Risperdal

(Risperidone)

ApprovedSmall molecule

Risperidone is used to treat mental health conditions like schizophrenia and bipolar disorder by helping to balance certain chemicals in the brain that affect mood and thinking.[2] Risperdal is currently approved and in use across 39 indications[4].[1]

Risperdal is one of 404 small molecule programs targeting Treatment Refractory Schizophrenia. It is currently in Approved.

Indications

331

Total Trials

Active Trials

403

Competitors

183

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Treatment Refractory SchizophreniaActive, not recruiting

Depressive DisorderApproved

22q11.2 Deletion SyndromeActive, not recruiting

Mental or Behavioural DisorderApproved

Aggressive BehaviorActive, not recruiting

Developmental DisabilityApproved

Asperger SyndromeApproved

Rett SyndromeApproved

Huntington DiseaseApproved

Oppositional Defiant DisorderApproved

Treatment Refractory SchizophreniaPreclinical

Active, not recruiting

Depressive DisorderApproved

Approved

22q11.2 Deletion SyndromePreclinical

Active, not recruiting

Mental or Behavioural DisorderApproved

Approved

Aggressive BehaviorApproved

Active, not recruiting

Developmental DisabilityApproved

Approved

Asperger SyndromeApproved

Approved

Rett SyndromeApproved

Approved

Huntington DiseaseApproved

Approved

Oppositional Defiant DisorderApproved

Approved

Showing 10 of 39 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Risperdal

Inapsine

1 3

Ozempic

Novo Nordisk

Preclinical

1 4

Resotran

Takeda

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Persantine

Boehringer Ingelheim

Preclinical

1 9

Luvox

SSolvay Pharmaceuticals

Preclinical

1 10

Catapres

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2030

Recruiting

Imaging

NCT07483294

Clinical

Trials by Indication[1]

Schizophrenia64 trials

Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia

Terminated· Lundbeck logo

Lundbeck·Phase 3·NCT03230864·119 enrolled

Adjunctive iTBS for First-Episode Schizophrenia

Completed·TThe First Hospital of Hebei Medical University·N/A·NCT07116850·100 enrolled

Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia

Completed·WWeill Medical College of Cornell University·Phase 4·NCT03323437·26 enrolled

Show 61 more trials

A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol in Patients With Chronic Schizophrenia

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00249119·1,579 enrolled

Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia

Unknown status· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 3·NCT02453893·288 enrolled

Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia

Completed·TTaiwan Otsuka Pharm. Co., Ltd·Phase 3·NCT00283179·83 enrolled

An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia

Terminated· Johnson & Johnson logo

Johnson & Johnson··NCT01894984·640 enrolled

Supported Employment and Skills Training in Conjunction With Pharmacotherapy in Schizophrenia Patients

Completed·UUniversity of California, Los Angeles·Phase 4·NCT00183625·107 enrolled

First Episode Schizophrenia and Cannabis-Related Disorder Study

Completed·—·N/A·NCT00573287·14 enrolled

An Active-Controlled Early Phase Study of MK-8189 in Adults With Schizophrenia (MK-8189-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03055338·224 enrolled

Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01193166

Schizophrenia Study In Adults

Completed· GSK logo

GSK·Phase 2·NCT00049946·231 enrolled

Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

Completed· Jiangsu Hansoh Pharmaceutical Co., Ltd. logo

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 2·NCT01623713·260 enrolled

Early Predictors of Poor Treatment Response in Patients With Schizophrenia Treated With Atypical Antipsychotics

Completed·CCalo Psychiatric Center·Phase 1·NCT03730857·111 enrolled

Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia

Terminated·KKettering Health Network·Phase 4·NCT00712270·21 enrolled

A Long-Term Study of MP-214 in Patients With Chronic Phase or Elderly Schizophrenia

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 2/3·NCT01625897·125 enrolled

Dopaminergic, Functional, Structural, and Cognitive Disturbances in First-episode Schizophrenia

Completed·BBirte Glenthoj·N/A·NCT00206960·56 enrolled

A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00216528·527 enrolled

Atypical Antipsychotic Treatment Effect On Brain Function In Schizophrenia Measured By FMRI

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT01234454·34 enrolled

Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia

Completed·—·Phase 4·NCT06236451·60 enrolled

Clozapine for Cannabis Use in Schizophrenia

Completed·—·Phase 4·NCT01639872·49 enrolled

Preventing Relapse in Schizophrenia: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy

Completed·NNorthwell Health·Phase 4·NCT00330863·357 enrolled

Identification and Treatment of the Liability to Develop Schizophrenia

Unknown status·—·Phase 4·NCT00305474·100 enrolled

A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia

Completed·—·N/A·NCT02192723·550 enrolled

Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone

Completed·SSumitomo Pharma (Suzhou) Co., Ltd.·Phase 3·NCT01516424·267 enrolled

Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Completed·IIntra-Cellular Therapies, Inc.·Phase 2·NCT01499563·335 enrolled

Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia

Terminated·BBioLineRx, Ltd.·Phase 2/3·NCT01363349·269 enrolled

Treatment for First-Episode Schizophrenia

Completed·NNorthwell Health·Phase 4·NCT00000374·125 enrolled

Standard Comprehensive Intervention to Treat First-episode Schizophrenia

Unknown status·PPeking University·N/A·NCT01057849·600 enrolled

Is MS14 Helpful in Schizophrenia?

