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Paliperidone and paliperidone palmitate
Paliperidone is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain to reduce psychotic symptoms.
Paliperidone is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain to reduce psychotic symptoms. Used for Schizophrenia, Schizoaffective disorder, Bipolar I disorder (acute mania and maintenance).
At a glance
| Generic name | Paliperidone and paliperidone palmitate |
|---|---|
| Also known as | Paliperidone: Invega®, Paliperidone palmitate: Xeplion® or Invega® Sustenna® |
| Sponsor | H. Lundbeck A/S |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor, Serotonin 5-HT2A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
Paliperidone acts as a dopamine D2 receptor antagonist and serotonin 5-HT2A receptor antagonist, which helps normalize neurotransmitter activity in patients with psychotic disorders. Paliperidone palmitate is a long-acting injectable formulation of paliperidone that provides sustained drug release over weeks to months, improving medication adherence in schizophrenia and schizoaffective disorder.
Approved indications
- Schizophrenia
- Schizoaffective disorder
- Bipolar I disorder (acute mania and maintenance)
Common side effects
- Extrapyramidal symptoms (akathisia, dystonia, parkinsonism)
- Weight gain
- Prolactin elevation
- Sedation
- Orthostatic hypotension
- Tachycardia
Key clinical trials
- An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine (PHASE4)
- Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum
- Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. (PHASE4)
- Bioequivalence Study of Long-Acting Paliperidone Palmitate in Patients With Schizophrenia (NA)
- Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia (PHASE4)
- Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone (PHASE1)
- "Extended" (Alternate Day) Antipsychotic Dosing (PHASE4)
- A Study of Paliperidone Palmitate 6-Month Formulation (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Paliperidone and paliperidone palmitate CI brief — competitive landscape report
- Paliperidone and paliperidone palmitate updates RSS · CI watch RSS
- H. Lundbeck A/S portfolio CI