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Drug ReportsPimavanserin
Pimavanserin
Nuplazid, Pimavanserin (pimavanserin) is a small molecule pharmaceutical. Pimavanserin was first approved as Nuplazid on 2016-04-29. It is used to treat hallucinations, parkinson disease, and schizophrenia spectrum and other psychotic disorders in the USA. The pharmaceutical is active against 5-hydroxytryptamine receptor 2A.
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EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
behavior and behavior mechanismsD001520
mental disordersD001523
Trade Name
FDA
EMA
Nuplazid (discontinued: Nuplazid, Pimavanserin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pimavanserin tartrate
Tradename
Company
Number
Date
Products
NUPLAZIDAcadia PharmaceuticalsN-207318 RX2018-06-28
1 products, RLD, RS
NUPLAZIDAcadia PharmaceuticalsN-210793 RX2018-06-28
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
nuplazidNew Drug Application2023-09-19
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Pimavanserin Tartrate, Nuplazid, Acadia Pharms Inc
104491852038-08-27DP
106464802038-08-27DP
108498912038-08-27DPU-1974
114527212038-08-27DP
105178602037-03-23U-1974
109530002037-03-23U-1974
76017402030-04-29DS, DP
77326152028-06-03DS, DP
76592852026-08-24U-1844
79235642025-09-26DS, DP
86181302024-01-15U-1845
89213932024-01-15U-1846
95662712024-01-15U-1974
100289442024-01-15U-1974
ATC Codes
N: Nervous system drugs
N05: Psycholeptics
N05A: Antipsychotics
N05AX: Other antipsychotics in atc
N05AX17: Pimavanserin
HCPCS
No data
Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinson diseaseD010300EFO_0002508G202654219
Psychotic disordersD011618F20.81363214
Mental disordersD001523EFO_0000677F91.9263213
Sleep initiation and maintenance disordersD007319F51.01123
Post-traumatic stress disordersD013313EFO_0001358F43.1123
Traumatic stress disordersD040921123
Neurodegenerative diseasesD019636EFO_0005772G31.9213
DementiaD003704EFO_0003862F03112
Lewy body diseaseD020961EFO_0006792G31.8311
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F0333
AggressionD000374EFO_000301533
Impulse control disruptive and conduct disordersD007174F63.222
DyskinesiasD020820HP_0002310G24112
Psychomotor agitationD01159522
HallucinationsD006212HP_0000738F06.011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Tourette syndromeD005879EFO_0004895F95.211
Tardive dyskinesiaD000071057G24.0111
SyndromeD01357711
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePimavanserin
INNpimavanserin
Description
Pimavanserin is a member of the class of ureas in which three of the four hydrogens are replaced by 4-fluorobenzyl, 1-methylpiperidin-4-yl, and 4-(isopropyloxy)benzyl groups. An atypical antipsychotic that is used (in the form of its tartrate salt) for treatment of hallucinations and delusions associated with Parkinson's disease. It has a role as an antipsychotic agent, a 5-hydroxytryptamine 2A receptor inverse agonist and a serotonergic antagonist. It is a member of ureas, a member of piperidines, a member of monofluorobenzenes, an aromatic ether and a tertiary amino compound. It is a conjugate base of a pimavanserin(1+).
Classification
Small molecule
Drug classserotonin 5-HT2 receptor antagonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1
Identifiers
PDB
CAS-ID706779-91-1
RxCUI
ChEMBL IDCHEMBL2111101
ChEBI ID
PubChem CID10071196
DrugBankDB05316
UNII IDJZ963P0DIK (ChemIDplus, GSRS)
Target
Agency Approved
HTR2A
HTR2A
Organism
Homo sapiens
Gene name
HTR2A
Gene synonyms
HTR2
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 2A
Protein synonyms
5-HT2 receptor, 5-hydroxytryptamine (serotonin) receptor 2A, G protein-coupled, serotonin 5-HT-2A receptor, Serotonin receptor 2A
Uniprot ID
Mouse ortholog
Htr2a (15558)
5-hydroxytryptamine receptor 2A (P35363)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 935 documents
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Safety
Black-box Warning
Black-box warning for: Nuplazid
Adverse Events
Top Adverse Reactions
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32,556 adverse events reported
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