPLAZID® (pimavanserin) for the Treatment of Alzheimer’s Disease Psychosis acadia.com ↗
The PDAC voted 9 to 3 that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population. |
| 2022-03-09 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces August 4, 2022 Action Date for Resubmitted Supplemental New Drug Application for NUPLAZID® (pimavanserin) for the Treatment of Alzheimer’s Disease Psychosis acadia.com ↗
The FDA’s Division of Psychiatry has also advised the company that it is planning to hold an Advisory Committee meeting in connection with its review. |
| 2022-02-16 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Announces Resubmission of Supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin) to Treat Alzheimer’s Disease Psychosis acadia.com ↗
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that it has resubmitted its supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) to the U.S. Food and Drug Administration (FDA). |
| 2021-12-22 | Zydus Lifesciences Limited | Regulatory Zydus Cadila receives tentative approval from USFDA for Pimavanserin Tablets zyduslife.com ↗
Zydus Cadila has received tentative approval from the USFDA to market Pimavanserin Tablets, 10 mg (US RLD: Nuplazid Tablets). |
| 2021-12-01 | ACADIA Pharmaceuticals Inc. | Results The Lancet Psychiatry Publishes Results from ADVANCE Study Evaluating Pimavanserin Treatment for Negative Symptoms of Schizophrenia acadia.com ↗
ADVANCE met its primary endpoint, with significant improvement observed with pimavanserin for the change from baseline to week 26 on the Negative Symptoms Assessment-16 (NSA-16) total score, compared with placebo (-10.4 vs. -8.5; p=0.043). |
| 2021-07-21 | ACADIA Pharmaceuticals Inc. | Results The New England Journal of Medicine Publishes Results from the Phase 3 HARMONY Study Evaluating Pimavanserin in Patients with Dementia-Related Psychosis acadia.com ↗
HARMONY met its primary endpoint by significantly reducing the risk of relapse of psychosis by 2.8 fold compared to placebo in the double-blind period (hazard ratio (HR)=0.35, two-sided p=0.005; one-sided p=0.0023). |
| 2021-06-03 | ACADIA Pharmaceuticals Inc. | Results NUPLAZID® (pimavanserin) Efficacy Data from Open-Label Extension (OLE) Study Published in Parkinsonism and Related Disorders acadia.com ↗
For patients treated with pimavanserin 8.5 mg or 17 mg investigational doses in the previous studies, further improvement was observed during the OLE with NUPLAZID 34 mg. |
| 2021-04-05 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Receives Complete Response Letter from U.S. FDA for Supplemental New Drug Application for Pimavanserin for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis acadia.com ↗
The FDA issued a CRL to indicate that they have completed their review of the application and has determined that the application cannot be approved in its present form. |
| 2021-03-08 | ACADIA Pharmaceuticals Inc. | Regulatory Acadia Pharmaceuticals Provides Regulatory Update on Supplemental New Drug Application for Pimavanserin for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis acadia.com ↗
The FDA stated that the notification does not reflect a final decision on the information under review. |
| 2020-07-20 | ACADIA Pharmaceuticals Inc. | Regulatory ACADIA Pharmaceuticals Announces U.S. FDA Accepted for Filing the Supplemental New Drug Application for NUPLAZID® (pimavanserin) for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis acadia.com ↗
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). |
| 2020-07-20 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Top-line Results from the Phase 3 CLARITY Study Evaluating Pimavanserin for the Adjunctive Treatment of Major Depressive Disorder acadia.com ↗
The study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score change from baseline to week 5. |
| 2020-06-15 | ACADIA Pharmaceuticals Inc. | Regulatory ACADIA Pharmaceuticals Submits Supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin) for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis acadia.com ↗ |
| 2019-12-05 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Presents Positive Top-line Results from Pivotal Phase 3 HARMONY Trial of Pimavanserin in Patients with Dementia-Related Psychosis at 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting acadia.com ↗
Pimavanserin met the primary endpoint of the study and was stopped at the pre-planned interim analysis by significantly reducing risk of relapse of psychosis by 2.8 fold compared to placebo (HR = 0.353; one-sided p=0.0023). |
| 2019-11-25 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Positive Top-line Results from ADVANCE Trial of Pimavanserin as Treatment for Negative Symptoms of Schizophrenia acadia.com ↗
