TheraRadar
Data updated: May 26, 2026

PRUCALOPRIDE SUCCINATE

Trial Activity: Declining 1 active trials
Gastrointestinal Approved 2024-12-26

Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Source: FDA Label • ZYDUS LIFESCIENCES
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Shire conducting 5 trials (18%)
31 indications explored (Broad Platform)
→ constipation (6 trials)
→ postoperative ileus (3 trials)
→ hepatic impairment (3 trials)
5
Indications
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-12-26
Routes
ORAL
Dosage Forms
TABLET

Companies

ZYDUS LIFESCIENCES AJANTA PHARMA LTD ALKEM LABS LTD Lupin AMNEAL Teva H2-PHARMA MSN Apotex TORRENT ZENARA SOMERSET THERAP SPECGX LLC Hikma NOVITIUM PHARMA APPCO ANNORA PHARMA
Active Ingredient: PRUCALOPRIDE SUCCINATE

PRUCALOPRIDE SUCCINATE Approval History

2025
2026
Original
New Indication
New Form
Label Update
36 FDA actions from 2024 to 2026
Feb 2026 ORIGINAL
Update
Jan 2026 SUPPL
Label · Labeling
Jan 2026 ORIGINAL
Update

What PRUCALOPRIDE SUCCINATE Treats

5 FDA approvals

Originally approved for its first indication in 2024 . Covers 5 distinct patient populations.

  • Other (5)
📋

Clinical Trial Registry

26 trials
Trial Sponsor ID Phase Status Title
NCT02425774 S56328 Ph 4 completed Anti-inflammatory Effect of Pre-operative Stimulation of the Cholinergic Anti-Inflammatory Pathway
NCT05455359 IRB-P00038381 Ph 4 recruiting Gastrointestinal Dysmotility on Aspiration Risk
NCT02510976 S53094 Ph 4 terminated Prucalopride Versus Placebo in Gastroparesis
NCT04759833 results posted TAK-555-3010 2022-003221-22 Ph 3 terminated A Study of Prucalopride For Functional Constipation in Children and Teenagers
NCT05496179 Future University in Egypt Ph 1, Ph 2 completed The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients
NCT05726097 2022-06303-02 Ph 3 completed Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
NCT05377619 5.151.164 Ph 1, Ph 2 completed Preventing Gastric Glitch With Prucalopride and Buspirone: N-of-1 Clinical Trial
NCT02947269 UOA-prucRCT1 Ph 3 completed Prucalopride in Postoperative Ileus
NCT01707667 results posted SPD555-403 2012-002495-13 Ph 4 completed Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
NCT01117051 OIC results posted M0001-C301 SPD555-301, 2009-015652-20 Ph 3 terminated Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
NCT01424228 SPD555-401 results posted M0001-C401 2011-000670-62, SPD555-401 Ph 4 completed Evaluation of Long-term Prucalopride Treatment With Chronic Constipation in Subjects Aged ≥ 18 Years
NCT01147926 results posted SPD555-302 M0001-C302, 2009-015719-42 Ph 3 completed Evaluation of Prucalopride in Male Subjects With Chronic Constipation.
NCT01330381 FC results posted SPD555-303 M0001-C303, 2010-022402-40 Ph 3 completed Prucalopride in Pediatric Subjects With Functional Constipation
NCT02031081 PruGP Ph 2, Ph 3 completed Prucalopride Versus Placebo in Gastroparesis
NCT03244553 IEMPru CGMC-Pru-02 Ph 2 completed Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study
NCT02228616 CR102381 PRUCOP4005, PRU-C-13-CN-004-V02 Ph 4 completed Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation
NCT03279341 S54750 Ph 4 completed Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects
NCT01116206 Resolor CR017173 PRUCRC3001 Ph 3 completed An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation
NCT01864915 DMED 1578-13 HOOKEY 9427-D2773-21C Ph 3 completed Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
NCT02004652 RIGS-2013-PRU Ph 2 completed Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery
NCT01655095 DMED-1478-12 Ph 3 completed Improving Bowel Preparation for the Colon Capsule
NCT01870674 YH12852-101 Ph 1 completed Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH12852 After Oral Administration in Healthy Male Subjects
NCT01251822 PEG-01/2010 (PRUC) Ph 3 completed Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation
NCT01134185 HI M0001-C103 Ph 1 completed Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment
NCT01036893 M0001-C101 Ph 1 completed M0001 Effects on Oral Contraceptive Plasma Levels
NCT00903747 M0001-C102 Ph 1 completed Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PRUCALOPRIDE SUCCINATE FDA Label Details

Indications & Usage

Prucalopride tablet is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride tablet is a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Looking for the branded version?

MOTEGRITY

Full clinical data, patents, trials, and competitive landscape for prucalopride succinate.

See MOTEGRITY

Data Sources

FDA Approval: ANDA218056 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment