NDAORALCAPSULE, DELAYED RELEASE
Approved
Jan 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
48
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 Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEXILANT (dexlansoprazole) is an oral delayed-release capsule proton pump inhibitor (PPI) approved by the FDA on January 30, 2009, and developed by Takeda. It reduces gastric acid secretion by inhibiting the proton pump in parietal cells, making it effective for acid-reflux disorders and related gastrointestinal conditions. The drug represents a newer generation PPI with potential for improved pharmacokinetics compared to earlier agents in its class.
$0.1BPart D
5.8 years to LOEMechanism 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 (48)
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
76 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
70 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.