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empagliflozin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives	4830	864070-44-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: empagliflozin BI 10773 jardiance	Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Molecular weight: 450.91 Formula: C23H27ClO7 CLOGP: 2.58 LIPINSKI: 0 HAC: 7 HDO: 4 TPSA: 108.61 ALOGS: -3.61 ROTB: 6 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

empagliflozin
BI 10773
jardiance

Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Molecular weight: 450.91
Formula: C23H27ClO7
CLOGP: 2.58
LIPINSKI: 0
HAC: 7
HDO: 4
TPSA: 108.61
ALOGS: -3.61
ROTB: 6

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
17.50	mg	O

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Hosey CM, Chan R, Benet LZ
S (Water solubility)	0.11 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

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Date	Agency	Company
Aug. 1, 2014	FDA	BOEHRINGER INGELHEIM
Dec. 26, 2014	PMDA	Nippon Boehringer Ingelheim Co., Ltd
March 20, 2014	EMA

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Diabetic ketoacidosis	4944.94	14.67	1180	19869	19325	63448648
Euglycaemic diabetic ketoacidosis	2395.44	14.67	480	20569	3194	63464779
Ketoacidosis	2109.00	14.67	445	20604	3933	63464040
Fungal infection	1085.20	14.67	421	20628	36453	63431520
Blood ketone body increased	267.39	14.67	51	20998	249	63467724
Glycosylated haemoglobin increased	213.95	14.67	97	20952	12301	63455672
Blood glucose increased	211.56	14.67	194	20855	83562	63384411
Metabolic acidosis	188.56	14.67	140	20909	44929	63423044
Malignant mediastinal neoplasm	159.91	14.67	45	21004	1401	63466572
Urine ketone body present	143.60	14.67	47	21002	2456	63465517

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Diabetic ketoacidosis	4539.75	14.73	1294	27295	16738	34911604
Euglycaemic diabetic ketoacidosis	2395.47	14.73	550	28039	2672	34925670
Ketoacidosis	1938.28	14.73	489	28100	3754	34924588
Fungal infection	357.09	14.73	199	28390	15736	34912606
Pollakiuria	310.64	14.73	196	28393	19478	34908864
Metabolic acidosis	242.22	14.73	234	28355	43446	34884896
Ketonuria	232.65	14.73	61	28528	550	34927792
Glycosylated haemoglobin increased	227.86	14.73	132	28457	11228	34917114
Urinary tract infection	225.10	14.73	309	28280	83772	34844570
Toe amputation	203.83	14.73	77	28512	2447	34925895

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Diabetic ketoacidosis	6914.92	12.55	1882	40490	32240	79669776
Euglycaemic diabetic ketoacidosis	4457.81	12.55	969	41403	5875	79696141
Ketoacidosis	3180.38	12.55	755	41617	7099	79694917
Metabolic acidosis	430.32	12.55	354	42018	82175	79619841
Fungal infection	397.88	12.55	258	42114	41490	79660526
Blood ketone body increased	369.13	12.55	84	42288	638	79701378
Pollakiuria	317.74	12.55	215	42157	37102	79664914
Glycosylated haemoglobin increased	295.93	12.55	162	42210	19098	79682918
Urine ketone body present	271.11	12.55	93	42279	3472	79698544
Ketonuria	268.55	12.55	72	42300	1136	79700880

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A10BD19	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD20	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD27	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BK03	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Sodium-glucose co-transporter 2 (SGLT2) inhibitors
CHEBI has role	CHEBI:35526	antidiabetic
CHEBI has role	CHEBI:73273	sodium-glucose transport protein subtype 2 inhibitors
FDA EPC	N0000187059	Sodium-Glucose Cotransporter 2 Inhibitor
FDA MoA	N0000187058	Sodium-Glucose Transporter 2 Inhibitors
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D000077203	Sodium-Glucose Transporter 2 Inhibitors

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352
Chronic heart failure	indication	48447003
Cardiovascular event	reduce risk	405617006

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.62	acidic
pKa2	13.26	acidic
pKa3	13.7	acidic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	8551957	Oct. 14, 2029	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	11090323	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	9949997	May 17, 2034	METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND HEART FAILURE BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	9949997	May 17, 2034	METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH PLUS HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS, HEART FAILURE AND REDUCED EJECTION FRACTION BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	9949997	May 17, 2034	METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	9949998	June 11, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
10MG;1GM	SYNJARDY XR	BOEHRINGER INGELHEIM	N208658	Dec. 9, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TREATMENT-NAÏVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
10MG;1GM	SYNJARDY XR	BOEHRINGER INGELHEIM	N208658	Dec. 9, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	10596120	March 7, 2032	TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN
10MG;1GM	SYNJARDY XR	BOEHRINGER INGELHEIM	N208658	Dec. 9, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	Aug. 18, 2024	REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE AND REDUCED EJECTION FRACTION
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	Feb. 24, 2025	LABELING REVISIONS RELATED TO CLINICAL STUDIES
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	Aug. 24, 2025	PEDIATRIC EXCLUSIVITY
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	June 20, 2026	NEW PATIENT POPULATION
10MG	JARDIANCE	BOEHRINGER INGELHEIM	N204629	Aug. 1, 2014	RX	TABLET	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
10MG;1GM	SYNJARDY XR	BOEHRINGER INGELHEIM	N208658	Dec. 9, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 20, 2026	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091
10MG;1GM	SYNJARDY XR	BOEHRINGER INGELHEIM	N208658	Dec. 9, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 20, 2026	PEDIATRIC EXCLUSIVITY
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	March 30, 2023	ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
12.5MG;1GM	SYNJARDY	BOEHRINGER INGELHEIM	N206111	Aug. 26, 2015	RX	TABLET	ORAL	June 20, 2026	NEW PATIENT POPULATION
12.5MG;1GM	SYNJARDY XR	BOEHRINGER INGELHEIM	N208658	Dec. 9, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 20, 2026	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium/glucose cotransporter 2	Transporter	P31639	SC5A2_HUMAN	INHIBITOR	Kd	7.24	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 4	Transporter	Q2M3M2	SC5A9_HUMAN		IC50	4.96	SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 5	Transporter	A0PJK1	SC5AA_HUMAN		IC50	5.96	SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 1	Transporter	P13866	SC5A1_HUMAN		IC50	5.08	SCIENTIFIC LITERATURE
Sodium/myo-inositol cotransporter 2	Transporter	Q8WWX8	SC5AB_HUMAN		IC50	5.70	SCIENTIFIC LITERATURE

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External reference:

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ID	Source
7R3	PDB_CHEM_ID
015572	NDDF
11949646	PUBCHEM_CID
1545653	RXNORM
227183	MMSL
30461	MMSL
4033569	VUID
4033569	VANDF
4754	IUPHAR_LIGAND_ID
703894008	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0164	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0164	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0164	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0182	TABLET, FILM COATED	10 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0182	TABLET, FILM COATED	10 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0182	TABLET, FILM COATED	10 mg	ORAL	NDA	32 sections
Jardiance	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0152	TABLET, FILM COATED	10 mg	ORAL	NDA	30 sections
Jardiance	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0152	TABLET, FILM COATED	10 mg	ORAL	NDA	30 sections
Jardiance	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0152	TABLET, FILM COATED	10 mg	ORAL	NDA	30 sections
Jardiance	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0152	TABLET, FILM COATED	10 mg	ORAL	NDA	30 sections

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