Clinical Trials

Numerous clinical trials across early to late phases evaluate prucalopride succinate primarily for gastrointestinal dysmotility conditions—including chronic constipation, gastroparesis, postoperative ileus, and opioid-induced constipation—alongside exploratory studies in depressive disorders and cognition. Sponsored by pharmaceutical companies and academic medical centers, these protocols assess pharmacokinetics, therapeutic efficacy, and safety. Across these investigations, recruitment statuses encompass completed, recruiting, withdrawn, and terminated studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06883175 RECRUITING
Dysphagia; Achalasia, Esophageal; Ineffective Esophageal Motility
Northwestern University
 2024-09-01
NCT05455359 RECRUITING
Esophageal Motility Disorders; Gastric Motor Dysfunction; Aspiration Pneumonia; Gastro Esophageal Reflux
Boston Children's Hospital
 2025-02-13 PHASE4
NCT06474286 NOT_YET_RECRUITING
Schizophrenia
University of Pittsburgh
 2026-07-31
NCT07127237 NOT_YET_RECRUITING
Bowel Preparation
Hospital de Clínicas Dr. Manuel Quintela
 2025-09 EARLY_PHASE1
NCT06816407 RECRUITING
Post-Op Complication
Future University in Egypt
 2025-03-02 PHASE3
NCT04759833 TERMINATED
Constipation
Takeda
 2021-07-13 PHASE3
NCT05220228 COMPLETED
Depression in Remission
University of Oxford
 2022-01-04
NCT05726097 COMPLETED
Colon Cancer; Inflammatory Bowel Diseases; Gastrointestinal Bleed; Colon Polyp
Region Skane
 2023-02-01 PHASE3
NCT05001763 UNKNOWN
Postoperative Ileus; Bladder Cancer
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2021-09-01 PHASE2
NCT05966246 COMPLETED
Gastric Cancer
Gangnam Severance Hospital
 2022-01-25
NCT05496179 COMPLETED
Enteral Feeding Intolerance
Ain Shams University
 2022-08-30 PHASE1; PHASE2
NCT05377619 COMPLETED
Dyspepsia
Universidade de Passo Fundo
 2022-01-06 PHASE1; PHASE2
NCT04838522 Recruiting
Chronic Constipation
Takeda|UC San Diego Human Milk Research Biorepository
 2022-03-02 --
NCT04985669 UNKNOWN
Patient Satisfaction
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2021-08-15 PHASE4
NCT04757493 UNKNOWN
Irritable Bowel Syndrome
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2021-03-10 PHASE2; PHASE3
NCT03676374 UNKNOWN
GERD
Universitaire Ziekenhuizen KU Leuven
 2019-02-18 PHASE4
NCT02510976 TERMINATED
Gastroparesis
Universitaire Ziekenhuizen KU Leuven
 2011-11 PHASE4
NCT02947269 COMPLETED
Postoperative Ileus; Colorectal Surgery; Postoperative Complications
University of Auckland, New Zealand
 2017-10-25 PHASE3
NCT04190173 UNKNOWN
Paralytic Ileus; Critically Ill
Prince of Songkla University
 2017-07-01 PHASE3
NCT03244553 COMPLETED
Ineffective Esophageal Motility; Dysphagia
University of Calgary
 2017-10-20 PHASE2
NCT03572790 COMPLETED
Molecular Mechanisms of Pharmacological Action; Depression; Depressive Disorder; Mood Disorders; Mental Disorders; Antidepressive Agents; Cognition
University of Oxford
 2018-06-11
NCT02031081 COMPLETED
Gastroparesis; Diabetes Mellitus
University of Calgary
 2014-03 PHASE2; PHASE3
NCT03863366 COMPLETED
Molecular Mechanisms of Pharmacological Action; Depression; Depressive Disorder; Mood Disorders; Mental Disorder; Antidepressive Agents; Cognition
University of Oxford
 2017-02-07
NCT02806206 UNKNOWN
Gastrointestinal Hemorrhage; Crohn Disease; Celiac Disease; Intestinal Diseases; Inflammatory Bowel Diseases
University of British Columbia
 2016-07 PHASE4
NCT02781493 UNKNOWN
Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopyp
Shandong University
 2016-06 PHASE4
NCT02228616 COMPLETED
Constipation
Xian-Janssen Pharmaceutical Ltd.
