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Dexilant

(dexlansoprazole)

ApprovedSmall molecule

Dexlansoprazole is used to treat acid reflux and heartburn by reducing the amount of acid produced in the stomach, and it also helps heal damage to the esophagus caused by stomach acid.[2] Dexilant is currently approved and in use across 7 indications[4].[1]

Dexilant is one of 140 small molecule programs targeting Barrett's esophagus. It is currently in Approved.

7

Indications

31

Total Trials

2

Active Trials

139

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

14

Patents

Pipeline

Status by Indication[4][1]

Indication

Barrett's EsophagusApproved

Peptic UlcerActive, not recruiting

Laryngopharyngeal RefluxActive, not recruiting

Gastroesophageal Reflux DiseaseActive, not recruiting

Peptic EsophagitisApproved

Eosinophilic EsophagitisActive, not recruiting

EsophagitisActive, not recruiting

Barrett's EsophagusApproved

Approved

Peptic UlcerApproved

Active, not recruiting

Laryngopharyngeal RefluxPreclinical

Active, not recruiting

Gastroesophageal Reflux DiseaseApproved

Active, not recruiting

Peptic EsophagitisApproved

Approved

Eosinophilic EsophagitisPhase 1

Active, not recruiting

EsophagitisApproved

Active, not recruiting

Competition

Competitive Landscape

80 competitors in Gastroesophageal Reflux Disease

#DrugCompanyPhaseTrials

Dexilant

Galzin

AAmerican Regent, Inc.

Prevacid

Alka-Seltzer

Rabeprazole ER

Zantac 150

Pulmicort

Esomeprazole Mg

Circadin

NNeurim Pharmaceuticals Ltd.

DWP14012

Daewoong Pharmaceutical Co. LTD.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Active, not recruiting

Esophagitis

NCT02615184

Phase 2Recruiting

Gastroesophageal Reflux Disease

NCT02616302

Clinical

Trials by Indication[1]

Gastroesophageal Reflux Disease5 trials

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

Recruiting· Takeda logo

Takeda·Phase 2·NCT02616302·70 enrolled

Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease

Completed· Takeda logo

Takeda·Phase 1·NCT01045096·36 enrolled

Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease

Completed· Takeda logo

Takeda·Phase 4·NCT02351960·296 enrolled

Show 2 more trials

Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents

Completed· Takeda logo

Takeda·Phase 2·NCT01642602·104 enrolled

Therapeutic Effect of Vonoprazan Versus Dexlansoprazole in Treatment of Gastroesophageal Reflux Disease

Completed·AAyman Magd Eldin Mohammad Sadek·Phase 4·NCT06778395·136 enrolled

Esophagitis4 trials

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

Active, not recruiting· Takeda logo

Takeda·Phase 2·NCT02615184·76 enrolled

Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis

Terminated· Takeda logo

Takeda·Phase 3·NCT02873702·37 enrolled

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

Completed· Takeda logo

Takeda·Phase 2·NCT01642615·63 enrolled

Show 1 more trial

Treatment Effect Between Dexlansoprazole and Double-dose Lansoprazole in Obesity Patients With Reflux Esophagitis

Unknown status·NNational Cheng-Kung University Hospital·Phase 4·NCT02759393·200 enrolled

Heartburn3 trials

Can E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT01149395·40 enrolled

A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

Completed· Takeda logo

Takeda·Phase 3·NCT00627016·305 enrolled

An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan

Completed·—·Phase 4·NCT03079050·33 enrolled

Treatment2 trials

The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux

Terminated·IIndiana University·N/A·NCT01317472·11 enrolled

Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

Withdrawn·UUniversity of Washington·N/A·NCT01328392

Oral2 trials

Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets

Completed· Takeda logo

Takeda·Phase 1·NCT02096458·8 enrolled

Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants

Completed· Takeda logo

Takeda·Phase 1·NCT02064907·52 enrolled

13 more indications

Clinical Trial2 trials

A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults (Part 1)

Completed·FFirst Affiliated Hospital of Zhejiang University·Phase 1·NCT03011125·28 enrolled

A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults（Part 2）

Unknown status·FFirst Affiliated Hospital of Zhejiang University·Phase 1·NCT03120273·70 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

Completed· Takeda logo

Takeda·Phase 3·NCT02873689·217 enrolled

Phase 11 trial

Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months

Withdrawn· Takeda logo

Takeda·Phase 1·NCT02442752

Effectiveness1 trial

Effectiveness of Physiologic Testing in PPI Non-Responders

Completed·NNorthwestern University·Phase 1·NCT03202537·240 enrolled

Tics1 trial

A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants

Completed· Takeda logo

Takeda·Phase 1·NCT03316976·40 enrolled

Laryngopharyngeal Reflux1 trial

Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy

Unknown status·AAdvanced Center for Specialty Care·Phase 4·NCT01328652·80 enrolled

Eosinophilic Esophagitis1 trial

Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis

Withdrawn·MMayo Clinic·Phase 1/2·NCT01479231

Barrett's esophagus1 trial

Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?

Completed·MMayo Clinic·Phase 4·NCT01093755·30 enrolled

Radiofrequency Ablation1 trial

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

Terminated· Takeda logo

Takeda·Phase 2·NCT02162758·6 enrolled

Head and Neck Cancer1 trial

Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy

Withdrawn·MM.D. Anderson Cancer Center·N/A·NCT00928161

Homeostasis1 trial

Effect of Dexlansoprazole on Bone Homeostasis

Completed· Takeda logo

Takeda·Phase 1·NCT01216293·115 enrolled

Helicobacter Pylori1 trial

Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

Completed·RRamathibodi Hospital·Phase 4·NCT03087162·180 enrolled

Unspecified2 trials

Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects.

Completed·UUniversity of Karachi·Phase 1·NCT04877834·60 enrolled

Pharmacodynamic Properties of CJ-12420 on Evening Dosing

Completed·HHK inno.N Corporation·Phase 1·NCT03043521·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 30, 2009

DEXILANT

NDA NDA022287

Jan 26, 2016

DEXILANT SOLUTAB

NDA NDA208056

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for dexlansoprazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Dexilant drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — dexlansoprazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for dexlansoprazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208056). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Dexilant. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Potassium-Transporting Atpase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[6]

Patent Cliff

Jul 17, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8461187Jan 17, 2026

9238029Jan 17, 2026

9011926Feb 24, 2026

8461187*PEDJul 17, 2026

7790755Aug 2, 2026

9 more patents

8105626Sep 27, 2026

7790755*PEDFeb 2, 2027

8105626*PEDMar 27, 2027

8871273Jan 11, 2028

8871273*PEDJul 11, 2028

9241910Mar 10, 2029

8173158Mar 17, 2030

8173158*PEDSep 17, 2030

9233103Mar 5, 2032

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