dexlansoprazole Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antiulcer, benzimidazole derivatives 4162 138530-94-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dexlansoprazole sesquihydrate
  • R-Lansoprazole
  • (R)-Lansoprazole
  • dexlansoprazole
  • kapidex
  • dexilant
  • TAK-390
  • TAK-390MR
Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+, K+)-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.
  • Molecular weight: 369.36
  • Formula: C16H14F3N3O2S
  • CLOGP: 2.60
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 67.87
  • ALOGS: -3.17
  • ROTB: 6

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 30, 2009 FDA TAKEDA PHARMS USA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Chronic kidney disease 1811.49 38.77 287 657 3831 2353310
Acute kidney injury 535.36 38.77 147 797 27975 2329166
Renal injury 485.60 38.77 77 867 900 2356241
End stage renal disease 461.71 38.77 67 877 404 2356737
Renal failure 347.54 38.77 95 849 17254 2339887
Diarrhoea 189.08 38.77 91 853 83473 2273668
Incorrect product administration duration 165.21 38.77 36 908 2459 2354682
Drug ineffective 157.93 38.77 86 858 101538 2255603
Tubulointerstitial nephritis 132.82 38.77 30 914 2408 2354733
Gastrooesophageal reflux disease 106.19 38.77 33 911 9062 2348079
Off label use 80.72 38.77 50 894 73548 2283593
Abdominal pain upper 77.59 38.77 33 911 22067 2335074
Drug hypersensitivity 73.06 38.77 40 904 46603 2310538
No adverse event 72.38 38.77 25 919 9503 2347638
Nausea 63.81 38.77 51 893 112138 2245003
Abdominal distension 55.37 38.77 21 923 10390 2346751
Nephrogenic anaemia 53.28 38.77 9 935 153 2356988
Renal haemangioma 51.12 38.77 6 938 2 2357139
Dyspnoea 49.35 38.77 38 906 78695 2278446
Rebound acid hypersecretion 48.69 38.77 6 938 6 2357135
Abdominal pain 46.93 38.77 27 917 34347 2322794
Muscle spasms 43.59 38.77 22 922 21544 2335597
Dizziness 42.68 38.77 31 913 58634 2298507
Vomiting 41.44 38.77 33 911 71569 2285572
Pruritus 41.15 38.77 27 917 43313 2313828
Anaphylactic reaction 39.01 38.77 16 928 9689 2347452

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Chronic kidney disease 1079.08 54.28 181 324 4136 1742140
End stage renal disease 431.11 54.28 64 441 548 1745728
Acute kidney injury 367.00 54.28 111 394 34833 1711443
Renal injury 317.93 54.28 54 451 1140 1745136
Renal failure 221.76 54.28 67 438 19950 1726326
Gastrooesophageal reflux disease 93.40 54.28 25 480 4622 1741654
Incorrect product administration duration 87.79 54.28 18 487 1037 1745239
Occupational exposure to air contaminants 78.62 54.28 9 496 2 1746274
Occupational dermatitis 66.45 54.28 8 497 7 1746269
Nephrogenic anaemia 65.84 54.28 11 494 200 1746076
Erythema of eyelid 58.70 54.28 10 495 205 1746071

Pharmacologic Action:

SourceCodeDescription
ATC A02BC06 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
FDA EPC N0000175525 Proton Pump Inhibitor
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D054328 Proton Pump Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Erosive esophagitis indication 40719004
Gastroesophageal reflux disease indication 235595009 DOID:8534
Maintenance of Healing Erosive Esophagitis indication
Duodenal ulcer disease off-label use 51868009 DOID:1724
Zollinger-Ellison syndrome off-label use 53132006 DOID:0050782
Gastric ulcer off-label use 397825006 DOID:10808
Duodenal Ulcer due to H. Pylori off-label use
Maintenance of Healing Duodenal Ulcer off-label use
NSAID-Induced Gastric Ulcer off-label use
Prevention of NSAID-Induced Gastric Ulcer off-label use
Pathological Gastric Hypersecretory Condition off-label use
Osteoporosis contraindication 64859006 DOID:11476
Fracture of bone contraindication 125605004
Hypomagnesemia contraindication 190855004
Disease of liver contraindication 235856003 DOID:409

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.23 acidic
pKa2 3.35 Basic
pKa3 2.72 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6462058 June 15, 2020 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6462058 June 15, 2020 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6462058 June 15, 2020 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6939971 June 15, 2020 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6939971 June 15, 2020 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6939971 June 15, 2020 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6462058 June 15, 2020 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6462058 June 15, 2020 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6462058 June 15, 2020 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6939971 June 15, 2020 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6939971 June 15, 2020 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6939971 June 15, 2020 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT SOLUTAB TAKEDA PHARMS USA N208056 Jan. 26, 2016 DISCN TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 6462058 June 15, 2020 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT SOLUTAB TAKEDA PHARMS USA N208056 Jan. 26, 2016 DISCN TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 6462058 June 15, 2020 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT SOLUTAB TAKEDA PHARMS USA N208056 Jan. 26, 2016 DISCN TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 6939971 June 15, 2020 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT SOLUTAB TAKEDA PHARMS USA N208056 Jan. 26, 2016 DISCN TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 6939971 June 15, 2020 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT SOLUTAB TAKEDA PHARMS USA N208056 Jan. 26, 2016 DISCN TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT SOLUTAB TAKEDA PHARMS USA N208056 Jan. 26, 2016 DISCN TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL 6664276 Jan. 30, 2023 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 FOR HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE)
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 FOR THE TREATMENT OF HEARTBURN ASSOCIATED WITH SYMPTOMATIC NON-EROSIVE GASTROESOPHAGEAL DISEASE (GERD)
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 FOR HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE)
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 FOR THE TREATMENT OF HEARTBURN ASSOCIATED WITH SYMPTOMATIC NON-EROSIVE GASTROESOPHAGEAL DISEASE (GERD)
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8784885 Oct. 15, 2023 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 8173158 March 17, 2030 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD) FOR 4 WEEKS
30MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 9233103 March 5, 2032 USE OF DEXLANSOPRAZOLE IN PATIENTS TAKING CLOPIDOGREL WITHOUT MEANINGFUL CYP2C19 INTERACTIONS
60MG DEXILANT TAKEDA PHARMS USA N022287 Jan. 30, 2009 RX CAPSULE, DELAYED RELEASE ORAL 9233103 March 5, 2032 USE OF DEXLANSOPRAZOLE IN PATIENTS TAKING CLOPIDOGREL WITHOUT MEANINGFUL CYP2C19 INTERACTIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Potassium-transporting ATPase Transporter INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
4028570 VUID
N0000189452 NUI
C2348248 UMLSCUI
D08903 KEGG_DRUG
442540007 SNOMEDCT_US
26184 MMSL
d07395 MMSL
816346 RXNORM
4028570 VANDF
441863009 SNOMEDCT_US
012953 NDDF
HS2S9VK3NH UNII
313640-86-7 SECONDARY_CAS_RN
8524 INN_ID
DB05351 DRUGBANK_ID
CHEBI:135931 CHEBI
5487 IUPHAR_LIGAND_ID
CHEMBL1201863 ChEMBL_ID
D064748 MESH_DESCRIPTOR_UI
9578005 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 50090-4374 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 19 sections
Kapidex HUMAN PRESCRIPTION DRUG LABEL 1 54868-5998 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA 16 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 54868-6152 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 19 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 55154-5154 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 19 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-171 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA 19 sections
Dexilant HUMAN PRESCRIPTION DRUG LABEL 1 64764-175 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 19 sections