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

Stem definition	Drug id	CAS RN
dipeptidyl aminopeptidase-IV inhibitors	4340	850649-61-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: vipidia alogliptin alogliptin benzoate nesina	a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4) that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus Molecular weight: 339.40 Formula: C18H21N5O2 CLOGP: 1.27 LIPINSKI: 0 HAC: 7 HDO: 1 TPSA: 93.67 ALOGS: -2.77 ROTB: 3 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

vipidia
alogliptin
alogliptin benzoate
nesina

a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4) that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus

Molecular weight: 339.40
Formula: C18H21N5O2
CLOGP: 1.27
LIPINSKI: 0
HAC: 7
HDO: 1
TPSA: 93.67
ALOGS: -2.77
ROTB: 3

Status: ONP

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

Drug dosage:

Dose	Unit	Route
25	mg	O

ADMET properties:

Property	Value	Reference
S (Water solubility)	18 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0.84 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

Date	Agency	Company	Orphan
Jan. 25, 2013	FDA	TAKEDA PHARMS USA

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
Pemphigoid	88.16	25.33	24	1944	7320	63479734
Cerebral infarction	46.76	25.33	20	1948	23873	63463181
Pancreatic carcinoma	43.42	25.33	14	1954	7614	63479440
Erythema multiforme	35.71	25.33	13	1955	10156	63476898
Interstitial lung disease	28.88	25.33	20	1948	61888	63425166
Hypoglycaemic encephalopathy	26.26	25.33	5	1963	307	63486747
Pancreatitis acute	26.24	25.33	14	1954	27152	63459902
Euglycaemic diabetic ketoacidosis	26.15	25.33	8	1960	3666	63483388

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
Pemphigoid	182.42	22.54	54	2741	8612	34945524
Cerebral infarction	72.78	22.54	38	2757	27417	34926719
Pancreatitis	57.94	22.54	37	2758	38854	34915282
Pancreatitis acute	55.36	22.54	32	2763	28109	34926027
Diabetic ketoacidosis	50.75	22.54	26	2769	18006	34936130
Spondylolysis	42.00	22.54	7	2788	73	34954063
Interstitial lung disease	40.87	22.54	37	2758	65245	34888891
Lumbosacral radiculoplexus neuropathy	39.08	22.54	6	2789	35	34954101
Tonsil cancer	37.11	22.54	10	2785	1128	34953008
Application site haematoma	30.28	22.54	5	2790	49	34954087
Gastric cancer	29.46	22.54	13	2782	6456	34947680
Hypoglycaemia	28.49	22.54	28	2767	54612	34899524
Appetite disorder	25.58	22.54	9	2786	2462	34951674
Glycosylated haemoglobin increased	25.23	22.54	14	2781	11346	34942790
Lactic acidosis	24.30	22.54	21	2774	34751	34919385
Angina pectoris	24.09	22.54	20	2775	31343	34922793
Drug-induced liver injury	23.43	22.54	19	2776	28813	34925323
Altered state of consciousness	22.76	22.54	17	2778	22876	34931260

