Invega(paliperidone)
Byannli, Erzofri, 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, Paliperidone (discontinued: Invega, Paliperidone)
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 | 3 products, RLD |
Show 1 discontinued
Paliperidone palmitate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INVEGA TRINZA | Johnson & Johnson | N-207946 RX | 2015-05-18 | 4 products, RLD, RS |
| INVEGA HAFYERA | Johnson & Johnson | N-207946 RX | 2021-08-30 | 2 products, RLD |
| INVEGA SUSTENNA | Johnson & Johnson | N-022264 RX | 2009-07-31 | 5 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| erzofri extended-release | New Drug Application | 2025-03-18 |
| invega | New Drug Application | 2025-02-06 |
| invega hafyera | New Drug Application | 2025-02-18 |
| invega sustenna | New Drug Application | 2025-02-14 |
| invega trinza | New Drug Application | 2025-02-14 |
| paliperidone | ANDA | 2025-03-25 |
| paliperidone palmitate | Export only | 2024-01-09 |
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
210 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 | 29 | 4 | 34 | 12 | 7 | 86 |
| Psychotic disorders | D011618 | — | F20.81 | 6 | 1 | 6 | 2 | — | 15 |
| Depression | D003863 | — | F33.9 | 1 | — | — | 2 | — | 3 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | — | 1 | — | 2 |
| Schizophrenia spectrum and other psychotic disorders | D019967 | — | — | — | — | — | 1 | — | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | 1 | — | 1 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 3 | — | 4 | — | 1 | 8 |
| Recurrence | D012008 | — | — | — | — | 5 | — | — | 5 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | — | 2 | — | — | 3 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | — | 2 | — | — | 2 |
| Disease progression | D018450 | — | — | — | — | 1 | — | — | 1 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | — | 1 | — | — | 1 |
| Mania | D000087122 | — | F30 | — | — | 1 | — | — | 1 |
| Psychotic affective disorders | D000341 | — | F39 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 1 | — | — | — | 1 |
| Compulsive personality disorder | D003193 | — | F60.5 | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Immunoassay | D007118 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | 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 |
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) |
Target
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Variants
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Financial
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Invega – Alkermes
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Invega – Johnson & Johnson
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Tabular view
Estimated US medical usage
Paliperidone
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 4,993 documents
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Safety
Black-box Warning
Black-box warning for: Erzofri extended-release, Invega, Invega hafyera, Invega sustenna, Invega trinza, Paliperidone
Adverse Events
Top Adverse Reactions
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50,513 adverse events reported
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