TheraRadar
Data updated: May 26, 2026

RISPERIDONE

CNS Approved 2008-06-30
Jump to: Indications Approvals Trials Competitors Safety Patents
42
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Discontinued
First Approved
2008-06-30
Routes
ORAL, INTRAMUSCULAR
Dosage Forms
TABLET, TABLET, ORALLY DISINTEGRATING, SOLUTION, POWDER

Companies

Apotex Sun Pharma JUBILANT CADISTA TORRENT PHARMS JUBILANT GENERICS NATCO PHARMA USA CHARTWELL MOLECULAR Novartis ANI PHARMS RISING Dr. Reddy's Teva PHARM ASSOC WATSON LABS RENATA Hikma TRIS PHARMA INC AMNEAL PHARMS IPCA LABS LTD HERITAGE PHARMA AVET CHARTWELL RX RANBAXY WOCKHARDT BIO AG LANNETT CO INC PRINSTON INC ZYDUS PHARMS USA INC AMNEAL SENORES PHARMS RATIOPHARM NOVITIUM PHARMA AJANTA PHARMA LTD ZYDUS PHARMS USA NANOMI PRECISION DOSE PH HEALTH SYNTHON PHARMS Aurobindo Pharma APOZEAL PHARMS SUN PHARMA CANADA
Active Ingredient: RISPERIDONE

RISPERIDONE Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1720 FDA actions from 2008 to 2026
May 2026 SUPPL
Label · Labeling
Nov 2025 SUPPL
Label · Labeling
Sep 2025 SUPPL
Label · Labeling

What RISPERIDONE Treats

42 FDA approvals

Originally approved for its first indication in 2008 . Covers 42 distinct patient populations.

  • Other (42)
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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

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

RISPERIDONE FDA Label Details

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RISPERDAL CONSTA

Full clinical data, patents, trials, and competitive landscape for risperidone.

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Data Sources

FDA Approval: ANDA077953 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.