Dexlansoprazole
- Generic Name
- Dexlansoprazole
- Brand Names
- Dexilant
- Drug Type
- Small Molecule
- Chemical Formula
- C16H14F3N3O2S
- CAS Number
- 138530-94-6
- Unique Ingredient Identifier
- UYE4T5I70X
- Background
Dexlansoprazole is a new generation proton pump inhibitor (PPI) used for the management of symptoms associated with gastroesophageal reflux disease (GERD) and erosive esophagitis. Dexlansoprazole is the R-enantiomer of Lansoprazole, which is composed of a racemic mixture of the R- and S-enantiomers. Compared to the older generation of PPIs (which includes Pa...
- Indication
Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for:
- Associated Conditions
- Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Healed erosive esophagitis
- Associated Therapies
- -
Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects.
- First Posted Date
- 2021-05-07
- Last Posted Date
- 2023-11-29
- Lead Sponsor
- University of Karachi
- Target Recruit Count
- 60
- Registration Number
- NCT04877834
- Locations
- 🇵🇰
Center for Bioequivalence Studies and clinical research, Karachi, Sindh, Pakistan
A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants
- First Posted Date
- 2017-10-23
- Last Posted Date
- 2019-05-10
- Lead Sponsor
- Takeda
- Target Recruit Count
- 40
- Registration Number
- NCT03316976
- Locations
- 🇨🇳
Phase I Clinical Trial Department, Beijing, Beijing, China
Effectiveness of Physiologic Testing in PPI Non-Responders
- First Posted Date
- 2017-06-28
- Last Posted Date
- 2023-01-12
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 240
- Registration Number
- NCT03202537
- Locations
- 🇺🇸
Northwestern Memorial Health Care, Chicago, Illinois, United States
Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients
- Conditions
- Interventions
- First Posted Date
- 2016-08-19
- Last Posted Date
- 2019-07-05
- Lead Sponsor
- Takeda
- Target Recruit Count
- 217
- Registration Number
- NCT02873689
- Locations
- 🇨🇳
Peking University First Hospital, Beijing, Beijing, China
🇨🇳Peking Union Medical College Hospital, Beijing, Beijing, China
🇨🇳The People's Hospital of Guangxi Zhuang Autonomous Region, Nan Ning, Guang XI, China
Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis
- Conditions
- Interventions
- First Posted Date
- 2016-08-19
- Last Posted Date
- 2019-02-22
- Lead Sponsor
- Takeda
- Target Recruit Count
- 37
- Registration Number
- NCT02873702
- Locations
- 🇨🇳
Binzhou Medical University Hospital, Binzhou, Shandong, China
🇨🇳Peking Union Medical College Hospital, Beijing, Beijing, China
🇨🇳Chongqing Three Gorges Central Hospital, Chong Qing, Chong Qing, China
Treatment Effect Between Dexlansoprazole and Double-dose Lansoprazole in Obesity Patients With Reflux Esophagitis
- Conditions
- Interventions
- First Posted Date
- 2016-05-03
- Last Posted Date
- 2016-05-03
- Lead Sponsor
- National Cheng-Kung University Hospital
- Target Recruit Count
- 200
- Registration Number
- NCT02759393
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
- First Posted Date
- 2015-11-26
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- Takeda
- Target Recruit Count
- 70
- Registration Number
- NCT02616302
- Locations
- 🇲🇽
SMIQ S. de R.L. de C.V., Queretaro, Mexico
🇺🇸Children's Center for Digestive Health Care, LLC, Atlanta, Georgia, United States
🇺🇸University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
A Study of Dexlansoprazole in Healing and Maintenance of Healed Erosive Esophagitis (EE) in Children
- First Posted Date
- 2015-11-26
- Last Posted Date
- 2023-08-18
- Lead Sponsor
- Takeda
- Target Recruit Count
- 76
- Registration Number
- NCT02615184
- Locations
- 🇺🇸
Children's Center for Digestive Health Care, LLC, Atlanta, Georgia, United States
🇺🇸D&H National Research Centers, Miami, Florida, United States
🇺🇸Gastrointestinal Associates, PA, Flowood, Mississippi, United States
A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA)
- First Posted Date
- 2015-08-20
- Last Posted Date
- 2015-08-20
- Lead Sponsor
- Genuine Research Center, Egypt
- Target Recruit Count
- 60
- Registration Number
- NCT02529787
- Locations
- 🇪🇬
Genuine Research Center GRC, Cairo, Egypt
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months
- Conditions
- Interventions
- First Posted Date
- 2015-05-13
- Last Posted Date
- 2020-04-15
- Lead Sponsor
- Takeda
- Registration Number
- NCT02442752
- Locations
- 🇺🇸
University of Louisville, Louisville, Kentucky, United States
🇲🇽Centro de Investigacion Clinica Acelerada, S.C., Mexico, Distrito Federal, Mexico
🇺🇸Children's Hospital Los Angeles, Los Angeles, California, United States
Drug Development Updates
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