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.