Dapagliflozin
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2012
- First approval year
- 2012
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Dapagliflozin
- Molecular weight
- 408.88
- Structure (SMILES)
- CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
- dapagliflozin component of br1019
- Dapagliflozin component of br1019
- dapagliflozin component of qtern
- Dapagliflozin component of qtern
- dapagliflozin component of qternmet
- Dapagliflozin component of qternmet
- Dapagliflozin component of qternmet dapaglifozin
- dapagliflozin component of qternmet dapaglifozin
- dapagliflozin component of qternmet xr
- Dapagliflozin component of qternmet xr
- dapagliflozin viatris
- Dapagliflozin viatris
- balcinrenone dapagliflozin
- bms 512148
- BMS-512148
- br1019 component dapagliflozin
- BR1019 component Dapagliflozin
- dapagliflozin
- Dapagliflozin
- Dapagliflozin (DAPA)
- Dapagliflozin (Treatment A)
- dapagliflozin [INN]
- DAPAGLIFLOZIN [MI]
- DAPAGLIFLOZIN [ORANGE BOOK]
- DAPAGLIFLOZIN [USAN]
- DAPAGLIFLOZIN [VANDF]
- Dapagliflozin [WHO-DD]
- Dapagliflozin 10 mg
- Dapagliflozin 10 MG
- Dapagliflozin 10 mg daily
- Dapagliflozin 10 mg film-coated tablet
- Dapagliflozin 10 MG Oral Tablet
- Dapagliflozin 10 mg tablets
- Dapagliflozin 10mg
- Dapagliflozin 10Mg Oral Tablet
- Dapagliflozin 10mg QD
- Dapagliflozin 5 mg
And 27 more, listed on the interactive page.
- ATC classification codes
- A10BK01
Sources for recorded values
- CAS registry numbers
- 461432-26-8
- ChEMBL ID
- CHEMBL429910
- InChIKey
- JVHXJTBJCFBINQ-ADAARDCZSA-N
- PubChem compound IDs
- 9887712
- RxNorm IDs (RxCUI)
- 1488564
- FDA ingredient codes (UNII)
- 1ULL0QJ8UC
- Applicant
- ASTRAZENECA AB
- Approval date
- 8 Jan 2014
- Application number
- NDA202293
- Status
- Authorised
- Status date
- 11 Nov 2012
- Authorisation date
- 11 Nov 2012
- Approved indications
- Type 2 diabetes mellitus Forxiga 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 type 2 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 Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Forxiga is indicated in adults for the treatment of chronic kidney disease.
- Product number
- EMEA/H/C/002322
- Authorisation holder
- AstraZeneca AB
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 1
- 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
- Heart Failure, Systolic
- Renal Insufficiency, Chronic
European medicines record
- Patents
- 34
- Designations
- 2
- Earliest recorded loss of exclusivity
- 1 Oct 2041
- 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
- dapagliflozin
- Type
- Synthetic organic
- Drug name stem
- -gliflozin
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Activation
- Action type
- ACTIVATION
- Target
- K2P7.1
- Gene symbol
- KCNK7
- Protein identifier
- Q9Y2U2
- Median affinity
- 4
- Affinity units
- pEC50
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Sodium/glucose cotransporter 1
- Gene symbol
- SLC5A1
- Protein identifier
- P13866
- Median affinity
- 6.4
- Affinity units
- pIC50
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- Sodium/glucose cotransporter 2
- Gene symbol
- SLC5A2
- Protein identifier
- P31639
- Median affinity
- 9.3
- 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
- 2
- Condition identifier
- EFO:0000195
- Subject identifier
- D024821
- Condition
- Atrial Fibrillation
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000275
- Subject identifier
- D001281
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Diabetic Nephropathies
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000401
- Subject identifier
- D003928
- Condition
- Myocardial Infarction
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Polycystic Ovary Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000660
- Subject identifier
- D011085
- Condition
- Obesity
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Hypertension, Pulmonary
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001361
- Subject identifier
- D006976
- Condition
- Liver Cirrhosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001422
- Subject identifier
- D008103
- Condition
- Coronary Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
- Condition
- Insulin Resistance
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002614
- Subject identifier
- D007333
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Reperfusion Injury
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002687
- Subject identifier
- D015427
- Condition
- Heart Failure
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Inflammatory Bowel Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003767
- Subject identifier
- D015212
- Condition
- Diabetic Retinopathy
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003770
- Subject identifier
- D003930
- Condition
- Brain Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003833
- Subject identifier
- D001932
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Motor Activity
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003940
- Subject identifier
- D009043
- Condition
- Glomerulonephritis, IGA
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004194
- Subject identifier
- D005922
- Condition
- Albuminuria
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004285
- Subject identifier
- D000419
- Condition
- Lupus Nephritis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0005761
- Subject identifier
- D008181
- Condition
- ST Elevation Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008585
- Subject identifier
- D000072657
- Condition
- Hyperuricemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009104
- Subject identifier
- D033461
And 20 more, listed on the interactive page.
