drug
as of 2026-07-01Pimavanserin
Pimavanserin 34 milligrams (MG) [Nuplazid]Pimavanserin tartrate (ACP-103)ACP-103Pimavanserin 34 mgPimavanserin 20 mg
UNII NA83F1SJSRRxCUI 2049269, 2049271, 2049275, 2049278FDA_ApplNo NDA207318SPL_set_id 1e6bea44-57d6-4bac-9328-46e1ee59f83bFDA_sponsor ACADIA PHARMS INCOrangeBook_Appl A214493, A214502, A214925, N207318, N210793
at a glance
small molecule
US-approved (2016) as NUPLAZID
Developed by ACADIA Pharmaceuticals Inc.
Orange Book protection to 2039
10 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
Mechanism of action
12.1 Mechanism of Action The mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with PDP is unclear. However, the effect of pimavanserin could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT 2A receptors and to a lesser extent at serotonin 5-HT 2C receptors.
Indications
Patents & exclusivity
Orange Book
patent 10646480*PED2039-02-27
patent 11452721*PED2039-02-27
patent 10849891*PED2039-02-27
patent 10449185*PED2039-02-27
patent 106464802038-08-27
patent 10849891 · U-19742038-08-27
patent 114527212038-08-27
patent 104491852038-08-27
patent 10517860*PED2037-09-23
patent 10953000*PED2037-09-23
patent 10953000 · U-19742037-03-23
patent 10517860 · U-19742037-03-23
exclusivity PED2029-10-27
exclusivity PED2029-10-27
exclusivity M-142029-04-27
exclusivity M-142029-04-27
Adverse-event signal
FAERS spontaneous · within-drug share
Mortality9.4%
top term: DEATH
Sedation3.6%
top term: SOMNOLENCE
Gi2.1%
top term: NAUSEA
Eps Akathisia2.0%
top term: TREMOR
Anticholinergic1.2%
top term: CONSTIPATION
Orthostatic0.3%
top term: HYPOTENSION
Spontaneous reports — a signal of reporting share, not incidence.
Trials
10
Comparing Antipsychotic Medications in LBD Over Time
NCT05590637Phase 4Recruiting
The Sub-Sero Study
NCT03994965Phase 2Withdrawn
Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
NCT03121586Phase 3Terminated
Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
NCT04531982Phase 3Completed
Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE)
NCT02970305Phase 2Completed
Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
NCT03325556Phase 3Completed
Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)
NCT02970292Phase 3Completed
A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
NCT00477672Phase 3Completed
Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational Drug
NCT00087542Phase 2Completed
Antipsychotic and Motor Effects of ACP-103 When Administered in Combination With Haloperidol and Risperidone
NCT00361166Phase 2Completed
KOLs & investigators
3
Facts & assertions
19 sourced
Anda Generic Count
3
Boxed Warning
present
Dosing Frequency
once daily
Faers Share Anticholinergic
0.012
Faers Share Eps Akathisia
0.02
Faers Share Gi
0.021
Faers Share Mortality
0.094
Faers Share Orthostatic
0.003
Faers Share Sedation
0.036
Has Generic Competition
yes
Latest Exclusivity Expiry
2029-10-27
Latest Patent Expiry
2039-02-27
Latest Protection Date
2039-02-27
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with PDP is unclear. However, the effect of pimavanserin could be mediated through a combination of inverse agonist and antagonist activity at serotonin 5-HT 2A receptors and
Originator Company
Acadia Pharms Inc
Safety Qt Prolongation
present in label
Safety Sedation Somnolence
present in label
Us Approved
yes
Us Original Approval Date
2016-04-29
relationships
The graph out of here
developer
company
trial
The Sub-Sero Study
trialPHASE2
indication
KOL
Bjørn H Ebdrup, MD, PhD
personKOL score 13
Sarah Horn, MD
personKOL score —
Daniel van Kammen, MD, PhD
personKOL score —