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
CombinationsGlyxambi, Jentadueto, Linagliptin metformin, Trijardy
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 | 2025-08-27 |
| 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
219 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 | 9 | 8 | 44 | 33 | 31 | 125 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 4 | 6 | 25 | 25 | 17 | 77 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | 1 | 2 | 4 | — | 7 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | 1 | 5 | 6 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | 3 | 2 | 1 | 6 |
| Renal insufficiency | D051437 | — | N19 | 1 | 1 | 1 | 3 | — | 6 |
| Albuminuria | D000419 | EFO_0004285 | R80.9 | — | 1 | 2 | 1 | 1 | 5 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | 1 | 2 | 1 | 5 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 2 | 1 | 3 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | 1 | 1 | 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 |
| 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 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 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 |
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 | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 1 | 1 |
| Diabetic ketoacidosis | D016883 | EFO_1000897 | — | — | — | — | — | 1 | 1 |
| Ischemic stroke | D000083242 | — | — | — | — | — | — | 1 | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 1 | 1 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 1 | 1 |
| Abdominal obesity | D056128 | — | — | — | — | — | — | 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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Number of persons purchased
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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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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,967 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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12,580 adverse events reported
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