DEXILANT (dexlansoprazole)
Dexilant is a medication used for patients 12 years and older who suffer from acid-related esophageal conditions. It helps patients with the healing of all grades of erosive esophagitis and provides ongoing relief from heartburn by maintaining that healing. Additionally, it treats the heartburn symptoms associated with non-erosive gastroesophageal reflux disease (GERD).
How DEXILANT Works
This drug works by suppressing the secretion of gastric acid in the stomach. It specifically targets and inhibits the (H+, K+)-ATPase enzyme, often called the proton pump, located on the surface of gastric parietal cells. By binding to this enzyme, it blocks the final step of acid production to reduce overall stomach acidity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-01-30
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE
DEXILANT Approval History
What DEXILANT Treats
3 indicationsDEXILANT is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erosive Esophagitis
- Gastroesophageal Reflux Disease
- Heartburn
DEXILANT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DEXILANT
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02615184 | TAK-390MR_205 2022-501350-11-00, U1111-1166-8811 | Ph 2 | terminated | 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 |
| NCT02616302 | TAK-390MR_204 2022-501349-64-00, U1111-1166-8748 | Ph 2 | active not recruiting | 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 |
| NCT01216293 results posted | TAK-390MR_104 U1111-1116-1638 | Ph 1 | completed | Effect of Dexlansoprazole on Bone Homeostasis |
| NCT04877834 BABE | CB-035-DEX(D)-2020 | Ph 1 | completed | Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects. |
| NCT02442752 | TAK-390MR_108 2014-001642-16, U1111-1162-4853 | Ph 1 | withdrawn | Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months |
| NCT02873689 results posted | TAK-390MR_302 U1111-1171-1002 | Ph 3 | completed | Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients |
| NCT03316976 results posted | TAK-390MR_106 U1111-1192-7711, CTR20160792 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants |
| NCT02873702 results posted | TAK-390MR_301 U1111-1142-0320 | Ph 3 | terminated | Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis |
| NCT02351960 results posted | DEX-P4-001 U1111-1155-8622 | Ph 4 | completed | Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease |
| NCT02162758 results posted | DEX-P4-003 U1111-1152-6767 | Ph 2 | terminated | Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation |
| NCT01149395 | 10-0417 | Ph 1 | completed | Can E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn |
| NCT01093755 results posted | 09-007252 | Ph 4 | completed | Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation? |
| NCT02529787 | GRC/1/12/406 | Ph 1 | completed | A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA) |
| NCT01642615 results posted | TAK-390MR_207 U1111-1128-6117, 2012-001681-15 | Ph 2 | completed | Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents |
| NCT02096458 results posted | TAK-390MR(OD)_107 U1111-1152-9255 | Ph 1 | completed | Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets |
| NCT01642602 results posted | TAK-390MR_206 U1111-1128-5977, 2012-001680-72 | Ph 2 | completed | Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents |
| NCT01479231 | 11-003759 | Ph 1, Ph 2 | withdrawn | Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis |
| NCT01045096 results posted | T-P107-174 U1111-1112-1684 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease |
| NCT00627016 results posted | T-GD07-170 U1111-1113-9537 | Ph 3 | completed | A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DEXILANT FDA Label Details
Indications & Usage
FDA Label (PDF)DEXILANT is indicated for the treatment of Erosive Esophagitis; Gastroesophageal Reflux Disease; Heartburn.
DEXILANT Patents & Exclusivity
Patents (12 active)
Pro Intelligence Preview
Deep insights for DEXILANT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 56 active patents
Trial Analysis
- • 23 total trials
- • Stage: Declining
Competitive Landscape
- • 16 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment