Jardiance(empagliflozin)
Glyxambi, Jardiance, Synjardy, Trijardy (empagliflozin) is a small molecule pharmaceutical. Empagliflozin was first approved as Jardiance on 2014-05-22. 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 sodium/glucose cotransporter 2. In addition, it is known to target sodium/glucose cotransporter 1.
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Commercial
Trade Name
FDA
EMA
Jardiance (generic drugs available since 2022-07-07)
CombinationsGlyxambi, Synjardy, Trijardy (generic drugs available since 2022-07-07)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Empagliflozin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| JARDIANCE | Boehringer Ingelheim | N-204629 RX | 2014-08-01 | 2 products, RLD, RS |
Empagliflozin
+
Linagliptin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GLYXAMBI | Boehringer Ingelheim | N-206073 RX | 2015-01-30 | 2 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 | 2021-06-17 |
| jardiance | New Drug Application | 2023-05-03 |
| synjardy | New Drug Application | 2023-02-09 |
| trijardy xr | New Drug Application | 2021-06-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| type 2 diabetes mellitus | EFO_0001360 | D003924 | E11 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
EMPAGLIFLOZIN, JARDIANCE, BOEHRINGER INGELHEIM | |||
| 2025-02-24 | M-82 | ||
| 2024-08-18 | I-869 | ||
EMPAGLIFLOZIN / LINAGLIPTIN, GLYXAMBI, BOEHRINGER INGELHEIM | |||
| 2023-03-30 | M-252 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Empagliflozin, Jardiance, Boehringer Ingelheim | |||
| 9949998 | 2034-06-11 | U-2290, U-2731 | |
| 9949997 | 2034-05-17 | U-2292, U-3199, U-3325, U-3532, U-3533 | |
| 10258637 | 2034-04-03 | U-2290, U-2731 | |
| 11090323 | 2034-04-03 | U-3191, U-3192, U-3193 | |
| 8551957 | 2029-10-14 | U-1651, U-2730 | |
| 7579449 | 2028-08-01 | DP | |
| 7713938 | 2027-04-15 | DS, DP | |
| Empagliflozin / Linagliptin / Metformin Hydrochloride, Trijardy Xr, Boehringer Ingelheim | |||
| 10596120 | 2032-03-07 | DP | U-2775, U-2776, U-2790, U-2792 |
| 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 | DP | U-2732 |
| Empagliflozin / Metformin Hydrochloride, Synjardy, Boehringer Ingelheim | |||
| 10610489 | 2030-09-30 | DP | |
| Empagliflozin / Linagliptin, Glyxambi, Boehringer Ingelheim | |||
| 8673927 | 2027-05-04 | U-1652 | |
| 9173859 | 2027-05-04 | DP | U-1772 |
| 11033552 | 2027-05-04 | DP | |
| 8883805 | 2025-11-26 | DP | |
| 7407955 | 2025-05-02 | DS, DP | |
| 8119648 | 2023-08-12 | U-1651, U-1652 | |
| 8178541 | 2023-08-12 | DP | U-1652, U-1653, U-1654 |
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
— A10BD19: Linagliptin and empagliflozin
— A10BD20: Metformin and empagliflozin
— A10BD27: Metformin, linagliptin and empagliflozin
— A10BK: Sodium-glucose co-transporter 2 (sglt2) inhibitors
— A10BK03: Empagliflozin
HCPCS
No data
Clinical
Clinical Trials
331 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 | 14 | 19 | 38 | 36 | 36 | 143 |
| Healthy volunteers/patients | — | 41 | 1 | — | 2 | — | 44 | ||
| Heart failure | D006333 | EFO_0003144 | I50 | 4 | 10 | 12 | 9 | 3 | 36 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 2 | 2 | 2 | 9 | — | 15 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | — | 8 | 1 | 12 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 4 | 3 | 2 | 1 | 11 |
| Chronic renal insufficiency | D051436 | N18 | 1 | 4 | 2 | 3 | 1 | 10 | |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 3 | 3 | 2 | 1 | 8 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 5 | 1 | 2 | — | 8 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | 3 | 3 | 6 |
Show 32 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | EFO_0002614 | 1 | 1 | 3 | — | — | 5 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 2 | 2 | 1 | — | — | 4 |
| Lipoatrophic diabetes mellitus | D003923 | EFO_0007346 | — | — | 2 | — | — | 2 | |
| Pharmacokinetics | D010599 | 1 | — | 1 | — | — | 2 | ||
