Pimavanserin
Nuplazid (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
Trade Name
FDA
EMA
Nuplazid (generic drugs available since 2024-01-16)
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 |
|---|---|---|---|---|
| NUPLAZID | Acadia Pharmaceuticals | N-207318 RX | 2018-06-28 | 1 products, RLD, RS |
| NUPLAZID | Acadia Pharmaceuticals | N-210793 RX | 2018-06-28 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
No data
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Pimavanserin Tartrate, Nuplazid, Acadia Pharms Inc | |||
| 10449185 | 2038-08-27 | DP | |
| 10646480 | 2038-08-27 | DP | |
| 10849891 | 2038-08-27 | DP | U-1974 |
| 11452721 | 2038-08-27 | DP | |
| 10517860 | 2037-03-23 | U-1974 | |
| 10953000 | 2037-03-23 | U-1974 | |
| 7601740 | 2030-04-29 | DS, DP | |
| 7732615 | 2028-06-03 | DS, DP | |
| 7659285 | 2026-08-24 | U-1844 | |
| 7923564 | 2025-09-26 | DS, DP | |
| 8618130 | 2024-01-15 | U-1845 | |
| 8921393 | 2024-01-15 | U-1846 | |
| 9566271 | 2024-01-15 | U-1974 | |
| 10028944 | 2024-01-15 | U-1974 | |
HCPCS
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Clinical
Clinical Trials
41 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 disease | D010300 | EFO_0002508 | G20 | 1 | 6 | 4 | 4 | 2 | 17 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | 1 | — | 2 | — | 3 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | 2 | — | 3 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | — | 2 | 1 | — | 3 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 3 | 3 | — | — | 6 |
| Psychotic disorders | D011618 | — | F20.81 | — | 2 | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 3 | — | — | — | 3 |
| Dyskinesias | D020820 | HP_0002310 | G24 | — | 1 | — | — | — | 1 |
| Hallucinations | D006212 | HP_0000738 | F06.0 | — | 1 | — | — | — | 1 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | 1 | — | — | — | — | 1 |
| Tardive dyskinesia | D000071057 | — | G24.01 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pimavanserin |
| INN | pimavanserin |
| 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 class | serotonin 5-HT2 receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 706779-91-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2111101 |
| ChEBI ID | — |
| PubChem CID | 10071196 |
| DrugBank | DB05316 |
| UNII ID | JZ963P0DIK (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
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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21,809 adverse events reported
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