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Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives	4758	842133-18-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: invokana canagliflozin hemihydrate canagliflozin anhydrous canagliflozin canagliflozin hydrate	A glucoside-derived SODIUM-GLUCOSE TRANSPORTER 2 inhibitor that stimulates urinary excretion of glucose by suppressing renal glucose reabsorption. It is used to manage BLOOD GLUCOSE levels in patients with TYPE 2 DIABETES. Molecular weight: 444.52 Formula: C24H25FO5S CLOGP: 4.55 LIPINSKI: 0 HAC: 5 HDO: 4 TPSA: 90.15 ALOGS: -5 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

invokana
canagliflozin hemihydrate
canagliflozin anhydrous
canagliflozin
canagliflozin hydrate

A glucoside-derived SODIUM-GLUCOSE TRANSPORTER 2 inhibitor that stimulates urinary excretion of glucose by suppressing renal glucose reabsorption. It is used to manage BLOOD GLUCOSE levels in patients with TYPE 2 DIABETES.

Molecular weight: 444.52
Formula: C24H25FO5S
CLOGP: 4.55
LIPINSKI: 0
HAC: 5
HDO: 4
TPSA: 90.15
ALOGS: -5
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.20	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution)	1.19 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.74 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	10.30 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	3.214		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	3.681		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	46.132	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	4.305	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	1.180	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	2.680	%	High	1
herg	hERG pIC50	4.914	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	5.224	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	4.920	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	1.070	%	High	1
kinase-safety-class	ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,JAK3,MAP2K6,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CG,PIM2,PRKDC,TEK,TGFBR1,ZAP70	28
kinase-selectivity-class	AXL,GRK2,MAP2K6	3
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	12.218		High	1
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	18.923		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	11.402		High	1
mppb	Mouse plasma protein binding (% unbound)	1.330		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	51.642		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pppb	Pig plasma protein binding (% unbound)	2.410	%	High	1
rat-kpuu-brain	Rat brain Kpuu	0.014	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	10.864	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	16.890	%	High	1
rppb	Rat plasma protein binding (% unbound)	0.720	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	16.293	uM	High	1

Approvals:

Date	Agency	Company
July 4, 2014	PMDA	MITSUBISHI TANABE PHARMA CORPORATION
March 29, 2013	FDA	JANSSEN PHARMS
Nov. 15, 2013	EMA	JANSSEN-CILAG INTERNATIONAL NV

FDA Adverse Event Reporting System (Female)