- Condition identifier
- EFO_0000195
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000266
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000275
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000400
- Condition identifier
- EFO_0000401
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000537
- Condition identifier
- EFO_0000589
- Condition identifier
- EFO_0000612
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000660
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001361
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001422
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001645
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001663
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002687
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003144
- Condition identifier
- EFO_0003770
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003884
- Condition identifier
- EFO_0003913
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003940
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004285
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004952
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005761
- Highest recorded phase
- 2
And 121 more, listed on the interactive page.
- Event
- acute kidney injury
- Reports
- 186
- Reporting signal score
- 133.717
- Event
- bladder cancer
- Reports
- 44
- Reporting signal score
- 77.8048
- Event
- blood glucose increased
- Reports
- 135
- Reporting signal score
- 147.609
- Event
- cardiospasm
- Reports
- 15
- Reporting signal score
- 71.0148
- Event
- dehydration
- Reports
- 119
- Reporting signal score
- 63.2105
- Event
- diabetes mellitus inadequate control
- Reports
- 71
- Reporting signal score
- 138.952
- Event
- diabetic ketoacidosis
- Reports
- 769
- Reporting signal score
- 2,759.89
- Event
- euglycaemic diabetic ketoacidosis
- Reports
- 183
- Reporting signal score
- 718.638
- Event
- fournier's gangrene
- Reports
- 53
- Reporting signal score
- 176.025
- Event
- fungal infection
- Reports
- 211
- Reporting signal score
- 521.725
- Event
- glomerular filtration rate decreased
- Reports
- 45
- Reporting signal score
- 77.16
- Event
- glucose urine present
- Reports
- 20
- Reporting signal score
- 61.3462
- Event
- glycosylated haemoglobin increased
- Reports
- 98
- Reporting signal score
- 216.953
- Event
- hyperglycaemia
- Reports
- 70
- Reporting signal score
- 75.5786
- Event
- immunisation
- Reports
- 11
- Reporting signal score
- 50.2411
- Event
- ketoacidosis
- Reports
- 190
- Reporting signal score
- 674.912
- Event
- ketonuria
- Reports
- 31
- Reporting signal score
- 111.833
- Event
- ketosis
- Reports
- 31
- Reporting signal score
- 114.403
- Event
- lactic acidosis
- Reports
- 63
- Reporting signal score
- 58.7435
- Event
- metabolic acidosis
- Reports
- 116
- Reporting signal score
- 187.059
- Event
- necrotising fasciitis
- Reports
- 30
- Reporting signal score
- 74.0961
- Event
- palmoplantar keratoderma
- Reports
- 15
- Reporting signal score
- 56.0161
- Event
- pollakiuria
- Reports
- 50
- Reporting signal score
- 56.5228
- Event
- polyuria
- Reports
- 32
- Reporting signal score
- 51.2678
- Event
- pruritus genital
- Reports
- 24
- Reporting signal score
- 76.2873
And 5 more, listed on the interactive page.