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
Pemphigoid	267.59	21.48	78	4855	15237	79724218
Cerebral infarction	114.37	21.48	56	4877	45620	79693835
Pancreatitis acute	79.09	21.48	45	4888	49559	79689896
Interstitial lung disease	70.04	21.48	57	4876	112543	79626912
Diabetic ketoacidosis	68.34	21.48	36	4897	34086	79705369
Pancreatitis	63.33	21.48	44	4889	68531	79670924
Pancreatic carcinoma	47.48	21.48	21	4912	13556	79725899
Hypoglycaemia	44.20	21.48	42	4891	101552	79637903
Euglycaemic diabetic ketoacidosis	42.56	21.48	16	4917	6828	79732627
Spondylolysis	39.78	21.48	7	4926	135	79739320
Gastric cancer	39.69	21.48	17	4916	10162	79729293
Hepatocellular carcinoma	38.28	21.48	16	4917	9005	79730450
Lumbosacral radiculoplexus neuropathy	37.00	21.48	6	4927	69	79739386
Lactic acidosis	36.27	21.48	32	4901	70327	79669128
Tonsil cancer	34.50	21.48	9	4924	1159	79738296
Erythema multiforme	33.57	21.48	18	4915	17633	79721822
Application site haematoma	29.72	21.48	5	4928	73	79739382
Hepatic function abnormal	29.47	21.48	29	4904	73078	79666377
Drug eruption	28.88	21.48	23	4910	43912	79695543
Altered state of consciousness	26.81	21.48	22	4911	43800	79695655
Glycosylated haemoglobin increased	26.77	21.48	16	4917	19244	79720211
Colon cancer	25.36	21.48	14	4919	14509	79724946
Drug-induced liver injury	24.39	21.48	25	4908	66092	79673363
Angina pectoris	23.65	21.48	22	4911	51710	79687745
Blood glucose increased	23.30	21.48	32	4901	114943	79624512
Constipation	22.23	21.48	52	4881	282998	79456457

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A10BD09	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD13	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BH04	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Dipeptidyl peptidase 4 (DPP-4) inhibitors
MeSH PA	D054873	Dipeptidyl-Peptidase IV Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006728	Hormones
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D054795	Incretins
MeSH PA	D011480	Protease Inhibitors
FDA MoA	N0000175912	Dipeptidyl Peptidase 4 Inhibitors
FDA EPC	N0000175913	Dipeptidyl Peptidase 4 Inhibitor
CHEBI has role	CHEBI:35526	antidiabetic
CHEBI has role	CHEBI:68612	dipeptidyl peptidase-4 inhibitors

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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.4	Basic
pKa2	1.33	Basic

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
EQ 12.5MG BASE;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	DISCN	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 12.5MG BASE;EQ 30MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 12.5MG BASE;EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	DISCN	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 25MG BASE;EQ 15MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 25MG BASE;EQ 30MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 25MG BASE;EQ 45MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 12.5MG BASE;1GM	KAZANO	TAKEDA PHARMS USA	N203414	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 12.5MG BASE;500MG	KAZANO	TAKEDA PHARMS USA	N203414	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 12.5MG BASE	NESINA	TAKEDA PHARMS USA	N022271	Jan. 25, 2013	RX	TABLET	ORAL	8173663	Dec. 2, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 25MG BASE	NESINA	TAKEDA PHARMS USA	N022271	Jan. 25, 2013	RX	TABLET	ORAL	8173663	Dec. 2, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 6.25MG BASE	NESINA	TAKEDA PHARMS USA	N022271	Jan. 25, 2013	RX	TABLET	ORAL	8173663	Dec. 2, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
EQ 12.5MG BASE	NESINA	TAKEDA PHARMS USA	N022271	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 25MG BASE	NESINA	TAKEDA PHARMS USA	N022271	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 6.25MG BASE	NESINA	TAKEDA PHARMS USA	N022271	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 12.5MG BASE;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	DISCN	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 12.5MG BASE;EQ 30MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 12.5MG BASE;EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	DISCN	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 25MG BASE;EQ 15MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 25MG BASE;EQ 30MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 25MG BASE;EQ 45MG BASE	OSENI	TAKEDA PHARMS USA	N022426	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 12.5MG BASE;1GM	KAZANO	TAKEDA PHARMS USA	N203414	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
EQ 12.5MG BASE;500MG	KAZANO	TAKEDA PHARMS USA	N203414	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Dipeptidyl peptidase 4	Enzyme	P27487	DPP4_HUMAN	INHIBITOR	IC50	9		CHEMBL	CHEMBL

External reference:

ID	Source
4032098	VUID
N0000186570	NUI
D06553	KEGG_DRUG
850649-62-6	SECONDARY_CAS_RN
4032097	VANDF
4032098	VANDF
C1958126	UMLSCUI
CHEBI:72323	CHEBI
T22	PDB_CHEM_ID
CHEMBL376359	ChEMBL_ID
DB06203	DRUGBANK_ID
C520853	MESH_SUPPLEMENTAL_RECORD_UI
6319	IUPHAR_LIGAND_ID
8814	INN_ID
JHC049LO86	UNII
11450633	PUBCHEM_CID
1368000	RXNORM
198438	MMSL
237036	MMSL
29087	MMSL
d07963	MMSL
014872	NDDF
014873	NDDF
702799001	SNOMEDCT_US
702800002	SNOMEDCT_US
703669009	SNOMEDCT_US
CHEMBL227529	ChEMBL_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Alogliptin	HUMAN PRESCRIPTION DRUG LABEL	1	45802-087	TABLET, FILM COATED	6.25 mg	ORAL	NDA authorized generic	28 sections
Alogliptin	HUMAN PRESCRIPTION DRUG LABEL	1	45802-087	TABLET, FILM COATED	6.25 mg	ORAL	NDA authorized generic	28 sections
Alogliptin	HUMAN PRESCRIPTION DRUG LABEL	1	45802-103	TABLET, FILM COATED	12.50 mg	ORAL	NDA authorized generic	28 sections
Alogliptin	HUMAN PRESCRIPTION DRUG LABEL	1	45802-103	TABLET, FILM COATED	12.50 mg	ORAL	NDA authorized generic	28 sections
Alogliptin	HUMAN PRESCRIPTION DRUG LABEL	1	45802-150	TABLET, FILM COATED	25 mg	ORAL	NDA authorized generic	28 sections
Alogliptin	HUMAN PRESCRIPTION DRUG LABEL	1	45802-150	TABLET, FILM COATED	25 mg	ORAL	NDA authorized generic	28 sections
alogliptin and metformin hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	45802-169	TABLET, FILM COATED	12.50 mg	ORAL	NDA	29 sections
alogliptin and metformin hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	45802-169	TABLET, FILM COATED	12.50 mg	ORAL	NDA	29 sections
alogliptin and metformin hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	45802-169	TABLET, FILM COATED	12.50 mg	ORAL	NDA	29 sections
alogliptin and metformin hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	45802-211	TABLET, FILM COATED	12.50 mg	ORAL	NDA	29 sections
alogliptin and metformin hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	45802-211	TABLET, FILM COATED	12.50 mg	ORAL	NDA	29 sections
alogliptin and metformin hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	45802-211	TABLET, FILM COATED	12.50 mg	ORAL	NDA	29 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-238	TABLET, FILM COATED	12.50 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-238	TABLET, FILM COATED	12.50 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-260	TABLET, FILM COATED	12.50 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-260	TABLET, FILM COATED	12.50 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-304	TABLET, FILM COATED	12.50 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-304	TABLET, FILM COATED	12.50 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-351	TABLET, FILM COATED	25 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-351	TABLET, FILM COATED	25 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-402	TABLET, FILM COATED	25 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-402	TABLET, FILM COATED	25 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-499	TABLET, FILM COATED	25 mg	ORAL	NDA authorized generic	30 sections
Alogliptin and Pioglitazone	HUMAN PRESCRIPTION DRUG LABEL	2	45802-499	TABLET, FILM COATED	25 mg	ORAL	NDA authorized generic	30 sections
Alogliptin	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5574	TABLET, FILM COATED	25 mg	ORAL	NDA authorized generic	27 sections
alogliptin and metformin hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	50090-5993	TABLET, FILM COATED	12.50 mg	ORAL	NDA	28 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-121	TABLET, FILM COATED	12.50 mg	ORAL	NDA	31 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-121	TABLET, FILM COATED	12.50 mg	ORAL	NDA	31 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-121	TABLET, FILM COATED	12.50 mg	ORAL	NDA	31 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-123	TABLET, FILM COATED	12.50 mg	ORAL	NDA	31 sections