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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

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.

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

FDA Approved Products

MOTEGRITY
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:ORAL
Strength:2 mg in 1 1
Approved: 2020/11/30
NDC:54092-547
MOTEGRITY
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2020/11/30
NDC:54092-546

Singapore Approved Products

Resolor Film-coated Tablet 2 mg
Manufacturer:Janssen Cilag S.p.A.
Form:TABLET, FILM COATED
Strength:2mg
Online:Yes
Approved: 2012/02/14
Approval:SIN14104P
Resolor Film-coated Tablet 1 mg
Manufacturer:Janssen Cilag S.p.A.
Form:TABLET, FILM COATED
Strength:1mg
Online:Yes
Approved: 2012/02/14
Approval:SIN14103P

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