Overview
Prucalopride is a dihydrobenzofurancarboxamide derivative from the benzofurane family that selectively stimulates 5-HT4 receptors and thus, it presents enterokinetic properties. The high selectivity of prucalopride allowed further development as it prevented the cardiac adverse reactions observed due to non-target effects of precedent therapies. Prucalopride was developed by Shire Development LLC and approved for use in Europe in 2009, in Canada on December 7, 2011 and by the FDA on December 17, 2018.
Indication
Prucalopride is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. CIC is one of the most common chronic functional gastrointestinal disorders worldwide. The diagnosis of this agent is very hard and it can be confirmed if the patient experience at least two of the following: -Straining during more than 25% of the bowel movements. -Lumpy or hard stools in 25% of the bowel movements. -Sensation of incomplete evacuation in more than 25% of all bowel movements. -Sensation of anorectal blockage or obstruction in more than 25% of the bowel movements. -Manual maneuvers required in more than 25% of the bowel movements. -Fewer than 3 bowel movements per week.
Associated Conditions
- Opioid Induced Constipation (OIC)
- Chronic idiopathic constipation (CIC)
- Refractory Chronic idiopathic constipation
Research Report
Prucalopride (DB06480): A Comprehensive Pharmacological and Clinical Monograph
Executive Summary
Prucalopride is a first-in-class, small molecule drug representing a significant advancement in the management of chronic idiopathic constipation (CIC). As a highly selective, high-affinity serotonin-4 (5−HT4) receptor agonist, its primary mechanism involves the stimulation of colonic peristalsis and the enhancement of gastrointestinal motility. This targeted action directly addresses the impaired motility that characterizes CIC. The development of prucalopride was distinguished by a rational drug design approach that successfully engineered a novel dihydrobenzofurancarboxamide chemical structure. This structure confers a high degree of selectivity for the 5−HT4 receptor, thereby avoiding the off-target interactions with cardiac ion channels (e.g., hERG) that led to the withdrawal of earlier, less selective agents in this class. Consequently, prucalopride possesses a markedly improved cardiovascular safety profile, a critical feature that facilitated its global regulatory approvals.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/17 | Not Applicable | Not yet recruiting | Hospital de Clínicas Dr. Manuel Quintela | ||
2025/02/10 | Phase 3 | Recruiting | |||
2024/06/25 | Not Applicable | Not yet recruiting | |||
2023/02/13 | Phase 3 | Completed | |||
2022/08/11 | Phase 1 | Completed | |||
2022/07/13 | Phase 4 | Not yet recruiting | |||
2022/05/17 | Phase 1 | Completed | Universidade de Passo Fundo | ||
2022/02/02 | Not Applicable | Completed | |||
2021/08/12 | Phase 2 | UNKNOWN | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2021/08/02 | Phase 4 | UNKNOWN | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. | 54092-546 | ORAL | 1 mg in 1 1 | 11/30/2020 | |
| Hikma Pharmaceuticals USA Inc | 0054-0750 | ORAL | 2 mg in 1 1 | 7/10/2025 | |
| Takeda Pharmaceuticals America, Inc. | 54092-547 | ORAL | 2 mg in 1 1 | 11/30/2020 | |
| Hikma Pharmaceuticals USA Inc | 0054-0749 | ORAL | 1 mg in 1 1 | 7/10/2025 | |
| Lupin Pharmaceuticals, Inc. | 70748-390 | ORAL | 2 mg in 1 1 | 8/14/2025 | |
| Lupin Pharmaceuticals, Inc. | 70748-389 | ORAL | 1 mg in 1 1 | 8/14/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/14/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Resolor Film-coated Tablet 2 mg | SIN14104P | TABLET, FILM COATED | 2mg | 2/14/2012 | |
| Resolor Film-coated Tablet 1 mg | SIN14103P | TABLET, FILM COATED | 1mg | 2/14/2012 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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