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 58 indications[4].[1]
Januvia is one of 1270 small molecule programs targeting Insulin resistance. It is currently in Approved.
58
Indications
423
Total Trials
3
Active Trials
1,269
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
4
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 58 indications
Competition
Competitive Landscape
1931 competitors in COVID-19
#DrugCompanyPhaseTrials
1Januvia
ZZydus Therapeutics Inc.
Approved
Bnt162b2
BioNTechPreclinical
Benadryl
PParkedale
Preclinical
SARS-COV-2 VACCINE
ModernaPreclinical
Glucocorticoid
AbbViePreclinical
Aprotinin
BayerPreclinical
Antithrombin-III
OctapharmaPreclinical
DAS181
AAnsun Biopharma, Inc.
Preclinical
Sivelestat Sodium
TThe First Hospital of Jilin University
Preclinical
Standard Preparation
LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Type 2 Diabetes42 trials
Show 39 more trials
Efficacy of Metformin Versus Sitagliptin on Benign Thyroid Nodules in Type 2 Diabetes
Unknown status·—·Phase 4·NCT04298684·90 enrolled
Type 2 Diabetes Mellitus38 trials
Show 35 more trials
Effect of Sitagliptin and Empagliflozin in Combination With Metformin on Hs-CRP Levels in Patients With Type 2 Diabetes Mellitus
Completed·—·Phase 3·NCT06952231·50 enrolled
Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus
Unknown status·—·N/A·NCT01642108·40 enrolled
Metformin16 trials
Show 13 more trials
Lip9 trials
Show 6 more trials
Sitagliptin Dose Determination Study
Completed·—·Phase 4·NCT01530178·8 enrolled
69 more indications
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
Cystic Fibrosis3 trials
Non-Diabetic Patients2 trials
Monotherapy2 trials
Fasting Conditions2 trials
Hyperglycemia2 trials
Diabetes Mellitus2 trials
Efficacy and Safety2 trials
Concentration2 trials
Treatment2 trials
TIA2 trials
Tics2 trials
Function2 trials
Safety and Efficacy2 trials
Insulin Secretion2 trials
Interaction2 trials
Kidney Transplant2 trials
Islet Transplantation2 trials
Cardiovascular2 trials
Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk
Completed·—··NCT07096063·887,132 enrolled
Coronary Atherosclerosis1 trial
Effects of a Dipeptidyl Peptidase-4 Inhibitor Sitagliptininsulin on the Progression of Coronary Atherosclerosis in Patients With Type 2 Diabetes
Unknown status·—·Phase 4·NCT03602638·300 enrolled
Dapagliflozin1 trial
Psoriasis1 trial
Liraglutide1 trial
Wolfram syndrome1 trial
Randomized1 trial
Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop
Completed·—·Phase 1·NCT02328040·17 enrolled
Hepatic Insufficiency1 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
Adolescent1 trial
Acute Myocardial Infarction1 trial
Efficacy1 trial
Comparison Between Efficacy of Trelagliptin and Sitagliptin in Type II Diabetic Patients
Enrolling by invitation·—·Phase 3·NCT07073768·126 enrolled
Adult Subject1 trial
Weight loss1 trial
Coronary Artery Disease1 trial
Recovery1 trial
Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery
Completed·—·N/A·NCT01272583·16 enrolled
GLP-11 trial
Feed-Back Suppression of Meal-Induced Glucagon-like Peptide 1 (GLP-1) Secretion
Completed·—·Phase 1·NCT02749032·24 enrolled
Inflammatory Response1 trial
Oxidative Stress1 trial
Autoimmune Diabetes1 trial
Observational Study1 trial
Type 2 Diabetic Patients1 trial
Humans1 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
Oral1 trial
Chronic Hepatitis1 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
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