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Home » Directories » FDA Approved Drugs » Motegrity (prucalopride)

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Motegrity (prucalopride)

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Contact Information

Contact: Takeda
Website: www.motegrity.com

Currently Enrolling Trials

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    General Information

    Motegrity (prucalopride) is a serotonin-4 (5-HT4) receptor agonist.

    Motegrity is specifically indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

    Motegrity is supplied as a tablet for oral administration. The recommended dose is as follows:

    Adults: 2 mg once daily

    Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min): 1 mg once daily

    Mechanism of Action

    Motegrity (prucalopride) is a selective serotonin type 4 (5-HT4) receptor agonist, a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility. 

    Side Effects

    Adverse effects associated with the use of Motegrity may include, but are not limited to, the following:

    • headache
    • abdominal pain
    • nausea
    • diarrhea
    • abdominal distension
    • dizziness
    • vomiting
    • flatulence
    • fatigue

    Clinical Trial Results

    The FDA approval of Motegrity was based on six double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks (studies 1-5) or 24 weeks (study 6) conducted in 2,484 adults. During studies, significantly more patients taking Motegrity achieved the primary endpoint (an average of ≥3 complete spontaneous bowel movements [CSBMs] per week over 12 weeks, considered normalization of BM frequency) than those in the placebo group (19-38% Motegrity ≤2 mg vs. 10-20% placebo) across five of six trials. A rapid response was seen with Motegrity as early as week 1, with improvements maintained throughout 12 weeks of treatment.

    Approval Date: 2018-12-01
    Company Name: Takeda
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