Dexlansoprazole
Dexilant, Dexlansoprazole (dexlansoprazole) is a small molecule pharmaceutical. Dexlansoprazole was first approved as Dexilant on 2009-01-30. It is used to treat gastroesophageal reflux, heartburn, and peptic esophagitis in the USA.
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Commercial
Therapeutic Areas
Trade Name
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Dexilant, Dexlansoprazole (discontinued: Dexilant)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dexilant | New Drug Application | 2025-02-17 |
| dexilant dexilant solutab | New Drug Application | 2017-08-16 |
| dexlansoprazole | ANDA | 2025-11-19 |
| equate lansoprazole delayed release | ANDA | 2020-05-06 |
| kapidex | New Drug Application | 2010-01-11 |
| kirkland signature lansoprazole delayed release | ANDA | 2020-03-23 |
| lansoprazole | ANDA | 2018-09-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| gastroesophageal reflux | EFO_0003948 | D005764 | K21 |
| peptic esophagitis | EFO_1001095 | D004942 | — |
| heartburn | — | D006356 | R12 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Dexlansoprazole, Dexilant, Takeda Pharms Usa | |||
| 9233103 | 2032-03-05 | U-1805 | |
| 8173158 | 2030-03-17 | U-949, U-950, U-951 | |
| 8871273 | 2028-01-11 | DP | |
| 8105626 | 2026-09-27 | DP | |
| 7790755 | 2026-08-02 | DP | |
| 9011926 | 2026-02-24 | DP | |
| 8461187 | 2026-01-17 | DP | |
| 9238029 | 2026-01-17 | DP | |
| Dexlansoprazole, Dexilant Solutab, Takeda Pharms Usa | |||
| 9241910 | 2029-03-10 | DP | |
HCPCS
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Clinical
Clinical Trials
305 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 6 | 3 | 8 | 4 | 6 | 27 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | 4 | 1 | 11 | 1 | 3 | 20 |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | 4 | 10 | 1 | 1 | 17 |
| Heartburn | D006356 | — | R12 | 1 | 1 | 2 | 1 | — | 5 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | 1 | 1 | 2 |
| Laryngopharyngeal reflux | D057045 | EFO_1001355 | — | — | — | — | 1 | 1 | 2 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | — | 1 | — | 1 |
| Endocrine gland neoplasms | D004701 | EFO_0003769 | D35 | — | — | — | 1 | — | 1 |
| Gastrinoma | D015408 | — | — | — | — | — | 1 | — | 1 |
| Zollinger-ellison syndrome | D015043 | — | E16.4 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ulcer | D014456 | MPATH_579 | — | — | — | 11 | — | 3 | 14 |
| Duodenal ulcer | D004381 | EFO_0004607 | K26 | — | — | 8 | — | 3 | 11 |
| Stomach ulcer | D013276 | — | K25 | — | — | 8 | — | 1 | 9 |
| Gout | D006073 | EFO_0004274 | M10 | — | 1 | 1 | — | — | 2 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 1 | — | — | 1 |
| Peptic ulcer | D010437 | — | K27 | — | — | 1 | — | — | 1 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | 1 | — | — | 2 | 3 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | — | — | 1 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | — | 1 | — | — | — | 1 |
| Metaplasia | D008679 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | 1 | — | — | — | 1 | 2 |
| Homeostasis | D006706 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 1 | 1 |
| Obstructive lung diseases | D008173 | — | — | — | — | — | — | 1 | 1 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | — | — | — | 1 | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dexlansoprazole |
| INN | dexlansoprazole |
| Description | Dexlansoprazole is a sulfoxide and a member of benzimidazoles. |
| Classification | Small molecule |
| Drug class | antiulcer agents (benzimidazole derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1c(OCC(F)(F)F)ccnc1C[S@@+]([O-])c1nc2ccccc2[nH]1 |
Identifiers
| PDB | — |
| CAS-ID | 138530-94-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201863 |
| ChEBI ID | — |
| PubChem CID | 9578005 |
| DrugBank | — |
| UNII ID | UYE4T5I70X (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Dexilant – Takeda
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Estimated US medical usage
Dexlansoprazole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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24,899 adverse events reported
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