NDAORALSOLUTION
Approved
Jun 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
21
Data completeness
4/8 — Partial
RISPERDAL (risperidone) by Johnson & Johnson. Approved for atypical antipsychotic [epc]. First approved in 1996.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RISPERDAL (risperidone) is an atypical antipsychotic approved in 1996 for treatment of schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder. It works by antagonizing dopamine D2 and serotonin 5-HT2A receptors, modulating abnormal neurotransmitter activity in psychotic and mood disorders. The oral solution formulation allows flexible dosing for patients who cannot swallow tablets.
$4MPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with modest Part D spending; commercial teams are likely focused on managing generic transition and optimizing niche patient segments.
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.