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prucalopride succinate

Trade name: Motegrity

Small moleculeapproved

Approved

Dec 14, 2018

Prucalopride is a novel enterokinetic compound and is the first representative of the benzofuran class. Prucalopride is a potent, selective and specific serotonin 5-HT4 receptor (5-HT4-R) agonist. Prucalopride (Resolor®), a highly selective serotonin 5-HT4 receptor agonist, is indicated in the European Economic Area for the treatment of adults with chronic idiopathic constipation (CIC) in whom laxatives have failed to provide adequate relief. — NCATS

Clinical trial activity

66 trials · 54 clinical orgs · 19 marketing orgs

Phase 1
15
Phase 2
34
Phase 3
22
Phase 4
11

Earliest trial started Dec 1, 1994 (NCT00576511)

Timeline

1990s

  1. Jan 1, 1994

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Dec 14, 2018

    Shire — Earliest FDA Approval

  2. Dec 14, 2018

    Shire — NDA Secondary Org

  3. Dec 14, 2018

    Shire — NDA Organization

  4. Dec 14, 2018

    Takeda — Marketing Organization

  5. Dec 14, 2018

    Takeda — NDA Secondary Org

2020s

  1. Dec 26, 2024

    Novitium Pharma — Marketing Organization

  2. Mar 17, 2025

    Teva — Marketing Organization

  3. Jun 24, 2025

    Alkem Labs Ltd — Marketing Organization

  4. Jun 24, 2025

    Amneal Pharmaceuticals — Marketing Organization

  5. Jun 24, 2025

    Annora Pharma — Marketing Organization

  6. Jun 24, 2025

    Apotex — Marketing Organization

  7. Jun 24, 2025

    Appco Pharma — Marketing Organization

  8. Jun 24, 2025

    H2-PHARMA — Marketing Organization

  9. Jun 24, 2025

    Hikma — Marketing Organization

  10. Jun 24, 2025

    Lupin — Marketing Organization

  11. Jun 24, 2025

    MSN Laboratories — Marketing Organization

  12. Jun 24, 2025

    Somerset Therapeutics LLC — Marketing Organization

  13. Jun 24, 2025

    Specgx Llc — Marketing Organization

  14. Jun 24, 2025

    Torrent Pharmaceuticals Limited — Marketing Organization

  15. Jun 24, 2025

    ZENARA — Marketing Organization

  16. Aug 7, 2025

    Zydus Discovery DMCC — Marketing Organization

  17. Jan 16, 2026

    Ajanta Pharma Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 14, 2018

Chemistry & pharmacology

Loading structure…

SMILES

COCCCN1CCC(NC(=O)c2cc(Cl)c(N)c3c2OCC3)CC1
Mol. weight
367.88 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • prucalopride
  • prucalopride
  • prucalopride
  • prucalopride
  • prucalopride
  • prucalopride
  • prucalopride
  • prucalopride
  • prucalopride succinate
  • prucalopride succinate
  • prucalopride succinate
  • prucalopride succinate
  • prucalopride succinate
  • prucalopride succinate
  • prucalopride succinate
  • prucalopride succinate
  • r093877
  • r093877
  • r 093877
  • r-093877
  • r-093877
  • r-108512
  • r-108512
  • resolor
  • resolor
  • resolor
  • resolor
  • resolor
  • resotran
  • resotrans

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07127237Early Phase 1 (Phase 1)Sep 30, 2025Hospital de Clínicas Dr. Manuel Quintela
NCT06816407Phase 3Mar 2, 2025Future University in Egypt
NCT06474286N/ANov 15, 2024National Institutes of Health (NIH), University of Pittsburgh
NCT06680882Phase 2Nov 7, 2024Anhui Medical University
NCT06883175N/ASep 1, 2024Northwestern University
NCT05726097Phase 3Feb 1, 2023Lund University, Region Skane, University of Southern Denmark
NCT05455359Phase 4Jul 18, 2022Harvard University
NCT05496179Phase 1/Phase 2 (Phase 2)Mar 7, 2022Ain Shams University, Future University in Egypt
NCT05966246N/AJan 25, 2022Yonsei University
NCT05377619Phase 1/Phase 2 (Phase 2)Jan 6, 2022Universidade de Passo Fundo
NCT05220228Early Phase 1 (Phase 1)Jan 4, 2022University of Oxford
NCT05001763Phase 2Sep 1, 2021Nanjing University
NCT04985669Phase 4Aug 15, 2021Bangladesh Medical University
NCT04759833Phase 3Aug 2, 2021Takeda
NCT04757493Phase 2/Phase 3 (Phase 3)Mar 10, 2021Bangladesh Medical University
NCT03676374Phase 4Oct 10, 2018Katholieke Universiteit Leuven
NCT03572790N/AJun 30, 2018University of Oxford
NCT03244553Phase 2Oct 20, 2017University of Calgary
NCT04190173Phase 3Jul 1, 2017Prince of Songkla University
NCT03863366N/AFeb 7, 2017University of Oxford
Showing 20 of 66 trials
Page 1 / 4

Organizations

Research & Development (54)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MovetisFor profit242331994
Katholieke Universiteit LeuvenAcademic/Hospital7531994
ShireFor profit6632010
Harvard UniversityAcademic/Hospital3121998
University of OxfordAcademic/Hospital3322017
Bangladesh Medical UniversityAcademic/Hospital2222021
Future University in EgyptAcademic/Hospital2122022
Janssen Pharmaceutica NVFor profit2012013
Johnson and JohnsonFor profit2222010
Mayo ClinicAcademic/Hospital2011998
Queen's University, BelfastAcademic/Hospital2212012
University of CalgaryAcademic/Hospital2222014
University of LondonAcademic/Hospital2021997
University of ParisAcademic/Hospital2012012
Yuhan Pharmaceutical CompanyFor profit2222013
Ain Shams UniversityAcademic/Hospital1112022
Anhui Medical UniversityAcademic/Hospital1112024
Binzhou Medical UniversityAcademic/Hospital1012016
Centre Universitaire de SanteAcademic/Hospital1011998
China Academy of Chinese Medical SciencesAcademic/Hospital1112014
54 organizations
Page 1 / 3

Marketing (22)

OrganizationOrg typeRelationshipDate
Ajanta Pharma LtdFor profitMKTGJan 16, 2026
Alkem Labs LtdFor profitMKTGJun 24, 2025
Amneal PharmaceuticalsFor profitMKTGJun 24, 2025
Annora PharmaFor profitMKTGJun 24, 2025
ApotexFor profitMKTGJun 24, 2025
Appco PharmaFor profitMKTGJun 24, 2025
H2-PHARMAFor profitMKTGJun 24, 2025
HikmaFor profitMKTGJun 24, 2025
LupinFor profitMKTGJun 24, 2025
LupinFor profitSYNJun 24, 2025
MSN LaboratoriesFor profitMKTGJun 24, 2025
Novitium PharmaFor profitMKTGDec 26, 2024
ShireFor profitNDA2Dec 14, 2018
ShireFor profitNDADec 14, 2018
Somerset Therapeutics LLCFor profitMKTGJun 24, 2025
Specgx LlcFor profitMKTGJun 24, 2025
TakedaFor profitMKTGDec 14, 2018
TakedaFor profitNDA2Dec 14, 2018
TevaFor profitMKTGMar 17, 2025
Torrent Pharmaceuticals LimitedFor profitMKTGJun 24, 2025
ZENARAFor profitMKTGJun 24, 2025
Zydus Discovery DMCCFor profitMKTGAug 7, 2025