risperidone
risperidone: developed by 5 companies · 5 clinical trials tracked · 5 FDA decisions.
risperidone evidence translation
What we can confirm
5 FDA records · 5 tracked trials
What it means
What to watch
Prepared research question
What is verified about risperidone, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 4 study sponsors
Development Pipeline (5)
| Company | Phase |
|---|---|
| Amneal Pharmaceuticals, Inc. (AMRX) | Approved |
| PRECISION BIOSCIENCES INC (DTIL) | Approved |
| LANNETT CO INC (LCI) | Approved |
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
| Teva Pharmaceutical Industries Limited (TEVA) | Approved |
Clinical Trials (5)
A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects With Schizophrenia, Followed by a 52-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
Primary endpoint: Change from Baseline to Week 12 in Marder Negative Symptoms Factor Score (NSFS)
A Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia
Primary endpoint: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia
Primary endpoint: Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score
Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Schizoaffective Disorders, Who is Receiving Psychiatric Home-care Treatment, When Switching From Typical Depot or Oral Antipsychotics to Long-acting Risperidone Microspheres
Primary endpoint: Change From Baseline in Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24
The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training
Primary endpoint: Total Weeks Worked
FDA Decisions5 records
Frequently asked questions
Who is developing risperidone?
risperidone is being developed by Amneal Pharmaceuticals, Inc., PRECISION BIOSCIENCES INC, LANNETT CO INC and 2 others.
How many clinical trials involve risperidone?
BioSniper tracks 5 clinical trials involving risperidone.
What is risperidone's latest FDA decision?
The most recent tracked FDA decision for risperidone is Approval for 1 INDICATIONS AND USAGE UZEDY is an atypical antipsychotic indicated: for the treatment of schizophrenia in adults. ( 1.1 ) as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. ( 1.2 ) 1.1 Schizophrenia UZEDY is indicated for the treatment of schizophrenia in adults . 1.2 Bipolar Disorder UZEDY is indicated as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder i, dated April 28, 2023.