NDAORALTABLET
Approved
Jan 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13
Data completeness
5/8 — Partial
TRULANCE (plecanatide) by Salix Pharmaceuticals is guanylate cyclase activators [moa]. First approved in 2017.
Drug data last refreshed 13h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRULANCE (plecanatide) is an oral small-molecule guanylate cyclase-C agonist approved in 2017 for chronic idiopathic constipation. It works by activating GC-C receptors in the intestine to increase fluid secretion and promote bowel movements. The drug represents a novel mechanism class within the constipation treatment landscape.
$119.0MPart D
Peak7.7 years to LOEProduct is in peak lifecycle stage with nearly $120M in annual Part D spending, indicating a stable commercial infrastructure but maturation-phase team dynamics.
Mechanism of Action
Guanylate Cyclase Activators
Pharmacologic Class:
Guanylate Cyclase-C Agonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Started Jun 2026
180 enrolled
Functional Constipation (FC)
Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation
Started Mar 2022
648 enrolled
Functional Constipation
Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
Started Jun 2018
218 enrolled
Irritable Bowel Syndrome With Constipation
A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
Started Jun 2018
7 enrolled
Chronic Idiopathic Constipation
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
Started Jan 2017
124 enrolled
Chronic Idiopathic 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.