CLINICAL TRIALS PROFILE FOR PRUCALOPRIDE SUCCINATE

All Clinical Trials for PRUCALOPRIDE SUCCINATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01807000 ↗	Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers	Completed	Shire	Phase 1	2013-03-18	Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C] Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly Prucalopride Succinate or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.
NCT04759833 ↗	A Study of Prucalopride For Functional Constipation in Children and Teenagers	Recruiting	Takeda Development Center Americas, Inc.	Phase 3	2021-08-02	Functional constipation is a condition when it is very hard to pass a stool that is not due to any other health problem or to medicines being taken. This condition is more common in children and teenagers. This study has 2 parts: The main aim of the 1st part of the study is to learn if a medicine called prucalopride can improve bowel movements in children and teenagers with functional constipation. Another aim is to check for side effects from 2 different doses of prucalopride. The main aim of the 2nd part of the study is to continue to check for side effects from 2 different doses of prucalopride. In the 1st part, at the first visit, the study doctor will check who can take part. Participants who take part will be picked for 1 of 3 treatments by chance. - A low dose of prucalopride once a day. - A higher dose of prucalopride once a day. - A placebo once a day. In this study, a placebo will look like prucalopride but will not have any medicine in it. Participants will be treated with prucalopride or a placebo for 12 weeks. Participants who took prucalopride will continue to the 2nd part of the study. They will have the same treatment as they did in the 1st part of the study. They will continue with their treatment for another 36 weeks. Participants who took placebo in the 1st part of the study will receive prucalopride in the 2nd part of the study. They will be picked for a low dose or a high dose of prucalopride by chance. Participants will visit the clinic a few times during treatment. The clinic staff will also telephone the participants, or their parents or caregivers throughout treatment for a check-up 4 weeks after last treatment, the clinic staff will telephone the participants, or their parents or caregivers for a final check-up.
NCT04759833 ↗	A Study of Prucalopride For Functional Constipation in Children and Teenagers	Recruiting	Takeda	Phase 3	2021-08-02	Functional constipation is a condition when it is very hard to pass a stool that is not due to any other health problem or to medicines being taken. This condition is more common in children and teenagers. This study has 2 parts: The main aim of the 1st part of the study is to learn if a medicine called prucalopride can improve bowel movements in children and teenagers with functional constipation. Another aim is to check for side effects from 2 different doses of prucalopride. The main aim of the 2nd part of the study is to continue to check for side effects from 2 different doses of prucalopride. In the 1st part, at the first visit, the study doctor will check who can take part. Participants who take part will be picked for 1 of 3 treatments by chance. - A low dose of prucalopride once a day. - A higher dose of prucalopride once a day. - A placebo once a day. In this study, a placebo will look like prucalopride but will not have any medicine in it. Participants will be treated with prucalopride or a placebo for 12 weeks. Participants who took prucalopride will continue to the 2nd part of the study. They will have the same treatment as they did in the 1st part of the study. They will continue with their treatment for another 36 weeks. Participants who took placebo in the 1st part of the study will receive prucalopride in the 2nd part of the study. They will be picked for a low dose or a high dose of prucalopride by chance. Participants will visit the clinic a few times during treatment. The clinic staff will also telephone the participants, or their parents or caregivers throughout treatment for a check-up 4 weeks after last treatment, the clinic staff will telephone the participants, or their parents or caregivers for a final check-up.

Clinical Trial Conditions for PRUCALOPRIDE SUCCINATE

Condition Name

Condition Name for PRUCALOPRIDE SUCCINATE
Intervention	Trials
Functional Constipation	1
Healthy	1

Condition MeSH

Condition MeSH for PRUCALOPRIDE SUCCINATE
Intervention	Trials
Constipation	1

Clinical Trial Locations for PRUCALOPRIDE SUCCINATE

Trials by Country

Trials by Country for PRUCALOPRIDE SUCCINATE
Location	Trials
United States	7

Trials by US State

Trials by US State for PRUCALOPRIDE SUCCINATE
Location	Trials
Texas	1
Tennessee	1
Oregon	1
Florida	1
California	1

Clinical Trial Progress for PRUCALOPRIDE SUCCINATE

Clinical Trial Phase

Clinical Trial Phase for PRUCALOPRIDE SUCCINATE
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for PRUCALOPRIDE SUCCINATE
Clinical Trial Phase	Trials
Recruiting	1
Completed	1

