Drugs / Dexlansoprazole
Dexlansoprazole
also known as
Dexilant · Dexlansoprazole MR · (r)-lansoprazole · Dexilant solutab · Dexlansoprazol · Kapidex · Lansoprazole r-form · NSC-758710 · +3 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DEXILANT | — | 2011-06-17 – 2016-07-08 | fda.gov ↗ |
| Approved | US (FDA) | DEXILANT | — | 2009-01-30 | fda.gov ↗ |
Trials 46
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03202537 | Jul 2017 → Jul 2022 | gastroesophageal reflux disease | Northwestern University | Completed | No outcome recorded |
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT02442752 | Jun → Dec 2025 | gastroesophageal reflux disease | Takeda | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03801148 | Jan → Feb 2019 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03316976 | Nov 2017 → Feb 2018 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT03120273 | May → Aug 2017 | — | First Affiliated Hospital of Zhejiang University | Unknown | No outcome recorded |
| Phase 1 | NCT03011125 | Jan → Mar 2017 | — | First Affiliated Hospital of Zhejiang University | Completed | No outcome recorded |
| Phase 1 | NCT02096458 | Feb 2014 | dyspepsia, esophagitis, gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02064907 | Feb → Mar 2014 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT01216293 | Nov 2010 → Aug 2014 | bone disorder | Takeda | Completed | Met primary |
| Phase 1 | NCT01149395 | Jun 2010 → Apr 2012 | dyspepsia, gastroesophageal reflux disease | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT01045096 | Mar 2010 → Feb 2011 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT00942175 | Dec 2009 → Jun 2010 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT00847210 | May → Sep 2009 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01479231 | Mar 2012 | eosinophilic esophagitis, gastroesophageal reflux disease | Mayo Clinic | Withdrawn | No outcome recorded Stop: Business |
| Phase 25 trials | ||||||
| Phase 2 | NCT02615184 | May 2023 → Apr 2026 | esophagitis | Takeda | Terminated | No outcome recorded |
| Phase 2 | NCT02616302 | Feb 2023 → Oct 2027 expected | gastroesophageal reflux disease | Takeda | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02162758 | Jul 2014 → Apr 2016 | Barrett esophagus | Takeda | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01642602 | Jul 2012 → Jan 2014 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT01642615 | Jul 2012 → Nov 2014 | esophagitis, gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03319121 | Mar 2015 → Dec 2017 | — | Universiti Sains Malaysia | Completed | Met primary |
| Phase 313 trials · 9 met primary · 1 missed | ||||||
| Phase 3 | NCT02873689 | Dec 2016 → Mar 2018 | dyspepsia, gastroesophageal reflux disease | Takeda | Completed | Missed primary |
| Phase 3 | NCT02873702 | Dec 2016 → Oct 2017 | esophagitis | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT00847808 | Feb 2009 → Apr 2010 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00627016 | Mar 2008 → Mar 2009 | gastroesophageal reflux disease | Takeda | Completed | Met primary |
| Phase 3 | NCT00321984 | Jun → Dec 2006 | gastroesophageal reflux disease | Takeda | Completed | Met primary |
| Phase 3 | NCT00321737 | May 2006 → May 2007 | gastroesophageal reflux disease, peptic esophagitis | Takeda | Completed | Met primary |
| Phase 3 | NCT00255190 | Jan 2006 → Jun 2008 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00255164 | Jan → Nov 2006 | gastroesophageal reflux disease, peptic esophagitis | Takeda | Completed | Met primary |
| Phase 3 | NCT00255151 | Jan → Nov 2006 | gastroesophageal reflux disease, peptic esophagitis | Takeda | Completed | Met primary |
| Phase 3 | NCT00251693 | Dec 2005 → Jan 2007 | gastroesophageal reflux disease, peptic esophagitis | Takeda | Completed | Met primary |
| Phase 3 | NCT00251719 | Dec 2005 → Jan 2007 | gastroesophageal reflux disease, peptic esophagitis | Takeda | Completed | Met primary |
| Phase 3 | NCT00251758 | Dec 2005 → May 2006 | gastroesophageal reflux disease | Takeda | Completed | Met primary |
| Phase 3 | NCT00251745 | Dec 2005 → May 2006 | gastroesophageal reflux disease | Takeda | Completed | Met primary |
| Phase 47 trials | ||||||
| Phase 4 | NCT07344506 | May 2025 → May 2026 overdue | Helicobacter pylori infectious disease | Dow University of Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT03079050 | Feb → Jul 2017 | gastroesophageal reflux disease | American University of Beirut Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03087162 | Jan → Dec 2017 | — | Ramathibodi Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02759393 | Oct 2015 → Jul 2017 | gastroesophageal reflux disease | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02351960 | Mar 2015 → Jun 2016 | gastroesophageal reflux disease | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT03128736 | Apr 2014 → Feb 2016 | gastroesophageal reflux disease | Kaohsiung Medical University Chung-Ho Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01328652 | Jun 2011 → Aug 2012 | tongue disorder, upper respiratory tract disorder | Advanced Center for Specialty Care | Unknown | No outcome recorded |
| Phase not applicable6 trials · 1 met primary | ||||||
| — | NCT03418337 | Aug 2017 → Jul 2018 | proton-pump inhibitor-responsive esophageal eosinophilia | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| — | NCT03829150 | Mar 2017 → Apr 2019 | Helicobacter pylori infectious disease | Chang Gung Memorial Hospital | Completed | Met primary |
| — | NCT02646332 | Dec 2015 → Jul 2020 | Helicobacter pylori infectious disease | Kaohsiung Veterans General Hospital. | Completed | No outcome recorded |