| Ascites | D001201 | HP_0001541 | R18 | 1 | 1 | 1 | — | — | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | 1 | — | — | 1 |
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | 1 | — | — | 1 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | 1 | — | — | 1 | |
| Tricuspid valve insufficiency | D014262 | HP_0005180 | — | — | 1 | — | — | 1 | |
| Gestational diabetes | D016640 | HP_0009800 | O24.4 | — | — | 1 | — | — | 1 |
Show 7 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glycogen storage disease type i | D005953 | Orphanet_364 | E74.01 | — | 2 | — | — | — | 2 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | 1 | — | — | — | 2 |
| Cognitive dysfunction | D060825 | G31.84 | — | 1 | — | — | 1 | 2 | |
| Glucose metabolism disorders | D044882 | — | 1 | — | — | — | 1 | ||
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | — | — | 1 |
| Fatty liver | D005234 | — | 1 | — | — | — | 1 | ||
| Body weight | D001835 | EFO_0004338 | — | 1 | — | — | — | 1 | |
| Acute liver failure | D017114 | — | 1 | — | — | — | 1 | ||
| Kidney calculi | D007669 | EFO_0004253 | N20.0 | — | 1 | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | — | — | — | — | 1 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | — | — | — | — | 1 | |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | 1 | — | — | — | — | 1 |
| Dialysis | D003956 | 1 | — | — | — | — | 1 | ||
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 1 | 1 |
| Bariatric surgery | D050110 | — | — | — | — | 1 | 1 | ||
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Acromegaly | D000172 | — | — | — | — | 1 | 1 | ||
| Myocardial reperfusion injury | D015428 | EFO_0002687 | — | — | — | — | 1 | 1 | |
| Glycogen storage disease type iib | D052120 | EFO_1001333 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | EMPAGLIFLOZIN |
| INN | empagliflozin |
| Description | Empagliflozin is a C-glycosyl compound consisting of a beta-glucosyl residue having a (4-chloro-3-{4-[(3S)-tetrahydrofuran-3-yloxy]benzyl}phenyl group at the anomeric centre. A sodium-glucose co-transporter 2 inhibitor used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It has a role as a sodium-glucose transport protein subtype 2 inhibitor and a hypoglycemic agent. It is a C-glycosyl compound, an aromatic ether, a tetrahydrofuryl ether and a member of monochlorobenzenes. |
| Classification | Small molecule |
| Drug class | phlorozin derivatives, phenolic glycosides |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 864070-44-0 |
| RxCUI | 1545653 |
| ChEMBL ID | CHEMBL2107830 |
| ChEBI ID | 82720 |
| PubChem CID | 11949646 |
| DrugBank | DB09038 |
| UNII ID | HDC1R2M35U (ChemIDplus, GSRS) |
Target
Agency Approved
SLC5A2
SLC5A2
Organism
Homo sapiens
Gene name
SLC5A2
Gene synonyms
SGLT2
NCBI Gene ID
Protein name
sodium/glucose cotransporter 2
Protein synonyms
Low affinity sodium-glucose cotransporter, Na(+)/glucose cotransporter 2, solute carrier family 5 (sodium/glucose cotransporter), member 2, solute carrier family 5 (sodium/glucose transporter), member 2, Solute carrier family 5 member 2
Uniprot ID
Mouse ortholog
Slc5a2 (246787)
sodium/glucose cotransporter 2 (Q923I7)
Alternate
SLC5A1
SLC5A1
Organism
Homo sapiens
Gene name
SLC5A1
Gene synonyms
NAGT, SGLT1
NCBI Gene ID
Protein name
sodium/glucose cotransporter 1
Protein synonyms
High affinity sodium-glucose cotransporter, Na+/glucose cotransporter 1, solute carrier family 5 (sodium/glucose cotransporter), member 1, Solute carrier family 5 member 1
Uniprot ID
Mouse ortholog
Slc5a1 (20537)
sodium/glucose cotransporter 1 (Q8C3K6)
Variants
Clinical Variant
No data
Financial
Jardiance - Eli Lilly
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,354 documents
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Safety
Black-box Warning
Black-box warning for: Synjardy, Trijardy xr
Adverse Events
Top Adverse Reactions
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9,547 adverse events reported
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