Unknown status·FFarzan Institute·Phase 2·NCT01083381·50 enrolled

Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00921804·296 enrolled

Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT00053703·116 enrolled

A Study to Assess Safety and Tolerabiltiy Associated With a Switch From Oral Antipsychotic Medications to Long-acting Injectable Risperidone in Patients With Schizophrenia.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00034775·141 enrolled

Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia

Completed·SSumitomo Pharma Co., Ltd.·Phase 3·NCT00711269·460 enrolled

Risperidone Maintenance Treatment in Schizophrenia

Completed·—·Phase 4·NCT00848432·404 enrolled

Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia

Completed·AAbbott·Phase 2·NCT00073164·400 enrolled

Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia

Completed·NNational Institute of Mental Health and Neuro Sciences, India·Phase 4·NCT00893256·48 enrolled

Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00337662·628 enrolled

Study Evaluating Vabicaserin in Subjects With Schizophrenia

Completed· Pfizer logo

Pfizer·Phase 2·NCT00563706·199 enrolled

15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01157351·450 enrolled

Omega-3 Dietary Supplements in Schizophrenia

Completed·DDelbert Robinson·N/A·NCT01786239·50 enrolled

An Open-label Study Evaluating the Maintenance of Clinical Effect in Adult Schizophrenia Patients Switched From Risperidone Tablets to an Equivalent Dose of a Rapidly-dissolving Tablet Formulation of Risperdone

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00246272·82 enrolled

Identification of Multi-modal Bio-markers for Early Diagnosis and Treatment Prediction in Schizophrenia Individuals

Unknown status·TTianjin Medical University General Hospital·Phase 1·NCT03790085·2,700 enrolled

Dopamine D2 and D3 Receptor Occupancy and Clinical Response in Older Patients With Schizophrenia

Unknown status·CCentre for Addiction and Mental Health·N/A·NCT00825045·14 enrolled

Antipsychotic Effects on Brain Function in Schizophrenia

Terminated·UUniversity of California, San Francisco·Phase 4·NCT01913327·4 enrolled

Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients

Completed·IIndivior Inc.·Phase 3·NCT02109562·354 enrolled

Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT02600741·296 enrolled

A Long Term Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236587·100 enrolled

Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia

Completed·—·Phase 4·NCT03075657·120 enrolled

Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia

Terminated· Johnson & Johnson logo

Johnson & Johnson··NCT00511628·1,717 enrolled

A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00604279·452 enrolled

Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00485498·122 enrolled

A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in the Treatment of Patients With Schizophrenia

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00253136·458 enrolled

CATIE- Schizophrenia Trial

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00014001·1,600 enrolled

Risperidone Augmentation in Patients With Schizophrenia

Completed·MMassachusetts General Hospital·Phase 4·NCT00289861·24 enrolled

Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia

Completed·FForest Laboratories·Phase 2·NCT00694707·732 enrolled

Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia

Completed·UUniversity of California, Los Angeles·Phase 4·NCT01451736·146 enrolled

The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

Terminated·BBirte Glenthoj·Phase 4·NCT02021201·1 enrolled

CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia

Completed·UUniversity of British Columbia·Phase 4·NCT00272584·100 enrolled

Investigate Risperidone for the Treatment of Schizophrenia in Adolescents

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00088075·160 enrolled

Lurasidone HCl - A Long Term Safety Phase 3 Study of Patients With Clinically Stable Schizophrenia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT00641745·629 enrolled

Metabolic Signatures and Biomarkers in Schizophrenia

Completed·—·Phase 1·NCT00466310·71 enrolled

Neuroendocrine and Metabolite Substrates in Schizophrenia

Unknown status·—··NCT02423096·200 enrolled

Safety and Efficacy of Zicronapine in Patients With Schizophrenia

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT01295372·160 enrolled

Schizoaffective Disorder13 trials

Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00236353·86 enrolled

A Study Comparing the Efficacy of Long-acting Injectable Risperidone and Olanzapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236457·629 enrolled

A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizophrenia or Schizoaffective Disorder

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00206102·1,098 enrolled

Show 10 more trials

A Study of Long-acting Injectable Risperidone in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00210691·273 enrolled

A Long Term Study of Safety for Long Acting Injectable Risperidone in Patients With Schizophrenia or Schizoaffective Disorder.

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00558298·811 enrolled

A Study of the Effects of Risperidone and Olanzapine on Blood Glucose (Sugar) in Patients With Schizophrenia or Schizoaffective Disorder

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00236379·59 enrolled

A Pharmacokinetic Study of Risperidone and Topiramate Administered Alone and in Combination in Patients With Bipolar Disorder or Schizoaffective Disorders

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT00986336·56 enrolled

Evaluation of the Usefulness to Doctors of the Risperdal Consta Treatment Guidebook Over a Three-month Period During Which Adult Patients With Schizophrenia or Schizoaffective Disorder Are Switching From Daily Doses or Risperidone Tablets to Long-acting Risperidone by Injection

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236548·1 enrolled

A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

Completed· Roche logo

Roche·Phase 2·NCT04512066·287 enrolled

Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00423878·215 enrolled

A Study Comparing Three Strategies to Switch Patients With Schizophrenia or Schizoaffective Disorder to Risperidone After Unsuccessful Treatment With Olanzapine.

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00378183·120 enrolled

An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01855074·80 enrolled

A Long-term Safety Study for Long-acting Injectable Risperidone in Schizophrenia or Schizoaffective Disorder Patients.

