Tradjenta, Trajenta(linagliptin)
Glyxambi, Jentadueto, Linagliptin, Tradjenta, Trajenta, Trijardy (linagliptin) is a small molecule pharmaceutical. Linagliptin was first approved as Tradjenta on 2011-05-02. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus. The pharmaceutical is active against dipeptidyl peptidase 4.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Linagliptin, Tradjenta (discontinued: Linagliptin)
CombinationsGlyxambi, Jentadueto, Linagliptin metformin, Trijardy (discontinued: Linagliptin metformin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Empagliflozin
+
Linagliptin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GLYXAMBI | Boehringer Ingelheim | N-206073 RX | 2015-01-30 | 2 products, RLD, RS |
Linagliptin
+
Metformin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| JENTADUETO | Boehringer Ingelheim | N-201281 RX | 2012-01-30 | 3 products, RLD, RS |
| JENTADUETO XR | Boehringer Ingelheim | N-208026 RX | 2016-05-27 | 2 products, RLD, RS |
Linagliptin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRADJENTA | Boehringer Ingelheim | N-201280 RX | 2011-05-02 | 1 products, RLD, RS |
Empagliflozin
+
Linagliptin
+
Metformin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRIJARDY XR | Boehringer Ingelheim | N-212614 RX | 2020-01-27 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| glyxambi | New Drug Application | 2024-06-10 |
| jentadueto | New Drug Application | 2024-06-27 |
| jentadueto xr | New Drug Application | 2024-05-24 |
| tradjenta | New Drug Application | 2024-09-19 |
| trijardy xr | New Drug Application | 2024-06-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LINAGLIPTIN, TRADJENTA, BOEHRINGER INGELHEIM | |||
| 2026-12-20 | PED | ||
| 2026-06-20 | M-295 | ||
| 2023-03-30 | M-252 | ||
LINAGLIPTIN / METFORMIN HYDROCHLORIDE, JENTADUETO, BOEHRINGER INGELHEIM | |||
| 2026-12-20 | PED | ||
| 2026-06-20 | M-295 | ||
| 2023-03-30 | M-252 | ||
LINAGLIPTIN / METFORMIN HYDROCHLORIDE, JENTADUETO XR, BOEHRINGER INGELHEIM | |||
| 2026-12-20 | PED | ||
| 2026-06-20 | M-295 | ||
| 2023-03-30 | M-252 | ||
EMPAGLIFLOZIN / LINAGLIPTIN, GLYXAMBI, BOEHRINGER INGELHEIM | |||
| 2023-03-30 | M-252 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Empagliflozin / Linagliptin, Glyxambi, Boehringer Ingelheim | |||
| 9949998 | 2034-06-11 | U-2290, U-2731 | |
| 10258637 | 2034-04-03 | U-2290, U-2731 | |
| 11090323 | 2034-04-03 | U-3191, U-3192 | |
| 8551957 | 2029-10-14 | DP | U-1651, U-2730 |
| 7579449 | 2028-08-01 | DP | |
| 8673927 | 2027-05-04 | U-1503, U-1652 | |
| 9173859 | 2027-05-04 | DP | U-1503, U-1772 |
| 11033552 | 2027-05-04 | DP | |
| 7713938 | 2027-04-15 | DS, DP | |
| 8883805 | 2025-11-26 | DP | |
| 7407955 | 2025-05-02 | DS, DP | |
| 8119648 | 2023-08-12 | U-774, U-802, U-1270, U-1651, U-1652 | |
| 8178541 | 2023-08-12 | U-775, U-1244, U-1245, U-1270, U-1652, U-1653, U-1654, U-1853 | |
| Linagliptin / Metformin Hydrochloride, Jentadueto Xr, Boehringer Ingelheim | |||
| 9555001 | 2033-03-06 | DP | U-1967, U-1968 |
| Empagliflozin / Linagliptin / Metformin Hydrochloride, Trijardy Xr, Boehringer Ingelheim | |||
| 10596120 | 2032-03-07 | DP | U-2776, U-2790 |
| 11564886 | 2032-03-07 | DP | U-3531 |
| 10406172 | 2030-06-15 | DP | U-2733 |
| 9155705 | 2030-05-21 | DP | |
| 9415016 | 2029-04-02 | DP | |
| 10022379 | 2029-04-02 | U-2339, U-2732 | |
| Linagliptin, Tradjenta, Boehringer Ingelheim | |||
| 8853156 | 2031-03-05 | DP | U-1642 |
| 8846695 | 2030-06-04 | U-1503 | |
| 9486526 | 2029-08-05 | U-1915 | |
| 10034877 | 2029-08-05 | U-2347 | |
| Linagliptin / Metformin Hydrochloride, Jentadueto, Boehringer Ingelheim | |||
| 10973827 | 2029-04-02 | DP | |
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BD: Combinations of oral blood glucose lowering drugs
— A10BD11: Metformin and linagliptin
— A10BD19: Linagliptin and empagliflozin
— A10BD27: Metformin, linagliptin and empagliflozin
— A10BH: Dipeptidyl peptidase 4 (dpp-4) inhibitors for blood glucose lowering
— A10BH05: Linagliptin
