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    Also known as: 668270-12-0, Tradjenta, Bi 1356, Bi-1356, Ondero, Linagliptin (bi-1356)
    Molecular Formula
    C25H28N8O2
    Molecular Weight
    472.5  g/mol
    InChI Key
    LTXREWYXXSTFRX-QGZVFWFLSA-N
    FDA UNII
    3X29ZEJ4R2
    Linagliptin
    A purine and quinazoline derivative that functions as an INCRETIN and DIPEPTIDYL-PEPTIDASE IV INHIBTOR. It is used as a HYPOGLYCEMIC AGENT in the treatment of TYPE II DIABETES MELLITUS.
    Linagliptin is a Dipeptidyl Peptidase 4 Inhibitor. The mechanism of action of linagliptin is as a Dipeptidyl Peptidase 4 Inhibitor.
    1 2D Structure

    Linagliptin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    8-[(3R)-3-aminopiperidin-1-yl]-7-but-2-ynyl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione
    2.1.2 InChI
    InChI=1S/C25H28N8O2/c1-4-5-13-32-21-22(29-24(32)31-12-8-9-17(26)14-31)30(3)25(35)33(23(21)34)15-20-27-16(2)18-10-6-7-11-19(18)28-20/h6-7,10-11,17H,8-9,12-15,26H2,1-3H3/t17-/m1/s1
    2.1.3 InChI Key
    LTXREWYXXSTFRX-QGZVFWFLSA-N
    2.1.4 Canonical SMILES
    CC#CCN1C2=C(N=C1N3CCCC(C3)N)N(C(=O)N(C2=O)CC4=NC5=CC=CC=C5C(=N4)C)C
    2.1.5 Isomeric SMILES
    CC#CCN1C2=C(N=C1N3CCC[C@H](C3)N)N(C(=O)N(C2=O)CC4=NC5=CC=CC=C5C(=N4)C)C
    2.2 Other Identifiers
    2.2.1 UNII
    3X29ZEJ4R2
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (r)-8-(3-amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione

    2. 1356, Bi

    3. 1h-purine-2,6-dione, 8-((3r)-3-amino-1-piperidinyl)-7-(2-butynyl)-3,7-dihydro-3-methyl-1-((4-methyl-2-quinazolinyl)methyl)-

    4. Bi 1356

    5. Bi-1356

    6. Bi1356

    7. Tradjenta

    8. Trajenta

    2.3.2 Depositor-Supplied Synonyms

    1. 668270-12-0

    2. Tradjenta

    3. Bi 1356

    4. Bi-1356

    5. Ondero

    6. Linagliptin (bi-1356)

    7. Trajenta

    8. Trazenta

    9. Bi-1356-bs

    10. Bs 1356 Bs

    11. Ione

    12. 3x29zej4r2

    13. Chembl237500

    14. (r)-8-(3-amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione

    15. Bi-1356bs

    16. Chebi:68610

    17. Bi 1356 Bs

    18. Bs-1356-bs

    19. (r)-8-(3-aminopiperidin-1-yl)-7-(but-2-ynyl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1h-purine-2,6(3h,7h)-dione

    20. (r)-8-(3-aminopiperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methylquinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione

    21. 8-[(3r)-3-aminopiperidin-1-yl]-7-but-2-yn-1-yl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-dione

    22. 8-[(3r)-3-aminopiperidin-1-yl]-7-but-2-ynyl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione

    23. 8-[(3r)-3-aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3- Methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-dione

    24. 8-[(3r)-3-aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-dione

    25. C25h28n8o2

    26. Unii-3x29zej4r2

    27. Linaglitpin

    28. Linagliptin [usan:inn:jan]

    29. Hsdb 8204

    30. Tradjenta (tn)

    31. 8-((3r)-3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1h-purine-2,6-dione

    32. 8-[(3r)-3-amino-1-piperidinyl]-7-(2-butynyl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1h-purine-2,6-dione

    33. Linagliptin [mi]

    34. Linagliptin [inn]

    35. Linagliptin [jan]

    36. Linagliptin [usan]

    37. Linagliptin [vandf]

    38. Linagliptin [mart.]

    39. Linagliptin [who-dd]

    40. Mls006010217

    41. Schembl160188

    42. Linagliptin (jan/usan/inn)

    43. Gtpl6318

    44. Amy8953

    45. Ex-a076

    46. Linagliptin [orange Book]

    47. Bcpp000185

    48. Dtxsid201021653

    49. Bcp02462

    50. Zinc3820029

    51. Bdbm50228403

    52. Glyxambi Component Linagliptin

    53. Mfcd14635356

    54. S3031

    55. Akos015951179

    56. Akos015995251

    57. Ac-8761

    58. Bcp9000854

    59. Ccg-269463

    60. Cs-0637

    61. Db08882

    62. Linagliptin Component Of Glyxambi

    63. Trijardy Xr Component Linagliptin

    64. Ncgc00346655-01

    65. Ncgc00346655-02

    66. 1h-purine-2,6-dione, 8-((3r)-3-amino-1-piperidinyl)-7-(2-butynyl)-3,7-dihydro-3-methyl-1-((4-methyl-2-quinazolinyl)methyl)-