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00495118·314 enrolled

Treatment7 trials

Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma

Completed·—·Phase 4·NCT00208182·20 enrolled

Evaluation of the Effects of Treatment of Psycho-stimulant and Cannabis-dependent Users in Israel

Unknown status·TTel-Aviv Sourasky Medical Center·N/A·NCT01510015·100 enrolled

A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

Completed·IIntra-Cellular Therapies, Inc.·Phase 3·NCT02469155·696 enrolled

Show 4 more trials

A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00378092·33 enrolled

Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT00294255·45 enrolled

Risperidone Treatment in Dually-Diagnosed Individuals - 2

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000267

A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients

Completed·DDenovo Biopharma LLC·Phase 2·NCT00845026·261 enrolled

Bipolar Disorder7 trials

A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00250367·151 enrolled

A Study of the Effectiveness and Safety of Risperidone as add-on Therapy to Mood Stabilizers in the Treatment of Manic Episodes Associated With Bipolar Disorder

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00253149·158 enrolled

Clozapine Versus Other Atypical Antipsychotics for Bipolar Disorder

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 4·NCT02562287·54 enrolled

Show 4 more trials

A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar Disorder

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00246246·48 enrolled

Controlled Trial of Valproate Versus Risperidone in Young Children With Bipolar Disorder

Completed·NNationwide Children's Hospital·Phase 3·NCT02456454·46 enrolled

Divalproex ER vs. Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder

Completed·TTuscaloosa Research & Education Advancement Corporation·Phase 4·NCT00203528·30 enrolled

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Psychosis7 trials

Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use

Active, not recruiting·LLone Baandrup·Phase 2·NCT04105231·64 enrolled

A Comparative Study of New Medications for Psychosis in Adolescents

Completed·UUniversity of Minnesota·N/A·NCT00222495·30 enrolled

Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis

Completed·NNorthwell Health·Phase 4·NCT00320671·198 enrolled

Show 4 more trials

Effectiveness of Second Generation Antipsychotics in First Episode Psychosis Patients: 1-year Follow-up

Unknown status·FFundación Marques de Valdecilla·Phase 4·NCT02532491·200 enrolled

A Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis

Completed·WWei Hao·Phase 4·NCT01822730·120 enrolled

Effectiveness of Second Generation Antipsychotics in First Episode Psychosis Patients: 3-year Follow-up

Unknown status·FFundación Marques de Valdecilla·Phase 4·NCT03090503·200 enrolled

A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis

Terminated·WWei Hao·Phase 4·NCT01813643·50 enrolled

62 more indications

Antipsychotics5 trials

Typical Versus Atypical Antipsychotics; Occupation of Striatal Receptors and the Appearance of Extrapyramidal Symptomatology, in Healthy Volunteers

Unknown status·HHospital Clinic of Barcelona·Phase 1·NCT01259973·24 enrolled

Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients

Completed·TTechnical University of Munich·Phase 4·NCT02307396·21 enrolled

Side Effects of Newer Antipsychotics in Older Adults

Completed·VVeterans Medical Research Foundation·Phase 4·NCT00245206·406 enrolled

Show 2 more trials

Antipsychotics and Risk of Hyperglycemic Emergencies

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02582736·725,489 enrolled

Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building

Unknown status·SShanghai Mental Health Center·Phase 4·NCT04446234·350 enrolled

Treatment Resistant Depression3 trials

Interpersonal Psychotherapy for Treatment Resistant Depression

Unknown status·HHospital de Clinicas de Porto Alegre·N/A·NCT01896349·74 enrolled

Use of Risperidone in ECT for Treatment Resistant Depression

Terminated·UUniversity of California, Los Angeles·Phase 4·NCT00203723·45 enrolled

Risperidone vs. Olanzapine as add-on Treatment in Treatment Resistant Depression

Completed·SSunnybrook Health Sciences Centre·Phase 1/2·NCT01282632·42 enrolled

Aggression3 trials

Haloperidol vs. Risperidone in the Treatment of Aggression in Psychotic Inmates

Terminated·UUniversity of Connecticut·N/A·NCT00203775

Risperidone Augmentation for Treatment-Resistant Aggression in ADHD

Completed·AArmenteros, Jorge L., M.D., P.A.·Phase 4·NCT00297739·25 enrolled

Treatment of Severe Childhood Aggression (The TOSCA Study)

Completed·MMichael Aman·Phase 4·NCT00796302·168 enrolled

Depression3 trials

Does Psilocybin Require Psychedelic Effects to Treat Depression?

Recruiting·CCentre for Addiction and Mental Health·Phase 2·NCT05710237·60 enrolled

Quetiapine Extended Release Depression Symptoms

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00640562·216 enrolled

A Study of Diagnosis and Treatment of Depression Based on Biological Evidence of Dopamine Reward Pathway

Unknown status·PPeking University·Phase 4·NCT03148509·300 enrolled

Alzheimer's Disease3 trials

Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone

Completed·—·Phase 4·NCT01119638·40 enrolled

Efficacy and Safety of Risperidone Compared With Placebo in the Treatment of Psychotic Symptoms in Patients With Alzheimer's Disease

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00034762·473 enrolled

Antipsychotic Discontinuation in Alzheimer's Disease

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00417482·180 enrolled

Agitation3 trials

Specific Interventions for Agitation in Alzheimer's Disease

Completed·UUS Department of Veterans Affairs·N/A·NCT00018291

Liquid Risperidone in the Treatment of Acute Agitation in Psychiatrically Hospitalized Children

