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
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Dexilant (generic drugs available since 2017-04-19)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dexilant | New Drug Application | 2023-07-25 |
| dexilant dexilant solutab | New Drug Application | 2017-08-16 |
| dexlansoprazole | ANDA | 2024-01-29 |
| equate lansoprazole delayed release | ANDA | 2019-11-21 |
| 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 |
| heartburn | — | D006356 | R12 |
| peptic esophagitis | EFO_1001095 | D004942 | — |
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
296 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 | 11 | 9 | 12 | 17 | 14 | 59 |
| Healthy volunteers/patients | — | — | — | 26 | — | 1 | 4 | — | 31 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | 8 | 14 | 5 | 28 |
| Esophagitis | D004941 | HP_0100633 | K20 | 2 | 5 | 9 | 3 | — | 19 |
| Stomach ulcer | D013276 | — | K25 | — | — | 11 | 1 | 1 | 13 |
| Heartburn | D006356 | — | R12 | 3 | 2 | 4 | 2 | — | 10 |
| Peptic ulcer | D010437 | HP_0004398 | K27 | — | — | 3 | 4 | 1 | 8 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | 4 | 1 | 2 | 7 |
| Laryngopharyngeal reflux | D057045 | EFO_1001355 | — | 1 | — | — | 3 | 3 | 7 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | — | 1 | 5 | 1 | — | 7 |
Show 33 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Duodenal ulcer | D004381 | EFO_0004607 | K26 | — | — | 10 | — | 2 | 12 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | 1 | — | — | 3 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 2 | 1 | — | — | 3 |
| Gout | D006073 | EFO_0004274 | M10 | — | 1 | 1 | — | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 1 | — | 1 | 2 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 1 | — | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
| Human experimentation | D006805 | — | — | — | — | 1 | — | — | 1 |
| Family | D005190 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 1 | — | — | — | 1 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | — | 1 | — | — | — | 1 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | — | 1 | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | 1 | — | — | — | 1 |
| Rectal neoplasms | D012004 | — | — | — | 1 | — | — | — | 1 |
| Avulsion fractures | D000071562 | — | — | 1 | 1 | — | — | — | 1 |
| Appendiceal neoplasms | D001063 | EFO_0003880 | C18.1 | — | 1 | — | — | — | 1 |
| Pseudomyxoma peritonei | D011553 | EFO_0007456 | — | — | 1 | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Homeostasis | D006706 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Mouth neoplasms | D009062 | EFO_0003868 | C06.9 | 1 | — | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Aortic valve disease | D000082862 | — | — | — | — | — | — | 1 | 1 |
| Calcium metabolism disorders | D002128 | EFO_0005769 | E83.5 | — | — | — | — | 1 | 1 |
| Non-erosive reflux disease | D000096663 | — | — | — | — | — | — | 1 | 1 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | — | — | 1 | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Glomerulonephritis | D005921 | HP_0000099 | N05 | — | — | — | — | 1 | 1 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | — | — | — | 1 | 1 |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | — | — | — | 1 | 1 |
| Lymphoma | D008223 | — | C85.9 | — | — | — | — | 1 | 1 |
Show 9 more
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) |
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Dexilant – Takeda
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Estimated US medical usage
Dexlansoprazole
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Safety
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No Black-box warning
Adverse Events
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22,405 adverse events reported
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