Ruixinshuo® is the commercial brand name of Risperidone Microspheres for Injection (II), a long-acting injectable atypical antipsychotic developed by Luye Pharma. It works by blocking dopamine D2 and serotonin 5-HT2A receptors, delivering sustained release of risperidone after intramuscular administration to maintain stable plasma drug concentrations.
Main Indications
For the maintenance treatment of schizophrenia in adult patients, to reduce the risk of symptom relapse.
Clinical Research
The domestic phase III clinical trial demonstrated that this long-acting risperidone microsphere formulation achieved non-inferior efficacy compared with oral risperidone in preventing relapse of schizophrenia, with improved medication adherence;
The study confirmed a predictable drug release profile and manageable safety profile in Chinese schizophrenic patients;
Additional studies evaluated switching strategies from other long-acting antipsychotics to this formulation.
Common Side Effects
Severe but important risks: Neuroleptic malignant syndrome, tardive dyskinesia, severe hypotension, QT prolongation;
Common mild adverse reactions: Insomnia, headache, anxiety, extrapyramidal symptoms, weight gain and injection site reaction.
Approval Status in China
Original drug Ruixinshuo® (Risperidone Microspheres for Injection (II), specification:25mg per vial) was officially approved for marketing in China in 2021. It is currently a prescription long-acting antipsychotic agent.
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