Completed·SStony Brook University·Phase 4·NCT00790075·24 enrolled

A Comparison of Two Standard Therapies in the Management of Dementia With Agitation

Completed·EEmory University·Phase 4·NCT00208819·50 enrolled

Efficacy3 trials

Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetic/Efficacy

Completed·IIndivior Inc.·Phase 2·NCT01677377·45 enrolled

Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone

Completed·IIndivior Inc.·Phase 4·NCT03978832·69 enrolled

Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine

Withdrawn·UUniversity of New Mexico·Phase 4·NCT05890768

Medication3 trials

Early Phase II Trials for Cocaine Medication Development - 1

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00000317·31 enrolled

A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02462473·9 enrolled

A Research in Pharmacogenomics and Accurate Medication of Risperidone

Unknown status·CCui Yimin··NCT03302364·800 enrolled

Cocaine Dependence3 trials

Risperidone for Treatment of Cocaine Dependence in Outpatients - 12

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000347

Risperidone for the Treatment of Cocaine Dependence - 7

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000342

Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence

Completed·MMassachusetts General Hospital·Phase 2·NCT00385801·31 enrolled

Obsessive-Compulsive Disorder2 trials

Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)

Withdrawn·—·Phase 2·NCT05401019

Risperidone or Cognitive-Behavioral Therapy for Improving Medication Treatment for Obsessive-compulsive Disorder

Completed·NNew York State Psychiatric Institute·N/A·NCT00389493·100 enrolled

Aripiprazole2 trials

Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02634463·81 enrolled

Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI

Unknown status·UUniversity of British Columbia··NCT02334904·60 enrolled

Schizotypal Personality Disorder2 trials

Risperidone in the Treatment of Psychotic-like and Deficit Symptoms of Schizotypal Personality Disorder

Completed·IIcahn School of Medicine at Mount Sinai·N/A·NCT00158028·25 enrolled

Schizotypal Personality Disorder Risperidone

Completed·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 1/2·NCT02535156·21 enrolled

Pervasive Developmental Disorder2 trials

Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)

Completed·—·Phase 1·NCT00147394·100 enrolled

Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)

Completed·—·Phase 1/2·NCT00166595·100 enrolled

Cognition2 trials

Effects of Ketamine and Risperidone on Cognition

Completed·UUniversity of Manchester·Phase 4·NCT01140620·87 enrolled

The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients

Terminated·UUniversity of Zurich·N/A·NCT00629252·14 enrolled

Adolescent2 trials

Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents

Completed·WWashington University School of Medicine·Phase 3·NCT00057681·379 enrolled

Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

Unknown status·FFederal University of Rio Grande do Sul·N/A·NCT00825552·20 enrolled

Oral2 trials

Comparison of Applied Behavioral Analysis (ABA) Versus ABA and Risperidone

Completed·WWashington University School of Medicine·N/A·NCT00374764·60 enrolled

Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005

Completed·LLyndra Inc.·Phase 3·NCT05779241·83 enrolled

Hallucinations2 trials

Transcranial Direct Current Stimulation for Hallucinations in First-Episode Schizophrenia

Withdrawn·NNorthwell Health·N/A·NCT02661347

A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Patients With Hallucinations and Delusions Associated With Alzheimer's Disease

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00287742·33 enrolled

Dementia2 trials

Dementia Antipsychotics And Antidepressants Discontinuation Study

Completed·SSykehuset Innlandet HF·Phase 4·NCT00594269·149 enrolled

Treating Behavioral Disturbances in Individuals With Dementia

Completed·UUniversity of Pittsburgh·Phase 2·NCT00073658·137 enrolled

Bipolar I Disorder2 trials

A Study of the Effectiveness and Safety of Risperidone Compared With Placebo in the Treatment of Manic Episodes Associated With Bipolar I Disorder, and the Maintenance of Anti-manic Effectiveness of Risperidone Compared With Haloperidol

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00253162·439 enrolled

A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00249236·291 enrolled

Fed2 trials

Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01618760·48 enrolled

Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions

Completed· Teva logo

Teva·Phase 1·NCT00829894·24 enrolled

AIN2 trials

Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2

Terminated·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000310

Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1

Terminated·—·Phase 2·NCT00000309

Autism2 trials

Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)

Completed·MMedical University of South Carolina·Phase 4·NCT01333072·80 enrolled

Pharmacogenomics in Autism Treatment

Completed·UUniversity of California, San Francisco·Phase 2/3·NCT00584701·49 enrolled

Olanzapine2 trials

Glucose Regulation During Risperidone and Olanzapine Treatment

Unknown status·NNational Center for Research Resources (NCRR)·N/A·NCT00006195

The Effects of Risperidone and Olanzapine on Thinking

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00108368

Metabolism2 trials

Glucose and Lipid Metabolism on Antipsychotic Medication

Completed·WWashington University School of Medicine·N/A·NCT00515723·96 enrolled

Comparative Effects of Chronic Treatment With Olanzapine and Risperidone on Glucose and Lipid Metabolism

Completed·NNathan Kline Institute for Psychiatric Research·Phase 4·NCT00287820·46 enrolled

Clozapine1 trial

CLOZAPINE Response in Biotype-1

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT04580134·524 enrolled

Mental Disorders1 trial

Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana

Completed·UUniversity of Ghana Medical School·Phase 4·NCT02593734·139 enrolled

Imaging1 trial

Cerebellum-based Imaging Neural Markers for Antipsychotic Response

Recruiting·NNorthwell Health··NCT07483294·120 enrolled

Drug1 trial

An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

Completed·OOrganon and Co··NCT01498770·42 enrolled

Antidepressants1 trial

Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD

Completed·SSykehuset Innlandet HF·Phase 4·NCT00433121·24 enrolled

Developmental Delay1 trial

Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00065273·50 enrolled

Delirium1 trial

Efficacy and Safety of Risperidone and Trazodone Monotherapy and Combination Therapy in Critically Ill Patients With Delirium

