NDAORALCAPSULE
Approved
Aug 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
LINZESS (linaclotide) by AbbVie is guanylate cyclase activators [moa]. First approved in 2012.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LINZESS (linaclotide) is an oral guanylate cyclase-C agonist approved in 2012 for treating chronic idiopathic constipation and irritable bowel syndrome with constipation. It works by activating guanylate cyclase-C receptors in the intestine, increasing fluid secretion and promoting bowel motility. The drug is currently at peak lifecycle stage with $1.8B in Part D spending (2023).
$1.8BPart D
PeakStable
7.4 years to LOEMature, stable revenue base with established market presence; brand team likely at steady-state size focused on market defense and patient retention.
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 (20)
A Study of Virtual Reality and Linaclotide for IBS-C
Started May 2024
65 enrolled
Irritable Bowel Syndrome With Constipation
A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
Started Apr 2023
19 enrolled
Functional Constipation
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Started Dec 2022
123 enrolled
Functional Constipation (FC)Chronic Idiopathic Constipation (CIC)
Evaluate the Safety of Linaclotide in IBS-C Patients in China
Started Sep 2020
3,028 enrolled
Irritable Bowel Syndrome-IBS
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
Started Nov 2019
381 enrolled
Irritable Bowel Syndrome With ConstipationFunctional 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.