Iloperidone
Fanapt (iloperidone) is a small molecule pharmaceutical. Iloperidone was first approved as Fanapt on 2009-05-06. It is used to treat schizophrenia and schizophrenia spectrum and other psychotic disorders in the USA. It is known to target 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 6, D(2) dopamine receptor, and 5-hydroxytryptamine receptor 7.
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FDA approval date
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Study first post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
Trade Name
FDA
EMA
Fanapt (discontinued: Iloperidone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Iloperidone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FANAPT | Vanda Pharmaceuticals | N-022192 RX | 2009-05-06 | 7 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fanapt | New Drug Application | 2025-06-30 |
| iloperidone | ANDA | 2025-03-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| schizophrenia | EFO_0000692 | D012559 | F20 |
| schizophrenia spectrum and other psychotic disorders | — | D019967 | — |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 4 | 1 | 3 | 1 | — | 8 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 2 | — | 1 | 2 | — | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | — | 1 |
| Psychotic disorders | D011618 | — | F20.81 | — | 1 | — | — | — | 1 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | 1 | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Iloperidone |
| INN | iloperidone |
| Description | Iloperidone is a member of the class of piperidines that is the 4-acetyl-2-methoxyphenyl ether of 3-(piperidin-1-yl)propan-1-ol which is substituted at position 4 of the piperidine ring by a 6-fluoro-1,2-benzoxazol-3-yl group. A member of the group of second generation antipsychotics (also known as an atypical antipsychotics), it is used for the treatment of schizophrenia. It has a role as a serotonergic antagonist, a dopaminergic antagonist and a second generation antipsychotic. It is a monoamine, an organofluorine compound, a tertiary amino compound, a methyl ketone, a member of 1,2-benzoxazoles, a member of piperidines, an aromatic ether and an aromatic ketone. |
| Classification | Small molecule |
| Drug class | antipsychotics (risperidone type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc(C(C)=O)ccc1OCCCN1CCC(c2noc3cc(F)ccc23)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 133454-47-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL14376 |
| ChEBI ID | 65173 |
| PubChem CID | 71360 |
| DrugBank | — |
| UNII ID | VPO7KJ050N (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
HTR1A
HTR1A
HTR6
HTR6
DRD2
DRD2
HTR7
HTR7
Organism
Homo sapiens
Gene name
HTR1A
Gene synonyms
ADRB2RL1, ADRBRL1
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 1A
Protein synonyms
5-HT1a receptor, 5-hydroxytryptamine (serotonin) receptor 1A, G protein-coupled, G-21, guanine nucleotide-binding regulatory protein-coupled receptor, Serotonin receptor 1A
Uniprot ID
Mouse ortholog
Htr1a (15550)
5-hydroxytryptamine receptor 1A (Q8BGS4)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Fanapt – Vanda Pharmaceuticals
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Estimated US medical usage
Iloperidone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,128 documents
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Safety
Black-box Warning
Black-box warning for: Fanapt, Iloperidone
Adverse Events
Top Adverse Reactions
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1,316 adverse events reported
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