Product Description
Dexlansoprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD; a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus [tube between the throat and stomach]) in adults and children 12 years of age and older. It is also used to treat esophagitis (swelling that may damage tissues of the esophagus) in adults and children 12 years of age and older. Dexlansoprazole is used for the maintenance treatment of esophagitis and healing in adults and children 12 years of age and older. Dexlansoprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach. (Sourced from: https://medlineplus.gov/druginfo/meds/a609017.html)
Mechanisms of Action: Proton Pump Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Bangladesh | Bosnia | Brazil | Canada | Colombia | Dominican Republic | Ecuador | Egypt | Germany | Hong Kong | India | Ireland | Israel | Italy | Jordan | Korea | Lebanon | Lithuania | Malaysia | Mexico | Peru | Philippines | Poland | Portugal | Russia | Saudi Arabia | Serbia | Singapore | Slovenia | South Africa | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United States | Uruguay | Vietnam
Approved Indications: Bile Reflux | Esophagitis | Gastroesophageal Reflux | Heartburn | Bile Reflux | Esophagitis | Gastroesophageal Reflux | Heartburn
Known Adverse Events: Abdominal Pain | Pain Unspecified | Diarrhea | Flatulence | Headache | Nasopharyngitis | Pharyngitis | Respiratory Tract Infections
Company: Takeda
Company Location: TOKYO M0 103-8668
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Poland
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Peptic Ulcer
Phase 2: Bile Reflux|Duodenal Ulcer|Esophagitis|Stomach Ulcer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| TAK-390MR_205 | P2 |
Unknown Status |
Esophagitis |
2027-10-31 |
|
| TAK-390MR_204 | P2 |
Unknown Status |
Bile Reflux |
2027-10-31 |
|
| CTR20210534 | P2 |
Not yet recruiting |
Duodenal Ulcer|Stomach Ulcer |
None |
|
| CTR20231884 | P3 |
Recruiting |
Peptic Ulcer |
None |