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Drug

Risperidone

Approved · FDA / EMA
ClassSerotonin 2a (5-HT2a) receptor antagonistEmerging researchLate-stage developmentCooling momentum
Also known as Perseris, RisperDAL, Rykindo, Uzedy+4 more

Perseris, RisperDAL, Rykindo, Uzedy, Risperidona, Rispéridone, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-2-methyl-4H-pyrido(1,2-A)pyrimidin-4-one, Risperidonum.

13
Research papers
9
Active clinical trials
3
Protein targets
53
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Risperidone vs Cariprazine in Acute Mania a Head to Head Comparison of Efficacy vs Tolerability

Clinical trial2026-06-24Results expected Q2 2028 · ClinicalTrials.gov

Cerebellar-cortical Circuitry and Prediction of Treatment Response in Early Psychosis

Clinical trial2026-05-26Results expected Q4 2029 · ClinicalTrials.gov

Effectiveness of Switching Antipsychotic Medications

Clinical trial2026-05-15Results posted · ClinicalTrials.gov

Relapse risk after discontinuation of risperidone in Alzheimer's disease.

Research2012-10-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Risperidone
Aliases & brands
PerserisRisperDALRykindoUzedyRisperidonaRispéridone3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-2-methyl-4H-pyrido(1,2-A)pyrimidin-4-oneRisperidonum
RxNorm CUI
35636
ChEMBL ID
CHEMBL85
ATC codes
N05AX08
UNII
L6UH7ZF8HC
Primary mechanism
Serotonin 2a (5-HT2a) receptor antagonist
Regulatory jurisdictions
fdaema

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

ANTAGONISTSerotonin 2a (5-HT2a) receptor antagonist
ANTAGONISTSerotonin 2c (5-HT2c) receptor antagonist
ANTAGONISTDopamine D2 receptor antagonist

Regulatory timeline

53 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2008-10-30
Latest approval
2022-02-14
Authorities
FDA · EMA
Total events
53
fdaU.S. Food and Drug Administration· 52 events
2026-07-01Label change
Label change: RISPERIDONE (ANDA076996)
Evidence ↗
2026-06-08Label change
Label change: RISPERIDONE (ANDA077494)
Evidence ↗
2025-11-04Label change
Label change: RISPERIDONE (ANDA091384)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2022-02-14Approval
Approval: Okedi (EMA)

Indication: Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

192 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
192
registered trials across all phases
LATEST COMPLETION 2026
9
Active studies
8
Recruiting
147
Late-stage (III+)
145
Completed
38
Discontinued
PHASE DISTRIBUTIONn = 192
Early Phase 12Phase 117Phase 1 / 23Phase 223Phase 2 / 34Phase 347Phase 465Phase N / A31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

13 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992024
Most influential
Recent papers
Major research themes8
Schizophrenia2Antipsychotic Agents1Cognitive Behavioral Therapy1Phosphoric Diester Hydrolases1Pyrimidines1Risperidone1Schizophrenic Psychology1Suicide Prevention1
Journals, researchers & institutions
Top journals
  • Journal of the American Academy of Child and Adolescent Psychiatry2
  • The New England journal of medicine2
  • Acta psychiatrica Scandinavica1
  • European archives of psychiatry and clinical neuroscience1
  • European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology1
  • International clinical psychopharmacology1
Leading researchers
  • Mittoux A4
  • Peuskens J4
  • Lieberman JA3
  • Tanghøj P3
  • Crocq MA2
  • Everitt B2
  • Findling RL2
  • Frazier JA2
Leading institutions
free-text, unnormalised
  • Case Western Reserve University.1
  • Centre Hospitalier1
  • College of Physicians and Surgeons1
  • Columbia University1
  • Drs. McClellan and Hlastala are with the University of Washington1
  • General Hospital Middelheim1

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Risperidone, with 3 overlapping disease areas.

3 shared targets3 shared diseases1 shared paper

Acts on the same molecular target as Risperidone, with 3 overlapping disease areas.

3 shared targets3 shared diseases1 shared paper

Acts on the same molecular target as Risperidone, with 3 overlapping disease areas.

Shared target3 shared diseases1 shared paper

Studied across 3 of the same disease areas as Risperidone in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.