| — | NCT02490449 | Dec 2014 → Dec 2015 | gastroesophageal reflux disease | Soonchunhyang University Hospital | Unknown | No outcome recorded |
| — | NCT01328392 | May 2011 → Apr 2012 | gastroesophageal reflux disease | University of Washington | Withdrawn | No outcome recorded Stop: Business |
| — | NCT01317472 | Mar 2011 → Nov 2013 | gastroesophageal reflux disease | Indiana University | Terminated | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT03043521 Comparator | May → Aug 2015 | — | HK inno.N Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02637557 Background | Mar 2016 → Apr 2017 | gastroesophageal reflux disease | Ironwood Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT00978016 Background | Sep 2009 → Dec 2010 | gastroesophageal reflux disease | XenoPort, Inc. | Completed | Missed primary |
| Phase 4 | NCT06778395 Comparator | Oct → Dec 2024 | gastroesophageal reflux disease | Ayman Magd Eldin Mohammad Sadek | Completed | No outcome recorded |
| Phase 4 | NCT03094416 Background | Jul 2018 → Jun 2020 | postsurgical hypothyroidism | IBSA Institut Biochimique SA | Completed | No outcome recorded |
| Phase 4 | NCT02541786 Comparator | Jan → Jun 2015 | Helicobacter pylori infectious disease | Kaohsiung Medical University | Completed | No outcome recorded |
| Phase 4 | NCT02249546 Comparator | Sep 2014 → Aug 2016 | Helicobacter pylori infectious disease | National Taiwan University Hospital | Unknown | Missed primary |
| Phase 4 | NCT01093755 Comparator | Mar 2010 → Nov 2014 | Barrett esophagus | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT01637571 Comparator | — | gastroesophageal reflux disease, intermediate coronary syndrome | University of Iowa | Withdrawn | No outcome recorded Stop: Business |
| — | NCT00928161 Comparator | Nov 2012 → Nov 2014 | gastroesophageal reflux disease, oropharynx cancer | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| — | NCT00880906 Comparator | Aug 2008 → Dec 2013 | eosinophilic esophagitis | Vanderbilt University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-11-01 | Alembic Pharmaceuticals Ltd. | Regulatory 13th November, 2025 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dexlansoprazole Delayed-Release Capsules, 30 mg and 60 mg. |
| 2011-04-04 | Impax Laboratories, LLC | Regulatory Impax Laboratories Confirms Patent Challenge Relating to DEXILANT(R) Delayed-ReleaseCapsules, 30 mg and 60 mg amneal.com ↗
Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of DEXILANT(R) with the U.S. Food & Drug Administration (FDA). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-01 | Alembic Pharmaceuticals Ltd. | 13th November, 2025 Vadodara, India alembicpharmaceuticals.com ↗ |
| 2011-04-04 | Impax Laboratories, LLC | Impax Laboratories Confirms Patent Challenge Relating to DEXILANT(R) Delayed-ReleaseCapsules, 30 mg and 60 mg amneal.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dexlansoprazole | “Allowable PPIs : Rabeprazole Sodium 20 mg QD, Esomeprazole Magnesium 20 mg or 40 mg QD, Lansoprazole 15 mg or 30 mg QD, Pantoprazole 20 mg or 40 mg QD, Omeprazole 20 mg or 40...” NCT00978016 ↗54“All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium...” NCT02637557 ↗ “with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily” NCT02646332 ↗ “oral dexlansoprazole (Dexilant 60 mg, Takeda Co. Ltd, Tokyo, Japan) once daily before breakfast for 8 weeks” NCT03418337 ↗ “extended release lansoprazole (Dexlansoprazole, Takeda Pharmaceuticals, Japan) 60 mg daily for 2 weeks” NCT03319121 ↗ “Dexlansoprazole 60mg qd Amoxicillin 1000mg bid Clarithromycin 500mg bid All for 14 days” NCT02249546 ↗ “omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole” NCT03094416 ↗ “Dexlansoprazole MR 60 mg qd for 7 days” NCT03829150 ↗ |
| Known as | (r)-lansoprazole | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201863 ↗ |
| Known as | Dexilant | “oral dexlansoprazole (Dexilant 60 mg, Takeda Co. Ltd, Tokyo, Japan) once daily before breakfast for 8 weeks” NCT03418337 ↗ |
| Known as | Dexilant solutab | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201863 ↗ |
| Known as | Dexlansoprazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201863 ↗ |
| Known as | Dexlansoprazole MR | “Dexlansoprazole MR 60 and 90 mg once daily also produced significant increases in the percentage of time with intragastric pH >4 over 24-h postdose compared with lansoprazole...” NCT02249546 ↗2“Dexlansoprazole MR, a modified-release formulation of dexlansoprazole, an enantiomer of lansoprazole, effectively heals erosive oesophagitis.” PMID 19681809 ↗ Aug 2009 “BACKGROUND: Dexlansoprazole MR is a dual delayed release formulation of dexlansoprazole, an enantiomer of lansoprazole.” PMID 19735233 ↗ Sep 2009 |
| Known as | Kapidex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201863 ↗ |
| Known as | Lansoprazole r-form | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201863 ↗ |
| Known as | NSC-758710 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201863 ↗ |
| Known as | T-168390 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201863 ↗ |
| Known as | TAK-390 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201863 ↗ |
| Known as | TAK-390 Modified Release (TAK-390MR) dexlansoprazole | “TAK-390 Modified Release (TAK-390MR) dexlansoprazole” NCT03316976 ↗ |
| Action | Inhibit | “a proton pump inhibitor with a novel dual delayed-release formulation” PMID 19183157 ↗ Apr 2009 |
| Modality | Other / unclassified | “a proton pump inhibitor” PMID 19183157 ↗ Apr 2009 |
| Route | Oral | “when administered orally as a single daily dose in the morning, before breakfast” NCT00251693 ↗ |