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20 Listed Dossiers

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CAPSULE, DELAYED RELEASE;ORAL - 30MG, CAPSULE, DELAYED RELEASE;ORAL - 60MG

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CAPSULE, DELAYED RELEASE;ORAL - 60MG

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Synopsis

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DRUG PRODUCT COMPOSITIONS

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US Patents

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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

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 Formula	C₁₆H₁₄F₃N₃O₂S
Molecular Weight	369.4 g/mol
XLogP3	2.8
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	5
Exact Mass	369.07588236 g/mol
Monoisotopic Mass	369.07588236 g/mol
Topological Polar Surface Area	87.1 Å²
Heavy Atom Count	25
Formal Charge	0
Complexity	480
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Dexilant
PubMed Health	Dexlansoprazole (By mouth)
Drug Classes	Gastric Acid Secretion Inhibitor
Drug Label	The 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 Ingredient	Dexlansoprazole
Dosage Form	Capsule, delayed release
Route	Oral
Strength	60mg; 30mg
Market Status	Prescription
Company	Takeda Pharms Usa

2 of 4
Drug Name	Dexlansoprazole
PubMed Health	Dexlansoprazole (By mouth)
Drug Classes	Gastric Acid Secretion Inhibitor
Drug Label	The 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 Ingredient	Dexlansoprazole
Dosage Form	Capsule, extended release
Route	Oral
Strength	60mg
Market Status	Tentative Approval
Company	Par Pharm

3 of 4
Drug Name	Dexilant
PubMed Health	Dexlansoprazole (By mouth)
Drug Classes	Gastric Acid Secretion Inhibitor
Drug Label	The 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 Ingredient	Dexlansoprazole
Dosage Form	Capsule, delayed release
Route	Oral
Strength	60mg; 30mg
Market Status	Prescription
Company	Takeda Pharms Usa

4 of 4
Drug Name	Dexlansoprazole
PubMed Health	Dexlansoprazole (By mouth)
Drug Classes	Gastric Acid Secretion Inhibitor
Drug Label	The 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 Ingredient	Dexlansoprazole
Dosage Form	Capsule, extended release
Route	Oral
Strength	60mg
Market Status	Tentative Approval
Company	Par 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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