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 885 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

433

Total Trials

Active Trials

884

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseCompleted

Metabolic SyndromeActive, not recruiting

Cardiovascular DiseaseApproved

AlbuminuriaActive, not recruiting

Systemic Inflammatory Response SyndromeActive, not recruiting

HyperlipidemiaApproved

Glucose IntoleranceApproved

Non-Alcoholic Fatty Liver DiseaseWithdrawn

Abnormal Glucose ToleranceApproved

Acute Myocardial InfarctionCompleted

Coronary Artery DiseaseApproved

Completed

Metabolic SyndromePreclinical

Active, not recruiting

Cardiovascular DiseaseApproved

Approved

AlbuminuriaApproved

Active, not recruiting

Systemic Inflammatory Response SyndromePreclinical

Active, not recruiting

HyperlipidemiaApproved

Approved

Glucose IntoleranceApproved

Approved

Non-Alcoholic Fatty Liver DiseaseApproved

Withdrawn

Abnormal Glucose ToleranceApproved

Approved

Acute Myocardial InfarctionApproved

Completed

Showing 10 of 46 indications

Competition

Competitive Landscape

251 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Januvia

ZZydus Therapeutics Inc.

Viread

1 3

Sovaldi

Gilead

Preclinical

1 4

Cysteine Hydrochloride

Novartis

Preclinical

1 5

Ibrance

Pfizer

Preclinical

1 6

Hepsera

Coreg

2 8

Doptelet

AAkarx

Preclinical

1 9

Statin

Bristol-Myers Squibb

Preclinical

1 10

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2/3Not yet recruiting

Lip

NCT05219409

Clinical

Trials by Indication[1]

Type 2 Diabetes Mellitus44 trials

Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01485614·200 enrolled

A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin With or Without a Sulfonylurea (MK-0431-838)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02532855·614 enrolled

A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01702298·42 enrolled

Show 41 more trials

Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT00363948·188 enrolled

A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00127192·363 enrolled

A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT01678820·299 enrolled

Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT00363519·195 enrolled

MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00532935·517 enrolled

Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

Completed· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT00363844·209 enrolled

A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00411554·319 enrolled

Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00993187·292 enrolled

Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01189890·480 enrolled

Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00875394·68 enrolled

MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00372060·134 enrolled

Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01177384·380 enrolled

MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00289848·530 enrolled

Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00337610·190 enrolled

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

A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01760447·223 enrolled

A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01076075·427 enrolled

MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00722371·1,615 enrolled

A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus

Terminated· Eli Lilly logo

Eli Lilly·Phase 2·NCT02111096·174 enrolled

Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Terminated·PPhenomix·Phase 3·NCT00998686·650 enrolled

A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00481663·555 enrolled

A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01034111·30 enrolled

Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone

Completed·JJW Pharmaceutical·Phase 3·NCT01529541·200 enrolled

The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus

Completed·KKineMed·N/A·NCT01092663·61 enrolled

Pharmacokinetics Study of Dipeptidyl Peptidase 4 Inhibitor to Control Type 2 Diabetes Mellitus

Completed·TThe Catholic University of Korea·Phase 4·NCT01449747·24 enrolled

Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01703221·414 enrolled

A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin

Completed· Eli Lilly logo

Eli Lilly·Phase 2/3·NCT00734474·1,202 enrolled

Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01545388·337 enrolled

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT00700817·665 enrolled

Effects of DPP-4 Inhibition on Calcium and Bone Metabolism in Type 2 Diabetes Mellitus

Withdrawn·UUniversity of Missouri-Columbia·Phase 1·NCT02444364

Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea

Completed·SSung-Chen Liu·Phase 4·NCT01195090·120 enrolled

Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01652729·365 enrolled

A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT01477853·166 enrolled

Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus

Unknown status·—·N/A·NCT01642108·40 enrolled

Efficacy and Safety of SYR-472 in Subjects With Type 2 Diabetes Mellitus

Completed· Takeda logo

Takeda·Phase 2·NCT00760344·386 enrolled

The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT00832624·10 enrolled

Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01999218·1,326 enrolled

Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00087516·741 enrolled

A Phase 2 Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM)

