Dexlansoprazole
Dexilant (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
Trade Name
FDA
EMA
Dexilant (generic drugs available since 2017-04-19)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dexlansoprazole
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DEXILANT | Takeda | N-022287 RX | 2009-01-30 | 2 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dexilant | New Drug Application | 2023-04-21 |
| dexlansoprazole | ANDA | 2023-05-26 |
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 | |
| 8722084 | 2023-10-15 | DP | |
| 8784885 | 2023-10-15 | DP | U-1552, U-1553, U-1554 |
| 6664276 | 2023-01-30 | DS, DP | U-949, U-950, U-951, U-1507 |
| Dexlansoprazole, Dexilant Solutab, Takeda Pharms Usa | |||
| 9241910 | 2029-03-10 | DP | |
HCPCS
No data
Clinical
Clinical Trials
212 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 | 10 | 6 | 11 | 14 | 8 | 46 |
| Healthy volunteers/patients | — | 26 | — | — | 4 | — | 30 | ||
| Esophagitis | D004941 | HP_0100633 | K20 | 2 | 5 | 9 | 3 | — | 19 |
| Stomach ulcer | D013276 | K25 | — | — | 11 | 1 | 1 | 13 | |
| Infections | D007239 | EFO_0000544 | — | — | 3 | 7 | 1 | 11 | |
| Peptic ulcer | D010437 | HP_0004398 | K27 | — | — | 3 | 4 | 1 | 8 |
| Heartburn | D006356 | R12 | 2 | 1 | 3 | 2 | — | 8 | |
| Laryngopharyngeal reflux | D057045 | EFO_1001355 | 1 | — | — | 3 | 3 | 7 | |
| Peptic esophagitis | D004942 | EFO_1001095 | — | 1 | 5 | 1 | — | 7 | |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | 2 | 2 | — | 4 |
Show 27 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 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 1 | — | — | 1 |
| Human experimentation | D006805 | — | — | 1 | — | — | 1 | ||
| Helicobacter infections | D016481 | EFO_1000961 | — | — | 1 | — | — | 1 | |
| Idiopathic pulmonary fibrosis | D054990 | J84.112 | — | — | 1 | — | — | 1 | |
| Respiratory tract infections | D012141 | J06.9 | — | — | 1 | — | — | 1 | |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 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 | — | 1 | — | — | — | 1 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 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 | |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | 1 | 1 | — | — | — | 1 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Aortic valve disease | D000082862 | — | — | — | — | 1 | 1 | ||
| Coronary artery disease | D003324 | I25.1 | — | — | — | — | 1 | 1 | |
| Glomerulonephritis | D005921 | N05 | — | — | — | — | 1 | 1 | |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | — | — | — | 1 | 1 |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | — | — | — | 1 | 1 |
| Neuroendocrine carcinoma | D018278 | — | — | — | — | 1 | 1 | ||
| Head and neck neoplasms | D006258 | — | — | — | — | 1 | 1 | ||
| Oropharyngeal neoplasms | D009959 | — | — | — | — | 1 | 1 | ||
| Peptic ulcer hemorrhage | D010438 | — | — | — | — | 1 | 1 | ||
| Nasal polyps | D009298 | HP_0100582 | J33 | — | — | — | — | 1 | 1 |
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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 | 816346 |
| ChEMBL ID | CHEMBL1201863 |
| ChEBI ID | — |
| PubChem CID | 9578005 |
| DrugBank | DB05351 |
| UNII ID | UYE4T5I70X (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Dexilant - Takeda
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 648 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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65,322 adverse events reported
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