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    Chemistry

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    Also known as: (r)-lansoprazole, 138530-94-6, Kapidex, R-(+)-lansoprazole, Dexilant, Dexilant solutab
    Molecular Formula
    C16H14F3N3O2S
    Molecular Weight
    369.4  g/mol
    InChI Key
    MJIHNNLFOKEZEW-RUZDIDTESA-N
    FDA UNII
    UYE4T5I70X
    Dexlansoprazole
    The R-isomer of lansoprazole that is used to treat severe GASTROESOPHAGEAL REFLUX DISEASE.
    Dexlansoprazole is a Proton Pump Inhibitor. The mechanism of action of dexlansoprazole is as a Proton Pump Inhibitor.
    1 2D Structure

    Dexlansoprazole

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[(R)-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1H-benzimidazole
    2.1.2 InChI
    InChI=1S/C16H14F3N3O2S/c1-10-13(20-7-6-14(10)24-9-16(17,18)19)8-25(23)15-21-11-4-2-3-5-12(11)22-15/h2-7H,8-9H2,1H3,(H,21,22)/t25-/m1/s1
    2.1.3 InChI Key
    MJIHNNLFOKEZEW-RUZDIDTESA-N
    2.1.4 Canonical SMILES
    CC1=C(C=CN=C1CS(=O)C2=NC3=CC=CC=C3N2)OCC(F)(F)F
    2.1.5 Isomeric SMILES
    CC1=C(C=CN=C1C[S@@](=O)C2=NC3=CC=CC=C3N2)OCC(F)(F)F
    2.2 Other Identifiers
    2.2.1 UNII
    UYE4T5I70X
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole

    2. Dexilant

    3. Dexlansoprazole Sesquihydrate

    4. Lansoprazole, R Isomer

    5. Lansoprazole, R-isomer

    6. R Lansoprazole

    7. R-isomer Lansoprazole

    8. R-lansoprazole

    9. T 168390

    10. T-168390

    11. T168390

    12. Tak 390

    13. Tak 390mr

    14. Tak-390

    15. Tak-390mr

    16. Tak390

    17. Tak390mr

    2.3.2 Depositor-Supplied Synonyms

    1. (r)-lansoprazole

    2. 138530-94-6

    3. Kapidex

    4. R-(+)-lansoprazole

    5. Dexilant

    6. Dexilant Solutab

    7. Tak 390

    8. Tak-390

    9. Lansoprazole R-form

    10. Lansoprazole, (r)-

    11. T 168390

    12. (r)-(+)-lansoprazole

    13. T-168390

    14. Uye4t5i70x

    15. (r)-2-(((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1h-benzo[d]imidazole

    16. Nsc-758710

    17. 2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole

    18. Tak-390mr

    19. 1h-benzimidazole, 2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-

    20. Dexlansoprazole [usan]

    21. Unii-uye4t5i70x

    22. Dexlansoprazole (inn/usan)

    23. Dexlansoprazole [usan:inn]

    24. (+)-lansoprazol

    25. 2-[(r)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole

    26. Dexilant (tn)

    27. (+)-2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1h-benzimidazole

    28. (+)-2-((r)-{(3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl}sulfinyl)-1h-benzimidazole

    29. 1h-benzimidazole, 2-[(r)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-

    30. Schembl44975

    31. Dexlansoprazole [inn]

    32. Dexlansoprazole [vandf]

    33. Gtpl5487

    34. Dexlansoprazole [mart.]

    35. Chembl1201863

    36. Dexlansoprazole [who-dd]

    37. Lansoprazole R-form [mi]

    38. 2-[(r)-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1h-benzimidazole

    39. Chebi:135931

    40. Hms3652c14

    41. Zinc599734

    42. Amy25226

    43. Bdbm50247930

    44. Dexlansoprazole [orange Book]

    45. Hy-13662b

    46. Mfcd13196699

    47. S4099

    48. Akos025290765

    49. Ccg-213301

    50. Db05351

    51. Nsc 758710

    52. Pb33188

    53. 2-[(r)-[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methylsulfinyl]-1h-benzimidazole

    54. Ncgc00386267-03

    55. Ac-26449

    56. As-18086

    57. Sw219466-1

    58. D08903

    59. Ab01563023_01

    60. Ab01563023_02

    61. Q5268339

    62. (r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole

    63. (r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]benzimidazole

    64. (r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1h-benzimidazole

    65. (r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole

    66. (r)-(+)2-([3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl)-1h-benzimidazole

    67. 2-[(r)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methane}sulfinyl]-1h-1,3-benzodiazole

    2.4 Create Date
    2006-10-24
    3 Chemical and Physical Properties
    Molecular Weight 369.4 g/mol
    Molecular Formula C16H14F3N3O2S
    XLogP32.8
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count5
    Exact Mass369.07588236 g/mol
    Monoisotopic Mass369.07588236 g/mol
    Topological Polar Surface Area87.1 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity480
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameDexilant
    PubMed HealthDexlansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion...
    Active IngredientDexlansoprazole
    Dosage FormCapsule, delayed release
    RouteOral
    Strength60mg; 30mg
    Market StatusPrescription
    CompanyTakeda Pharms Usa

