Empagliflozin
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2014
- First approval year
- 2014
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Empagliflozin
- Molecular weight
- 450.92
- Structure (SMILES)
- 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
- bi 10773
- Bi 10773
- empagliflozin component of glyxambi
- Empagliflozin component of glyxambi
- empagliflozin component of synjardy
- Empagliflozin component of synjardy
- empagliflozin component of trijardy xr
- Empagliflozin component of trijardy xr
- jardiance
- Jardiance
- 12 5 mg empagliflozin
- 12.5 mg empagliflozin
- 5 mg empagliflozin
- bi 10773
- BI 10773
- BI 10773 (Final Formulation)
- BI 10773 (high)
- BI 10773 (low)
- BI 10773 25 mg
- BI-10773
- bi10773
- Bi10773
- BI10773
- d glucitol 1 5 anhydro 1 c 4 chloro 3 4 3s tetrahydro 3 furanyl oxy phenyl methyl phenyl 1s
- D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S)-
- empagliflozin
- Empagliflozin
- EMPAGLIFLOZIN
- Empagliflozin (BI 10773)
- Empagliflozin (EMPA)
- empagliflozin (high dose bid)
- Empagliflozin (high dose qd)
- empagliflozin (Jardiance) 25 mg
- empagliflozin (low dose bid)
- empagliflozin (low dose qd)
And 56 more, listed on the interactive page.
- ATC classification codes
- A10BK03
Sources for recorded values
- CAS registry numbers
- 864070-44-0
- ChEMBL ID
- CHEMBL2107830
- InChIKey
- OBWASQILIWPZMG-QZMOQZSNSA-N
- PubChem compound IDs
- 11949646
- RxNorm IDs (RxCUI)
- 1545653
- FDA ingredient codes (UNII)
- HDC1R2M35U
- Applicant
- BOEHRINGER INGELHEIM
- Approval date
- 1 Aug 2014
- Application number
- NDA204629
- Status
- Authorised
- Status date
- 22 May 2014
- Authorisation date
- 22 May 2014
- Approved indications
- Type 2 diabetes mellitus Jardiance is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance in addition to other medicinal products for the treatment of diabetes For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Jardiance is indicated in adults for the treatment of chronic kidney disease.
- Product number
- EMEA/H/C/002677
- Authorisation holder
- Boehringer Ingelheim International GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Diabetes Mellitus, Type 2
- Heart Failure
- Renal Insufficiency, Chronic
European medicines record
- Patents
- 27
- Designations
- 2
- Earliest recorded loss of exclusivity
- 11 Dec 2034
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- empagliflozin
- Type
- Synthetic organic
- Drug name stem
- -gliflozin
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Sodium/glucose cotransporter 1
- Gene symbol
- SLC5A1
- Protein identifier
- P13866
- Median affinity
- 5.1
- Affinity units
- pIC50
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Sodium/glucose cotransporter 2
- Gene symbol
- SLC5A2
- Protein identifier
- P31639
- Median affinity
- 8.5
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Sodium/glucose cotransporter 2 inhibitor
- Action type
- Inhibitor
- Target
- Sodium/glucose cotransporter 2
- Protein identifier
- P31639
Open Targets mechanisms
- Mechanism
- Sodium/glucose cotransporter 2 inhibitor
- Action type
- Inhibitor
- Target
- Sodium/glucose cotransporter 2
DrugCentral mechanisms
- Action type
- Inhibitor
- Gene symbol
- SLC5A2
- Protein identifier
- P31639
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Metabolic Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000195
- Subject identifier
- D024821
- Condition
- Crohn Disease
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Diabetic Nephropathies
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000401
- Subject identifier
- D003928
- Condition
- Epilepsy
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000474
- Subject identifier
- D004827
- Condition
- Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Polycystic Ovary Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000660
- Subject identifier
- D011085
- Condition
- Hypertension, Portal
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000666
- Subject identifier
- D006975
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Insulin Resistance
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002614
- Subject identifier
- D007333
- Condition
- Kidney Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Non-alcoholic Fatty Liver Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003095
- Subject identifier
- D065626
- Condition
- Heart Failure
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Inflammatory Bowel Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003767
- Subject identifier
- D015212
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Kidney Calculi
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004253
- Subject identifier
- D007669
- Condition
- Diabetes, Gestational
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004593
- Subject identifier
- D016640
- Condition
- Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008583
- Subject identifier
- D009203
- Condition
- ST Elevation Myocardial Infarction
- Highest recorded phase
- 2
- Condition identifier
- EFO:0008585
- Subject identifier
- D000072657
- Condition
- Kidney Failure, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009909
- Subject identifier
- D007676
- Condition
- Diabetic Neuropathies
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000783
- Subject identifier
- D003929
- Condition
- Inappropriate ADH Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000982
- Subject identifier
- D007177
- Condition
- Prediabetic State
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001121
- Subject identifier
- D011236
- Condition
- Cardiotoxicity
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001482
- Subject identifier
- D066126
And 12 more, listed on the interactive page.
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000266
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000319
- Condition identifier
- EFO_0000373
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000400
- Condition identifier
- EFO_0000401
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000474
- Condition identifier
- EFO_0000537
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000612
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000729
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001361
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002503
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002546
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002687
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003095
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003144
- Condition identifier
- EFO_0003884
- Condition identifier
- EFO_0003913
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004253
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004517
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004593
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005207
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008583
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008585
- Highest recorded phase
- 2
And 97 more, listed on the interactive page.
