Resotran

(prucalopride)

ApprovedSmall molecule

Prucalopride is used to treat chronic constipation by helping the muscles in the digestive system contract and move stool through the bowel more effectively.[2] Resotran is currently approved and in use across 12 indications[4].[1]

Resotran is one of 267 small molecule programs targeting Depressive Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

266

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Depressive DisorderActive, not recruiting

SchizophreniaNot yet recruiting

DyspepsiaApproved

Liver DiseaseApproved

IleusApproved

CognitionActive, not recruiting

Esophageal Motility DisordersRecruiting

AcuteCompleted

Irritable Bowel SyndromeUnknown status

Chronic ConstipationCompleted

Depressive DisorderPreclinical

Active, not recruiting

SchizophreniaPreclinical

Not yet recruiting

DyspepsiaApproved

Approved

Liver DiseaseApproved

Approved

IleusApproved

Approved

CognitionPreclinical

Active, not recruiting

Esophageal Motility DisordersApproved

Recruiting

AcutePreclinical

Completed

Irritable Bowel SyndromeApproved

Unknown status

Chronic ConstipationApproved

Completed

Showing 10 of 12 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Resotran

Takeda

Approved

1 2

Ozempic

Novo Nordisk

Preclinical

1 3

Inapsine

Jazz Pharmaceuticals

Preclinical

1 4

Depakote

Ibrance

Lunesta

3 7

Luvox

SSolvay Pharmaceuticals

Preclinical

1 8

Catapres

Boehringer Ingelheim

Preclinical

1 9

Rapamune

PPrism Pharmaceuticals

Preclinical

1 10

Persantine

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

ApprovedRecruiting

Esophageal Motility Disorders

NCT05455359

Q4 2028

PreclinicalNot yet recruiting

Schizophrenia

NCT06474286

Clinical

Trials by Indication[1]

Chronic constipation17 trials

Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

Completed·MMovetis·Phase 3·NCT00483886·620 enrolled

Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation

Completed·MMovetis·Phase 3·NCT01070615·693 enrolled

Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

Completed·MMovetis·Phase 3·NCT00987844·1,775 enrolled

Show 14 more trials

Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

Completed·MMovetis·Phase 2·NCT00617513·174 enrolled

Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation

Completed·MMovetis·Phase 3·NCT00488137·716 enrolled

Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation

Completed·NNorgine·Phase 3·NCT01251822·240 enrolled

Efficacy and Safety Study of the Effect of Dose-Titration of Prucalopride for The Treatment of Chronic Constipation

Completed·MMovetis·Phase 3·NCT00577018·755 enrolled

Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

Completed·MMovetis·Phase 2·NCT00631813·253 enrolled

An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT01116206·507 enrolled

Efficacy and Safety Study of Prucalopride for the Treatment of Patients With Chronic Constipation

Completed·MMovetis·Phase 3·NCT00485940·641 enrolled

Efficacy and Safety Study of Prucalopride for the Re-Treatment of Chronic Constipation

Completed·MMovetis·Phase 3·NCT00598338·516 enrolled

Evaluation of Prucalopride in Male Subjects With Chronic Constipation.

Completed· Takeda logo

Takeda·Phase 3·NCT01147926·374 enrolled

Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

Completed·MMovetis·Phase 3·NCT00487422·303 enrolled

Effect Comparison of Electro-acupuncture and Prucalopride for Severe Chronic Constipation: a Randomized Controlled Trial

Completed·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·N/A·NCT02047045·560 enrolled

Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT02228616·280 enrolled

Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years

Completed· Takeda logo

Takeda·Phase 4·NCT01424228·364 enrolled

A Post Marketing Surveillance Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation

Withdrawn· Johnson & Johnson logo

Johnson & Johnson··NCT01692132

Constipation7 trials

Prucalopride in Patients With Chronic Idiopathic Constipation

Completed·MMovetis·Phase 2·NCT00575614·87 enrolled

Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation

Completed·YYuhan Corporation·Phase 1/2·NCT02538367·120 enrolled

Prucalopride in Pediatric Subjects With Functional Constipation

Completed· Takeda logo

Takeda·Phase 3·NCT01330381·215 enrolled

Show 4 more trials

Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation

Completed·MMovetis·Phase 2·NCT00596596·313 enrolled

Effect of Prucalopride in Patients With Severe Chronic Idiopathic Constipation

Completed·MMovetis·Phase 2·NCT00576511·53 enrolled

Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation

Terminated· Takeda logo

Takeda·Phase 3·NCT01117051·174 enrolled

A Study of Prucalopride For Functional Constipation in Children and Teenagers

Terminated· Takeda logo

Takeda·Phase 3·NCT04759833·175 enrolled

Bowel Preparation3 trials

Prucaloprida vs Bisacodyl as a Stimulant in Bowel Preparation for Video Colonoscopy in Adults

Not yet recruiting·HHospital de Clínicas Dr. Manuel Quintela·Phase 1·NCT07127237·124 enrolled

Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure

Completed·RRegion Skane·Phase 3·NCT05726097·147 enrolled

Improving Bowel Preparation for the Colon Capsule

Completed·QQueen's University·Phase 3·NCT01655095·20 enrolled

Postoperative Ileus3 trials

Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery

Completed·JJinling Hospital, China·Phase 2·NCT02004652·110 enrolled

Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy

Unknown status·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05001763·160 enrolled

Prucalopride in Postoperative Ileus

Completed·UUniversity of Auckland, New Zealand·Phase 3·NCT02947269·150 enrolled

Gastroparesis2 trials

Prucalopride Versus Placebo in Gastroparesis

Completed·UUniversity of Calgary·Phase 2/3·NCT02031081·15 enrolled

Prucalopride Versus Placebo in Gastroparesis

Terminated·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT02510976·60 enrolled

