Overview
Pimavanserin is an atypical antipsychotic indicated for the treatment of psychiatric disorders. Although the exact mechanism of action is unknown, it is thought that pimavanserin interacts with the serotonin receptors, particularly the 5-HT and HT receptors. Unlike other atypical antipsychotics, pimavanserin lacks inherent dopaminergic activity. In fact, pimavanserin is the first antipsychotic drug without D blocking activity. Therefore, pimavanserin can be used to treat psychotic symptoms without causing extrapyramidal or worsening motor symptoms. Pimavanserin is marketed under the trade name NUPLAZID and developed by Acadia Pharmaceuticals. It was approved by the FDA in April 2016 for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis thanks to favorable results from a pivotal six-week, randomized, placebo-controlled, parallel-group study. Pimavanserin was also under review as a potential treatment for dementia-related psychosis; however, as of April 2021, FDA approval has not been granted for this indication despite previous breakthrough designation.
Indication
用于伴随帕金森氏病精神病幻觉和妄想的治疗。
Associated Conditions
- Delusions
- Hallucinations
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/09/19 | Phase 2 | Recruiting | |||
2024/06/10 | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | ||
2023/10/05 | Phase 3 | Recruiting | |||
2023/08/21 | Phase 2 | Recruiting | |||
2023/06/08 | Phase 2 | Recruiting | |||
2023/04/03 | Early Phase 1 | Withdrawn | State University of New York - Downstate Medical Center | ||
2022/10/21 | Phase 4 | Recruiting | |||
2022/09/27 | Phase 2 | Terminated | |||
2022/08/31 | Phase 2 | Completed | |||
2022/07/01 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Acadia Pharmaceuticals Inc. | 63090-100 | ORAL | 10 mg in 1 1 | 9/19/2023 | |
Acadia Pharmaceuticals Inc. | 63090-340 | ORAL | 34 mg in 1 1 | 9/19/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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