HCPCS
No data
Clinical
Clinical Trials
208 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 7 | 8 | 44 | 31 | 31 | 121 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 5 | 6 | 27 | 28 | 22 | 88 |
| Insulin resistance | D007333 | HP_0000855 | — | — | 1 | 2 | 4 | — | 7 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | 2 | 2 | 1 | 6 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | 3 | 2 | 1 | 6 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 1 | 1 | 3 | — | 6 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 1 | 2 | 1 | 1 | 5 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | 1 | 4 | 5 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | 1 | 1 | 3 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | 1 | 2 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | — | 1 | — | — | 3 |
| Glucose metabolism disorders | D044882 | — | — | — | 1 | 1 | — | — | 2 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | 1 | 1 | — | — | 2 |
| Left ventricular dysfunction | D018487 | — | — | — | — | 2 | — | — | 2 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | 1 | — | — | 1 |
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | — | — | 1 | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | — | — | 1 | — | — | 1 |
| Respiratory tract diseases | D012140 | — | — | — | — | 1 | — | — | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | — | 1 | — | — | 1 |
| Coronavirus | D017934 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 50 | — | — | — | — | 50 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Ketosis | D007662 | HP_0002919 | R82.4 | — | — | — | — | 1 | 1 |
| Diabetic ketoacidosis | D016883 | EFO_1000897 | — | — | — | — | — | 1 | 1 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 1 | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Linagliptin |
| INN | linagliptin |
| Description | Linagliptin is a xanthine that is 7H-xanthine bearing (4-methylquinazolin-2-yl)methyl, methyl, but-2-yn-1-yl and 3-aminopiperidin-1-yl substituents at positions 1, 3, 7 and 8 respectively (the R-enantiomer). Used for treatment of type II diabetes. It has a role as an EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor and a hypoglycemic agent. It is a member of quinazolines and an aminopiperidine. It is functionally related to a 7H-xanthine. |
| Classification | Small molecule |
| Drug class | dipeptidyl aminopeptidase-IV inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C |
Identifiers
| PDB | — |
| CAS-ID | 668270-12-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL237500 |
| ChEBI ID | 68610 |
| PubChem CID | 10096344 |
| DrugBank | DB08882 |
| UNII ID | 3X29ZEJ4R2 (ChemIDplus, GSRS) |
Target
Agency Approved
DPP4
DPP4
Organism
Homo sapiens
Gene name
DPP4
Gene synonyms
ADCP2, CD26
NCBI Gene ID
Protein name
dipeptidyl peptidase 4
Protein synonyms
ADABP, ADCP-2, Adenosine deaminase complexing protein 2, CD26, Dipeptidyl peptidase IV, dipeptidylpeptidase 4, dipeptidylpeptidase IV (CD26, adenosine deaminase complexing protein 2), DPP IV, Gly-Pro naphthylamidase, Post-proline dipeptidyl aminopeptidase IV, T-cell activation antigen CD26, TP103, Xaa-Pro-dipeptidylaminopeptidase
Uniprot ID
Mouse ortholog
Dpp4 (13482)
dipeptidyl peptidase 4 (P28843)
Alternate
No data
Variants
No data
Financial
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Trajenta – Eli Lilly
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Estimated US medical usage
Linagliptin
Total medical expenditures per year (USD, in millions)
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Linagliptin
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Metformin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,213 documents
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Safety
Black-box Warning
Black-box warning for: Jentadueto, Jentadueto xr, Trijardy xr
Adverse Events
Top Adverse Reactions
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11,942 adverse events reported
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