NDAORALCAPSULE, DELAYED RELEASE
Approved
Jan 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
21
Data completeness
7/8 — Comprehensive
DEXILANT (dexlansoprazole) by Takeda is proton pump inhibitors [moa]. Approved for proton pump inhibitor [epc]. First approved in 2009.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Dexlansoprazole is a proton pump inhibitor (PPI) oral capsule approved in 2009 for acid-reflux disorders, including GERD and maintenance of healed erosive esophagitis. It works by irreversibly blocking gastric H+/K+-ATPase pumps, reducing gastric acid production. The dual-release formulation provides sustained acid suppression over 24 hours.
$0.087BPart D
PeakStable
5.7 years to LOEProduct is at peak maturity with sustained $87M in Part D spending; brand team size likely stable with focus on retention and lifecycle management rather than growth initiatives.
Mechanism of Action
Proton Pump Inhibitors
Pharmacologic Class:
Proton Pump Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months
Started Jun 2025
0Pediatric Gastroesophageal Reflux Disease
A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old
Started May 2023
24 enrolled
Erosive Esophagitis
A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old
Started Feb 2023
71 enrolled
Gastroesophageal Reflux Disease (GERD)
A Study of Dexlansoprazole Modified Release (MR) in Gastroesophageal Reflux Disease (GERD) Participants in the Russian Federation
Started Mar 2020
0Gastroesophageal Reflux Disease
A Study to Compare the Bioavailability (BA) of Dexlansoprazole Delayed-release Capsules
Started Jan 2019
122 enrolled
Healthy Volunteers
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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.