Januvia(sitagliptin)

Efficib, Janumet, Januvia, Juvisync, Ristaben, Ristfor, Steglujan, Tesavel, Velmetia, Xelevia (sitagliptin) is a small molecule pharmaceutical. Sitagliptin was first approved as Januvia on 2006-10-16. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat type 2 diabetes mellitus. The pharmaceutical is active against dipeptidyl peptidase 4.

Download report

Favorite

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nutritional and metabolic diseases	D009750
endocrine system diseases	D004700

Trade Name

FDA

EMA

Januvia

Combinations

Janumet, Steglujan (discontinued: Juvisync)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ertugliflozin

Sitagliptin phosphate

Tradename	Company	Number	Date	Products
STEGLUJAN	Merck Sharp & Dohme	N-209805 RX	2017-12-19	2 products, RLD, RS

Metformin hydrochloride

Sitagliptin phosphate

Tradename	Company	Number	Date	Products
JANUMET XR	Merck Sharp & Dohme	N-202270 RX	2012-02-02	3 products, RLD, RS
JANUMET	Merck Sharp & Dohme	N-022044 RX	2007-03-30	2 products, RLD, RS

Simvastatin

Sitagliptin phosphate

Tradename	Company	Number	Date	Products
JUVISYNC	Merck Sharp & Dohme	N-202343 DISCN	2011-10-07	6 products, RLD

Hide discontinued

Sitagliptin phosphate

Tradename	Company	Number	Date	Products
JANUVIA	Merck Sharp & Dohme	N-021995 RX	2006-10-16	3 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
janumet	New Drug Application	2023-06-19
januvia	New Drug Application	2023-06-20
steglujan	New Drug Application	2021-11-19

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
type 2 diabetes mellitus	EFO_0001360	D003924	E11

Agency Specific

FDA

EMA

Expiration	Code
ERTUGLIFLOZIN / SITAGLIPTIN PHOSPHATE, STEGLUJAN, MSD SUB MERCK
2024-09-17	M-275
METFORMIN HYDROCHLORIDE / SITAGLIPTIN PHOSPHATE, JANUMET, MSD SUB MERCK
2024-06-04	PED
2023-12-04	M-187
2023-02-12	PED
METFORMIN HYDROCHLORIDE / SITAGLIPTIN PHOSPHATE, JANUMET XR, MERCK SHARP DOHME
2024-06-04	PED
2023-12-04	M-187
2023-02-12	PED
SITAGLIPTIN PHOSPHATE, JANUVIA, MERCK SHARP DOHME
2024-06-04	PED
2023-12-04	M-187
2023-02-12	PED

Patent Expiration

Patent	Expires	Flag	FDA Information
Ertugliflozin / Sitagliptin Phosphate, Steglujan, Msd Sub Merck
9308204	2030-10-21	DP
9439901	2030-10-21		U-2214
8080580	2030-07-13	DS, DP	U-2214
7326708	2026-11-24	DS, DP	U-802, U-1188, U-1227, U-2214
Metformin Hydrochloride / Sitagliptin Phosphate, Janumet, Msd Sub Merck
8414921	2028-07-21	DP	U-1036

ATC Codes

A: Alimentary tract and metabolism drugs

— A10: Drugs used in diabetes

— A10B: Blood glucose lowering drugs, excl. insulins

— A10BD: Combinations of oral blood glucose lowering drugs

— A10BD07: Metformin and sitagliptin

— A10BD12: Pioglitazone and sitagliptin

— A10BD24: Sitagliptin and ertugliflozin

— A10BH: Dipeptidyl peptidase 4 (dpp-4) inhibitors for blood glucose lowering

— A10BH01: Sitagliptin

— A10BH51: Sitagliptin and simvastatin

HCPCS

No data

Clinical

Clinical Trials

437 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	37	34	124	79	38	309
Diabetes mellitus	D003920	EFO_0000400	E08-E13	2	3	3	7	4	18
Type 1 diabetes mellitus	D003922	EFO_0001359	E10	3	7	2	4	2	15
Healthy volunteers/patients	—			10	—	1	3	—	14
Obesity	D009765	EFO_0001073	E66.9	—	1	—	3	3	7
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	—	1	—	3	2	6
Glucose intolerance	D018149	HP_0000833	R73.03	—	2	—	2	1	5
Hyperglycemia	D006943	HP_0003074	R73.9	—	—	—	5	—	5
Hypertension	D006973	EFO_0000537	I10	—	—	—	2	2	4
Heart failure	D006333	EFO_0003144	I50	1	—	—	3	—	4

Show 25 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cystic fibrosis	D003550	EFO_0000390	E84	1	1	1	—	1	4
Hyperlipidemias	D006949	EFO_0003774	E78.5	—	1	3	—	—	3
Renal insufficiency	D051437	HP_0000083	N19	1	—	2	—	—	3
Graft vs host disease	D006086		D89.81	—	2	1	—	—	3
Chronic renal insufficiency	D051436		N18	—	—	2	—	1	3
Inferior wall myocardial infarction	D056989	EFO_1000983		—	1	2	—	—	2
Inflammation	D007249			—	1	1	—	—	2
Covid-19	D000086382		U07.1	—	—	1	—	—	1
Peptic ulcer	D010437	HP_0004398	K27	—	1	1	—	—	1
Iron metabolism disorders	D019189		E83.1	—	1	1	—	—	1

Show 5 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Psoriasis	D011565	EFO_0000676	L40	—	2	—	—	—	2
Gastroparesis	D018589	EFO_1000948	K31.84	1	1	—	—	—	2
Myeloid leukemia acute	D015470		C92.0	—	2	—	—	—	2
Non-hodgkin lymphoma	D008228		C85.9	—	2	—	—	—	2
Precursor cell lymphoblastic leukemia-lymphoma	D054198		C91.0	—	2	—	—	—	2
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340		—	2	—	—	—	2
Infertility	D007246	EFO_0000545		1	1	—	—	—	1
Hematopoietic stem cell transplantation	D018380			—	1	—	—	—	1
Hiv infections	D015658	EFO_0000764	B20	—	1	—	—	—	1
Myelodysplastic syndromes	D009190		D46	—	1	—	—	—	1

Show 3 more

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Therapeutic equivalency	D013810			2	—	—	—	—	2
Hepatitis c	D006526		B19.2	1	—	—	—	—	1
Liver neoplasms	D008113	EFO_1001513	C22.0	1	—	—	—	—	1
Hepatic insufficiency	D048550			1	—	—	—	—	1
Renal dialysis	D006435	EFO_0010690	Z99.2	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Vascular stiffness	D059289			—	—	—	—	1	1
Exocrine pancreatic insufficiency	D010188		K86.81	—	—	—	—	1	1
Systemic inflammatory response syndrome	D018746	EFO_1001478	R65.10	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

View more details

Drug

General

Drug common name	SITAGLIPTIN
INN	sitagliptin
Description	Sitagliptin is a triazolopyrazine that exhibits hypoglycemic activity. It has a role as a serine proteinase inhibitor, a hypoglycemic agent, an EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor, an environmental contaminant and a xenobiotic. It is a triazolopyrazine and a trifluorobenzene.
Classification	Small molecule
Drug class	dipeptidyl aminopeptidase-IV inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F

Identifiers

PDB	4FFW
CAS-ID	486460-32-6
RxCUI	593411
ChEMBL ID	CHEMBL1422
ChEBI ID	40237
PubChem CID	4369359
DrugBank	DB01261
UNII ID	QFP0P1DV7Z (ChemIDplus, GSRS)

Target

Agency Approved

DPP4

Organism

Homo sapiens

Gene name

DPP4

Gene synonyms

ADCP2, CD26

NCBI Gene ID

1803

Protein name

dipeptidyl peptidase 4

Protein synonyms

ADABP, ADCP-2, Adenosine deaminase complexing protein 2, CD26, Dipeptidyl peptidase IV, dipeptidylpeptidase 4, dipeptidylpeptidase IV (CD26, adenosine deaminase complexing protein 2), DPP IV, Gly-Pro naphthylamidase, Post-proline dipeptidyl aminopeptidase IV, T-cell activation antigen CD26, TP103, Xaa-Pro-dipeptidylaminopeptidase

Uniprot ID

Q53TN1

Mouse ortholog

Dpp4 (13482)

dipeptidyl peptidase 4 (P28843)

Alternate

No data

Variants

Clinical Variant

No data

Financial

Janumet - Merck Sharp & Dohme

€

₣

Mock data
Subscribe for the real data

Januvia - Merck Sharp & Dohme

€

₣

Mock data
Subscribe for the real data

Tabular view

Trends

PubMed Central

Top Terms for Disease or Syndrome:

Mock data
Subscribe for the real data

Additional graphs summarizing 11,196 documents

View more details

Safety

Black-box Warning

Black-box warning for: Janumet

Adverse Events

Top Adverse Reactions

Mock data
Subscribe for the real data

16,870 adverse events reported

View more details

Real-time Data on

Companies, Drugs, and Diseases

PharmaKB

MATERIALS

COMPANY