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	3458.45	19.73	800	14161	23607	90589879
Fungal infection	2234.89	19.73	633	14328	42028	90571458
Genital infection fungal	778.72	19.73	111	14850	112	90613374
Ketoacidosis	605.00	19.73	148	14813	5447	90608039
Euglycaemic diabetic ketoacidosis	579.92	19.73	146	14815	6055	90607431
Urinary tract infection	437.31	19.73	378	14583	305254	90308232
Full blood count abnormal	272.44	19.73	129	14832	36468	90577018
Toe amputation	260.96	19.73	62	14899	2007	90611479
Glycosylated haemoglobin increased	236.46	19.73	91	14870	15471	90598015
Malignant mediastinal neoplasm	181.77	19.73	43	14918	1365	90612121
Blood glucose increased	173.63	19.73	136	14825	95110	90518376
Hyperglycaemia	171.29	19.73	106	14855	50864	90562622
Urine ketone body present	161.03	19.73	44	14917	2508	90610978
Vulvovaginal mycotic infection	152.44	19.73	52	14909	6262	90607224
Glomerular filtration rate decreased	151.97	19.73	68	14893	16864	90596622
Dehydration	141.12	19.73	167	14794	194280	90419206
Diabetic foot infection	135.13	19.73	25	14936	226	90613260
Blood immunoglobulin E increased	133.03	19.73	43	14918	4382	90609104
Asthma	126.96	19.73	177	14784	241983	90371503
Weight decreased	126.04	19.73	225	14736	379685	90233801
Metabolic acidosis	122.47	19.73	89	14872	55587	90557899
Pancreatitis	106.69	19.73	90	14871	69736	90543750
Gangrene	100.71	19.73	47	14914	12829	90600657
Urine output increased	100.20	19.73	28	14933	1734	90611752
Pollakiuria	82.36	19.73	57	14904	32948	90580538
Myopathy toxic	80.55	19.73	19	14942	595	90612891
Hypoglycaemia	78.99	19.73	76	14885	69772	90543714
Osteomyelitis	76.40	19.73	51	14910	27795	90585691
Vulvovaginal pruritus	73.92	19.73	27	14934	3966	90609520
Pyelonephritis	73.26	19.73	45	14916	21271	90592215
Foot amputation	69.15	19.73	15	14946	319	90613167
Bronchiectasis	66.37	19.73	43	14918	22287	90591199
Ketosis	65.53	19.73	17	14944	792	90612694
Urosepsis	63.39	19.73	41	14920	21191	90592295
Leg amputation	59.36	19.73	20	14941	2317	90611169
Acute kidney injury	58.53	19.73	149	14812	320238	90293248
Vaginal infection	57.43	19.73	28	14933	8412	90605074
Acidosis	57.26	19.73	32	14929	12704	90600782
Gastrooesophageal reflux disease	55.59	19.73	99	14862	166238	90447248
Incorrect dose administered	54.20	19.73	66	14895	78864	90534622
Necrotising fasciitis	52.95	19.73	21	14940	3859	90609627
Polyuria	50.03	19.73	27	14934	10013	90603473
Diabetic foot	49.63	19.73	16	14945	1615	90611871
Blood ketone body increased	46.46	19.73	11	14950	350	90613136
Arthropathy	45.70	19.73	4	14957	366238	90247248
Treatment noncompliance	43.47	19.73	48	14913	51679	90561807
Maternal exposure during pregnancy	42.16	19.73	5	14956	360058	90253428
Contraindicated product administered	41.33	19.73	3	14958	320136	90293350
Limb amputation	40.95	19.73	7	14954	38	90613448
Amputation	39.02	19.73	9	14952	255	90613231
Blood glucose decreased	37.41	19.73	31	14930	23398	90590088
Vulvovaginal candidiasis	36.06	19.73	16	14945	3884	90609602
Wound	35.98	19.73	4	14957	302976	90310510
Vascular access site haemorrhage	35.88	19.73	8	14953	194	90613292
Nasal congestion	34.99	19.73	55	14906	83359	90530127
General physical health deterioration	34.78	19.73	8	14953	355107	90258379
Infusion related reaction	34.25	19.73	13	14948	416767	90196719
Drug intolerance	33.52	19.73	16	14945	447575	90165911
Pain	33.29	19.73	72	14889	996269	89617217
Low density lipoprotein increased	32.80	19.73	19	14942	8066	90605420
Hypoacusis	32.78	19.73	31	14930	27819	90585667
Dizziness	32.76	19.73	187	14774	589097	90024389
Vascular stenosis	32.69	19.73	9	14952	527	90612959
Intercepted medication error	32.28	19.73	10	14951	887	90612599
Glucose urine present	31.99	19.73	10	14951	914	90612572
Joint swelling	31.98	19.73	22	14939	503278	90110208
Glycosuria	31.41	19.73	11	14950	1431	90612055
Rhinorrhoea	31.34	19.73	54	14907	88262	90525224
Hyperkalaemia	30.30	19.73	45	14916	64919	90548567
Flank pain	29.79	19.73	25	14936	19197	90594289
Gastroenteritis	29.67	19.73	30	14931	29199	90584287
Lactic acidosis	29.56	19.73	39	14922	50424	90563062
Stomatitis	29.38	19.73	5	14956	274693	90338793
Abdominal discomfort	28.84	19.73	22	14939	477306	90136180
Haematuria	28.62	19.73	32	14929	34905	90578581
Fungal skin infection	28.50	19.73	15	14946	5286	90608200
Cerebral fungal infection	28.21	19.73	7	14954	272	90613214
Impaired healing	28.04	19.73	3	14958	234196	90379290
Osteomyelitis acute	27.46	19.73	7	14954	304	90613182
Helicobacter infection	26.92	19.73	3	14958	226847	90386639
Hepatic enzyme increased	26.84	19.73	13	14948	360723	90252763
Genital rash	26.57	19.73	8	14953	645	90612841
Diabetes mellitus inadequate control	26.31	19.73	23	14938	18661	90594825
Rhabdomyolysis	26.08	19.73	37	14924	51219	90562267
Vulvovaginitis	25.68	19.73	7	14954	395	90613091
Condition aggravated	25.28	19.73	37	14924	595508	90017978
Pyrexia	25.25	19.73	44	14917	660441	89953045
Ketonuria	25.16	19.73	8	14953	773	90612713
Diabetes mellitus	24.78	19.73	41	14920	64834	90548652
Cerebral infarction	24.65	19.73	26	14935	26570	90586916
Hemianopia homonymous	24.35	19.73	8	14953	857	90612629
Neutropenia	24.25	19.73	4	14957	224900	90388586
Haemorrhagic erosive gastritis	24.18	19.73	7	14954	492	90612994
Irritable bowel syndrome	23.97	19.73	3	14958	207445	90406041
Cystitis	23.94	19.73	41	14920	66677	90546809
Micturition disorder	23.54	19.73	11	14950	3009	90610477
Anion gap increased	23.22	19.73	10	14951	2260	90611226
Thirst	22.82	19.73	20	14941	16275	90597211
Dysuria	22.39	19.73	30	14931	39371	90574115
Renal abscess	22.32	19.73	8	14953	1113	90612373
Type 2 diabetes mellitus	22.27	19.73	79	14882	203165	90410321
Exposure during pregnancy	22.11	19.73	6	14955	238404	90375082
Urine ketone body	22.02	19.73	5	14956	132	90613354
Discomfort	21.79	19.73	9	14952	274326	90339160
Musculoskeletal stiffness	21.58	19.73	11	14950	296521	90316965
Diabetic ulcer	20.94	19.73	5	14956	165	90613321
Swelling	20.92	19.73	23	14938	419035	90194451
Alopecia	20.76	19.73	31	14930	495040	90118446
Hyperglycaemic hyperosmolar nonketotic syndrome	20.76	19.73	8	14953	1361	90612125
Therapeutic product effect decreased	20.64	19.73	10	14951	277561	90335925
Insomnia	20.60	19.73	15	14946	333459	90280027
Genital infection	20.29	19.73	5	14956	189	90613297
Thrombocytopenia	19.83	19.73	5	14956	208720	90404766

