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:

None

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	81.27	26.11	22	1729	5885	50597488
Cerebral infarction	46.59	26.11	20	1731	21584	50581789
Pancreatic carcinoma	44.74	26.11	14	1737	6200	50597173
Erythema multiforme	35.80	26.11	13	1738	9037	50594336
Interstitial lung disease	27.28	26.11	19	1732	53157	50550216
Hypoglycaemic encephalopathy	26.28	26.11	5	1746	273	50603100

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	176.57	22.68	52	2507	7529	29564439
Cerebral infarction	73.79	22.68	38	2521	24637	29547331
Pancreatitis acute	51.90	22.68	30	2529	24355	29547613
Pancreatitis	47.05	22.68	32	2527	34482	29537486
Spondylolysis	43.94	22.68	7	2552	49	29571919
Diabetic ketoacidosis	43.01	22.68	23	2536	16050	29555918
Interstitial lung disease	42.29	22.68	37	2522	57681	29514287
Lumbosacral radiculoplexus neuropathy	38.91	22.68	6	2553	33	29571935
Gastric cancer	32.23	22.68	13	2546	4781	29567187
Application site haematoma	29.89	22.68	5	2554	49	29571919
Hypoglycaemia	29.53	22.68	28	2531	48318	29523650
Tonsil cancer	28.88	22.68	8	2551	923	29571045
Glycosylated haemoglobin increased	23.84	22.68	13	2546	9413	29562555
Altered state of consciousness	23.70	22.68	17	2542	19872	29552096
Angina pectoris	22.70	22.68	19	2540	27831	29544137

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	252.82	19.84	74	4456	12912	64481290
Cerebral infarction	113.33	19.84	56	4474	40988	64453214
Pancreatitis acute	69.25	19.84	41	4489	42814	64451388
Interstitial lung disease	68.68	19.84	56	4474	97676	64396526
Diabetic ketoacidosis	57.42	19.84	32	4498	29813	64464389
Pancreatitis	52.36	19.84	39	4491	59568	64434634
Pancreatic carcinoma	50.36	19.84	21	4509	10352	64483850
Gastric cancer	45.00	19.84	17	4513	6476	64487726
Spondylolysis	40.87	19.84	7	4523	100	64494102
Hypoglycaemia	40.29	19.84	40	4490	89852	64404350
Euglycaemic diabetic ketoacidosis	36.90	19.84	14	4516	5396	64488806
Lumbosacral radiculoplexus neuropathy	36.40	19.84	6	4524	67	64494135
Lactic acidosis	32.57	19.84	30	4500	61380	64432822
Erythema multiforme	30.63	19.84	17	4513	15684	64478518
Hepatic function abnormal	29.51	19.84	29	4501	64284	64429918
Application site haematoma	29.09	19.84	5	4525	73	64494129
Altered state of consciousness	27.17	19.84	22	4508	37880	64456322
Tonsil cancer	25.57	19.84	7	4523	953	64493249
Colon cancer	25.42	19.84	14	4516	12725	64481477
Glycosylated haemoglobin increased	25.00	19.84	15	4515	16004	64478198
Blood glucose increased	22.58	19.84	31	4499	98042	64396160
Angina pectoris	21.93	19.84	21	4509	45060	64449142
Drug eruption	21.82	19.84	19	4511	36117	64458085
Hepatocellular carcinoma	21.78	19.84	11	4519	8392	64485810
Rhabdomyolysis	21.13	19.84	29	4501	91697	64402505
Drug-induced liver injury	20.95	19.84	21	4509	47622	64446580

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	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	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	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	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
CHEMBL227529	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

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	45802-103	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 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 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	45802-304	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	45802-402	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	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	64764-123	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
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-124	TABLET, FILM COATED	12.50 mg	ORAL	NDA	31 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-124	TABLET, FILM COATED	12.50 mg	ORAL	NDA	31 sections
Nesina	HUMAN PRESCRIPTION DRUG LABEL	1	64764-125	TABLET, FILM COATED	12.50 mg	ORAL	NDA	27 sections
Nesina	HUMAN PRESCRIPTION DRUG LABEL	1	64764-125	TABLET, FILM COATED	12.50 mg	ORAL	NDA	27 sections
Nesina	HUMAN PRESCRIPTION DRUG LABEL	1	64764-250	TABLET, FILM COATED	25 mg	ORAL	NDA	27 sections
Nesina	HUMAN PRESCRIPTION DRUG LABEL	1	64764-250	TABLET, FILM COATED	25 mg	ORAL	NDA	27 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-251	TABLET, FILM COATED	25 mg	ORAL	NDA	31 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-251	TABLET, FILM COATED	25 mg	ORAL	NDA	31 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-253	TABLET, FILM COATED	25 mg	ORAL	NDA	31 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-253	TABLET, FILM COATED	25 mg	ORAL	NDA	31 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-254	TABLET, FILM COATED	25 mg	ORAL	NDA	31 sections
OSENI	HUMAN PRESCRIPTION DRUG LABEL	2	64764-254	TABLET, FILM COATED	25 mg	ORAL	NDA	31 sections
KAZANO	HUMAN PRESCRIPTION DRUG LABEL	2	64764-335	TABLET, FILM COATED	12.50 mg	ORAL	NDA	30 sections