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Drug

Prucalopride succinate

Approved · FDA / EMA
Emerging researchLate-stage development

Also known as Motegrity, Prucalopride, prucalopride (as succinate).

RxNorm2107309
2
Research papers
5
Active clinical trials
3
Regulatory events
Latest activity
beta

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

Approval: PRUCALOPRIDE SUCCINATE (ANDA219234)

Regulatory2026-07-27FDA

Approval: PRUCALOPRIDE SUCCINATE (ANDA219180)

Regulatory2026-06-29FDA

Prucaloprida vs Bisacodyl as a Stimulant in Bowel Preparation for Video Colonoscopy in Adults: A Randomized Clinical Trial

Clinical trial2026-02-01Primary completion · ClinicalTrials.gov

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

Clinical trial2025-12-26Results expected Q2 2027 · ClinicalTrials.gov

A Pilot Study to Assess the Effect of Prucalopride on Cognitive Functioning in Patients With Schizophrenia

Clinical trial2025-12-02Results expected Q4 2026 · ClinicalTrials.gov

Evolution of the Chicago Classification: Bridging Physiology and Mechanics

Clinical trial2025-08-11Results expected Q2 2029 · ClinicalTrials.gov

The Effect of Different Doses of Prucalopride on Improving Gut Function Recovery Following Elective Colorectal Surgery: a Randomized, Double-blind Study

Clinical trial2025-05-01Primary completion · ClinicalTrials.gov

Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting of a 12-week Double-blind, Placebo-controlled Part (Part A) to Evaluate Efficacy and Safety Followed by a 36-week Double-blind Extension Part (Part B) to Document Long-term Safety up to Week 48

Clinical trial2023-11-13Terminated · ClinicalTrials.gov

The Effect of 2mg Sub-acute Prucalopride on Cognition and Emotional Processing in Participants Recovered From Depression

Clinical trial2023-11-13Completed · ClinicalTrials.gov

Electroacupuncture vs Prucalopride for Severe Chronic Constipation: A Multicenter, Randomized, Controlled, Noninferiority Trial.

Research2021-05-01The American journal of gastroenterology

Prucalopride is no more effective than placebo for children with functional constipation.

Research2014-09-16Gastroenterology

Approval: Resolor (EMA)

Regulatory2009-10-14EMA

Profile

Identifiers & mechanism

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

Canonical name
Prucalopride succinate
Aliases & brands
MotegrityPrucaloprideprucalopride (as succinate)
RxNorm CUI
2107309
Regulatory jurisdictions
fdaema

Regulatory timeline

3 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
2009-10-14
Latest approval
2026-07-27
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-07-27Approval
Approval: PRUCALOPRIDE SUCCINATE (ANDA219234)
Evidence ↗
2026-06-29Approval
Approval: PRUCALOPRIDE SUCCINATE (ANDA219180)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2009-10-14Approval
Approval: Resolor (EMA)

Indication: Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

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

61 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
61
registered trials across all phases
LATEST COMPLETION 2023
5
Active studies
5
Recruiting
39
Late-stage (III+)
47
Completed
9
Discontinued
PHASE DISTRIBUTIONn = 61
Early Phase 11Phase 19Phase 1 / 23Phase 29Phase 2 / 32Phase 320Phase 410Phase N / A7

Late-stage studies

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

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

RecruitingPH IVBoston Children's Hospitaln=1202027

Study of Comparative Effectiveness of Prucalopride and Lubiprostone in Constipation Predominant Irritable Bowel Syndrome

Unknown statusPH IVBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladeshn=1402022

A Placebo-controlled Trial With Prucalopride for the Treatment of Typical Reflux Symptoms in Patients With Gastro-esophageal Reflux Disease With Incomplete Proton Pump Inhibitor Response

Unknown statusPH IVUniversitaire Ziekenhuizen KU Leuvenn=602021

Prucalopride Versus Placebo in Functional Dyspepsia With Delayed Gastric Emptying

TerminatedPH IVUniversitaire Ziekenhuizen KU Leuvenn=602021

The Effect of Prucalopride on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: A Randomized Controlled Trial

Unknown statusPH IVUniversity of British Columbian=1222017

Recent completions

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

The Effect of 2mg Sub-acute Prucalopride on Cognition and Emotional Processing in Participants Recovered From Depression

CompletedN/AUniversity of Oxfordn=502023

Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

CompletedPH IIIRegion Skanen=1472023

The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients

CompletedPH I/IIAin Shams Universityn=702023

Gastric Glitch: a New Functional Disease Treated With Prucalopride and Buspirone in a N-of-1 Double-blind Clinical Trial

CompletedPH I/IIUniversidade de Passo Fundon=12022

A Randomized Double-blind Placebo Controlled Trial of Prucalopride to Reduce the Duration of Postoperative Ileus in Patients Undergoing Elective Colorectal Surgery

CompletedPH IIIUniversity of Auckland, New Zealandn=1502020

Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study

CompletedPH IIUniversity of Calgaryn=282019

Research activity

2 papers

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

Publications over time
20142021
Journals, researchers & institutions
Top journals
  • Gastroenterology1
  • The American journal of gastroenterology1
Leading researchers
  • Ausma J1
  • Benninga MA1
  • Bodi P1
  • Fang J1
  • Fu W1
  • Green A1
  • He L1
  • Kerstens R1
Leading institutions
free-text, unnormalised
  • Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University1
  • College of Acupuncture and Orthopedics1
  • Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine1
  • Emma Children's Hospital/Academic Medical Center1
  • Guang'anmen Hospital1
  • Guangdong Province Hospital of Traditional Chinese Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.