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PALIPERIDONE
Paliperidone is a marketed drug primarily indicated for the treatment of schizophrenia. Its key strength lies in its established market presence, supported by a key composition patent that remains in effect until 2028. The primary risk is the eventual patent expiry in 2028, which could lead to increased competition from generic versions.
At a glance
| Generic name | PALIPERIDONE |
|---|---|
| Drug class | Atypical Antipsychotic [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2006 |
Approved indications
- Schizophrenia
- Schizoaffective Disorder
Boxed warnings
- WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone extended-release tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone is not approved for use in patients with dementia-related psychosis. (5.1)
Common side effects
- Extrapyramidal symptoms
- Somnolence
- Tachycardia
- Akathisia
- Dyspepsia
- Constipation
- Weight increased
- Nasopharyngitis
Serious adverse events
- Nervous system disorders
- Gastrointestinal disorders
Key clinical trials
- Substance Misuse To Psychosis for Stimulants (PHASE2, PHASE3)
- A Bioequivalence Study of PP3M in Patients With Schizophrenia (NA)
- Predictive Validity of the Personal and Social Performance Scale for PANSS Outcomes in Schizophrenia (PHASE2)
- 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)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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 CI brief — competitive landscape report
- PALIPERIDONE updates RSS · CI watch RSS