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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
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
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
DEXILANTTakedaN-022287 RX2009-01-30
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
dexilantNew Drug Application2023-04-21
dexlansoprazole ANDA2023-05-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
gastroesophageal refluxEFO_0003948D005764K21
heartburnD006356R12
peptic esophagitisEFO_1001095D004942
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Dexlansoprazole, Dexilant, Takeda Pharms Usa
92331032032-03-05U-1805
81731582030-03-17U-949, U-950, U-951
88712732028-01-11DP
81056262026-09-27DP
77907552026-08-02DP
90119262026-02-24DP
84611872026-01-17DP
92380292026-01-17DP
87220842023-10-15DP
87848852023-10-15DPU-1552, U-1553, U-1554
66642762023-01-30DS, DPU-949, U-950, U-951, U-1507
Dexlansoprazole, Dexilant Solutab, Takeda Pharms Usa
92419102029-03-10DP
ATC Codes
A: Alimentary tract and metabolism drugs
A02: Drugs for acid related disorders
A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
A02BC: Proton pump inhibitors for peptic ulcer and gord
A02BC06: Dexlansoprazole
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 refluxD005764EFO_0003948K211061114846
Healthy volunteers/patients26430
EsophagitisD004941HP_0100633K20259319
Stomach ulcerD013276K25111113
InfectionsD007239EFO_000054437111
Peptic ulcerD010437HP_0004398K273418
HeartburnD006356R1221328
Laryngopharyngeal refluxD057045EFO_10013551337
Peptic esophagitisD004942EFO_10010951517
AsthmaD001249EFO_0000270J451224
Show 27 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Duodenal ulcerD004381EFO_0004607K2610212
Breast neoplasmsD001943EFO_0003869C50213
Type 1 diabetes mellitusD003922EFO_0001359E10213
GoutD006073EFO_0004274M10112
OsteoarthritisD010003EFO_0002506M15-M1911
Human experimentationD00680511
Helicobacter infectionsD016481EFO_100096111
Idiopathic pulmonary fibrosisD054990J84.11211
Respiratory tract infectionsD012141J06.911
PneumoniaD011014EFO_0003106J1811
Show 1 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Endometrial neoplasmsD016889EFO_000423011
Uterine neoplasmsD014594EFO_0003859C5511
Uterine cervical neoplasmsD00258311
Renal insufficiencyD051437HP_0000083N1911
Avulsion fracturesD000071562111
Appendiceal neoplasmsD001063EFO_0003880C18.111
Pseudomyxoma peritoneiD011553EFO_000745611
B-cell chronic lymphocytic leukemiaD015451C91.111
Deglutition disordersD003680HP_0002015R13.1111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HomeostasisD00670611
Biological availabilityD00168211
Mouth neoplasmsD009062EFO_0003868C06.911
Cystic fibrosisD003550EFO_0000390E8411
Therapeutic equivalencyD01381011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Aortic valve diseaseD00008286211
Coronary artery diseaseD003324I25.111
GlomerulonephritisD005921N0511
Membranous glomerulonephritisD015433EFO_0004254N03.211
Nephrotic syndromeD009404EFO_0004255N0411
Neuroendocrine carcinomaD01827811
Head and neck neoplasmsD00625811
Oropharyngeal neoplasmsD00995911
Peptic ulcer hemorrhageD01043811
Nasal polypsD009298HP_0100582J3311
Show 1 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDEXLANSOPRAZOLE
INNdexlansoprazole
Description
Dexlansoprazole is a sulfoxide and a member of benzimidazoles.
Classification
Small molecule
Drug classantiulcer 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-ID138530-94-6
RxCUI816346
ChEMBL IDCHEMBL1201863
ChEBI ID
PubChem CID9578005
DrugBankDB05351
UNII IDUYE4T5I70X (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Dexilant - Takeda
$
£
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Tabular view
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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