NDAORALTABLET1 Generic Approved
Approved
Dec 2018
Lifecycle
Peak
Competitive Pressure
45/100
Clinical Trials
16
Data completeness
3/8 — Basic
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MOTEGRITY (prucalopride) is an oral small-molecule 5-HT4 receptor agonist approved by the FDA in December 2018 for chronic idiopathic constipation. It works by enhancing intestinal muscle contractions to promote bowel movements in patients who have not responded adequately to conventional laxatives.
$62.0MPart D
Peak2.1 years to LOEThe product is at peak commercialization with $62M in Part D spending (2023), indicating an established market presence but modest scale relative to blockbuster comparators.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
A Study of Prucalopride in Breastfeeding Women With Constipation
Started Mar 2022
12 enrolled
Chronic Idiopathic Constipation (CIC)
A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy
Started Jan 2022
100 enrolled
ConstipationPregnancy
A Study of Prucalopride For Functional Constipation in Children and Teenagers
Started Jul 2021
175 enrolled
Constipation
Post-Marketing Study of Prucalopride Safety In Pregnancy
Started May 2021
127 enrolled
Chronic Idiopathic Constipation (CIC)
Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation
Started Oct 2014
280 enrolled
Constipation
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.