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Nuplazid Approval History

FDA Approved: Yes (First approved April 29, 2016)
Brand name: Nuplazid
Generic name: pimavanserin
Dosage form: Tablets and Capsules
Company: Acadia Pharmaceuticals, Inc.
Treatment for: Parkinson’s Disease Psychosis

Nuplazid (pimavanserin) is a non-dopaminergic, selective serotonin inverse agonist (SSIA) for the treatment of psychosis associated with Parkinson’s disease.

Development History and FDA Approval Process for Nuplazid

DateArticle
Sep 20, 2018FDA Issues Statement Reaffirming the Positive Benefit-Risk Profile of Nuplazid (pimavanserin) for Patients with Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis
Jun 29, 2018Approval Acadia Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for Nuplazid (pimavanserin)
Apr 29, 2016Approval FDA Approves Nuplazid (pimavanserin) for Parkinson’s Disease Psychosis
Mar 29, 2016FDA Advisory Committee Votes 12 to 2 That Benefits of Nuplazid (Pimavanserin) for the Treatment of Psychosis Associated with Parkinson’s Disease Outweigh the Risks
Nov  2, 2015Acadia Pharmaceuticals Announces FDA Priority Review of Nuplazid (Pimavanserin) NDA for Parkinson’s Disease Psychosis
Sep  3, 2015Acadia Pharmaceuticals Submits NDA for Nuplazid for the Treatment of Parkinson’s Disease Psychosis
Mar 21, 2013ACADIA Announces Presentation of Data from Its Pivotal Phase III Parkinson's Disease Psychosis Study with Pimavanserin at the American Academy of Neurology Annual Meeting
Nov 27, 2012ACADIA Announces Pimavanserin Meets Primary and Key Secondary Endpoints in Pivotal Phase III Parkinson's Disease Psychosis Trial

Further information

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