FDA Adverse Event Reporting System (Male)

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	2195.80	19.98	640	14370	21727	42584598
Toe amputation	694.69	19.98	169	14841	2760	42603565
Genital infection fungal	548.16	19.98	91	14919	140	42606185
Fungal infection	500.57	19.98	206	14804	19516	42586809
Euglycaemic diabetic ketoacidosis	382.41	19.98	122	14888	5538	42600787
Ketoacidosis	339.61	19.98	110	14900	5242	42601083
Diabetic foot infection	326.98	19.98	71	14939	675	42605650
Osteomyelitis	301.67	19.98	141	14869	18082	42588243
Balanoposthitis	286.74	19.98	74	14936	1547	42604778
Leg amputation	251.47	19.98	74	14936	2549	42603776
Glycosylated haemoglobin increased	223.16	19.98	103	14907	12821	42593504
Gangrene	213.98	19.98	77	14933	5049	42601276
Urine output increased	206.68	19.98	56	14954	1420	42604905
Foot amputation	185.60	19.98	46	14964	811	42605514
Glomerular filtration rate decreased	177.33	19.98	95	14915	16256	42590069
Diabetic foot	150.53	19.98	52	14958	3021	42603304
Pollakiuria	141.72	19.98	92	14918	22413	42583912
Weight decreased	136.23	19.98	254	14756	207694	42398631
Osteomyelitis acute	134.95	19.98	29	14981	261	42606064
Limb amputation	134.12	19.98	24	14986	70	42606255
Urine ketone body present	132.17	19.98	39	14971	1355	42604970
Dehydration	122.69	19.98	196	14814	141571	42464754
Blood glucose increased	120.64	19.98	139	14871	73560	42532765
Pancreatitis	117.07	19.98	107	14903	43161	42563164
Metabolic acidosis	117.03	19.98	116	14894	51742	42554583
Urinary tract infection	115.78	19.98	158	14852	99126	42507199
Amputation	109.33	19.98	30	14980	798	42605527
Skin injury	96.59	19.98	36	14974	2605	42603720
Skin ulcer	76.51	19.98	67	14943	25534	42580791
Ketosis	75.75	19.98	23	14987	882	42605443
Hepatic fibrosis	75.33	19.98	36	14974	4836	42601489
Necrotising oesophagitis	74.16	19.98	23	14987	948	42605377
Ketonuria	73.70	19.98	21	14989	643	42605682
Bone cyst	73.41	19.98	26	14984	1625	42604700
Joint ankylosis	73.02	19.98	26	14984	1651	42604674
Localised infection	70.47	19.98	58	14952	20315	42586010
Anti-cyclic citrullinated peptide antibody positive	69.69	19.98	26	14984	1886	42604439
Hypoglycaemia	67.79	19.98	94	14916	59760	42546565
Prostatitis	61.32	19.98	34	14976	6214	42600111
Blood ketone body increased	59.64	19.98	17	14993	521	42605804
Osteolysis	53.97	19.98	26	14984	3554	42602771
Anaemia	53.82	19.98	16	14994	280262	42326063
Febrile neutropenia	53.28	19.98	3	15007	185700	42420625
Cerebral infarction	52.97	19.98	60	14950	31109	42575216
Hand deformity	52.70	19.98	26	14984	3742	42602583
Lactic acidosis	52.61	19.98	72	14938	45189	42561136
Red blood cell sedimentation rate abnormal	52.26	19.98	26	14984	3810	42602515
Gas gangrene	52.12	19.98	11	14999	90	42606235
Hyperkalaemia	52.10	19.98	98	14912	80360	42525965
Alanine aminotransferase abnormal	51.54	19.98	28	14982	4916	42601409
Bone erosion	48.88	19.98	26	14984	4377	42601948
Gastrointestinal infection	48.49	19.98	30	14980	6713	42599612
Glucose urine present	47.57	19.98	18	14992	1357	42604968
Cellulitis	46.22	19.98	80	14930	61505	42544820
Acute kidney injury	45.90	19.98	252	14758	367085	42239240
Neutropenia	44.98	19.98	8	15002	199423	42406902
Thrombocytopenia	44.32	19.98	7	15003	190272	42416053
Hepatic cirrhosis	44.26	19.98	44	14966	19658	42586667
Thirst	42.56	19.98	31	14979	9077	42597248
Adverse event	41.00	19.98	46	14964	23594	42582731
Genital infection	40.97	19.98	8	15002	42	42606283
Polyuria	39.94	19.98	31	14979	9980	42596345
Toxicity to various agents	38.95	19.98	16	14994	229120	42377205
C-reactive protein abnormal	37.65	19.98	29	14981	9232	42597093
Diabetes mellitus inadequate control	35.73	19.98	35	14975	15355	42590970
Neuropathic arthropathy	34.73	19.98	9	15001	191	42606134
Osteomyelitis chronic	33.89	19.98	10	15000	347	42605978
Renal pain	33.58	19.98	19	14991	3608	42602717
Blood ketone body	33.42	19.98	8	15002	121	42606204
Treatment noncompliance	32.35	19.98	52	14958	37620	42568705
Asthma-chronic obstructive pulmonary disease overlap syndrome	31.90	19.98	14	14996	1545	42604780
Blood creatinine increased	31.81	19.98	98	14912	109905	42496420
Product prescribing error	31.03	19.98	42	14968	26070	42580255
Diabetic ulcer	30.74	19.98	7	15003	84	42606241
Pancytopenia	30.64	19.98	3	15007	117740	42488585
Dysuria	29.59	19.98	45	14965	31051	42575274
Pyrexia	29.52	19.98	59	14951	393983	42212342
Urinary tract infection fungal	29.10	19.98	10	15000	571	42605754
Phimosis	28.87	19.98	12	14998	1159	42605166
Incorrect dose administered	28.80	19.98	60	14950	52914	42553411
Multiple allergies	27.86	19.98	17	14993	3711	42602614
Acetonaemia	27.83	19.98	8	15002	253	42606072
Dizziness	27.75	19.98	166	14844	249088	42357237
Product use issue	27.63	19.98	74	14936	76677	42529648
Glycosylated haemoglobin decreased	27.58	19.98	9	15001	438	42605887
Mycobacterial infection	27.50	19.98	15	14995	2653	42603672
Therapeutic response increased	27.38	19.98	8	15002	268	42606057
General physical health deterioration	26.60	19.98	10	15000	151236	42455089
Abdominal discomfort	26.53	19.98	72	14938	75183	42531142
Psoriatic arthropathy	26.44	19.98	38	14972	24929	42581396
Haemoglobin decreased	26.43	19.98	7	15003	132464	42473861
Condition aggravated	26.22	19.98	32	14978	260722	42345603
Micturition disorder	25.72	19.98	14	14996	2466	42603859
Peripheral ischaemia	25.69	19.98	20	14990	6465	42599860
Acidosis	24.98	19.98	26	14984	12253	42594072
Diabetes mellitus	24.80	19.98	61	14949	60026	42546299
Hepatic steatosis	24.73	19.98	34	14976	21414	42584911
Death	24.30	19.98	85	14925	471100	42135225
Penile infection	24.03	19.98	6	15004	109	42606216
Extremity necrosis	23.80	19.98	13	14997	2306	42604019
Somnolence	23.71	19.98	10	15000	141095	42465230
Diabetic gangrene	23.42	19.98	7	15003	254	42606071
Malignant neoplasm progression	23.05	19.98	5	15005	108395	42497930
Disease progression	22.86	19.98	11	14999	143645	42462680
Necrotising fasciitis	22.44	19.98	16	14994	4530	42601795
Urine ketone body	22.27	19.98	5	15005	56	42606269
Anion gap increased	22.22	19.98	12	14998	2082	42604243
Genital rash	22.12	19.98	9	15001	823	42605502
Pneumonia	21.85	19.98	76	14934	422073	42184252
Drug interaction	21.71	19.98	38	14972	266961	42339364
Microalbuminuria	21.69	19.98	9	15001	865	42605460
Penile burning sensation	21.58	19.98	4	15006	15	42606310
Blood triglycerides increased	21.10	19.98	27	14983	15869	42590456
Flank pain	21.00	19.98	19	14991	7544	42598781
Penile adhesion	20.86	19.98	3	15007	0	42606325
Cellulitis of male external genital organ	20.80	19.98	5	15005	77	42606248
Polydipsia	20.34	19.98	15	14995	4473	42601852
Nausea	20.26	19.98	221	14789	396578	42209747
Blood lactic acid increased	20.01	19.98	19	14991	8020	42598305

FDA Adverse Event Reporting System (Geriatric)

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	4484.61	15.63	1154	22507	40904	110524734
Euglycaemic diabetic ketoacidosis	966.81	15.63	263	23398	11360	110554278
Toe amputation	838.80	15.63	193	23468	4145	110561493
Ketoacidosis	791.27	15.63	218	23443	9869	110555769
Fungal infection	571.24	15.63	258	23403	50548	110515090
Diabetic foot infection	471.39	15.63	91	23570	793	110564845
Genital infection fungal	420.57	15.63	69	23592	199	110565439
Osteomyelitis	373.99	15.63	174	23487	36426	110529212
Gangrene	297.50	15.63	117	23544	16224	110549414
Leg amputation	284.30	15.63	81	23580	4137	110561501
Glycosylated haemoglobin increased	259.10	15.63	118	23543	23501	110542137
Urine ketone body present	255.37	15.63	73	23588	3773	110561865
Metabolic acidosis	245.17	15.63	189	23472	99555	110466083
Foot amputation	233.07	15.63	53	23608	1075	110564563
Diabetic foot	203.04	15.63	62	23599	4033	110561605
Full blood count abnormal	192.11	15.63	130	23531	55922	110509716
Blood glucose increased	187.14	15.63	183	23478	132313	110433325
Urinary tract infection	176.89	15.63	278	23383	326004	110239634
Malignant mediastinal neoplasm	166.61	15.63	42	23619	1336	110564302
Hyperglycaemia	166.16	15.63	141	23520	84949	110480689
Pancreatitis	164.49	15.63	146	23515	93387	110472251
Dehydration	163.88	15.63	247	23414	279264	110286374
Osteomyelitis acute	160.02	15.63	35	23626	590	110565048
Glomerular filtration rate decreased	146.56	15.63	86	23575	28870	110536768
Acute kidney injury	129.56	15.63	362	23299	635068	109930570
Limb amputation	128.88	15.63	23	23638	123	110565515
Ketosis	128.69	15.63	36	23625	1718	110563920
Weight decreased	118.19	15.63	289	23372	467768	110097870
Blood ketone body increased	107.03	15.63	27	23634	861	110564777
Hypoglycaemia	102.03	15.63	125	23536	115979	110449659
Cerebral infarction	99.31	15.63	85	23576	51753	110513885
Blood immunoglobulin E increased	96.86	15.63	42	23619	7440	110558198
Asthma	90.89	15.63	179	23482	250112	110315526
Amputation	90.75	15.63	24	23637	925	110564713
Lactic acidosis	89.88	15.63	105	23556	92706	110472932
Pollakiuria	89.86	15.63	75	23586	44120	110521518
Ketonuria	89.73	15.63	26	23635	1409	110564229
Urine output increased	88.17	15.63	30	23631	2756	110562882
Skin ulcer	77.15	15.63	81	23580	63564	110502074
Joint ankylosis	75.56	15.63	26	23635	2471	110563167
Necrotising oesophagitis	74.13	15.63	23	23638	1577	110564061
Balanoposthitis	73.21	15.63	22	23639	1354	110564284
Polyuria	70.11	15.63	45	23616	17693	110547945
Cellulitis	68.97	15.63	108	23553	125908	110439730
Acidosis	67.18	15.63	48	23613	22483	110543155
Bone cyst	66.26	15.63	26	23635	3577	110562061
Bronchiectasis	66.17	15.63	58	23603	36435	110529203
Localised infection	65.49	15.63	62	23599	42986	110522652
Hyperkalaemia	64.31	15.63	109	23552	135687	110429951
Skin injury	63.74	15.63	26	23635	3956	110561682
Diabetes mellitus	62.67	15.63	91	23570	99290	110466348
Necrotising fasciitis	62.06	15.63	31	23630	7560	110558078
Diabetes mellitus inadequate control	61.50	15.63	51	23610	29724	110535914
Pyelonephritis	60.12	15.63	47	23614	25203	110540435
Gas gangrene	59.39	15.63	14	23647	334	110565304
Myopathy toxic	57.01	15.63	18	23643	1307	110564331
Prostatitis	55.84	15.63	25	23636	4776	110560862
Osteolysis	55.57	15.63	26	23635	5497	110560141
General physical health deterioration	52.83	15.63	13	23648	425282	110140356
Blood ketone body	50.42	15.63	11	23650	183	110565455