    67. As-35080

    68. Bl164627

    69. Hy-10284

    70. Jentadueto Component Of Linagliptin

    71. Linagliptin Component Of Jentadueto

    72. Smr004701306

    73. Linagliptin Component Of Trijardy Xr

    74. Sw219813-1

    75. D09566

    76. Ab01563307_01

    77. Ab01563307_03

    78. 270l120

    79. Q909745

    80. J-519354

    81. (r)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1h-purine-2,6(3h,7h)-dione

    82. (r)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1h-purine-2,6-dione

    83. 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(r)-aminopiperidin-1-yl)xanthine

    84. 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(r)aminopiperidin-1-yl)xanthine

    85. 1-[(4-methyl-quinazolin-2yl) Methyl]-3-methyl-7-(2-butyn-1-yl)-8-[3-(r) Amino-piperidin-1-yl]-xanthine

    86. 1-[(4-methylquinazolin-2-yl)-methyl]-3-methyl-7-(2-butin-1-yl)-8-(3-(r)-aminopiperidin-1-yl)-xanthine

    87. 1-[(4-methylquinazolin-2-yl)methyl]-3-methyl-7-(2-butin-1-yl)-8-(3-(r)-aminopiperidin-1-yl)-xanthine

    88. 1233245-11-8

    89. 1h-purine-2,6-dione, 8-((3r)-3-amino-1-piperidinyl)-7-(2-butynyl)-3,7-dihydro-3-methyl-1-((4-methyl-2- Quinazolinyl)methyl)-

    90. 8-[(3r)-3-aminopiperidin-1-yl]-7-but-2-yn-1-yl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-d

    91. 8-[(3r)-3-aminopiperidin-1-yl]-7-but-2-yn-1-yl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-d Ione

    92. Linagliptin; (r)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1h-purine-2,6(3h,7h)-dione

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 472.5 g/mol
    Molecular Formula C25H28N8O2
    XLogP31.9
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count4
    Exact Mass472.23352217 g/mol
    Monoisotopic Mass472.23352217 g/mol
    Topological Polar Surface Area114 Ų
    Heavy Atom Count35
    Formal Charge0
    Complexity885
    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 2  
    Drug NameTradjenta
    PubMed HealthLinagliptin (By mouth)
    Drug ClassesHypoglycemic
    Drug LabelTRADJENTA (linagliptin) tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,...
    Active IngredientLinagliptin
    Dosage FormTablet
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    2 of 2  
    Drug NameTradjenta
    PubMed HealthLinagliptin (By mouth)
    Drug ClassesHypoglycemic
    Drug LabelTRADJENTA (linagliptin) tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,...
    Active IngredientLinagliptin
    Dosage FormTablet
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    4.2 Therapeutic Uses

    Hypoglycemic Agents

    National Library of Medicine's Medical Subject Headings. Linagliptin. Online file (MeSH, 2014). Available from, as of July 18, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Tradjenta tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Tradjenta (Linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of July 18, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    4.3 Drug Warning

    /BOXED WARNING/ WARNING: RISK OF LACTIC ACIDOSIS. Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure. The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. If acidosis is suspected, Jentadueto should be discontinued and the patient hospitalized immediately. /Linagliptin and metformin hydrochloride combination product/

    NIH; DailyMed. Current Medication Information for Jentadueto (Linagliptin and Metformin Hydrochloride) Tablets (Revised: May 2014). Available from, as of July 18, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f6dd9b86-0d18-95d4-2bc7-05591bfdd597

    FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics. Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. This early communication is intended only to inform the public and health care professionals that the Agency intends to obtain and evaluate this new information. ... FDA will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report. The Warnings and Precautions section of drug labels and patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis. FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics. FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer. At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels. ...

    US FDA; Safety Alerts for Human Medicial Products: Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas (Posted March 14, 1013). Available from, as of August 1, 2014: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343805.htm

    There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking Tradjenta. Take careful notice of potential signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue Tradjenta and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Tradjenta.

    NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Tradjenta. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with Tradjenta, with some reports occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue Tradjenta, assess for other potential causes for the event, and institute alternative treatment for diabetes. Angioedema has also been reported with other dipeptidyl peptidase-4 (DPP-4) inhibitors. Use caution in a patient with a history of angioedema to another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with Tradjenta.

    NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    For more Drug Warnings (Complete) data for Linagliptin (20 total), please visit the HSDB record page.