- Event
- acute kidney injury
- Reports
- 553
- Reporting signal score
- 263.532
- Event
- arthralgia
- Reports
- 50
- Reporting signal score
- 192.838
- Event
- blood ketone body increased
- Reports
- 120
- Reporting signal score
- 466.095
- Event
- dehydration
- Reports
- 530
- Reporting signal score
- 312.821
- Event
- diabetic ketoacidosis
- Reports
- 3,077
- Reporting signal score
- 10,953.4
- Event
- drug hypersensitivity
- Reports
- 20
- Reporting signal score
- 211.83
- Event
- euglycaemic diabetic ketoacidosis
- Reports
- 1,115
- Reporting signal score
- 4,827.4
- Event
- fatigue
- Reports
- 165
- Reporting signal score
- 250.241
- Event
- fournier's gangrene
- Reports
- 580
- Reporting signal score
- 2,495.78
- Event
- fungal infection
- Reports
- 802
- Reporting signal score
- 1,921
- Event
- glycosylated haemoglobin increased
- Reports
- 208
- Reporting signal score
- 330.091
- Event
- headache
- Reports
- 142
- Reporting signal score
- 198.488
- Event
- injection site pain
- Reports
- 3
- Reporting signal score
- 208.375
- Event
- ketoacidosis
- Reports
- 1,081
- Reporting signal score
- 4,198.24
- Event
- ketonuria
- Reports
- 97
- Reporting signal score
- 323.709
- Event
- ketosis
- Reports
- 106
- Reporting signal score
- 371.829
- Event
- metabolic acidosis
- Reports
- 331
- Reporting signal score
- 423.31
- Event
- necrotising fasciitis
- Reports
- 128
- Reporting signal score
- 320.813
- Event
- pain
- Reports
- 88
- Reporting signal score
- 197.238
- Event
- pollakiuria
- Reports
- 220
- Reporting signal score
- 261.833
- Event
- toe amputation
- Reports
- 99
- Reporting signal score
- 243.097
- Event
- urinary tract infection
- Reports
- 556
- Reporting signal score
- 286.946
- Event
- urine ketone body present
- Reports
- 132
- Reporting signal score
- 404.436
- Event
- urosepsis
- Reports
- 155
- Reporting signal score
- 270.214
- NCT00558571
- NCT00749190
- NCT00789035
- NCT00881530
- NCT00885118
- NCT01011868
- NCT01131676
- NCT01159600
- NCT01167881
- NCT01177813
- NCT01193218
- NCT01210001
- NCT01248364
- NCT01257334
- NCT01276288
- NCT01289990
- NCT01316341
- NCT01368081
- NCT01422876
- NCT01581658
- NCT01649297
- NCT01734785
- NCT01778049
- NCT01867307
- NCT01907113
And 132 more, listed on the interactive page.
- Dose
- 10 mg
- Route
- Oral
- How often
- Once daily
Conditions of use
- Take with or without food
- Hydrogen bond acceptors
- 7
- Hydrogen bond donors
- 4
- Polar surface area
- 108.61
- Calculated partition coefficient (ALogP)
- 1.61
- Calculated partition coefficient (XLogP)
- 2
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 6
- Heavy atoms
- 31
- Molecular formula
- C23H27ClO7
- Monoisotopic mass
- 450.1445309
- Natural product
- Yes
- 0597-0152
- 0597-0153
- 0597-0159
- 0597-0164
- 0597-0168
- 0597-0175
- 0597-0180
- 0597-0182
- 0597-0280
- 0597-0290
- 0597-0295
- 0597-0300
- 0597-0380
- 0597-0385
- 0597-0390
- 0597-0395
- 71610-177
- 71610-900
- 50090-4384
- 50090-4492
- 50090-6452
- 50090-6457
- 55154-0411
- 55154-0412
- 67296-2324
- Recorded assays
- 138
- Active assays
- 13
- Confirmatory
- Other
- Sodium-Glucose Transporter 2 Inhibitors
Related records
Trials (527)
- " Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "
- "The Effect of The Combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart Disease"
- 12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
- 12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
- 24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension
- 4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes
- 4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)
- A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
- A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions
- A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes
- A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379
- A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
- A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
- A Extension Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance ( EMPIRE-02 )
- A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
- A Phase Ⅱ Study of Mosapride Citrate Injection in the Treatment of Postoperative Gastrointestinal Dysfunction
- A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy
- A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
- A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes
- A Study Based on Data From German Sick Funds That Looks at the Costs of Treatment of Type-2 Diabetic Patients With Empagliflozin vs. DPP-4 Inhibitors vs. GLP-1 Receptor Agonists
Approved for (4)
In development for (35)
- Acute kidney injury Phase 1
- Acute myocardial infarction Phase 3
- Autosomal dominant polycystic kidney disease Phase 2
- Cancer Phase 2
- Chronic renal failure syndrome Phase 2
- Congenital heart disease Phase 3
- Congestive heart failure Phase 3
- Crohn disease Phase 1
- Diabetic kidney disease Phase 3
- Diabetic neuropathy Phase 1
- Epilepsy Early phase 1
- Gestational diabetes Phase 3
- Glycogen storage disease due to glucose-6-phosphatase deficiency type IA Phase 2
- Glycogen storage disease I Phase 2
- Glycogen storage disease Ib Phase 2
- Heritable pulmonary arterial hypertension Phase 2
- Hypertensive disorder Phase 3
- Hypoglycemia Phase 2
- Idiopathic pulmonary arterial hypertension Phase 2
- Inappropriate ADH syndrome Phase 2
Other linked conditions (3)
- Cardiovascular disorder
- Fatty liver disease
- Ischemia reperfusion injury
Targets (1)
- SLC5A2 Sodium/glucose cotransporter 2 inhibitor