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ER OROS Paliperidone
Paliperidone is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain.
Paliperidone is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain. Used for Schizophrenia, Schizoaffective disorder, Bipolar I disorder (acute mania).
At a glance
| Generic name | ER OROS Paliperidone |
|---|---|
| Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor, Serotonin 5-HT2A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Paliperidone antagonizes dopamine D2 receptors and serotonin 5-HT2A receptors, which reduces psychotic symptoms and stabilizes mood. The ER OROS formulation uses osmotic-controlled release technology to provide extended-release delivery over 24 hours, maintaining steady plasma concentrations and improving medication adherence.
Approved indications
- Schizophrenia
- Schizoaffective disorder
- Bipolar I disorder (acute mania)
Common side effects
- Extrapyramidal symptoms (tremor, rigidity, akathisia)
- Weight gain
- Prolactin elevation
- Sedation
- Orthostatic hypotension
- Tachycardia
Key clinical trials
- A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia (PHASE3)
- A Study of the Pharmacokinetics of ER OROS Paliperidone in Volunteers With Normal or Impaired Renal Function (PHASE1)
- A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia (PHASE1)
- A Bioequivalence Study of 15 mg ER OROS Paliperidone (PHASE1)
- A Study of Paliperidone Enantiomer Disposition With Different Formulations and the Bioavailability of Immediate- and Extended-release Paliperidone (PHASE1)
- A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder (PHASE1)
- As Study of the Pharmacokinetics of Paliperidone Extended-release and Risperidone Immediate-release Formulations (PHASE1)
- A Study of the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese Volunteers (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |