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
Trade Name
FDA
EMA
Nuplazid
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nuplazid | New Drug Application | 2020-11-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hallucinations | HP_0000738 | D006212 | F06.0 |
| parkinson disease | EFO_0002508 | D010300 | G20 |
| 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 | |||
| 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
No data
Clinical
Clinical Trials
51 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Presbyopia | D011305 | H52.4 | 3 | 2 | 7 | — | 1 | 13 | |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | 1 | — | 3 | 4 |
| Ocular hypertension | D009798 | EFO_1001069 | H40.0 | — | — | 1 | — | 2 | 3 |
| Head and neck neoplasms | D006258 | — | 1 | 3 | — | — | 3 | ||
| Pseudophakia | D019591 | 1 | — | 1 | — | — | 2 | ||
| Dry eye syndromes | D015352 | H04.12 | — | 1 | 1 | — | — | 2 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | C80 | — | — | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 2 | — | — | — | — | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 3 | 3 |
| Exfoliation syndrome | D017889 | EFO_0004235 | — | — | — | — | 1 | 1 | |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Cataract | D002386 | EFO_0001059 | H26.9 | — | — | — | — | 1 | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
| Postoperative cognitive complications | D000079690 | — | — | — | — | 1 | 1 | ||
| Delirium | D003693 | R41.0 | — | — | — | — | 1 | 1 | |
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 1 | 1 | |
| Myopia | D009216 | H52.1 | — | — | — | — | 1 | 1 |
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 | 1791685 |
| 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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 736 documents
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Safety
Black-box Warning
Black-box warning for: Nuplazid
Adverse Events
Top Adverse Reactions
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1,037 adverse events reported
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