Januvia
(Sitagliptin)ApprovedSmall molecule
Sitagliptin is used to help control blood sugar levels in people with type 2 diabetes. It works by helping the pancreas release more insulin when blood sugar is high.[2] Januvia is currently approved and in use across 46 indications[4].[1]
Januvia is one of 901 small molecule programs targeting Hyperglycemia. It is currently in Approved.
46
Indications
432
Total Trials
3
Active Trials
900
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
4
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 46 indications
Competition
Competitive Landscape
265 competitors in Hepatocellular Carcinoma
#DrugCompanyPhaseTrials
1Januvia
ZZydus Therapeutics Inc.
Approved
Viread
GileadPreclinical
Sovaldi
GileadPreclinical
Cysteine Hydrochloride
NovartisPreclinical
Ibrance
PfizerPreclinical
Hepsera
GileadPreclinical
Doptelet
AAkarx
Preclinical
Miraclid
TTechpool Bio-Pharma Co., Ltd.
Preclinical
Vermox
WWim Janssens
Preclinical
Statin
Bristol-Myers SquibbPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Type 2 Diabetes44 trials
Show 41 more trials
An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
Completed·
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00642278·451 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00642278·451 enrolledSitagliptin in Combination With Beidougen Capsule for Type 2 Diabetes
Unknown status·—·Phase 4·NCT05667220·20 enrolled
Type 2 Diabetes Mellitus35 trials
Show 32 more trials
Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus
Unknown status·—·N/A·NCT01642108·40 enrolled
Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
Completed·—·Phase 4·NCT01341717·440 enrolled
Metformin13 trials
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Sitagliptin in Combination With Metformin and Sulfonylurea
Completed·—·Phase 4·NCT00686634·108 enrolled
Lip7 trials
Show 4 more trials
Type 2 Diabetic Patients4 trials
Show 1 more trial
69 more indications
Diabetes4 trials
Replication of the GRADE Diabetes Trial in Healthcare Claims Data
Completed·—··NCT05099198·6,403 enrolled
Replication of the TECOS Diabetes Trial in Healthcare Claims
Completed·—··NCT03936062·349,476 enrolled
How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin.
Completed·—·N/A·NCT00747383·74 enrolled
Show 1 more trial
Hyperglycemia4 trials
Show 1 more trial
Type 1 Diabetes3 trials
Novel Therapy to Preserve Beta Cell Function in New Onset Type 1 Diabetes
Terminated·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00837759·7 enrolled
A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes
Completed·—·Phase 4·NCT01718093·21 enrolled
Diabetes Mellitus3 trials
Non-Alcoholic Fatty Liver Disease3 trials
Tics3 trials
Cardiovascular3 trials
Islet Transplantation2 trials
Oral2 trials
Kidney Transplant2 trials
Endothelial Function2 trials
Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM
Unknown status·—·Phase 4·NCT02301806·30 enrolled
Dapagliflozin2 trials
Liraglutide2 trials
Efficacy and Safety2 trials
Fasting Conditions2 trials
Prevention2 trials
Acute Myocardial Infarction1 trial
Efficacy1 trial
Metabolic Syndrome1 trial
Renal insufficiency1 trial
Humans1 trial
LAM1 trial
Immune Thrombocytopenia1 trial
Chronic Hepatitis1 trial
TED1 trial
Quantification of the Dipeptidyl Peptidase (DPP)-4 Inhibition-mediated Enhancement of the Activity of the Entero-insular Axis
Completed·—·Phase 2/3·NCT00683735·20 enrolled
Allogeneic Hematopoietic Stem Cell Transplantation1 trial
Sitagliptin for Prevention of Acute Graft Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Completed·—·Phase 2·NCT02683525·37 enrolled
T2DM1 trial
Heart Failure1 trial
Empagliflozin1 trial
Function1 trial
Type 1 Diabetes Mellitus1 trial
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
Completed·—·Phase 4·NCT01235819·20 enrolled
Chronic Kidney Disease1 trial
Replication of the DAPA-CKD (Chronic Kidney Disease) Trial in Healthcare Claims Data
Completed·—··NCT04882813·87,727 enrolled
Liver Resection1 trial
Pregnancy1 trial
Phase II1 trial
Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant
Completed·—·Phase 2·NCT01720264·15 enrolled
Cystic Fibrosis1 trial
Beta-cell Function1 trial
Beta-Cell Function and Sitagliptin Trial (BEST)
Completed·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·Phase 2·NCT00420511·21 enrolled
Safety and Efficacy1 trial
Growth1 trial
Type 2 DM1 trial
Oxidative Stress1 trial
The Effect of Sitagliptin on Hypertension, Arterial Stiffness, Oxidative Stress and Inflammation
Unknown status·—·N/A·NCT00696982·60 enrolled
Gastric Bypass Surgery1 trial
SGLT-2 Inhibitor1 trial
Wolfram syndrome1 trial
Randomized1 trial
Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop
Completed·—·Phase 1·NCT02328040·17 enrolled
Monotherapy1 trial
Concentration1 trial
Costs1 trial
Hypoglycemia1 trial
Treatment With Sitagliptin for Reactive Hypoglycemia Secondary to Dysinsulinism
Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 4·NCT00847080·20 enrolled
Hepatic Insufficiency1 trial
Regulatory
FDA Approval Timeline[5]
Oct 16, 2006
JANUVIA
NDA NDA021995
Oct 18, 2023
ZITUVIO
NDA NDA211566
Jan 16, 2025
BRYNOVIN
NDA NDA219122
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Januvia drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Sitagliptin. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Dipeptidyl Peptidase IV Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- ZZydus Therapeutics Inc.
Patent Landscape[6]
Patent Cliff
May 24, 2027
Earliest patent expiration — generic entry possible after this date