NDASUBCUTANEOUSSUSPENSION, EXTENDED RELEASE
Approved
Apr 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
UZEDY (risperidone) by Teva. Approved for atypical antipsychotic [epc]. First approved in 2023.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UZEDY is a subcutaneous, extended-release suspension formulation of risperidone, an atypical antipsychotic approved by the FDA in April 2023. It is indicated for the treatment of schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder. Risperidone works by antagonizing dopamine D2 and serotonin 5-HT2A receptors, reducing psychotic symptoms and mood dysregulation.
$10MPart D
Peak15.7 years to LOEUZEDY is in peak commercial phase with modest Part D spending; expect focused efforts on market penetration and clinical evidence generation to compete against established long-acting risperidone competitors.
Mechanism of Action
Pharmacologic Class:
Atypical Antipsychotic
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.