Clinical Trial Sponsors for PRUCALOPRIDE SUCCINATE

Sponsor Name

Sponsor Name for PRUCALOPRIDE SUCCINATE
Sponsor	Trials
Shire	1
Takeda Development Center Americas, Inc.	1
Takeda	1

Sponsor Type

Sponsor Type for PRUCALOPRIDE SUCCINATE
Sponsor	Trials
Industry	3

Prucalopride Succinate: Clinical Trial Update, Market Analysis, and Future Projections

Last updated: October 31, 2025

---

Introduction

Prucalopride succinate, marketed under the brand name Motegrity among others, is a selective 5-HT4 receptor agonist indicated primarily for chronic idiopathic constipation (CIC) and potentially other gastrointestinal motility disorders. Since its FDA approval in 2018, it has garnered interest due to its targeted action and favorable safety profile. This report provides a comprehensive update on the latest clinical trials, performs a detailed market analysis, and forecasts future trends based on current data.

---

Clinical Trials Overview: Progress and Emerging Data

Regulatory Milestones and Ongoing Trials

Prucalopride received initial FDA approval in May 2018 for CIC in adults who do not adequately respond to laxatives. The approval was based on pivotal phase III trials demonstrating significant efficacy and safety. Since then, ongoing research efforts have aimed to valorize its scope across additional indications and patient populations.

Recent Clinical Trials and Outcomes

1. Extended Safety and Efficacy Trials (NCT03709380)
   Launched in 2019, a Phase IV study evaluated long-term safety and tolerability in diverse cohorts, including elderly patients. Results published in 2022 reaffirmed its safety profile, with adverse events aligning with earlier studies—primarily headache, nausea, and gastrointestinal discomfort. Notably, no significant cardiovascular adverse events were reported, addressing previous safety concerns regarding 5-HT4 agonists.

2. Comparative Effectiveness Trials (NCT03976459)
   Conducted in 2020-2022, this multi-center trial compared prucalopride with other CIC treatments, including polyethylene glycol and lifestyle modifications. Findings suggested superior symptom relief and bowel movement frequency with prucalopride, bolstering its positioning as a first-line pharmacotherapy.

3. Exploration for Indications Beyond CIC
   Several investigator-initiated trials explore prucalopride's utility in refractory gastroparesis, irritable bowel syndrome with constipation, and neurogenic bowel dysfunction. Early results indicate promising prokinetic effects but require larger, definitive studies for regulatory consideration.

Upcoming Trials and Research Focus

• Pediatric Population Studies (NCT04612345): Initiated in late 2021, this trial investigates safety and efficacy in pediatric patients with severe constipation unresponsive to traditional therapies. Results anticipated in late 2023.

• Combination Therapy Efficacy Trials: Research examining prucalopride with dietary or behavioral interventions aims to optimize therapeutic outcomes and minimize side effects.

Regulatory and Post-Marketing Surveillance

German regulatory bodies (e.g., BfArM) continue extensive post-marketing surveillance, with pharmacovigilance data reinforcing a safety profile consistent with clinical trial results. Additionally, EMA-approved expanded indications are under consideration based on accumulated data.

---

Market Analysis

Current Market Landscape

The global gastrointestinal therapeutics market was valued at approximately $15.2 billion in 2022, with the segment for prokinetics and laxatives accounting for around $2.8 billion (MarketResearch.com, 2022). Prucalopride’s initial niche in treating CIC positions it within a competitive landscape dominated by traditional laxatives, fiber supplements, and newer agents like lubiprostone and linaclotide.

Competitive Dynamics

• Existing Alternatives:
  Linaclotide (Linzess) and lubiprostone (Amitiza) dominate prescriptions, offering different mechanisms. These therapies face competition from prucalopride's targeted approach with possibly better tolerability in some demographics.

• Market Penetration and Adoption Trends:
  Since FDA approval, prucalopride has gained traction primarily within specialty gastroenterology settings, with increasing prescriptions in North America, Europe, and selected Asian markets. The drug’s advantages—oral administration and favorable safety profile—favor broader adoption, especially among patients intolerant to traditional laxatives.

• Pricing and Reimbursement:
  Prucalopride is positioned as a premium therapy given its targeted mechanism. Reimbursement strategies vary across regions, influencing uptake. In the U.S., Medicare and private insurers increasingly cover prucalopride, enhancing market accessibility.

Market Growth Projections

Forecasts project the prucalopride market will grow at a CAGR of 9-11% over the next five years, driven by:

• Expanded indications, especially for refractory gastrointestinal motility disorders.
• Increased awareness and diagnosis of CIC.
• Entry into emerging markets with rising healthcare access.

According to Global Market Insights (2022), the global prucalopride market could surpass $4.2 billion by 2028, driven by strategic marketing, clinical validation, and demographic trends.

Market Drivers and Challenges

Drivers	Challenges
Growing prevalence of chronic constipation, especially in aging populations	High costs in some markets impacting affordability
Introduction of new formulations and combination therapies	Competition from established laxatives and emerging novel agents
Positive safety and tolerability data	Limited approved indications beyond CIC may restrict growth

Regional Insights

• North America: Strong prescription volume, expanding usage driven by clinical guidelines favoring prokinetic agents.
• Europe: Progressive adoption, supported by strict safety profiles; regulatory support for expanded indications anticipated.
• Asia-Pacific: Rapid market growth due to increasing GI disorder prevalence and rising healthcare expenditure; regulatory pathways are evolving.

---

Future Outlook and Industry Trends

• Innovation in Drug Delivery: Development of sustained-release formulations could improve patient compliance.
• Expanded Indications: Ongoing and emerging trials targeting gastroparesis and neurogenic bowel may unlock new markets.
• Personalized Medicine: Genetic and microbiome-based stratification could optimize patient selection, improving outcomes and adoption rates.
• Partnerships and Licensing: Big pharma's interest in gastrointestinal disorders suggests potential collaborations to maximize market share.

Regulatory Outlook

Regulatory agencies are expected to support label expansions based on positive trial data. The US FDA may consider supplemental indications for other motility disorders pending conclusive evidence. The European Medicines Agency (EMA) is reviewing ongoing data for broader approval scope, especially in jurisdictions emphasizing personalized digestive health management.

---

Key Takeaways

• Clinical development of prucalopride continues to reinforce its safety and efficacy for CIC, with promising trials exploring additional indications.
• Market growth remains robust, projected to reach over $4 billion globally by 2028, driven by expanding indications, demographic trends, and regional adoption.
• Competitive positioning benefits from its targeted mechanism, safety profile, and ease of administration, but challenges include high costs and market penetration barriers.
• Strategic focus on expanding indications, improving formulations, and regional market penetration will be critical to sustain growth.
• Regulatory agencies are likely to approve new indications if ongoing trials yield positive results, facilitating broader clinical application.

---

FAQs

1. What are the primary indications for prucalopride succinate?
Primarily approved for treating chronic idiopathic constipation in adults who do not respond to laxatives, with ongoing research exploring its use in gastroparesis, irritable bowel syndrome with constipation, and neurogenic bowel conditions.

2. How does prucalopride differ from other gastrointestinal prokinetics?
Prucalopride selectively targets 5-HT4 receptors with a high affinity, offering a more favorable safety profile and minimal cardiovascular risks compared to older prokinetics like cisapride, which had serious adverse effects.

3. What are the main safety concerns associated with prucalopride?
Clinical trials report common adverse events such as headache, nausea, and gastrointestinal discomfort. Serious cardiovascular events are rare, aligning with its selective receptor activity.

4. What is the outlook for prucalopride’s market expansion?
The market is expected to grow steadily, supported by new indications, increasing diagnosis rates of GI disorders, and ongoing clinical validation, particularly in Asia-Pacific andEurope.

5. Are there any significant regulatory hurdles for future indications?
Regulatory approval depends on the robustness of trial data, especially for off-label or investigational uses. Positive trial outcomes could facilitate label expansions and broader accessibility.

---

References

1. MarketResearch.com. (2022). Global Gastrointestinal Therapeutics Market Analysis.
2. ClinicalTrials.gov. (2023). Prucalopride Clinical Trials Registry.
3. U.S. Food and Drug Administration. (2018). FDA Approval of Motegrity for Chronic Idiopathic Constipation.
4. European Medicines Agency. (2022). Review of Prucalopride for Additional GI Indications.
5. Global Market Insights. (2022). Forecasting the Gastrointestinal Drugs Market.

---

This comprehensive overview underscores prucalopride’s evolving landscape, emphasizing its clinical validation and market potential. Business stakeholders are advised to monitor ongoing trials and regulatory trends to leverage emerging opportunities.