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risperidone

Trade name: risperdal

Small moleculeapproved

Approved

Dec 29, 1993

Risperidone, a benzisoxazole derivative, is an atypical antipsychotic drug with high affinity for 5-hydrotryptamine (5-HT) and dopamine D2 receptors. It is FDA approved for the treatment of schizophrenia, bipolar mania, irritability associated with autistic disorder. Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone. Vice versa, Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors increase plasma concentrations of risperidone. Common adverse reactions include increased mortality in elderly patients with dementia-related psychosis, cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, tardive dyskinesia , metabolic Changes (hyperglycemia and diabetes mellitus, dyslipidemia, weight gain), hyperprolactinemia, orthostatic hypotension, leukopenia, neutropenia, agranulocytosis, potential for cognitive and motor impairment, seizures, dysphagia, priapism, disruption of body temperature regulation. — NCATS

Clinical trial activity

444 trials · 272 clinical orgs · 42 marketing orgs

Phase 1
62
Phase 2
170
Phase 3
114
Phase 4
156

Earliest trial started Aug 1, 1994 (NCT00000309)

Timeline

1990s

  1. Dec 29, 1993

    Johnson and Johnson — Earliest FDA Approval

  2. Dec 29, 1993

    Johnson and Johnson — NDA Secondary Org

  3. Dec 29, 1993

    Johnson and Johnson — NDA Organization

  4. Jan 1, 1994

    Earliest Phase 2 Sponsor(trial)

  5. Jan 1, 1995

    Johnson and Johnson — Earliest Phase 3 Sponsor(trial)

