UZEDY (risperidone)
UZEDY is indicated for the treatment of Schizophrenia; Bipolar Disorder.
How UZEDY Works
The exact mechanism of action of UZEDY is not fully established, but its therapeutic activity is thought to be mediated through the antagonism of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptors. The clinical effect results from the combined concentrations of the drug and its major metabolite, 9-hydroxyrisperidone. Additionally, the drug's interaction with receptors other than D2 and 5HT2 may contribute to its overall effects.
Details
- Status
- Prescription
- First Approved
- 2023-04-28
- Patent Cliff
- 2042
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
UZEDY Approval History
What UZEDY Treats
2 indicationsUZEDY is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
- Bipolar Disorder
UZEDY Boxed Warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. UZEDY is not approved for the treatment of patients with dementia-related psychosis and has not been studied in this patient population [see Warnings and Precautions ( 5.1 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed wa...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. UZEDY is not approved for the treatment of patients with dementia-related psychosis and has not been studied in this patient population [see Warnings and Precautions ( 5.1 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. UZEDY is not approved for use in patients with dementia-related psychosis. ( 5.1 )
UZEDY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to UZEDY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
84 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04580134 | ( STU-2020-0989 ) | Ph 4 | recruiting | CLOZAPINE Response in Biotype-1 |
| NCT07565428 | MIN-101C19 | Ph 3 | recruiting | Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications |
| NCT03055338 results posted | 8189-005 MK-8189-005 | Ph 2 | completed | An Active-Controlled Early Phase Study of Elpipodect (MK-8189) in Adults With Schizophrenia (MK-8189-005) |
| NCT04624243 results posted | 8189-008 MK-8189-008, jRCT2071200096 | Ph 2 | completed | Efficacy and Safety of Elpipodect (MK-8189) in Participants With an Acute Episode of Schizophrenia (MK-8189-008) |
| NCT06969755 BEEST | BEEST 1R01MH134883-01A1 | Ph 4 | recruiting | Biomarkers to Enhance Early Schizophrenia Treatment |
| NCT04478838 | 154-2018 | Ph 4 | recruiting | "Extended" (Alternate Day) Antipsychotic Dosing |
| NCT06368726 tDCS&ASD | SFND04042024 | Ph 1 | enrolling by invitation | Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders |
| NCT07503002 SLIM | IRB00460674 | Ph 1 | not yet recruiting | Shortened LSD Intervention for Major Depressive Disorder |
| NCT04105231 | CBD-P 2018-004893-84 | Ph 2 | active not recruiting | Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use |
| NCT01625897 results posted | A002-A7 | Ph 2, Ph 3 | completed | A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia |
| NCT06236451 | PGThesis/2023-24/100 | Ph 4 | completed | Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia |
| NCT01499563 results posted | ITI-007-005 | Ph 2 | completed | Study of a Novel Antipsychotic ITI-007 in Schizophrenia |
| NCT02469155 results posted | ITI-007-302 | Ph 3 | completed | A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment |
| NCT02634463 | CR108047 CODX0001-NAP-1004 | Ph 1 | completed | Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone |
| NCT04201834 results posted | 4443 | Ph 2 | completed | Risperidone for the Treatment of Huntington's Disease Involuntary Movements |
| NCT05890768 Lumafep | 22-396 | Ph 4 | withdrawn | Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine |
| NCT03557931 results posted | 4345-CL-0015 | Ph 2 | completed | A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication |
| NCT05779241 | LYN 005-C-301 | Ph 3 | completed | Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005 |
| NCT05401019 OCD-RT | OCD-RT 2022-000249-34 | Ph 2 | withdrawn | Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD) |
| NCT03323437 results posted | 1702018001 R01MH110270 | Ph 4 | completed | Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia |
| NCT04512066 results posted | BP41743 | Ph 2 | completed | A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder |
| NCT00845026 results posted | 12648 H8Y-MC-HBBR | Ph 2 | completed | A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients |
| NCT01171937 ProjectV | 07-06-033 P50HD055784 | Ph 2 | completed | Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior |
| NCT00711269 results posted | D1001002 JapicCTI-080585 | Ph 3 | completed | Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia |
| NCT01451736 | P50 MH066286 Phase II P50MH066286, R092670SCH4005 | Ph 4 | completed | Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia |
| NCT00698022 results posted | C-1073-205 | Ph 1 | completed | A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers |
| NCT03978832 results posted | INDV-7000-401 | Ph 4 | completed | Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone |
| NCT02918097 results posted | 09-013/2 | Ph 4 | completed | Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode |
| NCT03568500 results posted | 031-201-00186 | Ph 4 | completed | A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic |
| NCT01639872 CLOCS results posted | 1R01DA032533-01A1 D13012 1R01DA032533-01A1 | Ph 4 | completed | Clozapine for Cannabis Use in Schizophrenia |
| NCT01913327 APD results posted | 2010489 | Ph 4 | terminated | Antipsychotic Effects on Brain Function in Schizophrenia |
| NCT02021201 | H-A-2008-062 | Ph 4 | terminated | The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia |
| NCT02063945 | SHEBA-13-0564-DG-CTIL | Ph 4 | terminated | Methylphenidate vs. Risperidone for the Treatment of Children and Adolescents With ADHD and Disruptive Disorders |
| NCT03230864 Anew results posted | 17303A | Ph 3 | terminated | Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia |
| NCT02717195 DayBreak results posted | 16159A 2014-003569-12 | Ph 3 | completed | Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia |
| NCT02118688 | ICUDelirium | Ph 4 | withdrawn | Efficacy and Safety of Risperidone and Trazodone Monotherapy and Combination Therapy in Critically Ill Patients With Delirium |
| NCT00694707 results posted | RGH-MD-16 | Ph 2 | completed | Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia |
| NCT03075657 | T/IM-NF/Pharma/01/17 | Ph 4 | completed | Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia |
| NCT03887754 | Autism Spectrum Disorder | Ph 2 | completed | Therapeutic Issues for Autism |
| NCT03730857 | T1-02 | Ph 1 | completed | Early Predictors of Poor Treatment Response in Patients With Schizophrenia Treated With Atypical Antipsychotics |
| NCT01516424 results posted | D4906011 | Ph 3 | completed | Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone |
| NCT02109562 results posted | RB-US-09-0010 | Ph 3 | completed | Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients |
| NCT01677377 results posted | RB-US-09-0009 | Ph 2 | completed | Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy |
| NCT02307396 | 1723/1-1 2013-000338-37, DO 1723/1-1 | Ph 4 | completed | Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients |
| NCT01333072 BAART results posted | R01HD062550-01A1 | Ph 4 | completed | Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART) |
| NCT01175135 results posted | A8241012 2010-020764-38 | Ph 2 | completed | An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia |
| NCT02051387 CBD-IS | CBD-IS 2008-008245-38 | Ph 1 | completed | Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT00796302 results posted | R01MH077907 DSIR 84-CTS, 1R01MH077907-01A2 | Ph 4 | completed | Treatment of Severe Childhood Aggression (The TOSCA Study) |
| NCT02462473 results posted | CR106922 CODX0001NAP2002 | Ph 2 | terminated | A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry |
Showing 50 of 84 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
UZEDY FDA Label Details
Indications & Usage
FDA Label (PDF)UZEDY is indicated for the treatment of Schizophrenia; Bipolar Disorder.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. UZEDY is not approved for the treatment of patients with dementia-related psychosis and has not been s...
UZEDY Patents & Exclusivity
Patents (6 active)
Exclusivity
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Deep insights for UZEDY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 357 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.