Completed· Daiichi Sankyo logo

Daiichi Sankyo·N/A·NCT02628392·368 enrolled

Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02564211·77 enrolled

Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00509236·129 enrolled

Type 2 Diabetes41 trials

A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden

Completed· Novo Nordisk logo

Novo Nordisk··NCT02077946·1,059 enrolled

A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01557504·25 enrolled

Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00449930·1,050 enrolled

Show 38 more trials

Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose

Completed·NNanjing First Hospital, Nanjing Medical University·N/A·NCT05035849·60 enrolled

MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00482729·1,246 enrolled

Phase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes

Completed·LLG Life Sciences·Phase 3·NCT01602003·425 enrolled

Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00484419·169 enrolled

A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00541450·492 enrolled

Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT01131182·1,147 enrolled

Comparative Study of Sitagliptin and Gliclazide With Metformin in Type 2 Diabetes Patients With Glucotoxicity

Completed·ZZhibin Xu·Phase 4·NCT06613750·129 enrolled

TriMaster: Study of a DPP4 Inhibitor, SGLT2 Inhibitor and Thiazolidinedione as Third Line Therapy in Patients With Type 2 Diabetes.

Completed·RRoyal Devon and Exeter NHS Foundation Trust·Phase 4·NCT02653209·525 enrolled

Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)

Completed·PPopulation Health Research Institute·Phase 3·NCT02623998·102 enrolled

MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2 Diabetes

Completed·RRoyal Devon and Exeter NHS Foundation Trust·Phase 4·NCT01847144·143 enrolled

A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 Administered With Metformin to Type 2 Diabetes Patients

Completed· GSK logo

GSK·Phase 2·NCT02202161·70 enrolled

A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00637273·514 enrolled

Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain

Completed·FFundación Pública Andaluza para la gestión de la Investigación en Sevilla··NCT04149067·1,080 enrolled

Comparison of Fasiglifam (TAK-875) With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes

Terminated· Takeda logo

Takeda·Phase 3·NCT01834274·96 enrolled

Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00957060·400 enrolled

Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes

Completed·EEmory University·Phase 4·NCT01845831·292 enrolled

Efficacy of Metformin Versus Sitagliptin on Benign Thyroid Nodules in Type 2 Diabetes

Unknown status·—·Phase 4·NCT04298684·90 enrolled

A 2-Part Trial in Subjects With Type 2 Diabetes and in Healthy Subjects to Evaluate GSK1614235, a New Glucose Lowering Drug to Treat Type 2 Diabetes

Completed· GSK logo

GSK·Phase 1·NCT00976261·72 enrolled

Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

Completed· Sanofi logo

Sanofi·Phase 3·NCT00851903·112 enrolled

A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00701090·1,035 enrolled

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00676338·820 enrolled

Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin

Completed·SSeoul National University Bundang Hospital·Phase 3·NCT03076112·170 enrolled

A Study to Evaluate ITCA 650 Compared to Sitagliptin for the Treatment of Type 2 Diabetes

Withdrawn·IIntarcia Therapeutics·Phase 3·NCT01455909

Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes

Completed· GSK logo

GSK·Phase 3·NCT00838903·1,049 enrolled

Evaluation of the Effect of Sitagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes

Unknown status·SSecond Affiliated Hospital of Soochow University·N/A·NCT02900417·9 enrolled

BI 10773 add-on to Metformin in Patients With Type 2 Diabetes

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00749190·495 enrolled

Effects of Sitagliptin on Endothelial Function in Type 2 Diabetes on Background Metformin Therapy

Completed·MMedical College of Wisconsin·Phase 4·NCT01859793·38 enrolled

Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 3·NCT02607865·1,864 enrolled

Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00541229·103 enrolled

Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal in Patients With Type 2 Diabetes

Completed·LLund University·N/A·NCT01901861·12 enrolled

Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT01519674·582 enrolled

Effects of Sitagliptin on Gastric Emptying, Glycaemia and Blood Pressure in Type 2 Diabetes

Completed·RRoyal Adelaide Hospital·Phase 2·NCT02324010·14 enrolled

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. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00642278·451 enrolled

A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

Completed· GSK logo

GSK·Phase 3·NCT01098539·507 enrolled

The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT02008682·368 enrolled

Efficacy and Safety of Ursodeoxycholic Acid (UDCA) Added to the DPP-4 Inhibitor in People With Type 2 Diabetes and Chronic Liver Diseases

Unknown status·KKanazawa University·Phase 4·NCT01337440·20 enrolled

Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes

Completed·—·Phase 4·NCT04916093·60 enrolled

Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

Terminated·UUniversity of Manchester·Phase 4·NCT00766441·22 enrolled

Metformin20 trials

Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00885352·313 enrolled

Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00545584·1,512 enrolled

Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects

Completed·TThe Affiliated Hospital of Qingdao University·Phase 1·NCT04877106·48 enrolled

Show 17 more trials

A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00961857·48 enrolled

Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01093794·28 enrolled

Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)

Completed· Merck & Co. logo

Merck & Co.··NCT01065766·4,065 enrolled

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.

Completed·GGalenicum Health·Phase 1·NCT06124573·48 enrolled

Comparative Bioavailability Study of Metformin/Sitagliptin 850 mg/50 mg Tablets in Healthy Male and Female Volunteers

Completed·GGalenicum Health·Phase 1·NCT05549570·26 enrolled

Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00929201·61 enrolled

A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)

Terminated· Merck & Co. logo

Merck & Co.··NCT01357148·143 enrolled

ALPHA Sitagliptin Add on to Metformin (0431-103)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00833027·608 enrolled

A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00961480·24 enrolled

Comparative Bioavailability Study of Sitagliptin/Metformin 50 mg/1000 mg Tablets in Healthy Male and Female Volunteers

Completed·GGalenicum Health·Phase 1·NCT05549583·26 enrolled

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/1000 mg Relative to Originator

Unknown status·BBio-innova Co., Ltd·Phase 1·NCT06233240·34 enrolled

A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy

Completed·KKowa Research Institute, Inc.·Phase 2·NCT01169090·620 enrolled

Exploratory Study to Compare the Effects of Tenelia® or Januvia® on Glucose Variability in add-on to Metformin (CGMS Study)

Completed·HHandok Inc.·Phase 4·NCT02512523·39 enrolled

The Effect of Glimepiride Compared With Sitagliptin as an add-on Therapy to Metformin in Severe Insulin Deficiency Diabetes

Unknown status·PPeking University People's Hospital·Phase 4·NCT05386186·192 enrolled

Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT00820573·16 enrolled

A Study in Type 2 Diabetic Subjects on Stable Metformin Therapy to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administering Single and Multiple Oral Doses of GSK1292263

Completed· GSK logo

GSK·Phase 2·NCT01128621·66 enrolled

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator

Unknown status·BBio-innova Co., Ltd·Phase 1·NCT06233201·34 enrolled

Lip6 trials

Sitagliptin Added-on to Insulin Study (0431-051)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00395343·641 enrolled

Effects of Sitagliptin in Relatives of T1D Patients

Not yet recruiting·UUniversity of Milan·Phase 2/3·NCT05219409·70 enrolled

Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00751114·515 enrolled

Show 3 more trials

Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

Completed· Sanofi logo

Sanofi·Phase 4·NCT02200991·136 enrolled

Sitagliptin and Glucagon Counterregulation

Completed·LLund University·Phase 4·NCT02256189·28 enrolled

Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

Completed·SSamsung Medical Center·Phase 1·NCT01422590·26 enrolled

Type 1 Diabetes4 trials

Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes

Completed·SSanford Health·Phase 2·NCT01155284·70 enrolled

Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes

Completed·UUniversity of Colorado, Denver·Phase 4·NCT00978796·20 enrolled

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

Show 1 more trial

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

63 more indications

Diabetes Mellitus3 trials

Effect of DPP-IV Inhibitor on Glycemic Control and Autonomic Neuropathy in Adult Patients With Diabetes Mellitus

