Risperdal, Okedi(risperidone)
Okedi, Perseris, Risperdal, Rykindo, Uzedy (risperidone) is a small molecule pharmaceutical. Risperidone was first approved as Risperdal on 1993-12-29. It is used to treat autistic disorder, bipolar disorder, dementia, schizophrenia, and schizophrenia spectrum and other psychotic disorders amongst others in the USA. It has been approved in Europe to treat schizophrenia. The pharmaceutical is active against 5-hydroxytryptamine receptor 1B, D(2) dopamine receptor, 5-hydroxytryptamine receptor 2A, and 5-hydroxytryptamine receptor 1D. In addition, it is known to target 5-hydroxytryptamine receptor 1F, 5-hydroxytryptamine receptor 6, alpha-1B adrenergic receptor, 5-hydroxytryptamine receptor 1A, D(3) dopamine receptor, alpha-1A adrenergic receptor, histamine H1 receptor, 5-hydroxytryptamine receptor 7, alpha-1D adrenergic receptor, 5-hydroxytryptamine receptor 2C, and 5-hydroxytryptamine receptor 1E.
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Commercial
Trade Name
FDA
EMA
Perseris, Risperdal, Rykindo, Uzedy (generic drugs available since 2008-09-15)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Risperidone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PERSERIS KIT | Indivior | N-210655 RX | 2018-07-27 | 2 products, RLD, RS |
| RISPERDAL | Johnson & Johnson | N-020272 RX | 1993-12-29 | 6 products, RLD |
| RISPERDAL | Johnson & Johnson | N-020588 RX | 1996-06-10 | 1 products, RLD, RS |
| RISPERDAL CONSTA | Johnson & Johnson | N-021346 RX | 2003-10-29 | 4 products, RLD |
| RYKINDO | Shandong Luye Pharmaceutical | N-212849 RX | 2023-01-13 | 4 products, RLD, RS |
| UZEDY | Teva | N-213586 RX | 2023-04-28 | 7 products, RLD, RS |
Show 2 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| autistic disorder | EFO_0003758 | D001321 | F84.0 |
| bipolar disorder | EFO_0000289 | D001714 | F30.9 |
| dementia | HP_0000726 | D003704 | F03 |
| schizophrenia | EFO_0000692 | D012559 | F20 |
| schizophrenia spectrum and other psychotic disorders | — | D019967 | — |
| tourette syndrome | EFO_0004895 | D005879 | F95.2 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Risperidone, Uzedy, Teva | |||
| 9023897 | 2033-04-05 | DP | |
| 8221778 | 2027-11-12 | DP | U-543 |
| 8741327 | 2027-11-12 | DP | U-543 |
| 8802127 | 2025-01-12 | DP | |
| 9439905 | 2025-01-12 | DP | U-543 |
| 9717799 | 2025-01-12 | DP | |
| 9895447 | 2025-01-12 | DP | |
| 9925268 | 2025-01-12 | DP | |
| 10736965 | 2025-01-12 | DP | |
| Risperidone, Rykindo, Shandong Luye | |||
| 9446135 | 2032-04-10 | DP | U-3513 |
| 9532991 | 2032-04-10 | DP | U-3513 |
| 10098882 | 2032-04-10 | DP | U-3513 |
| 10406161 | 2032-04-10 | DP | U-3513 |
| 11110094 | 2032-04-10 | DP | |
| Risperidone, Perseris Kit, Indivior Inc | |||
| 9180197 | 2028-02-13 | DP | |
| 9186413 | 2028-02-13 | U-543 | |
| 10010612 | 2028-02-13 | DP | |
| 10376590 | 2028-02-13 | U-2608 | |
| 11013809 | 2028-02-13 | DP | U-3135 |
| 11110093 | 2026-11-05 | DP | U-3135 |
| 9597402 | 2026-09-26 | DP | |
| 10058554 | 2026-09-26 | U-2363 | |
| 10406160 | 2026-06-26 | DP | U-2608 |
Clinical
Clinical Trials
436 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 | 26 | 33 | 62 | 98 | 40 | 250 |
| Psychotic disorders | D011618 | F20.81 | 8 | 2 | 22 | 37 | 24 | 93 | |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 2 | — | 20 | 14 | 11 | 47 |
| Healthy volunteers/patients | — | 14 | — | — | 1 | 2 | 17 | ||
| Dementia | D003704 | F03 | — | 1 | 6 | 5 | 1 | 13 | |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | 5 | 5 | 2 | 12 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 2 | 3 | 3 | 1 | 8 |
| Attention deficit and disruptive behavior disorders | D019958 | HP_0010865 | F91.3 | — | — | 5 | 2 | — | 7 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 1 | — | 3 | 2 | — | 6 |
| Pervasive child development disorders | D002659 | EFO_0003756 | F84 | 2 | 1 | 2 | 1 | 1 | 6 |