Withdrawn·RRochester General Hospital·Phase 4·NCT02118688

TIPS1 trial

Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

Completed·NNorthwell Health·N/A·NCT00169988·8 enrolled

Magnetic Resonance Imaging1 trial

Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning

Unknown status·UUniversity of California, Irvine·Phase 4·NCT00937261·96 enrolled

Cognitive impairment1 trial

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

Completed· Astellas logo

Astellas·Phase 2·NCT03557931·233 enrolled

Double-blind1 trial

A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center, Phase II Study

Completed·BBioLineRx, Ltd.·Phase 2·NCT00567710·360 enrolled

Movement Disorder1 trial

Movement Disorders Caused by Antipsychotic Drugs in Older Patients

Completed·UUniversity of California, San Diego·Phase 1·NCT00255879·250 enrolled

Interaction1 trial

Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study

Completed·—·Phase 1·NCT02051387·74 enrolled

Maintenance Treatment1 trial

Atypical Antipsychotics for Continuation and Maintenance Treatment After an Acute Manic Episode

Completed·UUniversity of British Columbia·Phase 3·NCT01977300·159 enrolled

Tardive Dyskinesia1 trial

Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia

Completed·TTaoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan·Phase 4·NCT00621998·60 enrolled

Weight Gain1 trial

A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

Completed·CCorcept Therapeutics·Phase 1·NCT00698022·76 enrolled

Tourette syndrome1 trial

Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004393·50 enrolled

Acute1 trial

Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers

Completed·NNorthwell Health·N/A·NCT01931059·11 enrolled

Bipolar II Disorder1 trial

Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

Completed·MMassachusetts General Hospital·Phase 4·NCT00182013·106 enrolled

Irritability1 trial

A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01624675·39 enrolled

Disruptive Behavior Disorder1 trial

A Study of the Safety of Risperidone in the Treatment of Children and Adolescents With Conduct and Other Disruptive Behavior Disorders

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236470·232 enrolled

Effectiveness1 trial

Comparison of the Effectiveness of Brexpiprazole With That of Risperidone

Withdrawn· Lundbeck logo

Lundbeck·Phase 3·NCT02758067

Major Depressive Disorder1 trial

Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00095134·630 enrolled

Challenging Behavior1 trial

A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00254930·19 enrolled

Prospective1 trial

Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial

Completed·—·Phase 4·NCT00224315·24 enrolled

CAR1 trial

Risperidone LA Heathcare Resource Study

Completed·UUniversity of British Columbia·Phase 4·NCT00272597·30 enrolled

Cognitive Functions1 trial

Comparison of Cognitive Functions of Schizophrenic Patients Treated With Sertindole Versus Risperidone

Unknown status·SSheba Medical Center·Phase 4·NCT00480844·60 enrolled

Mood Disorder1 trial

Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Completed·UUniversity of Pittsburgh·Phase 4·NCT00177567·60 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT01222975·44 enrolled

Autism Spectrum Disorder1 trial

Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior

Completed·UUniversity of California, Los Angeles·Phase 2·NCT01171937·41 enrolled

Post-Traumatic Stress Disorder1 trial

Risperidone Treatment for Military Service Related Chronic Post Traumatic Stress Disorder

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00099983·296 enrolled

Generalized Anxiety Disorder1 trial

Study of Risperidone Monotherapy in Ambulatory Bipolar Disorder With Concurrent Moderately Severe Anxiety and Lifetime Panic or Generalized Anxiety Disorder

Completed·LLindner Center of HOPE·Phase 3·NCT00277654·111 enrolled

Growth1 trial

A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 4·NCT01050582·244 enrolled

TIA1 trial

Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00600756·798 enrolled

Cognitive Function1 trial

Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer

Completed·—··NCT01185418·80 enrolled

Single Ascending Dose1 trial

Single Ascending Dose Study of RBP-7000

Completed·IIndivior Inc.·Phase 1·NCT02768649·45 enrolled

Anxiety1 trial

the Effect of Formulation on Anxiety in Autist Childre A Randomized Controlled Trial Assesses Spirulina Syrup Plus Risperidone in Children With Non-idiopathic Autism. Anxiety is Measured Using the SCAS (Parent Version) Via Daily Online Surveys for One Week and Throughout a 3-month Follow-up Period.

Not yet recruiting·SShahid Sadoughi University of Medical Sciences and Health Services·N/A·NCT07060872·82 enrolled

Unspecified6 trials

Risperidone vs. Paroxetine for Panic Attacks

Terminated·—·Phase 2·NCT00206765·90 enrolled

Janssen Asperger's MRS (Magnetic Resonance Spectroscopy Risperidone Study

Completed·—·Phase 4·NCT00352196·23 enrolled

SPECT Study With SB-773812 In Schizophrenic Patients

Completed· GSK logo

GSK·Phase 1·NCT00269035·95 enrolled

Show 3 more trials

Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition

Completed·—·Phase 1·NCT01064232·30 enrolled

Bioequivalence Study of Risperidone Tablet 1 mg Under Fasting Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01722201·48 enrolled

Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT00856583·9,809 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 24, 1994

