drug
as of 2026-07-01Risperidone
risperidoneRisperidone + DesipramineRisperidone oral solutionRisperidone ISM® 100 mgRisperdal 4mg TabletRisperidone 2 mgRisperdalrisperidone, quetiapine
MeSH D018967UNII L6UH7ZF8HCRxCUI 104781, 104782, 104783, 104784, 199387, 211489FDA_ApplNo NDA020272SPL_set_id 7e117c7e-02fc-4343-92a1-230061dfc5e0FDA_sponsor JANSSEN PHARMSOrangeBook_Appl A076228, A076288, A076440, A076797, A076879, A076904, A076908, A076996
at a glance
small molecule · Atypical Antipsychotic [EPC]
US-approved (1993) as RISPERDAL
Orange Book protection to 2042
200 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
FDA class
Atypical Antipsychotic [EPC]
Mechanism of action
12.1 Mechanism of Action The mechanism of action of risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major metabolite, 9-hydroxyrisperidone (paliperidone) [see Clinical Pharmacology (12.3) ] . Antagonism at receptors other than D 2 and 5HT 2 may explain some of the other effects of risperidone [see Clinical Pharmacology (12.1) ] .
Indications
Labeled
SchizophreniaBipolar depressionBipolar maniaMajor depressive disorderIrritability/Autism
Investigational (via trials)
Patents & exclusivity
Orange Book
patent 12329851 · U-42142042-03-17
patent 12128132 · U-6012040-09-11
patent 12383493 · U-6012040-09-11
patent 90238972033-04-05
patent 9446135 · U-35132032-04-10
patent 10406161 · U-35132032-04-10
patent 10098882 · U-35132032-04-10
patent 9532991 · U-35132032-04-10
patent 111100942032-04-10
patent 108816052031-05-31
patent 100585042031-05-31
patent 104636072031-05-31
exclusivity NP2027-03-29
exclusivity CGT2026-05-12
exclusivity CGT2026-05-09
exclusivity NP2026-04-28
Adverse-event signal
FAERS spontaneous · within-drug share
Prolactin13.4%
top term: GYNAECOMASTIA
Weight Metabolic11.8%
top term: ABNORMAL WEIGHT GAIN
Eps Akathisia6.0%
top term: EXTRAPYRAMIDAL DISORDER
Sedation4.3%
top term: SOMNOLENCE
Mortality2.8%
top term: SUICIDE ATTEMPT
Gi2.5%
top term: NAUSEA
Qt Cardiac1.1%
top term: TACHYCARDIA
Nms0.9%
top term: NEUROLEPTIC MALIGNANT SYNDROME
Orthostatic0.8%
top term: HYPOTENSION
Anticholinergic0.6%
top term: CONSTIPATION
Hematologic0.4%
top term: NEUTROPENIA
Spontaneous reports — a signal of reporting share, not incidence.
Trials
200
Biomarkers to Enhance Early Schizophrenia Treatment
NCT06969755Phase 4Recruiting
Cerebellum-based Imaging Neural Markers for Antipsychotic Response
NCT07483294Phase 4Recruiting
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
NCT07565428Phase 3Recruiting
"Extended" (Alternate Day) Antipsychotic Dosing
NCT04478838Phase 4Recruiting
CLOZAPINE Response in Biotype-1
NCT04580134Phase 4Recruiting
A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder
NCT06878833Phase 3Withdrawn
Lumateperone for the Improvement of Apathy in Patients With Psychotic Symptoms.
NCT06482554Phase 3Recruiting
Effect of Curcumin Add-On Therapy on Quality of Life and IL-1β Levels in Patients With Schizophrenia
NCT07523256—Completed
Effect of Cognitive Behavioral Therapy on Auditory Hallucinations and NLR in Schizophrenia Patients
NCT07524868—Completed
Cognitive Behavioral Therapy Added to Risperidone for Schizophrenia
NCT07609953—Completed
Effect of Ashwagandha as Adjunct Therapy on BDNF and Cognitive Function in Schizophrenia Patients
NCT07541157—Completed
Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone
NCT07575516Phase 2Completed
Cannabidiol for Treatment of Non-affective Psychosis and Cannabis Use
NCT04105231Phase 2Active Not Recruiting
Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia
NCT06236451Phase 4Completed
Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia
NCT06276361Phase 1Completed
A Pilot Study of Adjunctive Structured Supportive Psychotherapy in Schizophrenia
NCT07671040—Completed
Non-interventional Study of Risperidone ISM® in Schizophrenia Patients Hospitalised Due to a Relapse
NCT05480046—Completed
Supportive Psychotherapy as Adjunct to Risperidone for Cognitive Function and Inflammation in Schizophrenia
NCT07477301Phase 2Completed
Adjunctive iTBS for First-Episode Schizophrenia
NCT07116850—Completed
Efficacy and Safety of Elpipodect (MK-8189) in Participants With an Acute Episode of Schizophrenia (MK-8189-008)
NCT04624243Phase 2Completed
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
NCT04940039Phase 4Completed
KF2022#3-trial: Effect of Tea and Cola Beverage on Absorption of Risperidone Oral Solution
NCT06218979Phase 1Completed
Relationship Between Efficacy of Lumateperone and Brain Glutamate and Dopamine
NCT05890768Phase 4Withdrawn
Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005
NCT05779241Phase 3Completed
KOLs & investigators
12
Christoph U. Correll, MDKOL score 96
Stefan Leucht, ProfessorKOL score 87
Suresh Durgam, MDKOL score 43
Leslie L Citrome, MD, MPHKOL score 32
Kimberly E Vanover, PhDKOL score 20
David P Walling, PhDKOL score 17
Ariel Graff-Guerrero, MD, PhDKOL score 15
Stephen R. Marder, MDKOL score 14
Benedicto Crespo-Facorro, ProfessorKOL score 12
Gary Remington, MD PhD FRCPCKOL score 12
Robert Litman, MDKOL score 9
Robert C. Smith, MD, PhDKOL score 9
Facts & assertions
29 sourced
Anda Generic Count
202
Boxed Warning
present
Dosing Frequency
see label
Faers Share Anticholinergic
0.006
Faers Share Eps Akathisia
0.06
Faers Share Gi
0.025
Faers Share Hematologic
0.004
Faers Share Mortality
0.028
Faers Share Nms
0.009
Faers Share Orthostatic
0.008
Faers Share Prolactin
0.134
Faers Share Qt Cardiac
0.011
Faers Share Sedation
0.043
Faers Share Weight Metabolic
0.119
Fda Pharm Class Epc
Atypical Antipsychotic [EPC]
Has Generic Competition
yes
Latest Exclusivity Expiry
2027-03-29
Latest Patent Expiry
2042-03-17
Latest Protection Date
2042-03-17
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism. The clinical effect from risperidone resu
Originator Company
Janssen Pharms
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Sedation Somnolence
present in label
Safety Weight Metabolic
present in label
Us Approved
yes
Us Original Approval Date
1993-12-29
relationships
The graph out of here
developer
trial
trial
indication
indication
indication
indication
indication
KOL
Christoph U. Correll, MD
personKOL score 96
Stefan Leucht, Professor
personKOL score 87
Suresh Durgam, MD
personKOL score 43
Leslie L Citrome, MD, MPH
personKOL score 32