Risperdal, Okedi(risperidone)
Okedi, Perseris, Risperdal, Risperidone, Risvan, 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 2A, 5-hydroxytryptamine receptor 1B, D(2) dopamine receptor, and 5-hydroxytryptamine receptor 1D. In addition, it is known to target 5-hydroxytryptamine receptor 1F, D(3) dopamine receptor, 5-hydroxytryptamine receptor 1A, alpha-1D adrenergic receptor, 5-hydroxytryptamine receptor 7, alpha-1B adrenergic receptor, 5-hydroxytryptamine receptor 2C, 5-hydroxytryptamine receptor 6, alpha-1A adrenergic receptor, histamine H1 receptor, and 5-hydroxytryptamine receptor 1E.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Perseris, Risperdal, Risperidone, Rykindo, Uzedy (discontinued: Risperdal, Risperidone, Rykindo)
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 | 3 products, RLD |
| UZEDY | Teva | N-213586 RX | 2023-04-28 | 7 products, RLD, RS |
Show 3 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| perseris | New Drug Application | 2025-01-28 |
| risperdal | New Drug Application | 2010-12-27 |
| risperdal consta | New Drug Application | 2025-04-15 |
| risperdal risperdal m-tab | New Drug Application | 2025-07-31 |
| risperdal risperdal m-tab risperdal oral solution | 2006-05-10 | |
| risperidone | ANDA | 2025-09-24 |
| risperidone oral disintegrate tablets | ANDA | 2010-08-18 |
| risperidone risperidone m-tab | New Drug Application | 2025-07-31 |
| rykindo | New Drug Application | 2025-07-01 |
| uzedy | New Drug Application | 2025-01-24 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
RISPERIDONE, UZEDY, TEVA | |||
| 2026-04-28 | NP | ||
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 | |||
| 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
592 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 | 39 | 51 | 81 | 123 | 85 | 367 |
| Psychotic disorders | D011618 | — | F20.81 | 12 | 6 | 31 | 51 | 40 | 140 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 3 | 1 | 20 | 19 | 16 | 59 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | 2 | 16 | 17 | 18 | 54 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 4 | 4 | 6 | 4 | 4 | 21 |
| Depression | D003863 | — | F33.9 | 3 | 3 | 7 | 4 | 3 | 19 |
| Healthy volunteers/patients | — | — | — | 15 | — | — | 1 | 2 | 18 |
| Autism spectrum disorder | D000067877 | — | F84.0 | 4 | 3 | 2 | 3 | 5 | 16 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | 1 | 3 | 4 | 4 | 5 | 16 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 1 | 6 | 5 | 2 | 14 |
Show 68 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Developmental disabilities | D002658 | EFO_0003852 | F89 | 2 | 1 | 3 | — | 1 | 6 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 1 | 2 | — | 2 | 5 |
| Intellectual disability | D008607 | EFO_0003847 | F73 | — | 1 | 1 | — | 1 | 3 |
| Vascular dementia | D015140 | — | F01 | — | — | 3 | — | — | 3 |
| Delusions | D003702 | — | — | — | — | 1 | — | 1 | 2 |
| Hallucinations | D006212 | — | F06.0 | — | — | 1 | — | 1 | 2 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | 1 | — | 1 | 2 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Somatoform disorders | D013001 | — | F45 | — | — | 1 | — | — | 1 |
| Disease progression | D018450 | — | — | — | — | 1 | — | — | 1 |
Show 8 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 2 | — | — | 1 | 4 |
| Accelerated idioventricular rhythm | D016170 | — | — | — | 2 | — | — | — | 2 |
| Huntington disease | D006816 | Orphanet_399 | G10 | 1 | 1 | — | — | — | 2 |
| Schizotypal personality disorder | D012569 | — | F21 | 1 | 1 | — | — | 1 | 2 |
| Hot flashes | D019584 | — | — | — | 2 | — | — | — | 2 |
| Anhedonia | D059445 | — | R45.84 | — | 1 | — | — | — | 1 |
| Psychotic affective disorders | D000341 | — | F39 | — | 1 | — | — | — | 1 |
| Chorea | D002819 | EFO_0004152 | G25.5 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 5 | — | — | — | — | 5 |
| Immunoassay | D007118 | — | — | 1 | — | — | — | — | 1 |
| Central nervous system diseases | D002493 | — | G96.9 | 1 | — | — | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | 1 | — | — | — | — | 1 |
| Pharmacogenomic testing | D000071185 | — | — | 1 | — | — | — | — | 1 |
| Addictive behavior | D016739 | EFO_0004347 | — | 1 | — | — | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Fasting | D005215 | EFO_0002756 | — | 1 | — | — | — | — | 1 |
| Movement disorders | D009069 | EFO_0004280 | G25 | 1 | — | — | — | — | 1 |
| Drug-induced dyskinesia | D004409 | EFO_1000904 | — | 1 | — | — | — | — | 1 |
Show 4 more
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 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 2 | 2 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 2 | 2 |
| Paranoid schizophrenia | D012563 | — | F20.0 | — | — | — | — | 2 | 2 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
Show 44 more
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 |
Identifiers
| PDB | — |
| CAS-ID | 106266-06-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL85 |
| ChEBI ID | 8871 |
| PubChem CID | 5073 |
| DrugBank | DB00734 |
| UNII ID | L6UH7ZF8HC (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
ADRA1D
ADRA1D
Organism
Homo sapiens
Gene name
ADRA1D
Gene synonyms
ADRA1A
NCBI Gene ID
Protein name
alpha-1D adrenergic receptor
Protein synonyms
adrenergic, alpha -1D-, receptor, adrenergic, alpha-1A-, receptor, Alpha-1A adrenergic receptor, Alpha-1D adrenoceptor, Alpha-1D adrenoreceptor, Alpha-adrenergic receptor 1a
Uniprot ID
Mouse ortholog
Adra1d (11550)
alpha-1D adrenergic receptor (P97714)
Variants
No data
Financial
Revenue by drug
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Risperdal – Alkermes
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Risperdal – Johnson & Johnson
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Estimated US medical usage
Risperidone
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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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Perseris, Risperdal, Risperdal consta, Risperdal risperdal m-tab, Risperdal risperdal m-tab risperdal oral solution, Risperidone, Risperidone oral disintegrate tablets, Risperidone risperidone m-tab, Rykindo, Uzedy
Adverse Events
Top Adverse Reactions
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109,606 adverse events reported
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