NDAORALTABLET, ORALLY DISINTEGRATING
Approved
Apr 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
21
Data completeness
3/8 — Basic
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RISPERDAL (risperidone) is an atypical antipsychotic small molecule approved in 2003 for schizophrenia and related psychotic disorders. It works by antagonizing dopamine D2 and serotonin 5-HT2A receptors in the central nervous system. The drug is available in oral tablet and orally disintegrating formulations.
$0.004BPart D
LOE ApproachingDeclining
As a mature product approaching loss of exclusivity, the brand team is likely focused on managed decline and portfolio transition rather than growth initiatives.
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 (21)
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
Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions in Chinese Healthy Participants
Started Dec 2017
0Healthy
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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.