NDAORALCAPSULE
Approved
Jan 2006
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
AMITIZA (lubiprostone) by Pfizer is chloride channel activators [moa]. First approved in 2006.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMITIZA (lubiprostone) is an oral small-molecule chloride channel activator approved in 2006 for chronic idiopathic constipation and irritable bowel syndrome with constipation. It works by activating ClC-2 chloride channels on the apical membrane of the intestinal epithelium, increasing intestinal fluid secretion and promoting bowel movements. The drug is administered as an oral capsule and represents a unique mechanism in the gastrointestinal therapeutic space.
$8MPart D
LOE ApproachingDeclining
1.3 years to LOEModest Part D utilization (18,592 claims) reflects a mature, stable product facing near-term patent expiration with likely smaller commercial teams focused on harvest strategy.
Mechanism of Action
Chloride Channel Activators
Pharmacologic Class:
Chloride Channel Activator
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Lubiprostone to Treat Constipation
Started Sep 2021
3,000 enrolled
Constipation
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
Started Nov 2016
49 enrolled
Healthy Volunteers
Lubiprostone for Chronic Idiopathic Constipation Treatment
Started May 2016
211 enrolled
Constipation
Lubiprostone for Treatment of Chronic Idiopathic Constipation
Started Apr 2016
156 enrolled
Chronic Idiopathic Constipation
Lubiprostone for the Treatment of Chronic Idiopathic Constipation
Started Mar 2016
204 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.