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:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ
S (Water solubility)	18 mg/mL	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

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Approvals:

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

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
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

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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
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

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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
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

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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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
CHEBI has role	CHEBI:35526	antidiabetic
CHEBI has role	CHEBI:68612	dipeptidyl peptidase-4 inhibitors
FDA EPC	N0000175913	Dipeptidyl Peptidase 4 Inhibitor
FDA MoA	N0000175912	Dipeptidyl Peptidase 4 Inhibitors
MeSH PA	D054873	Dipeptidyl-Peptidase IV Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006728	Hormones

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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

🐶 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)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
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 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 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;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	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	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	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS 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	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	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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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

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External reference:

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ID	Source
T22	PDB_CHEM_ID
014872	NDDF
014873	NDDF
11450633	PUBCHEM_CID
1368000	RXNORM
198438	MMSL
237036	MMSL
29087	MMSL
4032097	VANDF
4032098	VUID

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Pharmaceutical products:

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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	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	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

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