Pimavanserin demonstrated a statistically significant improvement on the study’s primary endpoint, the change from baseline to week 26 on the Negative Symptom Assessment-16 (NSA-16) total score, compared to placebo (-10.4 vs. -8.5; p=0.043; effect size = 0.21). |
| 2019-10-07 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Presents Additional Positive Data from the Phase 2 CLARITY Study with Pimavanserin in Adjunctive Major Depressive Disorder at 2019 Psych Congress acadia.com ↗
In the study, pimavanserin met the overall primary endpoint, the key secondary endpoint, and seven of the eleven pre-specified additional secondary endpoints, including the Massachusetts General Hospital Sexual Functioning Index (MGH-SFI) (nominal p=0.0003)1. |
| 2019-09-24 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces that The Journal of Clinical Psychiatry Publishes Positive Phase 2 CLARITY Results for Pimavanserin as Adjunctive Treatment for Patients with Major Depressive Disorder acadia.com ↗
In this 10-week, randomized, double-blind, placebo-controlled study (n=207), pimavanserin met the overall primary endpoint of the study by significantly reducing the 17-item Hamilton Depression Rating Scale (HAMD-17) total score compared to placebo (p=0.039). |
| 2019-09-23 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Presents New Data on PD Patients Treated with Pimavanserin for Depression at the 2019 International Congress of Parkinson’s Disease and Movement Disorders acadia.com ↗
Pimavanserin as monotherapy or adjunct to SSRI/SNRI therapies significantly improved depression symptoms for Parkinson’s patients |
| 2019-09-19 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals to Present New Clinical Data and Outcomes Research at Upcoming Scientific Meetings acadia.com ↗
New data presented at the International Congress of Parkinson’s Disease and Movement Disorders will highlight treatment benefit of pimavanserin in patients with comorbid Parkinson’s disease and depression |
| 2019-09-09 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Pivotal Phase 3 HARMONY Trial Stopped Early for Positive Efficacy as Pimavanserin Meets the Primary Endpoint in Patients with Dementia-Related Psychosis acadia.com ↗
Pimavanserin achieved robust statistical superiority over placebo in time to relapse of dementia-related psychosis at planned interim efficacy analysis |
| 2019-07-22 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Top-line Results from Phase 3 ENHANCE Trial of Pimavanserin as Adjunctive Treatment for Patients with Schizophrenia acadia.com ↗
Pimavanserin did not achieve statistical significance on the primary endpoint, but showed a consistent trend in improvement of psychotic symptoms (p=0.0940) |
| 2018-10-31 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Positive Top-line Results from Phase 2 CLARITY Trial of Pimavanserin for Adjunctive Treatment in Patients with Major Depressive Disorder (MDD) acadia.com ↗
In the trial, pimavanserin met the overall primary endpoint of the weighted average results of Stage 1 and Stage 2 by significantly reducing 17-item Hamilton Depression Rating Scale (HAMD-17) total score compared to placebo (p=0.039). |
| 2018-09-20 | Neuren Pharmaceuticals Limited | Regulatory FDA reaffirms positive benefit-risk of ACADIA's NUPLAZID neurenpharma.com ↗ |
| 2018-09-20 | ACADIA Pharmaceuticals Inc. | Regulatory FDA Issues Statement Reaffirming the Positive Benefit-Risk Profile of NUPLAZID® (pimavanserin) for Patients with Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis acadia.com ↗
After a thorough review, FDA’s conclusion remains unchanged that the drug’s benefits outweigh its risks for patients with hallucinations and delusions of Parkinson’s disease psychosis. |
| 2018-09-10 | ACADIA Pharmaceuticals Inc. | Results Analyses of Pimavanserin Studies Evaluating Treatment in Alzheimer’s Disease Psychosis and Parkinson’s Disease Psychosis Published in The Journal of Prevention of Alzheimer’s Disease Suggest Potential for Treating Dementia-Related Psychosis acadia.com ↗
In this subgroup of patients with more severe delusions and hallucinations, at the primary efficacy endpoint, pimavanserin demonstrated significant improvement relative to placebo with a similar and acceptable tolerability profile. |
| 2018-06-29 | ACADIA Pharmaceuticals Inc. | Regulatory ACADIA Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for NUPLAZID® (Pimavanserin) acadia.com ↗
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced FDA approval of a new capsule dose formulation and a new tablet strength of NUPLAZID (pimavanserin) to help in the treatment of patients living with hallucinations and delusions associated with Parkinson’s disease psychosis. |
