NDASUBCUTANEOUSFOR SUSPENSION, EXTENDED RELEASE
Approved
Jul 2018
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PERSERIS KIT is a subcutaneous, extended-release formulation of risperidone, a second-generation antipsychotic indicated for schizophrenia and bipolar disorder. This long-acting injection offers monthly dosing convenience compared to daily oral risperidone, improving adherence in patients with psychotic disorders. The mechanism relies on risperidone's dopamine D2 and serotonin 5-HT2A receptor antagonism delivered via a proprietary subcutaneous depot technology.
LOE Approaching1.6 years to LOE
Product approaching loss of exclusivity in 1.7 years with limited publicly available commercial data; brand team likely focused on market retention and generic transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant
Started Apr 2021
34 enrolled
Schizophrenia
Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone
Started Jun 2019
69 enrolled
Schizophrenia
A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities
Started Oct 2018
34 enrolled
Schizophrenia
Mirror-image Study of Paliperidone Palmitate and Risperidone Long-acting Injection
Started Jan 2018
328 enrolled
Schizophrenia Spectrum and Other Psychotic Disorders
Comparison of the Effectiveness of Brexpiprazole With That of Risperidone
Started Jun 2016
0Schizophrenia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.