Urosepsis	50.17	15.63	46	23615	30629	110535009
Vulvovaginal mycotic infection	50.07	15.63	24	23637	5353	110560285
Febrile neutropenia	49.82	15.63	5	23656	316762	110248876
Alanine aminotransferase abnormal	47.95	15.63	28	23633	9306	110556332
Incorrect dose administered	47.49	15.63	82	23579	103559	110462079
Thrombocytopenia	46.70	15.63	9	23652	348876	110216762
Hepatic fibrosis	46.26	15.63	26	23635	8040	110557598
Neutropenia	45.46	15.63	12	23649	374608	110191030
Anion gap increased	45.41	15.63	21	23640	4323	110561315
Treatment noncompliance	44.80	15.63	66	23595	72924	110492714
Infusion related reaction	44.78	15.63	13	23648	381149	110184489
Urine ketone body	44.69	15.63	10	23651	188	110565450
Gastrooesophageal reflux disease	44.08	15.63	110	23551	179866	110385772
Acetonaemia	43.30	15.63	12	23649	553	110565085
Diabetic ulcer	43.24	15.63	10	23651	219	110565419
Gastrointestinal infection	42.13	15.63	30	23631	13975	110551663
Glucose urine present	40.28	15.63	16	23645	2273	110563365
Condition aggravated	39.62	15.63	60	23601	734776	109830862
Osteomyelitis chronic	39.22	15.63	12	23649	785	110564853
Anaemia	38.74	15.63	36	23625	547050	110018588
Flank pain	38.44	15.63	35	23626	23095	110542543
Pancreatitis acute	37.71	15.63	55	23606	60219	110505419
Maternal exposure during pregnancy	37.64	15.63	5	23656	254878	110310760
Diabetic ketosis	37.32	15.63	12	23649	924	110564714
Glossodynia	36.25	15.63	3	23658	222001	110343637
Pyrexia	35.68	15.63	88	23573	898177	109667461
Glycosuria	34.81	15.63	15	23646	2615	110563023
Stomatitis	34.05	15.63	8	23653	270234	110295404
Peripheral ischaemia	33.98	15.63	24	23637	11034	110554604
Blood triglycerides increased	33.63	15.63	33	23628	23893	110541745
Contraindicated product administered	31.98	15.63	7	23654	248260	110317378
Pancreatic carcinoma	31.81	15.63	26	23635	14846	110550792
Vascular access site haemorrhage	31.78	15.63	8	23653	253	110565385
Blood bicarbonate decreased	31.40	15.63	18	23643	5779	110559859
Overdose	31.34	15.63	6	23655	233788	110331850
Gastroenteritis	31.22	15.63	40	23621	38760	110526878
Pancytopenia	31.22	15.63	4	23657	209609	110356029
Vascular stenosis	31.13	15.63	10	23651	768	110564870
Neuropathic arthropathy	29.88	15.63	9	23652	558	110565080
Urinary tract infection fungal	29.78	15.63	11	23650	1284	110564354
Hepatic steatosis	29.74	15.63	44	23617	48787	110516851
Blood glucose decreased	29.59	15.63	34	23627	29454	110536184
Alopecia	28.25	15.63	22	23639	364731	110200907
Dry gangrene	28.06	15.63	10	23651	1054	110564584
Diabetic gangrene	27.43	15.63	7	23654	234	110565404
Mycobacterial infection	27.42	15.63	15	23646	4402	110561236
Extremity necrosis	26.65	15.63	14	23647	3788	110561850
Genital rash	25.84	15.63	10	23651	1325	110564313
Wound	25.73	15.63	9	23652	234428	110331210
Vulvovaginal candidiasis	25.64	15.63	13	23648	3272	110562366
Product prescribing error	25.34	15.63	42	23619	51289	110514349
Blood creatinine increased	24.99	15.63	91	23570	182798	110382840
Renal pain	24.95	15.63	19	23642	9798	110555840
Swelling	24.95	15.63	23	23638	351018	110214620
Irritable bowel syndrome	24.78	15.63	3	23658	164212	110401426
Dysuria	24.18	15.63	45	23616	60186	110505452
Pemphigus	23.96	15.63	8	23653	214562	110351076
Penile infection	23.93	15.63	5	23656	67	110565571
Low density lipoprotein increased	23.56	15.63	19	23642	10647	110554991
Thirst	23.44	15.63	26	23635	21681	110543957