- NCT00162305
- NCT00263276
- NCT00357370
- NCT00528372
- NCT00528879
- NCT00538174
- NCT00554450
- NCT00562250
- NCT00643851
- NCT00660907
- NCT00663260
- NCT00673231
- NCT00680745
- NCT00683878
- NCT00736879
- NCT00831779
- NCT00839683
- NCT00842556
- NCT00855166
- NCT00859898
- NCT00904176
- NCT00908271
- NCT00930865
- NCT00972244
- NCT00976495
And 228 more, listed on the interactive page.
- Dose
- 5 mg
- Route
- Oral
- How often
- Once daily
Conditions of use
- Take with food
- Hydrogen bond acceptors
- 6
- Hydrogen bond donors
- 4
- Polar surface area
- 99.38
- Calculated partition coefficient (ALogP)
- 1.84
- Calculated partition coefficient (XLogP)
- 2.3
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 6
- Heavy atoms
- 28
- Molecular formula
- C21H25ClO6
- Monoisotopic mass
- 408.1339662
- Natural product
- Yes
- 0480-3527
- 0480-3528
- 0781-5985
- 0781-5990
- 27241-151
- 27241-152
- 33342-406
- 33342-407
- 33342-408
- 33342-409
- 33342-585
- 33342-586
- 46708-392
- 46708-393
- 59651-154
- 59651-155
- 59651-156
- 59651-157
- 59651-159
- 59651-160
- 62332-392
- 62332-393
- 63304-026
- 63304-027
- 63304-028
And 36 more, listed on the interactive page.
- Recorded assays
- 415
- Active assays
- 81
- Confirmatory
- Other
- Sodium-Glucose Transporter 2 Inhibitors
Oral bioavailability
- Median
- 88.2
- Mean
- 88.6367
- Minimum
- 83
- Maximum
- 100
- Unit
- %
- Assays
- 6
- Standard deviation
- 6.04821
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Related records
Trials (577)
- "Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes"
- "Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"
- A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
- A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
- A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease
- A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting.
- A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients
- A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal
- A Clinical Trial to Evaluate the Blood Pressure Lowering Effect of a Candemore Plus Tab Versus Cantabell Tab in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
- A Clinical Trial to Evaluate the Bone Metabolism and the Blood Sugar of Evogliptin and Dapagliflozin
- A Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of Telmisartan and Dapagliflozin.
- A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus and High Body Mass Index (BMI)
- A Comparison of Postprandial Glucose After a MMTT, and the Metabolic Effects of Insulin Withdrawal in a Crossover Study in Subjects With Type 1 Diabetes
- A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
- A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers
- A Phase 2b Diabetic Kidney Disease Study
- A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
- A Phase I PK Study of Balcinrenone/Dapagliflozin in Healthy Chinese Participants
- A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment
- A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic Subjects
Approved for (4)
In development for (37)
- Acute kidney injury Phase 3
- AL amyloidosis Phase 2
- Alzheimer disease Phase 1
- Atrial fibrillation Phase 3
- Brain neoplasm Phase 1
- Breast cancer Phase 2
- Chronic renal failure syndrome Phase 3
- Cirrhosis of liver Phase 2
- Coronary artery disorder Phase 3
- COVID-19 Phase 3
- Cystinuria Phase 2
- Depressive disorder Phase 2
- Diabetic kidney disease Phase 2
- Diabetic neuropathy Phase 2
- Diabetic retinopathy Phase 3
- Diastolic heart failure Phase 2
- Exocrine pancreatic carcinoma Phase 1
- Fabry disease Phase 2
- Fatty liver disease Phase 3
- IgA glomerulonephritis Phase 3
Other linked conditions (5)
- Alport syndrome
- Glucose metabolism disease
- Hypertensive disorder
- Metabolic disease
- Systolic heart failure
Targets (1)
- SLC5A2 Sodium/glucose cotransporter 2 inhibitor