| 2018-04-27 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Presentation of Clinical Experience Data for NUPLAZID (Pimavanserin) at 2018 American Academy of Neurology (AAN) Annual Meeting acadia.com ↗
Data from the study show: >70% of all patients treated with NUPLAZID reported clinical improvement, while 88% of patients treated longer than four weeks improved. |
| 2017-11-03 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Presents Data from the Phase II Study of Pimavanserin in Alzheimer’s Disease Psychosis at the Clinical Trials on Alzheimer’s Disease (CTAD) 2017 Meeting acadia.com ↗
Data presented at CTAD showed multiple sensitivity and responder analyses supportive of the primary result and demonstrated substantively greater benefit in those patients with more severe psychosis. |
| 2016-12-20 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Positive Top-Line Results From Phase II Study of Pimavanserin for Alzheimer’s Disease Psychosis acadia.com ↗
In this Phase II exploratory study, pimavanserin met the primary endpoint showing a statistically significant reduction in psychosis versus placebo as measured by the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Psychosis score at week 6 of dosing (p=0.0451). |
| 2016-09-19 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Sponsors National Parkinson Foundation’s Caregiver Summit acadia.com ↗
Caregivers of PDP patients have an increased risk of developing emotional and social distress that is decreased when PDP is treated with pimavanserin (Poster P42.11). |
| 2016-04-29 | ACADIA Pharmaceuticals Inc. | Regulatory FDA Approves ACADIA Pharmaceuticals’ NUPLAZID™ (pimavanserin) - The First Drug Approved for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis acadia.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. |
| 2016-03-29 | ACADIA Pharmaceuticals Inc. | Regulatory FDA Advisory Committee Votes 12 to 2 That Benefits of ACADIA Pharmaceuticals’ NUPLAZID™ (Pimavanserin) for the Treatment of Psychosis Associated with Parkinson’s Disease Outweigh the Risks acadia.com ↗
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits of NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease outweigh the risks of treatment. |
| 2015-11-02 | ACADIA Pharmaceuticals Inc. | Regulatory ACADIA Pharmaceuticals Announces FDA Priority Review of NUPLAZID™ (Pimavanserin) New Drug Application for Parkinson’s Disease Psychosis acadia.com ↗
today announced that the New Drug Application (NDA) for NUPLAZID™ (pimavanserin) has been accepted for review by the U.S. Food and Drug Administration (FDA) and the agency has granted it Priority Review. |
| 2015-09-03 | ACADIA Pharmaceuticals Inc. | Regulatory ACADIA Pharmaceuticals Submits New Drug Application for NUPLAZID™ for the Treatment of Parkinson’s Disease Psychosis acadia.com ↗
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease. |
| 2015-08-06 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Publication of Data from Its -015 Open Label Safety Study in Parkinson’s Disease Psychosis in the Journal of the American Medical Directors Association acadia.com ↗
This is the first published report evaluating the long-term impact of antipsychotics on mortality and serious adverse events in patients with PDP. |
| 2015-06-16 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Presents Integrated Data from Its Phase III Program with NUPLAZID™ (Pimavanserin) for Parkinson’s Disease Psychosis at the 19th International Congress of Parkinson’s Disease and Movement Disorders acadia.com ↗
Data from Integrated Analysis of Two Phase III Studies Show Robust and Consistent Efficacy of NUPLAZID Across a Wide Array of Study Measures |
| 2014-12-08 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Presents Caregiver Burden Data at the International Congress of Non-Motor Dysfunctions in Parkinson’s Disease and Related Disorders acadia.com ↗
Data from an analysis of Phase III studies in patients with PDP showed that treatment with NUPLAZID reduced caregiver burden compared to PDP patients on placebo. |
| 2014-09-02 | ACADIA Pharmaceuticals Inc. | Regulatory ACADIA Pharmaceuticals Receives FDA Breakthrough Therapy Designation for NUPLAZID™ (Pimavanserin) for Parkinson’s Disease Psychosis acadia.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to NUPLAZID™ (pimavanserin) for the treatment of Parkinson’s disease psychosis. |
| 2014-08-28 | ACADIA Pharmaceuticals Inc. | Regulatory ACADIA Pharmaceuticals Announces Trade Name NUPLAZID™ for Pimavanserin acadia.com ↗
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in neurological and related central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has provisionally accepted the trade name “NUPLAZID”™ for pimavanserin. |
| 2013-11-01 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Publication in The Lancet of Pivotal Phase III Parkinson’s Disease Psychosis Trial with Pimavanserin acadia.com ↗
