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Also known as Paliperidone ER OROS
Paliperidone OROS · 3 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| Paliperidone ER OROS® | DRUG | - |
| paliperidone ER Oros | DRUG | - |
Inclusion Criteria: * Subjects who had completed the double-blind phase or discontinued due to lack of efficacy after at least 21 days of treatment, who signed the informed consent for the open-label phase, and who the investigator agreed that open-label treatment was in the best interest of the su...
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Paliperidone OROS is an extended-release oral formulation of paliperidone, a small molecule antipsychotic developed by Johnson & Johnson. It is being studied for the treatment of schizophrenia. The OROS designation refers to the osmotic controlled-release oral delivery system used to release the drug over time.
Paliperidone OROS is being studied for the treatment of schizophrenia, including in geriatric patients aged 65 and older. Clinical trials have evaluated its safety, tolerability, and long-term effectiveness in patients diagnosed with schizophrenia. It remains an investigational formulation in clinical development rather than an approved product.
Paliperidone OROS targets the serotonin 5-HT2A receptor, encoded by HTR2A, and the dopamine D2 receptor, encoded by DRD2. It acts as an antagonist at both receptors. This dual serotonin and dopamine receptor antagonism is the pharmacological basis for its activity in schizophrenia.
Paliperidone OROS is developed by Johnson & Johnson, which trades under the ticker JNJ. The company has sponsored the clinical trial program evaluating the extended-release oral formulation in schizophrenia, including pharmacokinetic studies and Phase 3 safety and tolerability trials.
Paliperidone OROS is in Phase 3 clinical development. Three trials have been completed, including two Phase 3 studies and one Phase 1 pharmacokinetic study, with no trials currently active. It is an investigational formulation and is not approved by the FDA.
Paliperidone OROS has been evaluated in three completed trials: NCT00758030, a Phase 1 pharmacokinetic study in healthy Japanese and Caucasian adults; NCT00752427, a Phase 3 open-label extension in geriatric schizophrenia patients; and NCT00210769, a Phase 3 long-term safety and effectiveness study in adults with schizophrenia.
Yes, Paliperidone OROS is also known as Paliperidone ER OROS and Paliperidone ER OROS®. These names refer to the same extended-release oral paliperidone formulation developed by Johnson & Johnson for schizophrenia, so searches using any of these names point to the same investigational asset.