24 more indications

Oral2 trials

Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects

Completed·YYuhan Corporation·Phase 1·NCT01870674·127 enrolled

M0001 Effects on Oral Contraceptive Plasma Levels

Completed·MMovetis·Phase 1·NCT01036893·16 enrolled

Irritable Bowel Syndrome2 trials

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

Unknown status·—·Phase 4·NCT04985669·140 enrolled

The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome

Unknown status·—·Phase 2/3·NCT04757493·160 enrolled

Elderly1 trial

Evaluation of the Safety and Tolerability of Prucalopride in Constipated Elderly Subjects Living in a Nursing Facility

Completed·MMovetis·Phase 2·NCT00627692·100 enrolled

Clinical Trial1 trial

Preventing Gastric Glitch With Prucalopride and Buspirone: N-of-1 Clinical Trial

Completed·UUniversidade de Passo Fundo·Phase 1/2·NCT05377619·1 enrolled

Colorectal Surgery1 trial

Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery

Recruiting·FFuture University in Egypt·Phase 3·NCT06816407·180 enrolled

Cardiac1 trial

A Trial in Healthy Volunteers, to Evaluate the Tolerability and Cardiac Safety of Prucalopride

Completed·MMovetis·Phase 1·NCT00488215·32 enrolled

Endoscopy1 trial

Prucalopride Prior to Small Bowel Capsule Endoscopy

Unknown status·UUniversity of British Columbia·Phase 4·NCT02806206·122 enrolled

Renal Impairment1 trial

Prucalopride Subjects With Renal Impairment

Completed·MMovetis·Phase 1·NCT01674192·34 enrolled

Cognition1 trial

Prucalopride and Cognition in Recovered Depression

Completed·UUniversity of Oxford·N/A·NCT05220228·50 enrolled

Intensive Care Unit1 trial

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

Completed·—·Phase 1/2·NCT05496179·70 enrolled

Motor Function1 trial

The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT04429802·17 enrolled

Dysphagia1 trial

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

Completed·UUniversity of Calgary·Phase 2·NCT03244553·28 enrolled

Single Dose1 trial

Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Completed·MMovetis·Phase 1·NCT01674166·38 enrolled

Hepatic Impairment1 trial

Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment

Completed·MMovetis·Phase 1·NCT01134185·24 enrolled

Function1 trial

Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Completed·MMovetis·Phase 1·NCT01670669·37 enrolled

LAM1 trial

Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway

Completed·KKU Leuven·Phase 4·NCT02425774·31 enrolled

Paralytic ileus1 trial

Efficacy of PRUcalopride in Critically Ill Patients With Paralytic ILeus

Unknown status·PPrince of Songkla University·Phase 3·NCT04190173·62 enrolled

TED1 trial

Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters

Completed·MMovetis·Phase 1·NCT00903747·120 enrolled

Refractory1 trial

Prucalopride Treatment for Refractory Gastro-esophageal Reflux Disease

Unknown status·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT03676374·60 enrolled

OSA1 trial

Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule

Completed·QQueen's University·Phase 3·NCT01864915·60 enrolled

Acute1 trial

Effects of Acute Prucalopride Administration in Healthy Volunteers

Completed·UUniversity of Oxford·N/A·NCT03863366·41 enrolled

Schizophrenia1 trial

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

Not yet recruiting·UUniversity of Pittsburgh·Preclinical·NCT06474286·34 enrolled

Esophageal Motility Disorders1 trial

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

Recruiting·BBoston Children's Hospital·Approved·NCT05455359·120 enrolled

Unspecified5 trials

The Colonic Transit Time: a Modifiable Determinant of Intestinal Production and Uptake of Microbial Metabolites?

Withdrawn·UUniversitaire Ziekenhuizen KU Leuven··NCT01869751

Effects of Seven Day Prucalopride Administration in Healthy Volunteers

Completed·UUniversity of Oxford·N/A·NCT03572790·50 enrolled

Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects

Completed·UUniversity Hospital, Gasthuisberg·Phase 4·NCT03279341·10 enrolled

Show 2 more trials

Safety Study of Prucalopride in Healthy Volunteers

Completed·MMovetis·Phase 1·NCT00793429

Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity

Completed· Takeda logo

Takeda·Phase 4·NCT01707667·13 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 14, 2018

MOTEGRITY

NDA NDA210166

Sources

References

[1]
ClinicalTrials.gov — 62 trial records for prucalopride. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Resotran drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — prucalopride compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for prucalopride. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210166). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 4 (5-HT4) Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

Resotran

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2028

Trials by Indication[1]

Chronic constipation17 trials

Constipation7 trials

Bowel Preparation3 trials

Postoperative Ileus3 trials

Gastroparesis2 trials

Oral2 trials

Irritable Bowel Syndrome2 trials

Elderly1 trial

Clinical Trial1 trial

Colorectal Surgery1 trial

Cardiac1 trial

Endoscopy1 trial

Renal Impairment1 trial

Cognition1 trial

Intensive Care Unit1 trial

Motor Function1 trial

Dysphagia1 trial

Single Dose1 trial

Hepatic Impairment1 trial

Function1 trial

LAM1 trial

Paralytic ileus1 trial

TED1 trial

Refractory1 trial

OSA1 trial

Acute1 trial

Schizophrenia1 trial

Esophageal Motility Disorders1 trial

Unspecified5 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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