RISPERDAL

NDA NDA020272

Dec 22, 1994

RISPERDAL

NDA NDA020272

Apr 12, 1995

RISPERDAL

NDA NDA020272

Feb 28, 1996

RISPERDAL

NDA NDA020272

Mar 7, 1996

RISPERDAL

NDA NDA020272

Jun 10, 1996

RISPERDAL

NDA NDA020588

Jun 10, 1996

RISPERDAL

NDA NDA020588

Apr 15, 1997

RISPERDAL

NDA NDA020588

Oct 17, 1997

RISPERDAL

NDA NDA020588

Oct 17, 1997

RISPERDAL

NDA NDA020272

Apr 2, 1998

RISPERDAL

NDA NDA020272

May 13, 1998

RISPERDAL

NDA NDA020272

May 19, 1998

RISPERDAL

NDA NDA020588

Jun 3, 1998

RISPERDAL

NDA NDA020588

Oct 8, 1998

RISPERDAL

NDA NDA020588

Oct 26, 1998

RISPERDAL

NDA NDA020272

Jan 27, 1999

RISPERDAL

NDA NDA020272

May 10, 1999

RISPERDAL

NDA NDA020272

May 10, 1999

RISPERDAL

NDA NDA020272

Jul 2, 1999

RISPERDAL

NDA NDA020588

Jul 2, 1999

RISPERDAL

NDA NDA020272

Oct 27, 1999

RISPERDAL

NDA NDA020272

Jul 20, 2001

RISPERDAL

NDA NDA020272

Sep 28, 2001

RISPERDAL

NDA NDA020272

Oct 22, 2001

RISPERDAL

NDA NDA020588

Oct 22, 2001

RISPERDAL

NDA NDA020272

Mar 3, 2002

RISPERDAL

NDA NDA020272

Mar 3, 2002

RISPERDAL

NDA NDA020588

Jul 9, 2002

RISPERDAL

NDA NDA020272

Nov 19, 2002

RISPERDAL

NDA NDA020588

Nov 19, 2002

RISPERDAL

NDA NDA020272

Apr 2, 2003

RISPERDAL

NDA NDA021444

Apr 2, 2003

RISPERDAL

NDA NDA021444

Sep 10, 2003

RISPERDAL

NDA NDA021444

Sep 10, 2003

RISPERDAL

NDA NDA020272

Sep 10, 2003

RISPERDAL

NDA NDA020588

Oct 29, 2003

RISPERDAL

NDA NDA021444

Oct 29, 2003

RISPERDAL CONSTA

NDA NDA021346

Oct 29, 2003

RISPERDAL

NDA NDA020588

Oct 29, 2003

RISPERDAL

NDA NDA020272

Nov 21, 2003

RISPERDAL

NDA NDA021444

Nov 21, 2003

RISPERDAL

NDA NDA020272

Nov 21, 2003

RISPERDAL

NDA NDA020588

Dec 4, 2003

RISPERDAL

NDA NDA020272

Dec 4, 2003

RISPERDAL

NDA NDA020272

Dec 4, 2003

RISPERDAL

NDA NDA021444

Dec 4, 2003

RISPERDAL

NDA NDA020588

Dec 4, 2003

RISPERDAL

NDA NDA021444

Dec 4, 2003

RISPERDAL

NDA NDA020588

Dec 23, 2004

RISPERDAL

NDA NDA021444

Aug 17, 2005

RISPERDAL CONSTA

NDA NDA021346

Aug 17, 2005

RISPERDAL

NDA NDA021444

Aug 17, 2005

RISPERDAL

NDA NDA020588

Aug 17, 2005

RISPERDAL

NDA NDA020272

Jul 31, 2006

RISPERDAL CONSTA

NDA NDA021346

Sep 20, 2006

RISPERDAL CONSTA

NDA NDA021346

Oct 6, 2006

RISPERDAL

NDA NDA020272

Oct 6, 2006

RISPERDAL

NDA NDA021444

Oct 6, 2006

RISPERDAL

NDA NDA020272

Oct 6, 2006

RISPERDAL

NDA NDA021444

Oct 6, 2006

RISPERDAL

NDA NDA020588

Oct 6, 2006

RISPERDAL

NDA NDA020588

Oct 6, 2006

RISPERDAL

NDA NDA020588

Oct 20, 2006

RISPERDAL CONSTA

NDA NDA021346

Mar 9, 2007

RISPERDAL CONSTA

NDA NDA021346

Apr 12, 2007

RISPERDAL CONSTA

NDA NDA021346

Apr 12, 2007

RISPERDAL CONSTA

NDA NDA021346

Aug 22, 2007

RISPERDAL

NDA NDA021444

Aug 22, 2007

RISPERDAL

NDA NDA020588

Aug 22, 2007

RISPERDAL

NDA NDA021444

Aug 22, 2007

RISPERDAL

NDA NDA020272

Aug 22, 2007

RISPERDAL

NDA NDA020588

Aug 22, 2007

RISPERDAL

NDA NDA020272

Aug 14, 2008

RISPERDAL CONSTA

NDA NDA021346

Aug 14, 2008

RISPERDAL

NDA NDA021444

Aug 14, 2008

RISPERDAL

NDA NDA020272

Aug 14, 2008

RISPERDAL

NDA NDA020588

Oct 8, 2008

RISPERDAL CONSTA

NDA NDA021346

Oct 8, 2008

RISPERDAL CONSTA

NDA NDA021346

Oct 8, 2008

RISPERDAL CONSTA

NDA NDA021346

Oct 8, 2008

RISPERDAL CONSTA

NDA NDA021346

May 15, 2009

RISPERDAL CONSTA

NDA NDA021346

May 15, 2009

RISPERDAL CONSTA

NDA NDA021346

Jul 19, 2009

RISPERDAL

NDA NDA020272

Jul 19, 2009

RISPERDAL

NDA NDA021444

Jul 19, 2009

RISPERDAL CONSTA

NDA NDA021346

Jul 19, 2009

RISPERDAL

NDA NDA020588

Aug 30, 2010

RISPERDAL CONSTA

NDA NDA021346

Aug 30, 2010

