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Data updated: Jun 28, 2026

DEXILANT SOLUTAB (dexlansoprazole) · Takeda

Gastrointestinal Approved 2016-01-26

DEXILANT SOLUTAB is FDA-approved to treat 3 conditions (same as DEXLANSOPRAZOLE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2016-01-26
Patent Cliff
2029

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Companies

Takeda
Active Ingredient: DEXLANSOPRAZOLE

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
Oct 2016 SUPPL
Label · Labeling
FDA Letter Label
Jul 2016 SUPPL
Efficacy
FDA Letter Label
Jan 2016 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What DEXILANT SOLUTAB Treats

3 indications

DEXILANT SOLUTAB is approved for 3 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as DEXLANSOPRAZOLE (same active ingredient).

Source: FDA Label
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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NCT02442752 TAK-390MR_108 2014-001642-16, U1111-1162-4853 Ph 1 withdrawn Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months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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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

FDA Label (PDF)

DEXILANT SOLUTAB is FDA-approved to treat 3 conditions — same approved indications as DEXLANSOPRAZOLE.

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
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 7 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA208056 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.