Invega(paliperidone)
Byannli, Invega, Paliperidone, Trevicta, Xeplion (paliperidone) is a small molecule pharmaceutical. Paliperidone was first approved as Invega on 2006-12-19. It is used to treat bipolar disorder, depressive disorder, schizophrenia, and schizophrenia spectrum and other psychotic disorders in the USA. It has been approved in Europe to treat psychotic disorders and schizophrenia.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| mental disorders | D001523 |
Trade Name
FDA
EMA
Invega, Invega hafyera, Invega sustenna, Invega trinza (generic drugs available since 2015-08-03)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Paliperidone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INVEGA | Johnson & Johnson | N-021999 RX | 2006-12-19 | 4 products, RLD |
Show 1 discontinued
Paliperidone palmitate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INVEGA SUSTENNA | Johnson & Johnson | N-022264 RX | 2009-07-31 | 5 products, RLD |
| INVEGA HAFYERA | Johnson & Johnson | N-207946 RX | 2021-08-30 | 2 products, RLD |
| INVEGA TRINZA | Johnson & Johnson | N-207946 RX | 2015-05-18 | 4 products, RLD, RS |
Labels
FDA
EMA
No data
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PALIPERIDONE PALMITATE, INVEGA HAFYERA, JANSSEN PHARMS | |||
| 2024-08-30 | NS | ||
PALIPERIDONE PALMITATE, INVEGA TRINZA, JANSSEN PHARMS | |||
| 2024-08-30 | NS | ||
Patent Expiration
HCPCS
Code | Description |
|---|---|
| J2426 | Injection, paliperidone palmitate extended release, 1 mg |
Clinical
Clinical Trials
209 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 | 11 | 48 | 45 | 26 | 167 |
| Psychotic disorders | D011618 | — | F20.81 | 10 | 2 | 6 | 11 | 5 | 34 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 3 | — | 4 | 1 | 5 | 13 |
| Schizophrenia spectrum and other psychotic disorders | D019967 | — | — | 1 | — | — | 1 | 2 | 4 |
| Treatment-resistant schizophrenia | D000090663 | — | — | — | — | — | 2 | — | 2 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | 1 | — | 1 |
| Hyperprolactinemia | D006966 | HP_0000870 | E22.1 | — | — | — | 1 | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 1 | — | 1 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | 1 | — | 1 |
| Acute disease | D000208 | — | — | — | — | — | 1 | — | 1 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | 2 | — | 2 | — | — | 4 |
| Mania | D000087122 | — | F30 | — | — | 1 | — | 1 | 2 |
| Heroin dependence | D006556 | EFO_0004240 | — | — | — | 1 | — | — | 1 |
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | — | — | 1 | — | — | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | — | 1 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | — | 1 | — | — | 1 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Drug therapy | D004358 | — | — | — | 1 | 1 | — | — | 1 |
| Tic disorders | D013981 | — | F95 | — | 1 | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Accelerated idioventricular rhythm | D016170 | — | — | — | 1 | — | — | — | 1 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 1 | — | — | — | 1 |
| Dual (psychiatry) diagnosis | D017831 | — | — | — | 1 | — | — | — | 1 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 1 | — | — | — | 1 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 2 | — | — | — | — | 2 |
| Schizotypal personality disorder | D012569 | — | F21 | 1 | — | — | — | — | 1 |
| Immunoassay | D007118 | — | — | 1 | — | — | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | 1 | — | — | — | — | 1 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Paranoid schizophrenia | D012563 | — | F20.0 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Periodontal diseases | D010510 | — | K05.6 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Paliperidone |
| INN | paliperidone |
| Description | 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one is a member of the class of pyridopyrimidines that is 9-hydroxy-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 is a member of 1,2-benzoxazoles, a heteroarylpiperidine, an organofluorine compound, a pyridopyrimidine and a secondary alcohol. |
| 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)CCCC2O |
Identifiers
| PDB | — |
| CAS-ID | 1020719-55-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1621 |
| ChEBI ID | 83804 |
| PubChem CID | 115237 |
| DrugBank | DB01267 |
| UNII ID | 838F01T721 (ChemIDplus, GSRS) |
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Invega – Alkermes
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Invega – Johnson & Johnson
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Estimated US medical usage
Paliperidone
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Trends
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Safety
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No Black-box warning
Adverse Events
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41,583 adverse events reported
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