RISPERDAL

NDA NDA020588

Aug 30, 2010

RISPERDAL

NDA NDA020588

Aug 30, 2010

RISPERDAL

NDA NDA020588

Aug 30, 2010

RISPERDAL

NDA NDA020588

Aug 30, 2010

RISPERDAL

NDA NDA021444

Aug 30, 2010

RISPERDAL

NDA NDA021444

Aug 30, 2010

RISPERDAL

NDA NDA021444

Aug 30, 2010

RISPERDAL

NDA NDA021444

Aug 30, 2010

RISPERDAL

NDA NDA020272

Aug 30, 2010

RISPERDAL

NDA NDA020272

Aug 30, 2010

RISPERDAL

NDA NDA020272

Aug 30, 2010

RISPERDAL

NDA NDA020272

Aug 30, 2010

RISPERDAL CONSTA

NDA NDA021346

Aug 30, 2010

RISPERDAL CONSTA

NDA NDA021346

Aug 30, 2010

RISPERDAL CONSTA

NDA NDA021346

Dec 1, 2010

RISPERDAL CONSTA

NDA NDA021346

Dec 1, 2010

RISPERDAL

NDA NDA020588

Dec 1, 2010

RISPERDAL

NDA NDA021444

Dec 1, 2010

RISPERDAL

NDA NDA020272

Jun 15, 2011

RISPERDAL

NDA NDA020272

Jun 15, 2011

RISPERDAL

NDA NDA021444

Jun 15, 2011

RISPERDAL CONSTA

NDA NDA021346

Jun 15, 2011

RISPERDAL

NDA NDA020588

Aug 24, 2011

RISPERDAL

NDA NDA020588

Aug 24, 2011

RISPERDAL CONSTA

NDA NDA021346

Aug 24, 2011

RISPERDAL

NDA NDA020272

Aug 24, 2011

RISPERDAL

NDA NDA021444

Sep 24, 2011

RISPERDAL CONSTA

NDA NDA021346

Sep 24, 2011

RISPERDAL

NDA NDA021444

Sep 24, 2011

RISPERDAL

NDA NDA020272

Sep 24, 2011

RISPERDAL

NDA NDA020588

Sep 24, 2011

RISPERDAL

NDA NDA020272

Sep 24, 2011

RISPERDAL

NDA NDA021444

Sep 24, 2011

RISPERDAL

NDA NDA020588

Sep 24, 2011

RISPERDAL CONSTA

NDA NDA021346

Dec 7, 2011

RISPERDAL CONSTA

NDA NDA021346

Dec 7, 2011

RISPERDAL CONSTA

NDA NDA021346

Mar 12, 2012

RISPERDAL

NDA NDA020588

Mar 12, 2012

RISPERDAL

NDA NDA021444

Mar 12, 2012

RISPERDAL CONSTA

NDA NDA021346

Mar 12, 2012

RISPERDAL

NDA NDA020272

Aug 2, 2012

RISPERDAL

NDA NDA020272

Aug 2, 2012

RISPERDAL

NDA NDA020588

Aug 2, 2012

RISPERDAL

NDA NDA021444

Feb 8, 2013

RISPERDAL

NDA NDA020272

Feb 26, 2013

RISPERDAL CONSTA

NDA NDA021346

Jun 13, 2013

RISPERDAL

NDA NDA020272

Jul 18, 2013

RISPERDAL CONSTA

NDA NDA021346

Oct 10, 2013

RISPERDAL CONSTA

NDA NDA021346

Oct 22, 2013

RISPERDAL CONSTA

NDA NDA021346

Apr 28, 2014

RISPERDAL

NDA NDA020588

Apr 28, 2014

RISPERDAL

NDA NDA020272

Apr 28, 2014

RISPERDAL

NDA NDA021444

Apr 28, 2014

RISPERDAL CONSTA

NDA NDA021346

Jun 5, 2014

RISPERDAL CONSTA

NDA NDA021346

Feb 9, 2016

RISPERDAL

NDA NDA020272

Mar 1, 2016

RISPERDAL

NDA NDA020272

Mar 1, 2016

RISPERDAL CONSTA

NDA NDA021346

Mar 1, 2016

RISPERDAL

NDA NDA020588

Mar 1, 2016

RISPERDAL

NDA NDA021444

Nov 18, 2016

RISPERDAL CONSTA

NDA NDA021346

Feb 23, 2017

RISPERDAL

NDA NDA020272

Feb 23, 2017

RISPERDAL CONSTA

NDA NDA021346

Feb 23, 2017

RISPERDAL

NDA NDA021444

Feb 23, 2017

RISPERDAL

NDA NDA020588

Apr 12, 2018

RISPERDAL CONSTA

NDA NDA021346

Jul 27, 2018

RISPERDAL

NDA NDA020272

Jul 27, 2018

RISPERDAL

NDA NDA021444

Jul 27, 2018

RISPERDAL CONSTA

NDA NDA021346

Jul 27, 2018

RISPERDAL

NDA NDA020588

Jul 27, 2018

PERSERIS KIT

NDA NDA210655

Jan 25, 2019

RISPERDAL CONSTA

NDA NDA021346

Jan 25, 2019

RISPERDAL

NDA NDA020588

Jan 25, 2019

RISPERDAL

NDA NDA020272

Jan 25, 2019

RISPERDAL

NDA NDA021444

Nov 22, 2019

RISPERDAL CONSTA

NDA NDA021346

Feb 5, 2020

RISPERDAL CONSTA

NDA NDA021346

Feb 5, 2020

RISPERDAL

NDA NDA021444

Feb 5, 2020

RISPERDAL

NDA NDA020588

Feb 5, 2020

RISPERDAL

NDA NDA020272

Jan 7, 2021

RISPERDAL CONSTA

NDA NDA021346

Feb 12, 2021

RISPERDAL

NDA NDA020272

Feb 12, 2021

RISPERDAL CONSTA

NDA NDA021346

Feb 12, 2021

RISPERDAL

NDA NDA020588

Feb 12, 2021

RISPERDAL

NDA NDA021444

Mar 11, 2022

RISPERDAL

NDA NDA020588

Dec 2, 2022