In the -020 Study, pimavanserin demonstrated significant and clinically meaningful benefits and was safe and well tolerated in patients with PDP. |
| 2013-06-18 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Multiple Presentations of Data from Phase III Pimavanserin Program at the 17th International Congress of Parkinson’s Disease and Movement Disorders acadia.com ↗
The overall efficacy and safety profile observed to date shows that pimavanserin has the potential to offer a new treatment option that may provide significant advantages relative to current antipsychotics used off-label for the treatment of PDP. |
| 2013-03-21 | ACADIA Pharmaceuticals Inc. | Results ACADIA Announces Presentation of Data from Its Pivotal Phase III Parkinson’s Disease Psychosis Study with Pimavanserin at the American Academy of Neurology Annual Meeting acadia.com ↗
Pimavanserin met the primary endpoint in the -020 Study by demonstrating highly significant antipsychotic efficacy on the 9-item SAPS-PD scale (p=0.001). |
| 2012-11-27 | ACADIA Pharmaceuticals Inc. | Results ACADIA Announces Pimavanserin Meets Primary and Key Secondary Endpoints in Pivotal Phase III Parkinson’s Disease Psychosis Trial acadia.com ↗
Pimavanserin met the primary endpoint in the Phase III trial by demonstrating highly significant antipsychotic efficacy as measured using the 9-item SAPS-PD scale (p=0.001). |
| 2012-07-09 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Reports Promising Effects of Pimavanserin in Preclinical Model of Alzheimer’s Disease Psychosis acadia.com ↗
Treatment with pimavanserin prevented DOI-induced responses, reversed the augmented responses to amphetamine, and normalized prepulse inhibition in animals with amyloid pathology. |
| 2010-04-14 | ACADIA Pharmaceuticals Inc. | Results Dr. Joseph Friedman to Present Data From ACADIA Pharmaceuticals' First Phase III Trial With Pimavanserin for Parkinson's Disease Psychosis at the 62nd American Academy of Neurology Annual Meeting acadia.com ↗
As previously reported, all study arms showed marked improvements in mean SAPS scores but neither of the active arms showed a statistically significant separation from placebo at the end of the six-week treatment period. |
| 2009-10-06 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Provides Update on Pimavanserin Collaborative Development Program acadia.com ↗
While the -012 Study did not meet its primary endpoint of antipsychotic efficacy and had a larger than expected placebo response, signals of antipsychotic efficacy were observed in the pimavanserin 40 mg study arm. |
| 2009-09-01 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Results from Phase III Trial of Pimavanserin in Parkinson's Disease Psychosis acadia.com ↗
The study did not meet its primary endpoint of antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. |
| 2008-04-16 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals to Present Data from Its Phase II Trial with Pimavanserin for Parkinson's Disease Psychosis at the 60th American Academy of Neurology Annual Meeting acadia.com ↗
The primary endpoint of the study was met as pimavanserin did not worsen parkinsonism symptoms that affect activities of daily living and motor function, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS). |
| 2008-02-05 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Presentation of Data on Pimavanserin Co-Therapy at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders acadia.com ↗
New Data Demonstrate Less Increase in Serum Glucose Levels With Pimavanserin Co-Therapy |
| 2007-11-02 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals to Present Preclinical Data on Its Advanced Schizophrenia Programs at the 37th Annual Meeting of the Society for Neuroscience acadia.com ↗
Pimavanserin also reversed the adverse effects of these antipsychotic agents on cognitive function, one of the untreated symptom domains of schizophrenia. |
| 2007-03-29 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals' Schizophrenia Programs to Be Presented at the 2007 International Congress on Schizophrenia Research acadia.com ↗
including enhanced efficacy, a faster onset of antipsychotic action, and an improved side effect profile. |
| 2007-03-19 | ACADIA Pharmaceuticals Inc. | Results ACADIA Announces Positive Results From ACP-103 Phase II Schizophrenia Co-Therapy Trial acadia.com ↗
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced positive top-line results from its Phase II schizophrenia co-therapy trial with ACP-103, ACADIA's proprietary and selective 5-HT2A inverse agonist. |
| 2006-04-19 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Positive Clinical Trial Results Demonstrating That ACP-103 Increases Slow Wave Sleep acadia.com ↗