Unknown status·NNagaoka Red Cross Hospital··NCT01545024·60 enrolled

Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment

Completed·—·Phase 4·NCT01099618·48 enrolled

Vascular Effects of Sitagliptin in Diabetes Mellitus

Unknown status·HHannover Medical School·Phase 4·NCT01096277·70 enrolled

Type 2 Diabetic Patients3 trials

The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00716092·121 enrolled

24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

Completed· Sanofi logo

Sanofi·Phase 3·NCT00976937·319 enrolled

Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT02338921·78 enrolled

Kidney Transplant2 trials

Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant

Completed·WWashington University School of Medicine·Phase 4·NCT01928199·61 enrolled

Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney Transplantation

Terminated·UUniversity of Nebraska·Phase 4·NCT00936663·3 enrolled

MPA2 trials

Incretins in Impaired Fasting Glucose

Completed·MMayo Clinic·Phase 4·NCT00364377·22 enrolled

Incretin Effect in People With Impaired Fasting Glucose

Completed·UUniversity of Colorado, Denver·N/A·NCT00795275·26 enrolled

Cystic Fibrosis2 trials

Sitagliptin in Cystic Fibrosis-Related Diabetes

Terminated·UUniversity of British Columbia·Phase 2·NCT01257464·3 enrolled

Effect of Chronic Incretin-based Therapy in Cystic Fibrosis

Completed·UUniversity of Pennsylvania·N/A·NCT01879228·26 enrolled

Fasting Conditions2 trials

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.

Completed·GGalenicum Health·Phase 1·NCT06124495·58 enrolled

Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.

Completed·GGalenicum Health·Phase 1·NCT06124560·58 enrolled

Prevention2 trials

DPP-4 Inhibition and TZD for DM Prevention

Terminated·EEmory University·N/A·NCT01006018·3 enrolled

Sitagliptin for Prevention of aGVHD After Alternative Donor Transplation

Completed·TThe First Affiliated Hospital of Soochow University·Phase 3·NCT05149365·190 enrolled

Dapagliflozin2 trials

Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05266404·46 enrolled

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00842556·18 enrolled

Efficacy and Safety2 trials

Study to Assess the Efficacy and Safety of Sitagliptin in Recently Diagnosed, Naive Type 2 Diabetics With Inadequate Glycemic Control on Diet and Exercise (0431-158)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00832390·29 enrolled

Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

Completed·DDong-A ST Co., Ltd.·Phase 3·NCT02949193·222 enrolled

Treatment2 trials

Treatment of Diabetes After Gastric Bypass With Sitagliptin

Completed·BBlandine Laferrere·N/A·NCT01512797·37 enrolled

The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01106677·1,284 enrolled

TIA2 trials

Initial Combination With Pioglitazone Study (0431-064)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00397631·520 enrolled

30-Week Extension to an Initial Combination Study (24 Weeks in Duration) of Sitagliptin With Pioglitazone (0431-064)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01028391·317 enrolled

Acute Myocardial Infarction2 trials

DPP-4 Inhibitors and Acute Myocardial Infarction:Effects on Platelet Function

Completed·UUniversity of Sao Paulo General Hospital·Phase 3·NCT02377388·74 enrolled

Beta-cell Function in Glucose Abnormalities and Acute Myocardial Infarction

Completed·KKarolinska Institutet·Phase 4·NCT00627744·85 enrolled

Efficacy2 trials

Comparison Between Efficacy of Trelagliptin and Sitagliptin in Type II Diabetic Patients

