Risperdal, Okedi(risperidone)
Okedi, Perseris, Risperdal, Rykindo (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 2A, 5-hydroxytryptamine receptor 1B, 5-hydroxytryptamine receptor 1D, and D(2) dopamine receptor. In addition, it is known to target alpha-1A adrenergic receptor, D(3) dopamine receptor, alpha-1B adrenergic receptor, 5-hydroxytryptamine receptor 2C, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 1E, alpha-1D adrenergic receptor, histamine H1 receptor, 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 7, and 5-hydroxytryptamine receptor 1F.
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Commercial
Trade Name
FDA
EMA
Perseris, Risperdal, Rykindo (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 New Time Pharmaceutical | N-212849 RX | 2023-01-13 | 4 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| perseris | New Drug Application | 2019-12-18 |
| risperdal | New Drug Application | 2023-03-06 |
| risperidone | ANDA | 2023-05-02 |
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, 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
434 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
HTR2A
HTR2A
HTR1B
HTR1B
HTR1D
HTR1D
DRD2
DRD2
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
ADRA1A
ADRA1A
DRD3
DRD3
ADRA1B
ADRA1B
HTR2C
HTR2C
HTR6
HTR6
HTR1E
HTR1E
ADRA1D
ADRA1D
HRH1
HRH1
HTR1A
HTR1A
HTR7
HTR7
HTR1F
HTR1F
Organism
Homo sapiens
Gene name
ADRA1A
Gene synonyms
ADRA1C
NCBI Gene ID
Protein name
alpha-1A adrenergic receptor
Protein synonyms
Alpha-1A adrenoceptor, Alpha-1A adrenoreceptor, Alpha-1C adrenergic receptor, Alpha-adrenergic receptor 1c, G protein coupled receptor
Uniprot ID
Mouse ortholog
Adra1a (11549)
alpha-1A adrenergic receptor (Q8BV77)
Variants
Clinical Variant
No data
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 23,689 documents
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Safety
Black-box Warning
Black-box warning for: Perseris, Risperdal, Risperidone
Adverse Events
Top Adverse Reactions
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2,682 adverse events reported
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