    2 of 4  
    Drug NameDexlansoprazole
    PubMed HealthDexlansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion...
    Active IngredientDexlansoprazole
    Dosage FormCapsule, extended release
    RouteOral
    Strength60mg
    Market StatusTentative Approval
    CompanyPar Pharm

    3 of 4  
    Drug NameDexilant
    PubMed HealthDexlansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion...
    Active IngredientDexlansoprazole
    Dosage FormCapsule, delayed release
    RouteOral
    Strength60mg; 30mg
    Market StatusPrescription
    CompanyTakeda Pharms Usa

    4 of 4  
    Drug NameDexlansoprazole
    PubMed HealthDexlansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion...
    Active IngredientDexlansoprazole
    Dosage FormCapsule, extended release
    RouteOral
    Strength60mg
    Market StatusTentative Approval
    CompanyPar Pharm

    4.2 Drug Indication

    Dexlansoprazole is indicated for healing all grades of erosive esophagitis (EE), maintaining and healing of EE and relief of heartburn, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Dexlansoprazole is a proton pump inhibitor (PPI) and is included in the drug class of antisecretory compounds. It blocks the final step of gastric acid secretion by specific inhibition of the (H+, K+)-ATPase at the secretory surface of the parietal cells on gastric mucosa.

    5.2 MeSH Pharmacological Classification

    Anti-Ulcer Agents

    Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

    Proton Pump Inhibitors

    Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DEXLANSOPRAZOLE
    5.3.2 FDA UNII
    UYE4T5I70X
    5.3.3 Pharmacological Classes
    Proton Pump Inhibitors [MoA]; Proton Pump Inhibitor [EPC]
    5.4 ATC Code

    A - Alimentary tract and metabolism

    A02 - Drugs for acid related disorders

    A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

    A02BC - Proton pump inhibitors

    A02BC06 - Dexlansoprazole

    5.5 Absorption, Distribution and Excretion

    Absorption

    After oral administration, the peak plasma concentration increases approximately dose proportionally. The dual delayed release formulation achieves two plasma concentration peaks, where the first peak occurs one to two hours after administration, followed by a second peak within four to five hours. The delivery technology of dexlansoprazole MR is designed to release the drug in two separate pH-dependent phases, the first in the proximal duodenum (25% of total drug dose) and the second (75% of total drug dose) in the more distal small intestine. The median time (Tmax) to peak plasma concentrations (Cmax) of 30 mg dexlansoprazole was 4 hours and ranged from 1 to 6 hours with the Cmax value of 688 ng/mL. AUC was found to be 3275 (ngh/mL).

    Route of Elimination

    Dexlansoprazole is cleared from the body by either fecal excretion (50.7%) or renal excretion (47.6%) following oral ingestion, with no unchanged drug detected in the urine.

    Volume of Distribution

    The apparent volume of distribution after multiple doses in symptomatic GERD patients was 40.3 L.

    Clearance

    Apparent clearance (CL/F) in healthy subjects was 11.4 to 11.6 L/hour, respectively, after five days of 30 or 60 mg once daily administration.

    5.6 Metabolism/Metabolites

    Dexlansoprazole is extensively metabolized in the liver by oxidation, reduction, and subsequent formation of sulfate, glucuronide and glutathione conjugates to inactive metabolites. Oxidative metabolites are formed by the cytochrome P450 (CYP) enzyme system including hydroxylation mainly by CYP2C19, and oxidation to the sulfone by CYP3A4. Dexlansoprazole is the major circulating component in plasma regardless of CYP2C19 metabolizer status. In CYP2C19 intermediate and extensive metabolizers, the major plasma metabolites are 5-hydroxy dexlansoprazole and its glucuronide conjugate, while in CYP2C19 poor metabolizers dexlansoprazole sulfone is the major plasma metabolite.

    Lansoprazole has known human metabolites that include 5-Hydroxylansoprazole and Lansoprazole Sulfone.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    Dexlansoprazole is eliminated with a half-life of approximately one to two hours in healthy subjects and in patients with symptomatic GERD.

    5.8 Mechanism of Action

    Dexlansoprazole inhibits the H/K ATPase enzyme, which is involved in the secretion of hydrochloric acid, hydrolyzing ATP and exchanging H+ ions from the cytoplasm for K+ ions in the secretory canaliculus, which results in HCl secretion into the gastric lumen. Dexlansoprazole inhibits this effect of H/K ATPase by demonstrating a high degree of activation in the acidic environment. After passing through the liver and reaching the gastric parietal cells activated by a meal, PPIs undergo protonation in the acidic pH environment, followed by conversion to sulphenamide which represents the active form of the drug. Sulphenamide inhibits the activity of the proton pump and hence the transport of hydrogen ions into the gastric lumen via covalent binding to the SH groups of the cysteine residues of H/K ATPase. The delivery technology of dexlansoprazole MR is designed to release the drug in two separate pH-dependent phases, the first in the proximal duodenum (25% of total drug dose) and the second (75% of total drug dose) in the more distal small intestine. Dexlansoprazole reduces both basal and stimulated gastric acid secretion.

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    16-Jan-2021
    31-Aug-2024
    KGS
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    Average Price (USD/KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    (USD/KGS)    		 Number of Transactions

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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 30MG

    USFDA APPLICATION NUMBER - 22287

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