Parkinson Disease Psychosis
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CLINICAL_TRIALS trial_result · 2026-02-27Clinical Trial Update: A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis [Phase 3]
Phase 3 study evaluating the safety and efficacy of pimavanserin for Parkinson's disease psychosis has completed.
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CLINICAL_TRIALS research · 2025-08-28Clinical Trial Update: Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis [Phase 4]
A Phase 4 clinical trial comparing pimavanserin with quetiapine for treatment of Parkinson disease psychosis is currently recruiting.
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CLINICAL_TRIALS research · 2025-08-12Clinical Trial Update: Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases [Phase 4]
Phase 4 trial update describing the PET tracer [18F]MH.MZ for imaging serotonin 2A receptors in Parkinson's disease and Parkinson's disease …
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FDA approval · 2025-01-22FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
The FDA approved a supplemental application for Nuplazid (pimavanserin tartrate) from Acadia Pharmaceuticals Inc. The action concerns a supp…
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CLINICAL_TRIALS trial_result · 2025-01-14Clinical Trial Update: Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis [Phase 4]
Open-label Phase 4 study assessing pimavanserin on activities of daily living in Parkinson disease psychosis. Results have been posted.
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CLINICAL_TRIALS trial_result · 2024-06-10Clinical Trial Update: Bioequivalence Study of Pimavanserin 34 mg Capsule [Phase 1]
This update reports the completion of a Phase 1 bioequivalence study of pimavanserin 34 mg capsules for Parkinson disease psychosis.
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FDA approval · 2024-01-16FDA Approved: PIMAVANSERIN — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved the original Abbreviated New Drug Application for Pimavanserin (Pimavanserin) by Novadoz Pharmaceuticals LLC, authorizing a gen…
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FDA approval · 2023-09-15FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
FDA approved a supplemental application for Nuplazid (pimavanserin tartrate) submitted by Acadia Pharmaceuticals Inc. This action updates th…
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FDA label_change · 2023-09-15FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
FDA approved Acadia's supplemental application for NUPLAZID (pimavanserin tartrate), resulting in an updated labeling for the product. The c…
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CLINICAL_TRIALS trial_result · 2023-06-05Clinical Trial Update: A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis [Phase 2]
Phase 2 study evaluating SEP-363856 for Parkinson disease psychosis completed with results posted, detailing efficacy and safety/tolerabilit…
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FDA approval · 2020-11-23FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
The FDA approved a supplemental application for Nuplazid (pimavanserin tartrate) submitted by Acadia Pharmaceuticals Inc., updating the labe…
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FDA label_change · 2020-11-23FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
FDA approved a supplemental application for Nuplazid (pimavanserin tartrate) from Acadia Pharmaceuticals, resulting in updated labeling.
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FDA label_change · 2019-09-27FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
The FDA approved a supplemental application for NUPLAZID (pimavanserin tartrate) submitted by Acadia Pharmaceuticals, resulting in updated l…
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CLINICAL_TRIALS trial_result · 2019-06-24Clinical Trial Update: A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis [Phase 3]
Phase 3 trial evaluating safety and tolerability of pimavanserin (ACP-103) in Parkinson's disease psychosis has completed with results poste…
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FDA approval · 2019-05-10FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
The FDA approved a supplemental application for NUPLAZID (pimavanserin tartrate) submitted by Acadia Pharmaceuticals Inc.
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FDA approval · 2019-05-10FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
The FDA approved a supplemental application for NUPLAZID (pimavanserin tartrate) from Acadia Pharmaceuticals Inc. The action represents an a…
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FDA approval · 2019-03-04FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
The FDA approved a supplemental NDA for NUPLAZID (pimavanserin tartrate) submitted by Acadia Pharmaceuticals.
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FDA approval · 2019-03-04FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
The FDA approved a supplemental application for NUPLAZID (pimavanserin tartrate) submitted by Acadia Pharmaceuticals, signaling a labeling u…
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FDA approval · 2018-06-28FDA Approved: NUPLAZID — Original Application (Acadia Pharmaceuticals Inc.)
FDA approved NUPLAZID (pimavanserin tartrate) for the first time, marking the drug's original approval for Parkinson disease psychosis.
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FDA label_change · 2018-06-28FDA Approved: NUPLAZID — Supplemental Application (Acadia Pharmaceuticals Inc.)
FDA is reviewing a supplemental application for Nuplazid (pimavanserin tartrate) from Acadia Pharmaceuticals, seeking labeling changes.
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CLINICAL_TRIALS approval · 2017-04-18Clinical Trial Update: Expanded Access of Pimavanserin for Patients With PD Psychosis
Expanded access for Pimavanserin (Nuplazid) in Parkinson's disease psychosis is noted, with the status indicating approval for marketing.
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FDA approval · 2016-04-29FDA Approved: NUPLAZID — Original Application (Acadia Pharmaceuticals Inc.)
The FDA approved Nuplazid (pimavanserin tartrate) from Acadia Pharmaceuticals in its original NDA, for the treatment of hallucinations and d…
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CLINICAL_TRIALS trial_result · 2014-09-09Clinical Trial Update: A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis [Phase 3]
Phase 3 study assessing safety and efficacy of pimavanserin in Parkinson's disease psychosis completed with results posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-03-26Clinical Trial Update: A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis [Phase 3]
Phase 3 trial results show safety and efficacy data for pimavanserin in Parkinson's disease psychosis; results posted in 2014.
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CLINICAL_TRIALS trial_result · 2014-03-26Clinical Trial Update: A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis [Phase 3]
Phase 3 study evaluating pimavanserin for Parkinson's disease psychosis has completed. Results were posted in 2014.