Data updated: May 26, 2026
DEXILANT SOLUTAB (dexlansoprazole)
Gastrointestinal
Approved 2016-01-26
2
Indications
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-01-26
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
DEXILANT SOLUTAB Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2016 to 2016 · 1 indication expansions
What DEXILANT SOLUTAB Treats
2 FDA approvalsOriginally approved for its first indication in 2016 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
18 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| NCT02442752 | TAK-390MR_108 2014-001642-16, U1111-1162-4853 | Ph 1 | withdrawn | Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months |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? |
| 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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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 SOLUTAB FDA Label Details
View full patent landscape →
7 OB patents · 3 families ·
77 international docs across 27 countries
DEXILANT SOLUTAB Patents & Exclusivity
Latest Patent: Mar 2029
Patents (7 active)
US9241910
Expires Mar 10, 2029
US8871273*PED
Expires Jul 11, 2028
US8871273
Expires Jan 11, 2028
US8461187*PED
Expires Jul 17, 2026
US9011926
Expires Feb 24, 2026
US9238029
Expires Jan 17, 2026
US8461187
Expires Jan 17, 2026
Source: FDA Orange Book
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Revenue Insights
- • Quarterly revenue tracking
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Patent Timeline
- • Cliff: 2029
- • 7 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.