INVEGA SUSTENNA® is the commercial brand name of Paliperidone Palmitate Injection (3‑Month), a long‑acting injectable atypical antipsychotic developed by Janssen. After intramuscular injection, it slowly releases paliperidone, which blocks central dopamine D2 and serotonin 5‑HT2A receptors to exert antipsychotic effects.
Main Indications
Treatment of schizophrenia in adult patients who have been stabilized with paliperidone palmitate one‑month formulation.
Clinical Research
Global multicenter phase III trials demonstrated that this 3‑month long‑acting injectable formulation maintains symptom control and significantly reduces relapse risk compared with placebo in stabilized schizophrenia patients;
Registration trials in Chinese subjects confirmed stable therapeutic efficacy and tolerability consistent with global trial populations;
Long‑term observational studies verified sustained disease stability and a predictable safety profile following repeated intramuscular administration every 3 months.
Common Side Effects
Severe but important risks: Neuroleptic malignant syndrome, tardive dyskinesia, severe hypersensitivity reactions, cerebrovascular adverse events in elderly dementia‑related psychosis patients;
Common mild adverse reactions: Headache, insomnia, injection‑site reactions, akathisia, tremor, dizziness and weight gain.
Approval Status in China
Original drug INVEGA SUSTENNA® (Paliperidone Palmitate Injection (3‑Month), 525 mg) was officially approved for marketing in China in 2021. It is currently a prescription antipsychotic biologic‑related injectable drug included in China’s category B medical insurance catalogue.
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