Show 31 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | F33.9 | — | — | 4 | — | — | 4 | |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | 2 | — | 2 | 4 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | — | 2 | — | 1 | 4 |
| Vascular dementia | D015140 | F01 | — | — | 3 | — | — | 3 | |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | 1 | — | — | 2 |
| Intellectual disability | D008607 | F73 | — | 1 | 1 | — | — | 2 | |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | — | — | 2 | — | — | 2 |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Smoking cessation | D016540 | EFO_0004319 | — | — | 1 | — | — | 1 | |
| Adjustment disorders | D000275 | F43.2 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | F14 | 1 | 7 | — | — | 1 | 9 | |
| Huntington disease | D006816 | G10 | 1 | 1 | — | — | — | 2 | |
| Schizotypal personality disorder | D012569 | F21 | 1 | 1 | — | — | 1 | 2 | |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 1 | — | — | 1 | 2 |
| Chorea | D002819 | EFO_0004152 | G25.5 | — | 1 | — | — | — | 1 |
| Heat stress disorders | D018882 | T67.2 | — | 1 | — | — | — | 1 | |
| Post-head injury coma | D020207 | — | 1 | — | — | — | 1 | ||
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunoassay | D007118 | 1 | — | — | — | — | 1 | ||
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Fasting | D005215 | EFO_0002756 | 1 | — | — | — | — | 1 | |
| Drug-induced dyskinesia | D004409 | EFO_1000904 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 3 | 3 |
| Paranoid schizophrenia | D012563 | F20.0 | — | — | — | — | 2 | 2 | |
| Recurrence | D012008 | — | — | — | — | 1 | 1 | ||
| Body weight | D001835 | EFO_0004338 | — | — | — | — | 1 | 1 | |
| Dissociative disorders | D004213 | F44.1 | — | — | — | — | 1 | 1 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Sleep initiation and maintenance disorders | D007319 | F51.01 | — | — | — | — | 1 | 1 | |
| Psychomotor agitation | D011595 | — | — | — | — | 1 | 1 | ||
| Circadian rhythm sleep disorders | D020178 | G47.2 | — | — | — | — | 1 | 1 | |
| Disorganized schizophrenia | D012562 | F20.1 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | RISPERIDONE |
| INN | risperidone |
| Description | Risperidone is a member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2. It has a role as a serotonergic antagonist, an alpha-adrenergic antagonist, a H1-receptor antagonist, a second generation antipsychotic, a dopaminergic antagonist, a psychotropic drug and an EC 3.4.21.26 (prolyl oligopeptidase) inhibitor. It is a pyridopyrimidine, an organofluorine compound, a heteroarylpiperidine and a member of 1,2-benzoxazoles. |
| Classification | Small molecule |
| Drug class | antipsychotics (risperidone type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2 |
Target
Agency Approved
HTR1B
HTR1B
DRD2
DRD2
HTR2A
HTR2A
HTR1D
HTR1D
Organism
Homo sapiens
Gene name
HTR1B
Gene synonyms
HTR1DB
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 1B
Protein synonyms
5-HT-1D-beta, 5-hydroxytryptamine (serotonin) receptor 1B, G protein-coupled, S12, Serotonin 1D beta receptor, Serotonin receptor 1B
Uniprot ID
Mouse ortholog
Htr1b (15551)
5-hydroxytryptamine receptor 1B (P28334)
Alternate
HTR1F
HTR1F
HTR6
HTR6
ADRA1B
ADRA1B
HTR1A
HTR1A
DRD3
DRD3
ADRA1A
ADRA1A
HRH1
HRH1
HTR7
HTR7
ADRA1D
ADRA1D
HTR2C
HTR2C
HTR1E
HTR1E
Variants
Clinical Variant
No data
Financial
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Risperdal - Johnson & Johnson
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 24,011 documents
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Safety
Black-box Warning
Black-box warning for: Perseris, Risperdal, Rykindo , Uzedy
Adverse Events
Top Adverse Reactions
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2,654 adverse events reported
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