Enrolling by invitation·—·Phase 3·NCT07073768·126 enrolled

Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy

Completed· Novartis logo

Novartis·Phase 4·NCT01398592·187 enrolled

Tics2 trials

Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00305604·206 enrolled

Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763

Completed· Novartis logo

Novartis·Phase 1/2·NCT01619332·220 enrolled

Concentration2 trials

A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00975052·16 enrolled

A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00830076·18 enrolled

Diabetes2 trials

Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes

Withdrawn· Novartis logo

Novartis·Phase 2·NCT01824264

Replication of the GRADE Diabetes Trial in Healthcare Claims Data

Completed·—··NCT05099198·6,403 enrolled

Islet Transplantation2 trials

Effect of Sitagliptin on Graft Function Following Islet Transplantation

Terminated·UUniversity of British Columbia·Phase 3·NCT00853944·12 enrolled

Incretin Effect and Use After Clinical Islet Transplantation

Completed·UUniversity of Alberta·Phase 2·NCT00768651·8 enrolled

Oral2 trials

Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study

Completed·JJoslin Diabetes Center·Phase 2/3·NCT04409795·3 enrolled

A Study in Type 2 Diabetics of Single and Multiple Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics

Completed· GSK logo

GSK·Phase 2·NCT01119846·100 enrolled

Function2 trials

Vildagliptin vs Sitagliptin add-on to Insulin - Impact on Glycemic Profile and Correlation of Hypoglycemic Episodes and Heart Function

Completed· Novartis logo

Novartis·Phase 4·NCT01686932·51 enrolled

Study on Exploring the Effect of DPP-4 Inhibitors on β-cell Function by Using the Two-step Hyperglycemic Clamp

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02386943·12 enrolled

Growth1 trial

Effect of DPP4 Inhibition on Growth Hormone Secretion

Completed·VVanderbilt University·Phase 4·NCT01701973·44 enrolled

Interaction1 trial

Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin

Completed· Theracos logo

Theracos·Phase 1·NCT02956044·54 enrolled

Non-Diabetic Patients1 trial

Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery

Completed·EEmory University·Phase 4·NCT02443402·68 enrolled

Insulin resistance1 trial

Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics

Completed·GGuangwei Li·Phase 4·NCT01610154·85 enrolled

Gestational Diabetes1 trial

Metformin and Sitagliptin in Women With Previous Gestational Diabetes

Completed·UUniversity of Pisa·Phase 2·NCT01336322·40 enrolled

Liraglutide1 trial

Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects

Completed·SSun Yat-sen University·Phase 4·NCT02147925·75 enrolled

Albuminuria1 trial

Use of Sitagliptin to Decrease Microalbuminuria

Terminated·UUniversity of Missouri-Columbia·Phase 4·NCT02048904·142 enrolled

Randomized1 trial

Randomized Trial Comparing Sitagliptin to Placebo in Closed Loop

Completed·—·Phase 1·NCT02328040·17 enrolled

Wolfram syndrome1 trial

Treatment of Wolfram Syndrome Type 2 With the Chelator Deferiprone and Incretin Based Therapy

Unknown status·HHadassah Medical Organization·Phase 2/3·NCT02882477·20 enrolled

Monotherapy1 trial

Sitagliptin + Metformin Compared to Metformin Monotherapy and Placebo in Women With a Recent GDM

Completed·WWoman's·Phase 4·NCT01856907·36 enrolled

Costs1 trial

Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone

Completed· GSK logo

GSK··NCT01332370·5,391 enrolled

Hyperglycemia1 trial

Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio

Completed·UUniversity of Diyala··NCT05822674·80 enrolled

Hepatic Insufficiency1 trial

A Study of MK0431 in Patients WIth Hepatic Insufficiency (0431-017)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00696826·20 enrolled