  6. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Aug 3, 2006

    Ranbaxy — Marketing Organization

  2. Jun 30, 2008

    Teva — Marketing Organization

  3. Jun 30, 2008

    Heritage Pharma — Marketing Organization

  4. Sep 15, 2008

    Apotex — Marketing Organization

  5. Sep 15, 2008

    Mylan — Marketing Organization

  6. Sep 15, 2008

    Dash Pharms — Marketing Organization

  7. Oct 8, 2008

    Ceyone Life Sciences — Marketing Organization

  8. Oct 8, 2008

    Rising Pharmaceuticals — Marketing Organization

  9. Oct 9, 2008

    Wockhardt — Marketing Organization

  10. Oct 9, 2008

    Celltrion — Marketing Organization

  11. Oct 16, 2008

    Pliva — Marketing Organization

  12. Oct 24, 2008

    Dr. Reddy's Laboratories — Marketing Organization

  13. Dec 5, 2008

    Watson Pharmaceuticals — Marketing Organization

  14. Dec 29, 2008

    Renata — Marketing Organization

  15. Jan 30, 2009

    Ani Pharmaceuticals — Marketing Organization

  16. Mar 23, 2009

    Jubilant Innovation Ltd. — Marketing Organization

  17. Apr 30, 2009

    Par Pharmaceuticals — Marketing Organization

  18. May 1, 2009

    Zydus Discovery DMCC — Marketing Organization

  19. May 29, 2009

    West-Ward Pharmaceutical — Marketing Organization

  20. Jun 17, 2009

    Oxford Pharmaceuticals — Marketing Organization

  21. Jul 29, 2009

    Torrent Pharmaceuticals Limited — Marketing Organization

  22. Jul 29, 2009

    Hikma — Marketing Organization

  23. Jul 29, 2009

    Pharmaceutical Associates — Marketing Organization

  24. Sep 4, 2009

    Aurobindo Pharma — Marketing Organization

  25. Oct 8, 2009

    Atlantide Pharmaceuticals — Marketing Organization

  26. Oct 16, 2009

    Sandoz — Marketing Organization

  27. Oct 16, 2009

    Novartis — Marketing Organization

  28. Oct 22, 2009

    Byondis — Marketing Organization

2010s

  1. Jun 8, 2010

    Ratiopharm — Marketing Organization

  2. Jun 28, 2010

    Precision Dose — Marketing Organization

  3. Dec 3, 2010

    Lannett Company, Inc. — Marketing Organization

  4. Feb 7, 2011

    Taro Pharmaceuticals — Marketing Organization

  5. Apr 19, 2011

    Actavis — Marketing Organization

  6. May 18, 2011

    Chartwell Pharmaceuticals — Marketing Organization

  7. May 25, 2011

    Amneal Pharmaceuticals — Marketing Organization

  8. Aug 24, 2011

    Ajanta Pharma Ltd — Marketing Organization

  9. Nov 29, 2011

    Prinston Inc — Marketing Organization

  10. Dec 12, 2012

    Tris Pharma, Inc. — Marketing Organization

  11. Mar 10, 2014

    Sun Pharmaceuticals — Marketing Organization

  12. Jul 27, 2018

    Indivior Inc. — NDA Secondary Org

  13. Jul 27, 2018

    Indivior Inc. — Marketing Organization

2020s

  1. Jan 13, 2023

    Luye Pharma — Marketing Organization

  2. Jan 13, 2023

    Luye Pharma — NDA Secondary Org

  3. Apr 28, 2023

    Teva — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 29, 1993

Chemistry & pharmacology

Loading structure…

SMILES

CC1=C(CCN2CCC(CC2)C3=NOC4=C3C=CC(F)=C4)C(=O)N5CCCCC5=N1
Mol. weight
410.4845 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • espidone
  • ly03004
  • r 64,766
  • r-64766
  • r-64766
  • r-64-766
  • r-64-766
  • rcn3028
  • ripedon
  • riperidone
  • rispadal
  • risperdal
  • risperdal
  • risperdal
  • risperdal
  • risperdal consta
  • risperdal consta
  • risperdal consta long acting
  • risperdal m
  • risperdal m-tab
  • risperdal m-tab
  • risperdal quicklet
  • risperdone
  • risperdone
  • risperidal
  • risperidona
  • risperidona
  • risperidone
  • risperidone
  • risperidone
  • risperidone
  • risperidone
  • risperidone
  • risperidone
  • risperidone
  • risperidone
  • risperidone
  • risperidone
  • risperidonum
  • risperidonum
  • risperin
  • risperin
  • rispolept
  • rispolept
  • rispolin
  • rispolin
  • sequinan
  • sequinan

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06969755Phase 4Jul 30, 2025National Institute of Mental Health (NIMH), Northwell Health
NCT07060872N/AJul 7, 2025Shahid Sadoughi University of Medical Science
NCT06878833Phase 3Apr 18, 2025Lyndra Inc.
NCT06512220Phase 2Aug 31, 2024University of Toronto
NCT06482554Phase 3Jun 30, 2024Louisiana State University
NCT06236451Phase 4Apr 5, 2024All India Institute of Medical Sciences
NCT06368726Phase 1Apr 1, 2024Fundacion para la Salud Materno Infantil, Spanish Foundation for Neurometrics Development
NCT07116850N/AJan 1, 2024Hebei University
NCT06218979Phase 1Dec 4, 2023University of Helsinki
NCT06276361Phase 1Sep 26, 2023Rovi Pharmaceuticals Laboratories
NCT05710237Phase 2Jul 1, 2023University of Toronto
NCT05868720N/AJul 1, 2023All India Institute of Medical Sciences
NCT05890768Phase 4May 11, 2023University of New Mexico
NCT05779241Phase 3Apr 30, 2023Lyndra Inc.
NCT05542264Phase 1Nov 15, 2022Sunovion
NCT05401019Phase 2Jun 30, 2022Clinical Academic Center, 2CA-Braga, Portugal, University of Minho
NCT05402111Phase 1Jun 13, 2022Sunovion
NCT05146245Phase 4Dec 1, 2021Erasmus University Rotterdam, Stichting de Merel, ZonMw: The Netherlands Organisation for Health Research and Development
NCT04903353Phase 4Nov 1, 2021Vanderbilt University
NCT05039489N/ASep 6, 2021Central South University
Showing 20 of 444 trials
Page 1 / 23

Organizations

Research & Development (272)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Johnson and JohnsonFor profit1029351995
Janssen Pharmaceutica NVFor profit87051995
National Institute of Mental Health (NIMH)Government38651997
Northwell HealthAcademic/Hospital151421998
AstraZenecaFor profit12942001
Department of Veteran AffairsGovernment11641994
OtsukaFor profit11732004
PfizerFor profit10832001
Eli LillyFor profit9732001
Harvard UniversityAcademic/Hospital9631998
Jiao Tong UniversityAcademic/Hospital9442005
Central South UniversityAcademic/Hospital8622003
Columbia UniversityAcademic/Hospital8331995
National Institute on Drug Abuse (NIDA)Government8621994
National Institutes of Health (NIH)Government8131997
Rovi Pharmaceuticals LaboratoriesFor profit8832011
University of California, Los AngelesAcademic/Hospital8731997
University of TorontoAcademic/Hospital8742002
Washington University in St. LouisAcademic/Hospital8732000
Indivior Inc.For profit7742010
272 organizations
Page 1 / 14

Marketing (57)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGApr 19, 2011
Ajanta Pharma LtdFor profitMKTGAug 24, 2011
Amneal PharmaceuticalsFor profitMKTGMay 25, 2011
Amneal PharmaceuticalsFor profitSYNJun 17, 2009
Ani PharmaceuticalsFor profitMKTGJan 30, 2009
Ani PharmaceuticalsFor profitSYNJan 30, 2009
ApotexFor profitMKTGSep 15, 2008
Atlantide PharmaceuticalsFor profitMKTGOct 8, 2009
Aurobindo PharmaFor profitMKTGSep 4, 2009
ByondisFor profitMKTGOct 22, 2009
CelltrionFor profitMKTGOct 9, 2008
Ceyone Life SciencesFor profitMKTGOct 8, 2008
Chartwell PharmaceuticalsFor profitMKTGMay 18, 2011
Chartwell PharmaceuticalsFor profitSYNMar 12, 2012
Dash PharmsFor profitMKTGSep 15, 2008
Dr. Reddy's LaboratoriesFor profitMKTGOct 24, 2008
Heritage PharmaFor profitSYNJun 30, 2008
Heritage PharmaFor profitMKTGJun 30, 2008
HikmaFor profitMKTGJul 29, 2009
HikmaFor profitSYNJul 29, 2009
Indivior Inc.For profitNDA2Jul 27, 2018
Indivior Inc.For profitMKTGJul 27, 2018
Johnson and JohnsonFor profitNDA2Dec 29, 1993
Johnson and JohnsonFor profitNDADec 29, 1993
Jubilant Innovation Ltd.For profitMKTGMar 23, 2009
Jubilant Innovation Ltd.For profitSYNNov 4, 2011
Lannett Company, Inc.For profitMKTGDec 3, 2010
Luye PharmaFor profitMKTGJan 13, 2023
Luye PharmaFor profitNDA2Jan 13, 2023
MylanFor profitMKTGSep 15, 2008
MylanFor profitSYNMar 30, 2011
NovartisFor profitMKTGOct 16, 2009
Oxford PharmaceuticalsFor profitMKTGJun 17, 2009
Par PharmaceuticalsFor profitMKTGApr 30, 2009
Pharmaceutical AssociatesFor profitMKTGJul 29, 2009
PlivaFor profitMKTGOct 16, 2008
Precision DoseFor profitMKTGJun 28, 2010
Prinston IncFor profitMKTGNov 29, 2011
RanbaxyFor profitMKTGAug 3, 2006
RatiopharmFor profitMKTGJun 8, 2010
RenataFor profitMKTGDec 29, 2008
Rising PharmaceuticalsFor profitMKTGOct 8, 2008
SandozFor profitMKTGOct 16, 2009
Sun PharmaceuticalsFor profitMKTGMar 10, 2014
Sun PharmaceuticalsFor profitSYNAug 6, 2010
Taro PharmaceuticalsFor profitMKTGFeb 7, 2011
TevaFor profitMKTGJun 30, 2008
TevaFor profitNDA2Apr 28, 2023
Torrent Pharmaceuticals LimitedFor profitMKTGJul 29, 2009
Torrent Pharmaceuticals LimitedFor profitSYNOct 30, 2008
Tris Pharma, Inc.For profitMKTGDec 12, 2012
Watson PharmaceuticalsFor profitMKTGDec 5, 2008
West-Ward PharmaceuticalFor profitMKTGMay 29, 2009
West-Ward PharmaceuticalFor profitSYNJul 29, 2009
WockhardtFor profitMKTGOct 9, 2008
Zydus Discovery DMCCFor profitMKTGMay 1, 2009
Zydus Discovery DMCCFor profitSYNOct 16, 2008