    4.4 Drug Indication

    Linagliptin is indicated for the treatment of type II diabetes in addition to diet and exercise. It should not be used to treat type I diabetes or in diabetic ketoacidosis. An extended-release combination product containing empagliflozin, linagliptin, and metformin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise.

    FDA Label

    Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:

    as

    * monotherapy:

    - in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

    as

    * combination therapy:

    - in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.

    - in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

    - in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    A 5mg oral dose of linagliptin results in >80% inhibition of dipeptidyl peptidase 4 (DPP-4) for 24 hours. Inhibition of DPP-4 increases the concentration of glucagon-like peptide 1 (GLP-1), leading to decreased glycosylated hemoglobin and fasting plasma glucose.

    5.2 MeSH Pharmacological Classification

    Dipeptidyl-Peptidase IV Inhibitors

    Compounds that suppress the degradation of INCRETINS by blocking the action of DIPEPTIDYL-PEPTIDASE IV. This helps to correct the defective INSULIN and GLUCAGON secretion characteristic of TYPE 2 DIABETES MELLITUS by stimulating insulin secretion and suppressing glucagon release. (See all compounds classified as Dipeptidyl-Peptidase IV Inhibitors.)

    Hypoglycemic Agents

    Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)

    Incretins

    Peptides which stimulate INSULIN release from the PANCREATIC BETA CELLS following oral nutrient ingestion, or postprandially. (See all compounds classified as Incretins.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    LINAGLIPTIN
    5.3.2 FDA UNII
    3X29ZEJ4R2
    5.3.3 Pharmacological Classes
    Dipeptidyl Peptidase 4 Inhibitors [MoA]; Dipeptidyl Peptidase 4 Inhibitor [EPC]
    5.4 ATC Code

    A10BH05

    A - Alimentary tract and metabolism

    A10 - Drugs used in diabetes

    A10B - Blood glucose lowering drugs, excl. insulins

    A10BH - Dipeptidyl peptidase 4 (dpp-4) inhibitors

    A10BH05 - Linagliptin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Oral bioavailability of linagliptin is 30%.

    Route of Elimination

    84.7% of linagliptin is eliminated in the feces and 5.4% is eliminated in the urine.

    Volume of Distribution

    A single intravenous dose of 5mg results in a volume of distribution of 1110L. However an intravenous infusion of 0.5-10mg results in a volume of distribution of 380-1540L.

    Clearance

    Total clearance of linagliptin is 374mL/min.

    Available animal data have shown excretion of linagliptin in milk at a milk-to-plasma ratio of 4:1.

    NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    After oral administration of a single 5-mg dose to healthy subjects, peak plasma concentrations of linagliptin occurred at approximately 1.5 hours post dose (Tmax); the mean plasma area under the curve (AUC) was 139 nmol*h/L and maximum concentration (Cmax) was 8.9 nmol/L.

    NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    The absolute bioavailability of linagliptin is approximately 30%. High-fat meal reduced Cmax by 15% and increased AUC by 4%; this effect is not clinically relevant. Tradjenta may be administered with or without food.

    NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    Following administration of an oral (14C)-linagliptin dose to healthy subjects, approximately 85% of the administered radioactivity was eliminated via the enterohepatic system (80%) or urine (5%) within 4 days of dosing. Renal clearance at steady state was approximately 70 mL/min.

    NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    For more Absorption, Distribution and Excretion (Complete) data for Linagliptin (6 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    An oral dose of linagliptin is excreted primarily in the feces. 90% of an oral dose is excreted unchanged in the urine and feces. The predominant metabolite in the plasma is CD1790 and the predominant metabolite recovered after excretion was M489(1). Other metabolites are produced through oxidation, oxidative degradation, N-acetylation, glucuronidation, and cysteine adduct formation. Other metabolites have been identified through mass spectrometry though no structures were determined. Metabolism of linagliptin is mediated by cytochrome P450 3A4, aldo-keto reductases, and carbonyl reductases.

    Following oral administration, the majority (about 90%) of linagliptin is excreted unchanged, indicating that metabolism represents a minor elimination pathway. A small fraction of absorbed linagliptin is metabolized to a pharmacologically inactive metabolite, which shows a steady-state exposure of 13.3% relative to linagliptin.

    NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    5.7 Biological Half-Life

    The terminal half life of linagliptin is 155 hours.

    The effective half-life for accumulation of linagliptin, as determined from oral administration of multiple doses of linagliptin 5 mg, is approximately 12 hours.

    NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    Plasma concentrations of linagliptin decline in at least a biphasic manner with a long terminal half-life (>100 hours), related to the saturable binding of linagliptin to DPP-4.

    NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    5.8 Mechanism of Action

    Linagliptin is a competitive, reversible DPP-4 inhibitor. Inhibition of this enzyme slows the breakdown of GLP-1 and glucose-dependant insulinotropic polypeptide (GIP). GLP-1 and GIP stimulate the release of insulin from beta cells in the pancreas while inhibiting release of glucagon from pancreatic beta cells. These effects together reduce the breakdown of glycogen in the liver and increase insulin release in response to glucose.

    Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta-cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha-cells, resulting in a reduction in hepatic glucose output.

    NIH; DailyMed. Current Medication Information for Tradjenta (Linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of July 31, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 5MG

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    ABOUT THIS PAGE

    Looking for 668270-12-0 / Linagliptin API manufacturers, exporters & distributors?

    Linagliptin manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Linagliptin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Linagliptin manufacturer or Linagliptin supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Linagliptin manufacturer or Linagliptin supplier.

    PharmaCompass also assists you with knowing the Linagliptin API Price utilized in the formulation of products. Linagliptin API Price is not always fixed or binding as the Linagliptin Price is obtained through a variety of data sources. The Linagliptin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Linagliptin

    Synonyms

    668270-12-0, Tradjenta, Bi 1356, Bi-1356, Ondero, Linagliptin (bi-1356)

    Cas Number

    668270-12-0

    Unique Ingredient Identifier (UNII)

    3X29ZEJ4R2

    About Linagliptin

    A purine and quinazoline derivative that functions as an INCRETIN and DIPEPTIDYL-PEPTIDASE IV INHIBTOR. It is used as a HYPOGLYCEMIC AGENT in the treatment of TYPE II DIABETES MELLITUS.

    JENTADUETO Manufacturers

    A JENTADUETO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of JENTADUETO, including repackagers and relabelers. The FDA regulates JENTADUETO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. JENTADUETO API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of JENTADUETO manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    JENTADUETO Suppliers

    A JENTADUETO supplier is an individual or a company that provides JENTADUETO active pharmaceutical ingredient (API) or JENTADUETO finished formulations upon request. The JENTADUETO suppliers may include JENTADUETO API manufacturers, exporters, distributors and traders.

    click here to find a list of JENTADUETO suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    JENTADUETO USDMF

    A JENTADUETO DMF (Drug Master File) is a document detailing the whole manufacturing process of JENTADUETO active pharmaceutical ingredient (API) in detail. Different forms of JENTADUETO DMFs exist exist since differing nations have different regulations, such as JENTADUETO USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A JENTADUETO DMF submitted to regulatory agencies in the US is known as a USDMF. JENTADUETO USDMF includes data on JENTADUETO's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The JENTADUETO USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of JENTADUETO suppliers with USDMF on PharmaCompass.

    JENTADUETO JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The JENTADUETO Drug Master File in Japan (JENTADUETO JDMF) empowers JENTADUETO API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the JENTADUETO JDMF during the approval evaluation for pharmaceutical products. At the time of JENTADUETO JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of JENTADUETO suppliers with JDMF on PharmaCompass.

    JENTADUETO KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a JENTADUETO Drug Master File in Korea (JENTADUETO KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of JENTADUETO. The MFDS reviews the JENTADUETO KDMF as part of the drug registration process and uses the information provided in the JENTADUETO KDMF to evaluate the safety and efficacy of the drug.

    After submitting a JENTADUETO KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their JENTADUETO API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of JENTADUETO suppliers with KDMF on PharmaCompass.

    JENTADUETO WC

    A JENTADUETO written confirmation (JENTADUETO WC) is an official document issued by a regulatory agency to a JENTADUETO manufacturer, verifying that the manufacturing facility of a JENTADUETO active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting JENTADUETO APIs or JENTADUETO finished pharmaceutical products to another nation, regulatory agencies frequently require a JENTADUETO WC (written confirmation) as part of the regulatory process.

    click here to find a list of JENTADUETO suppliers with Written Confirmation (WC) on PharmaCompass.

    JENTADUETO NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing JENTADUETO as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for JENTADUETO API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture JENTADUETO as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain JENTADUETO and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a JENTADUETO NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of JENTADUETO suppliers with NDC on PharmaCompass.

    JENTADUETO GMP

    JENTADUETO Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of JENTADUETO GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right JENTADUETO GMP manufacturer or JENTADUETO GMP API supplier for your needs.

    JENTADUETO CoA

    A JENTADUETO CoA (Certificate of Analysis) is a formal document that attests to JENTADUETO's compliance with JENTADUETO specifications and serves as a tool for batch-level quality control.

    JENTADUETO CoA mostly includes findings from lab analyses of a specific batch. For each JENTADUETO CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    JENTADUETO may be tested according to a variety of international standards, such as European Pharmacopoeia (JENTADUETO EP), JENTADUETO JP (Japanese Pharmacopeia) and the US Pharmacopoeia (JENTADUETO USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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