Ill-defined disorder	23.34	15.63	3	23658	156850	110408788
Hypoacusis	23.31	15.63	33	23628	35158	110530480
Intercepted medication error	23.16	15.63	9	23652	1207	110564431
Bladder cancer	23.12	15.63	25	23636	20267	110545371
Musculoskeletal toxicity	22.77	15.63	6	23655	228	110565410
Headache	22.34	15.63	105	23556	882272	109683366
Polydipsia	22.05	15.63	16	23645	7672	110557966
Somnolence	21.72	15.63	19	23642	297430	110268208
Post streptococcal glomerulonephritis	21.26	15.63	5	23656	118	110565520
Nephrolithiasis	21.20	15.63	45	23616	66167	110499471
Disease progression	21.17	15.63	13	23648	244021	110321617
Dizziness	21.01	15.63	235	23426	697958	109867680
Exposure during pregnancy	21.00	15.63	5	23656	167419	110398219
Nasal congestion	20.90	15.63	57	23604	98225	110467413
Injury	20.89	15.63	6	23655	177259	110388379
Red blood cell sedimentation rate abnormal	20.88	15.63	26	23635	24483	110541155
Haemoglobin decreased	20.55	15.63	14	23647	248713	110316925
Blood glucose abnormal	20.40	15.63	19	23642	12897	110552741
Renal impairment	20.28	15.63	87	23574	188358	110377280
Osteoarthritis	20.06	15.63	7	23654	182616	110383022
Asthma-chronic obstructive pulmonary disease overlap syndrome	20.03	15.63	14	23647	6330	110559308
Helicobacter infection	19.93	15.63	7	23654	181870	110383768
Cerebral fungal infection	19.92	15.63	7	23654	708	110564930
Vulvovaginal pruritus	19.82	15.63	11	23650	3320	110562318
Oedema peripheral	19.51	15.63	25	23636	328635	110237003
Hepatic enzyme increased	19.47	15.63	24	23637	320868	110244770
Haemorrhagic erosive gastritis	19.31	15.63	7	23654	775	110564863
Discomfort	19.24	15.63	11	23650	214696	110350942
Acute myocardial infarction	19.24	15.63	50	23611	83727	110481911
Type 2 diabetes mellitus	19.20	15.63	82	23579	177150	110388488
White blood cell count decreased	18.84	15.63	13	23648	229377	110336261
Phimosis	18.83	15.63	7	23654	832	110564806
Mobility decreased	18.78	15.63	14	23647	237408	110328230
Penile burning sensation	18.74	15.63	3	23658	7	110565631
Sepsis	18.69	15.63	127	23534	327219	110238419
Malignant neoplasm progression	18.65	15.63	7	23654	174560	110391078
Hypovolaemia	18.48	15.63	23	23638	21651	110543987
Necrosis	18.44	15.63	17	23644	11389	110554249
Hepatic cirrhosis	18.32	15.63	43	23618	67583	110498055
Toxicity to various agents	18.32	15.63	48	23613	480507	110085131
Hyperglycaemic hyperosmolar nonketotic syndrome	18.08	15.63	10	23651	2999	110562639
Genital infection	18.01	15.63	5	23656	232	110565406
Hemianopia homonymous	17.87	15.63	8	23653	1527	110564111
Hallucination, auditory	17.85	15.63	25	23636	26372	110539266
Renal abscess	17.77	15.63	8	23653	1548	110564090
Sudden hearing loss	17.77	15.63	9	23652	2260	110563378
Breast disorder	17.60	15.63	9	23652	2305	110563333
Drug intolerance	17.56	15.63	38	23623	406474	110159164
Peripheral arterial occlusive disease	17.32	15.63	15	23646	9265	110556373
Blood lactic acid increased	17.17	15.63	19	23642	15802	110549836
Product use in unapproved indication	16.81	15.63	45	23616	447332	110118306
Colon cancer	16.57	15.63	19	23642	16424	110549214
Sinusitis	16.17	15.63	24	23637	296664	110268974
Liver injury	16.12	15.63	6	23655	150407	110415231
Blood glucose normal	15.99	15.63	3	23658	22	110565616
Completed suicide	15.92	15.63	17	23644	242364	110323274
Spinal ligament ossification	15.88	15.63	3	23658	23	110565615
Albumin urine present	15.87	15.63	6	23655	747	110564891
Rhinorrhoea	15.67	15.63	53	23608	102613	110463025

