dexlansoprazole
Trade name: dexilant
Approved
Jan 30, 2009
Dexlansoprazole (trade names Kapidex, Dexilant) is a proton pump inhibitor (PPI) that is marketed by Takeda Pharmaceuticals for the treatment of erosive esophagitis and gastro-oesophageal reflux disease. Dexlansoprazole is used to heal and maintain healing of erosive esophagitis and to treat heartburn associated with gastroesophageal reflux disease (GERD). It lasts longer than lansoprazole, to which it is chemically related, and needs to be taken less often. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules and orally disintegrating tablets. The capsules and tablets contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. The most significant adverse reactions (≥2%) reported in clinical trials were diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. — NCATS
Clinical trial activity
59 trials · 36 clinical orgs · 8 marketing orgs
Earliest trial started Dec 1, 2005 (NCT00251745)
Timeline
2000s
2010s
- Jan 1, 2010
Earliest Phase 2 Sponsor(trial)
- Apr 19, 2017
Endo Pharmaceuticals — Marketing Organization
- Apr 19, 2017
Par Pharmaceuticals — Marketing Organization
- Apr 19, 2017
Bristol-Myers Squibb — Marketing Organization
- Apr 19, 2017
PH HEALTH — Marketing Organization
2020s
- Sep 16, 2022
TWi Biotechnology, Inc. — Marketing Organization
- Jan 19, 2024
Mylan — Marketing Organization
- Nov 12, 2025
Alembic — Marketing Organization
Indications
Studied for
- Barrett Esophagus · Phase 4
- Biological Availability · Phase 1
- Bone and Bones · Phase 1
- Chest Pain · Phase 4
- Colitis, Ulcerative · Phase 2
- Deglutition Disorders · Phase 1/Phase 2
- Drugs, Generic · Phase 1
- Drug Therapy · Phase 4
- Eosinophilic Esophagitis · Phase 1/Phase 2
- Esophagitis · Phase 3
- Esophagitis, Peptic · Phase 3
- Gastroesophageal Reflux · Phase 4
- Healthy Volunteers · Phase 1
- Heartburn · Phase 3
- Helicobacter pylori · Phase 4
- Homeostasis · Phase 1
- Inflammation · Phase 4
- Intestinal Neoplasms · Phase 4
- Laryngopharyngeal Reflux · Phase 4
- Pharmacology, Clinical · Phase 1
- Proton Pump Inhibitors · Phase 4
- Tonsillitis · Phase 4
Mechanism of action
ATP4A
- Potassium-transporting ATPaseINHIBITOR
Potassium-transporting ATPase inhibitor
Alpha subunit is likely binding site
Approval history
- approvedJan 30, 2009
Chemistry & pharmacology
SMILES
CC1=C(OCC(F)(F)F)C=CN=C1C[S@@+]([O-])C2=NC3=C(N2)C=CC=C3- Mol. weight
- 369.361 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaDexlansoprazole ↗
- NCATSUYE4T5I70X ↗
- ChEMBLCHEMBL1201863 ↗
Also known as
- 2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole
- 2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole
- dexilant
- dexilant
- dexilant
- dexilant
- dexilant
- dexlansoprazole
- dexlansoprazole
- dexlansoprazole
- dexlansoprazole
- dexlansoprazole
- dexlansoprazole
- dexlansoprazole
- dexlansoprazole
- dexlansoprazole sesquihydrate
- dexlansoprazole sesquihydrate
- dexlansoprazole sesquihydrate
- dexlansoprazole sesquihydrate
- dexlansoprazole sesquihydrate
- dexlansoprazole sesquihydrate
- doxirazole
- kapidex
- kapidex
- kapidex
- (r)-lansoprazole
- r-lansoprazole
- t-168390
- t-168390
- tak-114
- tak-390
- tak-390
- tak-390
- tak-390mr
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07015866 | N/A | Jul 30, 2025 | Chinese University of Hong Kong, The Hong Kong Polytechnic University, University of Derby |
