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 49 indications[4].[1]
Risperdal is one of 705 small molecule programs targeting Asperger syndrome. It is currently in Approved.
49
Indications
329
Total Trials
8
Active Trials
704
Competitors
8
FDA Applications
NDA/BLA/ANDA regulatory filings
35
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 48 indications
Competition
Competitive Landscape
583 competitors in Schizophrenia
#DrugCompanyPhaseTrials
1Risperdal
WWim Janssens
Approved
Celexa
AbbViePreclinical
Ozempic
Novo NordiskPreclinical
Resotran
TakedaPreclinical
Inapsine
Alnylam PharmaceuticalsPreclinical
Zocor
OOrganon and Co
Preclinical
Depakote
AbbViePreclinical
Ibrance
PfizerPreclinical
Lunesta
Akero TherapeuticsPreclinical
Luvox
SSolvay Pharmaceuticals
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Schizophrenia64 trials
Show 61 more trials
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.·Phase 3·NCT00236587·100 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236587·100 enrolledStudy of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia
Completed·—·Phase 4·NCT03075657·120 enrolled
A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia
Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00645515·240 enrolled
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
Completed·Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00246285·381 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00246285·381 enrolled
Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder
Completed·—·Phase 4·NCT00130923·95 enrolled
First Episode Schizophrenia and Cannabis-Related Disorder Study
Completed·—·N/A·NCT00573287·14 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
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
Metabolic Profile and Anthropometric Changes in Schizophrenia
Completed·—·N/A·NCT00534183·2,006 enrolled
Treatment10 trials
Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma
Completed·—·Phase 4·NCT00208182·20 enrolled
Show 7 more trials
A Single-Blind Trial of Risperidone vs. Paroxetine for Treatment of Panic Attacks
Completed·—·N/A·NCT00457106·90 enrolled
Bipolar Disorder9 trials
Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
Completed·Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00076115·13 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00076115·13 enrolledShow 6 more trials
Placebo Controlled Trial of Valproate and Risperidone in Young Children With Bipolar Disorders
Completed·—·Phase 3·NCT00221403·46 enrolled
Schizoaffective Disorder8 trials
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.·Phase 3·NCT00236548·1 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236548·1 enrolled
Show 5 more trials
Psychosis6 trials
Antipsychotic to Treat Psychosis Syndrome
Unknown status·—·N/A·NCT02137616·300 enrolled
67 more indications
Dementia4 trials
Antipsychotics4 trials
Antipsychotics and Risk of Hyperglycemic Emergencies
Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02582736·725,489 enrolled
Show 1 more trial
Bipolar I Disorder4 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.·Phase 3·NCT00253162·439 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00253162·439 enrolledAdolescent3 trials
Pervasive Developmental Disorder3 trials
Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)
Completed·—·Phase 1/2·NCT00166595·100 enrolled
Depression3 trials
Fed3 trials
Treatment Resistant Depression3 trials
Cognition3 trials
Hallucinations2 trials
TIPS2 trials
Borderline personality disorder2 trials
Oral2 trials
Pediatric2 trials
Long-term Antipsychotic Pediatric Safety Trial
Completed·—··NCT03522168·509 enrolled
Tics2 trials
Cocaine Dependence2 trials
Efficacy2 trials
Autism2 trials
Agitation2 trials
Anxiety2 trials
Psilocybin2 trials
Cognitive Functions1 trial
Trial1 trial
Mental Disorders1 trial
Single Dose1 trial
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
Effectiveness1 trial
Transcranial Magnetic Stimulation1 trial
Opioids1 trial
Reducing the Abuse Liability of Prescription Opioids
Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT04587115·15 enrolled
Disruptive Behavior Disorder1 trial
Olanzapine1 trial
Tardive Dyskinesia1 trial
Weight Gain1 trial
Challenging Behavior1 trial
Conduct Disorder1 trial
Absorption1 trial
Fasting Conditions1 trial
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
Completed·—·Phase 1·NCT01155921·36 enrolled
Apathy1 trial
Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
Recruiting·LLouisiana State University Health Sciences Center Shreveport·Phase 3·NCT06482554·80 enrolled
Labor1 trial
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
Completed·—·Phase 1·NCT01155934·36 enrolled
Memory1 trial
Generalized Anxiety Disorder1 trial
Adult Subject1 trial
Safety and Efficacy1 trial
Antidepressants1 trial
Schizotypal Personality Disorder1 trial
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
Delirium1 trial
Magnetic Resonance Imaging1 trial
Obsessive-Compulsive Disorder1 trial
Interaction1 trial
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study
Completed·—·Phase 1·NCT02051387·74 enrolled
Cognitive impairment1 trial
Maintenance Treatment1 trial
Tourette syndrome1 trial
Alzheimer's Disease1 trial
Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone
Completed·—·Phase 4·NCT01119638·40 enrolled
Double-blind1 trial
AIN1 trial
Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1
Terminated·—·Phase 2·NCT00000309
Lip1 trial
Different Safety Profile of Risperidone and Paliperidone Extended-release
Completed·—·Phase 4·NCT01284959·34 enrolled
Unspecified3 trials
Janssen Asperger's MRS (Magnetic Resonance Spectroscopy Risperidone Study
Completed·—·Phase 4·NCT00352196·23 enrolled
Risperidone vs. Paroxetine for Panic Attacks
Terminated·—·Phase 2·NCT00206765·90 enrolled
Regulatory
FDA Approval Timeline[5]
Jun 10, 1996
RISPERDAL
NDA NDA020588
May 10, 1999
RISPERDAL
NDA NDA020272
Apr 2, 2003
RISPERDAL
NDA NDA021444
Apr 12, 2007
RISPERDAL CONSTA
NDA NDA021346
Jul 27, 2018
PERSERIS KIT
NDA NDA210655
Jan 13, 2023
RYKINDO
NDA NDA212849
Apr 28, 2023
UZEDY
NDA NDA213586
Mar 29, 2024
RISVAN
NDA NDA214835
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Risperdal drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Risperidone. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
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
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10085936May 31, 2031
10881605May 31, 2031
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10058504May 31, 2031
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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