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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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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 Application2025-01-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
parkinson diseaseEFO_0002508D010300G20
hallucinations—D006212F06.0
schizophrenia spectrum and other psychotic disorders—D019967—
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
45 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_0002508G201542214
Psychotic disordersD011618—F20.81—351211
Mental disordersD001523EFO_0000677F91.9—251210
Neurodegenerative diseasesD019636EFO_0005772G31.9——21—3
Sleep initiation and maintenance disordersD007319—F51.01———1—1
Post-traumatic stress disordersD013313EFO_0001358F43.1———1—1
Traumatic stress disordersD040921—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20—33——6
DepressionD003863—F33.9—22——4
Depressive disorderD003866EFO_1002014F32.A—22——4
Major depressive disorderD003865EFO_0003761F22—12——3
Autistic disorderD001321EFO_0003758F84.0—32——3
Autism spectrum disorderD000067877—F84.0—32——3
Pervasive child development disordersD002659EFO_0003756F84—32——3
DementiaD003704EFO_0003862F03——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F03—3———3
AggressionD000374EFO_0003015——3———3
Impulse control disruptive and conduct disordersD007174—F63.2—2———2
Psychomotor agitationD011595———2———2
HallucinationsD006212—F06.0—1———1
Indications Phases 1
No data
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
3356
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
Q5T8C0
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 1,093 documents
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Safety
Black-box Warning
Black-box warning for: Nuplazid
Adverse Events
Top Adverse Reactions
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46,245 adverse events reported
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