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Prucalopride

Generic Name
Prucalopride
Brand Names
Motegrity, Resolor, Resotran
Drug Type
Small Molecule
Chemical Formula
C18H26ClN3O3
CAS Number
179474-81-8
Unique Ingredient Identifier
0A09IUW5TP
Background

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
Clinical Trials
Related News

Sunshine Biopharma Expands Portfolio with Two Gastrointestinal Drugs for Chronic Idiopathic Constipation

• Sunshine Biopharma's Canadian subsidiary, Nora Pharma Inc., has acquired rights to two gastrointestinal drugs, with Prucalopride already launched and a second product planned within 9 months. • Prucalopride, a generic version of Resotran®, selectively stimulates 5-HT4 receptors to treat chronic idiopathic constipation in adult women when laxatives prove inadequate. • The chronic idiopathic constipation market, currently valued at over $200 million CAD annually, is projected to grow at a CAGR of 4.64% from 2024 to 2034.

Prucalopride Shows Broad Efficacy in Chronic Constipation Across Patient Demographics, New Analysis Reveals

• Post-hoc analysis of six phase 3 and 4 clinical trials demonstrates prucalopride's effectiveness in treating chronic idiopathic constipation across different age groups, with significant improvements in bowel movements. • The drug showed strong efficacy in patients with normal to mildly impaired renal function and those with underweight to overweight BMI, though benefits were less pronounced in obese patients. • While more treatment-related adverse events were reported in the prucalopride group, researchers found no unexpected safety concerns across all patient subgroups studied.

ANI Pharmaceuticals Launches Prucalopride Tablets for Chronic Idiopathic Constipation with 180-Day Exclusivity

• ANI Pharmaceuticals has launched Prucalopride Tablets, a generic version of Motegrity, after receiving FDA approval and a Competitive Generic Therapy (CGT) designation. • Prucalopride, a selective 5-HT4 receptor agonist, enhances colon muscle movement to alleviate infrequent bowel movements in adults with chronic idiopathic constipation. • Clinical trials have demonstrated prucalopride's efficacy and safety in treating chronic constipation, showing a higher proportion of patients achieving at least 3 spontaneous bowel movements per week compared to placebo. • Real-world studies suggest prucalopride has higher treatment persistence and adherence compared to other prescription medications for chronic idiopathic constipation.
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