| NCT06778395 | Phase 4 | Oct 1, 2024 | Zagazig University |
| NCT06778824 | N/A | Apr 2, 2024 | Hualien Tzu Chi General Hospital |
| NCT04877834 | Phase 1 | Sep 18, 2021 | SAMI Pharmaceutical, Karachi Pakistan, University of Karachi |
| NCT03801148 | Phase 1 | Jan 10, 2019 | Takeda |
| NCT03316976 | Phase 1 | Nov 22, 2017 | Takeda |
| NCT03418337 | N/A | Aug 1, 2017 | Taipei Veteran General hospital |
| NCT03202537 | Early Phase 1 (Phase 1) | Jul 1, 2017 | Northwestern University, Vanderbilt University, Washington University in St. Louis |
| NCT03131895 | Phase 1 | Apr 24, 2017 | Takeda |
| NCT03829150 | N/A | Mar 1, 2017 | Chang Gung University, Kaohsiung Medical University |
| NCT03079050 | Phase 4 | Feb 27, 2017 | American University of Beirut, Takeda |
| NCT03087162 | Phase 4 | Jan 1, 2017 | Mahidol University |
| NCT03011125 | Phase 1 | Jan 1, 2017 | Jiangsu Aosaikang Pharmaceutical Co., Ltd., Zhejiang University |
| NCT02873689 | Phase 3 | Dec 31, 2016 | Takeda |
| NCT02873702 | Phase 3 | Dec 31, 2016 | Takeda |
| NCT02442752 | Phase 1 | Feb 1, 2016 | Takeda |
| NCT02646332 | N/A | Dec 1, 2015 | Taichung Veterans General Hospital |
| NCT02616302 | Phase 2 | Nov 1, 2015 | Takeda |
| NCT02615184 | Phase 2 | Nov 1, 2015 | Takeda |
| NCT02759393 | Phase 4 | Oct 1, 2015 | National Cheng Kung University |
Organizations
Research & Development (36)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Takeda | For profit | 34 | 30 | 5 | 2005 |
| Kaohsiung Medical University | Academic/Hospital | 3 | 2 | 2 | 2014 |
| Chang Gung University | Academic/Hospital | 2 | 1 | 2 | 2014 |
| Mayo Clinic | Academic/Hospital | 2 | 2 | 2 | 2010 |
| Vanderbilt University | Academic/Hospital | 2 | 1 | 2 | 2008 |
| Advanced Center for Specialty Care | Academic/Hospital | 1 | 1 | 1 | 2011 |
| American University of Beirut | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Chinese University of Hong Kong | Academic/Hospital | 1 | 0 | 1 | 2025 |
| CJ HealthCare Corp. | For profit | 1 | 1 | 1 | 2015 |
| Genuine Research Center, Egypt | For profit | 1 | 1 | 1 | 2013 |
| Hikma | For profit | 1 | 0 | 1 | 2013 |
| Hualien Tzu Chi General Hospital | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Indiana University | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Jiangsu Aosaikang Pharmaceutical Co., Ltd. | For profit | 1 | 0 | 1 | 2017 |
| Mahidol University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| National Cheng Kung University | Academic/Hospital | 1 | 1 | 1 | 2015 |
| National Taiwan University | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Natrogen Therapeutics International, Inc | For profit | 1 | 1 | 1 | 2010 |
| Northwestern University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Restech, Inc | For profit | 1 | 0 | 1 | 2011 |
Marketing (8)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alembic | For profit | MKTG | Nov 12, 2025 |
| Bristol-Myers Squibb | For profit | MKTG | Apr 19, 2017 |
| Endo Pharmaceuticals | For profit | MKTG | Apr 19, 2017 |
| Mylan | For profit | MKTG | Jan 19, 2024 |
| PH HEALTH | For profit | MKTG | Apr 19, 2017 |
| Par Pharmaceuticals | For profit | MKTG | Apr 19, 2017 |
| TWi Biotechnology, Inc. | For profit | MKTG | Sep 16, 2022 |
| Takeda | For profit | NDA | Jan 30, 2009 |