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A10BD16	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BK02	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Sodium-glucose co-transporter 2 (SGLT2) inhibitors
MeSH PA	D000077203	Sodium-Glucose Transporter 2 Inhibitors
MeSH PA	D007004	Hypoglycemic Agents
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000187058	Sodium-Glucose Transporter 2 Inhibitors
FDA EPC	N0000187059	Sodium-Glucose Cotransporter 2 Inhibitor
CHEBI has role	CHEBI:35526	hypoglycemic agent
CHEBI has role	CHEBI:73273	sodium-glucose transport protein subtype 2 inhibitor

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

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352
Chronic kidney disease (CKD) associated with type 2 diabetes (T2D)	indication

🐶 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)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
100MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
100MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
300MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
300MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
300MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
150MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
150MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
50MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
50MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
150MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
150MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
50MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
50MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
100MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
100MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
100MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
300MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
300MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
300MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
150MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
150MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
50MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
50MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
150MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
150MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
150MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
50MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
50MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
50MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
300MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
150MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
150MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
50MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
50MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
150MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
150MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
50MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
50MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Dec. 18, 2027	NEW PATIENT POPULATION
100MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY
300MG	INVOKANA	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY
150MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY
150MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY
50MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY
50MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY
150MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY
150MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY
50MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY
50MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	June 18, 2028	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium/glucose cotransporter 2	Transporter	P31639	SC5A2_HUMAN	INHIBITOR	IC50	8.66	WOMBAT-PK	CHEMBL
Sodium/glucose cotransporter 1	Transporter	P13866	SC5A1_HUMAN		IC50	5.72	CHEMBL
Sodium/glucose cotransporter 2	Transporter		SC5A2_RAT		IC50	8.63	CHEMBL
Protease	Enzyme		Q9YQ12_9HIV1		Ki	6.20	CHEMBL
Sodium/glucose cotransporter 2	Transporter		SC5A2_MOUSE		IC50	8.70	CHEMBL

External reference:

ID	Source
D09592	KEGG_DRUG
928672-86-0	SECONDARY_CAS_RN
4032289	VANDF
CHEBI:73272	CHEBI
L3R	PDB_CHEM_ID
CHEMBL4594217	ChEMBL_ID
CHEMBL2048484	ChEMBL_ID
4582	IUPHAR_LIGAND_ID
DB08907	DRUGBANK_ID
0SAC974Z85	UNII
1373458	RXNORM
200558	MMSL
29373	MMSL
d08080	MMSL
014959	NDDF
1268978008	SNOMEDCT_US
703676004	SNOMEDCT_US
703681008	SNOMEDCT_US
725664009	SNOMEDCT_US
C2974540	UMLSCUI
D000068896	MESH_DESCRIPTOR_UI
9225	INN_ID
24812758	PUBCHEM_CID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
INVOKANA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4364	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
INVOKANA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5034	TABLET, FILM COATED	100 mg	ORAL	NDA	29 sections
INVOKANA	HUMAN PRESCRIPTION DRUG LABEL	1	50458-140	TABLET, FILM COATED	100 mg	ORAL	NDA	32 sections
INVOKANA	HUMAN PRESCRIPTION DRUG LABEL	1	50458-141	TABLET, FILM COATED	300 mg	ORAL	NDA	32 sections
INVOKAMET	HUMAN PRESCRIPTION DRUG LABEL	2	50458-540	TABLET, FILM COATED	50 mg	ORAL	NDA	34 sections
INVOKAMET	HUMAN PRESCRIPTION DRUG LABEL	2	50458-541	TABLET, FILM COATED	50 mg	ORAL	NDA	34 sections
INVOKAMET	HUMAN PRESCRIPTION DRUG LABEL	2	50458-542	TABLET, FILM COATED	150 mg	ORAL	NDA	34 sections
INVOKAMET	HUMAN PRESCRIPTION DRUG LABEL	2	50458-543	TABLET, FILM COATED	150 mg	ORAL	NDA	34 sections
INVOKAMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	50458-940	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	34 sections
INVOKAMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	50458-941	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	34 sections
INVOKAMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	50458-942	TABLET, FILM COATED, EXTENDED RELEASE	150 mg	ORAL	NDA	34 sections
INVOKAMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	50458-943	TABLET, FILM COATED, EXTENDED RELEASE	150 mg	ORAL	NDA	34 sections
INVOKANA	HUMAN PRESCRIPTION DRUG LABEL	1	55154-1425	TABLET, FILM COATED	100 mg	ORAL	NDA	32 sections
INVOKANA	HUMAN PRESCRIPTION DRUG LABEL	1	55154-1426	TABLET, FILM COATED	300 mg	ORAL	NDA	32 sections

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Using the assistant

canagliflozin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: