Overview
Paliperidone is the primary active metabolite of risperidone. The mechanism of action is unknown but it is likely to act via a similar pathway to risperidone. It has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism. Paliperidone is also active as an antagonist at alpha 1 and alpha 2 adrenergic receptors and H1 histaminergic receptors, which may explain some of the other effects of the drug. Paliperidone was approved by the FDA for treatment of schizophrenia on December 20, 2006. It is available as an extended-release tablet, a once-monthly intramuscular injection, an every-three-month intramuscular injection, and a twice-yearly gluteal injection.
Indication
As an oral extended-release tablet and a once-monthly extended-release suspension for intramuscular injection, paliperidone is indicated for the treatment of adults and adolescents with schizophrenia and in the treatment of schizoaffective disorder in combination with antidepressants or mood stabilizers. Paliperidone is also available in both an every-three-month and twice-yearly extended-release suspension for intramuscular injection for the treatment of schizophrenia.
Associated Conditions
- Schizoaffective Disorders
- Schizophrenia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/20 | Not Applicable | Not yet recruiting | Jiangsu Province Nanjing Brain Hospital | ||
2023/09/29 | Phase 4 | Not yet recruiting | Consorcio Centro de Investigación Biomédica en Red (CIBER) | ||
2021/06/25 | Phase 4 | Completed | |||
2021/06/10 | Phase 1 | Completed | |||
2021/02/15 | Phase 1 | Completed | Calo Psychiatric Center | ||
2020/10/01 | Phase 1 | Completed | |||
2020/07/21 | Phase 4 | Recruiting | |||
2019/09/03 | Not Applicable | Completed | |||
2019/08/22 | N/A | UNKNOWN | |||
2019/01/18 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ascent Pharmaceuticals, Inc. | 43602-295 | ORAL | 3 mg in 1 1 | 8/28/2023 | |
| Inventia Healthcare Limited | 49252-035 | ORAL | 9 mg in 1 1 | 6/25/2019 | |
| Mylan Pharmaceuticals Inc. | 0378-3980 | ORAL | 6 mg in 1 1 | 2/14/2019 | |
| Ascent Pharmaceuticals, Inc. | 43602-296 | ORAL | 6 mg in 1 1 | 8/28/2023 | |
| REMEDYREPACK INC. | 70518-3873 | ORAL | 3 mg in 1 1 | 4/2/2024 | |
| Janssen Pharmaceuticals, Inc. | 50458-563 | INTRAMUSCULAR | 156 mg in 1 mL | 7/31/2022 | |
| Sun Pharmaceutical Industries, Inc. | 47335-766 | ORAL | 6 mg in 1 1 | 3/4/2021 | |
| Tris Pharma Inc | 27808-224 | ORAL | 6 mg in 1 1 | 10/7/2022 | |
| NorthStar RxLLC | 16714-868 | ORAL | 6 mg in 1 1 | 3/29/2025 | |
| AvKARE | 42291-917 | ORAL | 6 mg in 1 1 | 8/10/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/31/2024 | ||
Authorised | 6/24/2007 | ||
Authorised | 6/18/2020 | ||
Authorised | 12/5/2014 | ||
Authorised | 3/4/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PARNIDO PROLONGED-RELEASE TABLETS 6MG | SIN16782P | TABLET, MULTILAYER, EXTENDED RELEASE | 6.00mg | 5/15/2023 | |
| PARNIDO PROLONGED-RELEASE TABLETS 3MG | SIN16781P | TABLET, MULTILAYER, EXTENDED RELEASE | 3.00mg | 5/15/2023 | |
| INVEGA Sustenna Prolonged Release Suspension for IM Injection 25mg/0.25 ml | SIN13968P | INJECTION, SUSPENSION, EXTENDED RELEASE | 25mg/0.25ml | 6/13/2011 | |
| INVEGA HAFYERA PROLONGED RELEASE SUSPENSION FOR IM INJECTION IN PREFILLED SYRINGE 700MG/3.5ML | SIN16654P | INJECTION, SUSPENSION, EXTENDED RELEASE | 700mg/3.5mL | 12/19/2022 | |
| INVEGA TRINZA PROLONGED RELEASE SUSPENSION FOR IM INJECTION 350MG/1.75ML | SIN15188P | INJECTION, SUSPENSION, EXTENDED RELEASE | 350mg/1.75ml | 3/6/2017 | |
| INVEGA TRINZA PROLONGED RELEASE SUSPENSION FOR IM INJECTION 263MG/1.315ML | SIN15187P | INJECTION, SUSPENSION, EXTENDED RELEASE | 263mg/1.315ml | 3/6/2017 | |
| INVEGA Sustenna Prolonged Release Suspension for IM Injection 100mg/1.0ml | SIN13971P | INJECTION, SUSPENSION, EXTENDED RELEASE | 100mg/1ml | 6/13/2011 | |
| Invega Extended-Release Tablet 6mg | SIN13381P | TABLET, EXTENDED RELEASE | 6mg | 12/7/2007 | |
| INVEGA TRINZA PROLONGED RELEASE SUSPENSION FOR IM INJECTION 175MG/0.875ML | SIN15186P | INJECTION, SUSPENSION, EXTENDED RELEASE | 175mg/0.875ml | 3/6/2017 | |
| Invega Extended-Release Tablet 3mg | SIN13380P | TABLET, EXTENDED RELEASE | 3mg | 12/7/2007 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| INVEGA EXTENDED-RELEASE TAB 9MG | N/A | N/A | N/A | 12/31/2007 | |
| COMPASSIA PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/1.5ML | N/A | N/A | N/A | 12/18/2024 | |
| COMPASSIA PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML | N/A | N/A | N/A | 12/18/2024 | |
| PALIPERIDONE TEVA PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/1.5ML | N/A | N/A | N/A | 12/24/2024 | |
| PALIPERIDONE TEVA PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML | N/A | N/A | N/A | 12/24/2024 | |
| PALIPERIDONE TEVA PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.75ML | N/A | N/A | N/A | 12/24/2024 | |
| COMPASSIA PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.75ML | N/A | N/A | N/A | 12/18/2024 | |
| COMPASSIA PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 50MG/0.5ML | N/A | N/A | N/A | 12/18/2024 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| INVEGA | 02300273 | Tablet (Extended-Release) - Oral | 3 MG | 10/2/2007 | |
| INVEGA | 02300311 | Tablet (Extended-Release) - Oral | 12 MG | N/A | |
| MYLAN-PALIPERIDONE | Mylan Pharmaceuticals ULC | 02437139 | Tablet (Extended-Release) - Oral | 6 MG | N/A |
| INVEGA | 02300281 | Tablet (Extended-Release) - Oral | 6 MG | 10/2/2007 | |
| MAR-PALIPERIDONE | marcan pharmaceuticals inc | 02511029 | Tablet (Extended-Release) - Oral | 6 MG | 6/29/2021 |
| INVEGA | 02300303 | Tablet (Extended-Release) - Oral | 9 MG | 10/2/2007 | |
| MAR-PALIPERIDONE | marcan pharmaceuticals inc | 02511010 | Tablet (Extended-Release) - Oral | 3 MG | 6/29/2021 |
| MYLAN-PALIPERIDONE | Mylan Pharmaceuticals ULC | 02456400 | Tablet (Extended-Release) - Oral | 3 MG | N/A |
| MAR-PALIPERIDONE | marcan pharmaceuticals inc | 02511037 | Tablet (Extended-Release) - Oral | 9 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| PALIPERIDONA CINFA 3 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Laboratorios Cinfa S.A. | 85826 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| PALIPERIDONA ALTER 6 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Laboratorios Alter S.A. | 83346 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| PALIPERIDONA TEVA 3 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | 83112 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| PALIPERIDONA CINFA 9 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Laboratorios Cinfa S.A. | 85828 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| INVEGA 6 mg COMPRIMIDOS DE LIBERACION PROLONGADA | 07395006 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| PALIPERIDONA CINFA 6 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Laboratorios Cinfa S.A. | 85827 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| INVEGA 9 mg COMPRIMIDOS DE LIBERACION PROLONGADA | 07395011 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| INVEGA 9 MG COMPRIMIDOS DE LIBERACION PROLONGADA | 107395049 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| PALIPERIDONA ALTER 9 MG COMPRIMIDOS DE LIBERACION PROLONGADA EFG | Laboratorios Alter S.A. | 83347 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| INVEGA 6 MG COMPRIMIDOS DE LIBERACION PROLONGADA | 107395045 | COMPRIMIDO DE LIBERACIÓN PROLONGADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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