Results of the study demonstrated that ACP-103 induced a robust and statistically significant increase in slow wave sleep that was dose-related. |
| 2006-03-23 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Positive Results From Phase II Trial of ACP-103 for Treatment-Induced Psychosis in Patients With Parkinson's Disease acadia.com ↗
ACP-103 met the primary endpoint of the clinical trial, which was motoric tolerability as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), by demonstrating that it did not worsen motor function in patients with Parkinson's disease. |
| 2005-12-01 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Reports Results From Phase II Study of ACP-103 in Schizophrenia Patients With Haloperidol-Induced Akathisia acadia.com ↗
"We are encouraged by the ability of ACP-103 to treat haloperidol-induced akathisia in patients with schizophrenia," said Uli Hacksell, Ph.D., ACADIA's Chief Executive Officer. |
| 2005-06-22 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Encouraging Interim Results From Ongoing Phase II Trial of ACP-103 for Treatment-Induced Psychosis in Patients With Parkinson's Disease acadia.com ↗
Results of the interim analysis demonstrated that the ACP-103 treatment group showed a greater reduction in psychotic symptoms on both rating scales, relative to the placebo treatment group. |
| 2004-09-15 | ACADIA Pharmaceuticals Inc. | Results ACADIA Clinical Study Shows ACP-103 Improves Clinical Profile of Antipsychotic Drug Treatment acadia.com ↗
Results of the clinical study showed that ACP-103 reduced both the motor disturbances and hyperprolactinemia, a condition of elevated prolactin secretion, caused by haloperidol treatment. |
| 2004-06-29 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Presents Favorable Results From Phase Ib/IIa Clinical Trial and PET Study of ACP-103 acadia.com ↗
Results of these studies demonstrated that ACP-103, ACADIA's proprietary 5-HT2A inverse agonist, was safe and well tolerated in Parkinson's disease patients at drug plasma levels many fold higher than those required for maximal brain occupancy of the 5-HT2A receptors, suggesting a large therapeutic index. |
| 2003-08-06 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Successfully Completes Phase I Clinical Testing of ACP-103 acadia.com ↗
Results from the clinical trial demonstrated that ACP-103 was safe and well tolerated with dose proportional pharmacokinetics and a long half-life supporting once-daily dosing. |
All press releases naming this drug 101 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 101 releases opens the full record — a long page | ||
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pimavanserin | “Pimavanserin, a promising serotonin 2A receptor antagonist, may help to counteract atomoxetine's noradrenergic effects by increasing arousal threshold and possibly reducing OSA...” PMID 40158847 ↗ Mar 2025 |
| Known as | ACP-103 | “pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks” NCT00658567 ↗6“Pimavanserin tartrate (ACP-103)” NCT00477672 ↗ “pimavanserin tartrate (ACP-103)” NCT01518309 ↗ “Pimavanserin tartrate (ACP-103)” NCT00550238 ↗ |
| Known as | Nuplazid | “Pimavanserin, marketed under the tradename NUPLAZID® was approved in 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions...” NCT03947216 ↗5“Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)” NCT03575052 ↗ “Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)” NCT03482882 ↗ “It is currently marketed under the name NUPLAZID (pimavanserin) capsules by Acadia Pharmaceuticals.” NCT04794413 ↗ “Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]” NCT05999240 ↗ “Drug: Pimavanserin 34 milligrams (MG) [Nuplazid]” NCT03994965 ↗ |
| Known as | pimavanserin tartrate | “Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)” NCT02035553 ↗7“Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth” NCT02992132 ↗ “pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks” NCT00658567 ↗ “Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]” NCT05999240 ↗ “pimavanserin tartrate (ACP-103)” NCT01518309 ↗ “Pimavanserin tartrate (ACP-103)” NCT00477672 ↗ “Pimavanserin tartrate (ACP-103)” NCT00550238 ↗ |
| Known as | Pimavanserina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111101 ↗ |
| Known as | Pimavanserine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2111101 ↗ |
| Action | Inhibit | “the effect of the 5HT2A/C receptor inverse agonist ACP-103” NCT00086294 ↗ |
| Modality | Small molecule | — CHEMBL2111101 ↗ |
| Route | Oral | “Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill with no active ingredient) once a week for 10 weeks or vice versa (placebo followed...” NCT00086294 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor inverse agonist” CHEMBL2111101 ↗ |