 2014-10-14 PHASE4
NCT02538367 COMPLETED
Functional Constipation
Yuhan Corporation
 2015-08 PHASE1; PHASE2
NCT02047045 COMPLETED
Constipation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
 2014-04
NCT03279341 COMPLETED
Chronic Constipation
University Hospital, Gasthuisberg
 2012-12-03 PHASE4
NCT02425774 COMPLETED
Postoperative Ileus
KU Leuven
 2014-07 PHASE4
NCT04429802 COMPLETED
Gastrointestinal Motility Disorder; Dyspepsia
Universitaire Ziekenhuizen KU Leuven
 2013-09-26
NCT01870674 COMPLETED
Healthy
Yuhan Corporation
 2013-08 PHASE1
NCT02004652 COMPLETED
Postoperative Ileus
Jinling Hospital, China
 2013-11 PHASE2
NCT01864915 COMPLETED
Bowel Cleansing; Colon Capsule Completion Times
Queen's University
 2013-06 PHASE3
NCT01707667 COMPLETED
Chronic Constipation
Shire
 2013-02-27 PHASE4
NCT01147926 COMPLETED
Male Subjects With Chronic Constipation
Shire
 2010-09-23 PHASE3
NCT04429802 Completed
Gastrointestinal Motility Disorder|Dyspepsia
Universitaire Ziekenhuizen KU Leuven
 2013-09-26 Not Applicable
NCT01807000 COMPLETED
Healthy
Shire
 2013-03-18 PHASE1
NCT01330381 COMPLETED
Functional Constipation
Shire
 2011-04-28 PHASE3
NCT01807000 Completed
Healthy
Shire|Takeda
 2013-03-18 Phase 1
NCT01692132 Withdrawn
Chronic Constipation
Janssen Pharmaceutica
 2013-02 --
NCT01424228 COMPLETED
Constipation
Shire
 2011-04-06 PHASE4
NCT03279341 Completed
Chronic Constipation
University Hospital Gasthuisberg
 2012-12-03 Phase 4
NCT01655095 COMPLETED
Quality of Bowel Preparation for the Colon Capsule; Colon Capsule Completion Rates; Colon Capsule Polyp Detection
Queen's University
 2012-07 PHASE3
NCT01117051 TERMINATED
Non-cancer Pain; Opioid Induced Constipation
Shire
 2010-05-19 PHASE3
NCT01251822 COMPLETED
Constipation
Norgine
 2010-11 PHASE3
NCT01116206 COMPLETED
Constipation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2010-05 PHASE3
NCT01134185 COMPLETED
Hepatic Impairment
Movetis
 2010-05 PHASE1
NCT01117051 Terminated
Non-cancer Pain|Opioid Induced Constipation
Shire|Takeda
 2010-05-19 Phase 3
NCT01036893 COMPLETED
Healthy Volunteers
Movetis
 2009-12 PHASE1
NCT00903747 COMPLETED
Constipation
Movetis
 2009-01 PHASE1
NCT00987844 COMPLETED
Chronic Constipation
Movetis
 1998-07 PHASE3
NCT01070615 COMPLETED
Chronic Constipation
Movetis
 1998-06 PHASE3
NCT00627692 COMPLETED
Constipation
Movetis
 1999-02 PHASE2
NCT00488215 COMPLETED
Constipation
Movetis
 2000-01 PHASE1
NCT00598338 COMPLETED
Constipation
Movetis
 1999-04 PHASE3
NCT00577018 COMPLETED
Constipation
Movetis
 1998-08 PHASE3
NCT00487422 COMPLETED
Constipation
Movetis
 1998-10 PHASE3
NCT01674192 COMPLETED
Constipation
Movetis
 1997-07 PHASE1
NCT01670669 COMPLETED
Constipation
Movetis
 1998-11 PHASE1
NCT00488137 COMPLETED
Constipation
Movetis
 1998-03 PHASE3
NCT00485940 COMPLETED
Constipation
Movetis
 1998-03 PHASE3
NCT00483886 COMPLETED
Constipation
Movetis
 1998-04 PHASE3
NCT01674166 COMPLETED
Constipation
Movetis
 1998-11 PHASE1
NCT00575614 COMPLETED
Constipation
Movetis
 1997-04 PHASE2
NCT00596596 COMPLETED
Constipation
Movetis
 1996-09 PHASE2
NCT00631813 COMPLETED
Constipation
Movetis
 1995-11 PHASE2
NCT00617513 COMPLETED
Constipation
Movetis
 1995-03 PHASE2
NCT00576511 COMPLETED
Chronic Constipation
Movetis
 1994-12 PHASE2
NCT00793429 COMPLETED
Healthy
Movetis
 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-08-11)

Check the Prucalopride Succinate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Prucalopride succinate acts as a high-affinity, selective 5-HT4 receptor agonist that binds human 5-HT(4a) and 5-HT(4b) receptor subtypes with Ki values of 2.5 nM and 8 nM, respectively, stimulating downstream enterokinetic signaling cascades. This activity enhances gastrointestinal motility and accelerates intestinal transit, addressing the underlying pathophysiology in clinical conditions such as chronic constipation, gastroparesis, and postoperative ileus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.