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Farxiga, Forxiga(dapagliflozin)
Ebymect, Edistride, Farxiga, Forxiga, Qtern, Qternmet, Qtrilmet, Xigduo (dapagliflozin) is a small molecule pharmaceutical. Dapagliflozin was first approved as Forxiga on 2012-11-11. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat chronic renal insufficiency, diabetes mellitus, glucose metabolism disorders, heart failure, and metabolic diseases amongst others. It is known to target sodium/glucose cotransporter 1 and sodium/glucose cotransporter 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Farxiga (generic drugs available since 2022-02-22)
Combinations
Qtern, Xigduo (discontinued: Qternmet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dapagliflozin
Tradename
Company
Number
Date
Products
FARXIGAAstraZenecaN-202293 RX2014-01-08
2 products, RLD, RS
Dapagliflozin
+
Metformin hydrochloride
Tradename
Company
Number
Date
Products
XIGDUO XRAstraZenecaN-205649 RX2014-10-29
5 products, RLD, RS
Dapagliflozin
+
Metformin hydrochloride
+
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
QTERNMET XRAstraZenecaN-210874 DISCN2019-05-02
4 products, RLD
Hide discontinued
Dapagliflozin
+
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
QTERNAstraZenecaN-209091 RX2017-02-27
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
farxigaNew Drug Application2023-05-08
qternNew Drug Application2020-01-24
xigduoNew Drug Application2020-01-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
Agency Specific
FDA
EMA
Expiration
Code
DAPAGLIFLOZIN, FARXIGA, ASTRAZENECA AB
2024-04-30I-857
2023-05-05I-834
Patent Expiration
Patent
Expires
Flag
FDA Information
Dapagliflozin, Farxiga, Astrazeneca Ab
109738362040-03-09U-3127
86859342030-05-26U-1522
87216152030-01-18DP
79195982029-12-16DP
78515022028-08-19DP
82217862028-03-21DP
83619722028-03-21U-493, U-1976, U-1977, U-2139
87162512028-03-21DP
85016982027-06-20DPU-493, U-1976, U-1977
83296482026-08-18U-2139, U-2212, U-2213
89068512026-08-18U-2139
65151172025-10-04DS, DPU-493, U-2139
74562542025-06-30DPU-2139
84316852025-04-13DPU-2139
84611052025-04-13DPU-2139
92380762024-04-15DPU-2139
Dapagliflozin / Metformin Hydrochloride, Xigduo Xr, Astrazeneca Ab
96160282030-11-12DP
Dapagliflozin / Metformin Hydrochloride / Saxagliptin Hydrochloride, Qternmet Xr, Astrazeneca Ab
86287992025-07-13DP
RE441862023-07-31DS, DPU-493
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
— A10BD15: Metformin and dapagliflozin
— A10BD21: Saxagliptin and dapagliflozin
— A10BD25: Metformin, saxagliptin and dapagliflozin
— A10BK: Sodium-glucose co-transporter 2 (sglt2) inhibitors
— A10BK01: Dapagliflozin
HCPCS
No data
Clinical
Clinical Trials
389 clinical trials
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Mock data
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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 mellitusD003924EFO_0001360E112414577417182
Heart failureD006333EFO_0003144I501101214337
Type 1 diabetes mellitusD003922EFO_0001359E1066102123
Chronic renal insufficiencyD051436N1831032118
Diabetes mellitusD003920EFO_0000400E08-E131134110
ObesityD009765EFO_0001073E66.9—22318
Prediabetic stateD011236EFO_1001121R73.03—224—7
Cardiovascular diseasesD002318EFO_0000319I98—13216
Myocardial infarctionD009203EFO_0000612I21—11215
HypertensionD006973EFO_0000537I10——13—4
Show 42 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Metabolic syndromeD024821EFO_0000195E88.81—23——3
Renal insufficiencyD051437HP_0000083N19—12——3
Inferior wall myocardial infarctionD056989EFO_1000983——1—12
Covid-19D000086382U07.1—12——2
Polycystic ovary syndromeD011085EFO_0000660E28.2——2——2
Cognitive dysfunctionD060825G31.84—11—12
Insulin resistanceD007333EFO_0002614——1—12
Iga glomerulonephritisD005922EFO_0004194——1——1
ConfusionD003221F44.89——1——1
Morbid obesityD009767EFO_0001074—11——1
Show 10 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CystinuriaD003555E72.01—2———2
Weight lossD015431HP_0001824—2———2
Breast neoplasmsD001943EFO_0003869C50—2———2
Liver cirrhosisD008103EFO_0001422K74.0—2———2
Sleep apnea syndromesD012891EFO_0003877G47.3—1———1
Diastolic heart failureD054144EFO_1000899I50.30—1———1
AgingD000375GO_0007568R41.8111———1
CardiomyopathiesD009202EFO_0000318I42—1———1
Heart disease risk factorsD000082742—1———1
Alzheimer diseaseD000544EFO_0000249F0311———1
Show 11 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—17————17
Catheter ablationD0171151————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Diabetic ketoacidosisD016883EFO_10008971————1
Therapeutic equivalencyD0138101————1
Prostatic neoplasmsD011471C611————1
Reperfusion injuryD0154271————1
Vascular ringD000073872Q25.451————1
Brain neoplasmsD001932EFO_0003833C711————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary tract infectionsD014552EFO_0003103N39.0————11
Unstable anginaD000789EFO_1000985I20.0————11
Diabetic cardiomyopathiesD058065EFO_1001458————11
Left ventricular dysfunctionD018487————11
St elevation myocardial infarctionD000072657————11
Tricuspid valve insufficiencyD014262HP_0005180————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDAPAGLIFLOZIN
INNdapagliflozin
Description
Dapagliflozin is a C-glycosyl comprising beta-D-glucose in which the anomeric hydroxy group is replaced by a 4-chloro-3-(4-ethoxybenzyl)phenyl group. Used (in the formo f its propanediol monohydrate) to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. It has a role as a hypoglycemic agent and a sodium-glucose transport protein subtype 2 inhibitor. It is a C-glycosyl compound, an organochlorine compound and an aromatic ether.
Classification
Small molecule
Drug classphlorozin derivatives, phenolic glycosides
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Identifiers
PDB—
CAS-ID461432-26-8
RxCUI1488564
ChEMBL IDCHEMBL429910
ChEBI ID85078
PubChem CID9887712
DrugBankDB06292
UNII ID1ULL0QJ8UC (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
SLC5A1
SLC5A1
SLC5A2
SLC5A2
Organism
Homo sapiens
Gene name
SLC5A1
Gene synonyms
NAGT, SGLT1
NCBI Gene ID
6523
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
P13866
Mouse ortholog
Slc5a1 (20537)
sodium/glucose cotransporter 1 (Q8C3K6)
Variants
Clinical Variant
No data
Financial
Forxiga - Bristol Myers Squibb
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Qtern - AstraZeneca
$
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Farxiga - AstraZeneca
$
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,617 documents
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Safety
Black-box Warning
Black-box warning for: Xigduo
Adverse Events
Top Adverse Reactions
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26 adverse events reported
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