RISPERDAL

NDA NDA021444

Dec 2, 2022

RISPERDAL

NDA NDA020272

Jan 13, 2023

RYKINDO

NDA NDA212849

Apr 28, 2023

UZEDY

NDA NDA213586

Mar 29, 2024

RISVAN

NDA NDA214835

Jan 22, 2025

RISPERDAL

NDA NDA020272

Jan 22, 2025

RISPERDAL CONSTA

NDA NDA021346

Jan 22, 2025

RISPERDAL

NDA NDA020588

Jan 22, 2025

RISPERDAL

NDA NDA021444

Sources

References

[1]
ClinicalTrials.gov — 331 trial records for Risperidone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Risperdal drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Risperidone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Risperidone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020272). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Risperdal. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 2a (5-Ht2a) Receptor Antagonist; Serotonin 2c (5-Ht2c) Receptor Antagonist; Dopamine D2 Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWim Janssens

Patent Landscape[6]

Patent Cliff

Sep 26, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10406160Jun 26, 2026

9597402Sep 26, 2026

10058554Sep 26, 2026

11110093Nov 5, 2026

8741327Nov 12, 2027

30 more patents

8221778Nov 12, 2027

9186413Feb 13, 2028

10376590Feb 13, 2028

11712475Feb 13, 2028

11013809Feb 13, 2028

10010612Feb 13, 2028

9180197Feb 13, 2028

10463607May 31, 2031

11759416May 31, 2031

11752094May 31, 2031

10085936May 31, 2031

10881605May 31, 2031

10335366May 31, 2031

10058504May 31, 2031

11752092May 31, 2031

11241377May 31, 2031

11173110May 31, 2031

11007139May 31, 2031

10195138May 31, 2031

10182982May 31, 2031

11752093May 31, 2031

9446135Apr 10, 2032

11110094Apr 10, 2032

10406161Apr 10, 2032

9532991Apr 10, 2032

10098882Apr 10, 2032

9023897Apr 5, 2033

12128132Sep 11, 2040

12383493Sep 11, 2040

12329851Mar 17, 2042

Risperdal

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2030

Trials by Indication[1]

Schizophrenia64 trials

Schizoaffective Disorder13 trials

Treatment7 trials

Bipolar Disorder7 trials

Psychosis7 trials

Antipsychotics5 trials

Treatment Resistant Depression3 trials

Aggression3 trials

Depression3 trials

Alzheimer's Disease3 trials

Agitation3 trials

Efficacy3 trials

Medication3 trials

Cocaine Dependence3 trials

Obsessive-Compulsive Disorder2 trials

Aripiprazole2 trials

Schizotypal Personality Disorder2 trials

Pervasive Developmental Disorder2 trials

Cognition2 trials

Adolescent2 trials

Oral2 trials

Hallucinations2 trials

Dementia2 trials

Bipolar I Disorder2 trials

Fed2 trials

AIN2 trials

Autism2 trials

Olanzapine2 trials

Metabolism2 trials

Clozapine1 trial

Mental Disorders1 trial

Imaging1 trial

Drug1 trial

Antidepressants1 trial

Developmental Delay1 trial

Delirium1 trial

TIPS1 trial

Magnetic Resonance Imaging1 trial

Cognitive impairment1 trial

Double-blind1 trial

Movement Disorder1 trial

Interaction1 trial

Maintenance Treatment1 trial

Tardive Dyskinesia1 trial

Weight Gain1 trial

Tourette syndrome1 trial

Acute1 trial

Bipolar II Disorder1 trial

Irritability1 trial

Disruptive Behavior Disorder1 trial

Effectiveness1 trial

Major Depressive Disorder1 trial

Challenging Behavior1 trial

Prospective1 trial

CAR1 trial

Cognitive Functions1 trial

Mood Disorder1 trial

Fasting Conditions1 trial

Autism Spectrum Disorder1 trial

Post-Traumatic Stress Disorder1 trial

Generalized Anxiety Disorder1 trial

Growth1 trial

TIA1 trial

Cognitive Function1 trial

Single Ascending Dose1 trial

Anxiety1 trial

Unspecified6 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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