Adolescent1 trial

A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00730275·35 enrolled

Adult Subject1 trial

An Open-Label, Single- & Multiple-Dose Study to Investigate the Pharmacokinetics of Sitagliptin 100 mg in Healthy Chinese Adult Subjects (0431-108)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00642798·16 enrolled

Weight loss1 trial

Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss

Completed·UUniversity Medical Centre Ljubljana·Phase 4·NCT02941445·24 enrolled

Recovery1 trial

Dipeptidyl Peptidase-4 Inhibitors and Alpha-cell Recovery

Completed·—·N/A·NCT01272583·16 enrolled

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

GLP-11 trial

Feed-Back Suppression of Meal-Induced Glucagon-like Peptide 1 (GLP-1) Secretion

Completed·—·Phase 1·NCT02749032·24 enrolled

Autoimmune Diabetes1 trial

Protective Effects of Sitagliptin on β Cell Function in Patients With Adult-onset Latent Autoimmune Diabetes (LADA)

Completed·EEuropean Foundation for the Study of Diabetes·Phase 1/2·NCT01159847·30 enrolled

Observational Study1 trial

An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

Completed· Merck & Co. logo

Merck & Co.··NCT01357135·3,453 enrolled

COVID-191 trial

The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients

Unknown status·UUniversity of Milan·Phase 3·NCT04365517·170 enrolled

Drug Transporter1 trial

Drug Transporter Interaction Study PHENTRA_2015_KPUK

Completed·UUniversity of Cologne·Phase 4·NCT02743260·24 enrolled

Coronary Artery Disease1 trial

Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease

Completed·WWuhan General Hospital of Guangzhou Military Command·Phase 4·NCT01863147·66 enrolled

Metabolic Syndrome1 trial

Effect of Sitagliptin and an ACE Inhibitor on Blood Pressure in Metabolic Syndrome

Completed·VVanderbilt University·Phase 4·NCT00666848·24 enrolled

ESS1 trial

Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00758069·80 enrolled

Renal insufficiency1 trial

Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

Completed· Novartis logo

Novartis·Phase 3·NCT00770081·75 enrolled

Cancer1 trial

DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients

Unknown status·NNagaoka Red Cross Hospital··NCT01588587·500 enrolled

Humans1 trial

Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans

Completed·UUniversity Health Network, Toronto·Phase 2/3·NCT01600703·21 enrolled

LAM1 trial

Study of Comparing the Different Effect of DPP-4 Inhibitors and Sulfonylurea by Using "Biphase-Hyperglycemic Clamp"

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01660386·12 enrolled

Immune Thrombocytopenia1 trial

The Combination of Sitagliptin and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05353673·120 enrolled

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

Interleukin1 trial

Role of Interleukin-6 in Exercise

Completed·UUniversity of Zurich·N/A·NCT01073826·56 enrolled

Non-Alcoholic Fatty Liver Disease1 trial

Evaluation of the DPP-4 Inhibitor Sitagliptin in the Treatment of Non-Alcoholic Fatty Liver Disease Using MRI

Withdrawn·UUniversity of Missouri-Columbia·Phase 4·NCT02263677

T2DM1 trial

A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM

Completed·DDong-A ST Co., Ltd.·Phase 1·NCT03646721·108 enrolled

Heart Failure1 trial

Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure

Completed·SStanford University·Phase 1·NCT00657280·16 enrolled

Outcome1 trial

Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

Completed·UUniversity of Minnesota·Phase 4·NCT01186562·83 enrolled

Empagliflozin1 trial

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00881530·660 enrolled

Endothelial Function1 trial

Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM

Unknown status·—·Phase 4·NCT02301806·30 enrolled

Inflammatory Response1 trial

Perioperative Sitagliptin Medication for Reduction of the Inflammatory Response Associated With Cardiopulmonary Bypass

Completed·UUniversity Hospital Muenster··NCT05725798·20 enrolled

Renal Transplant Recipients1 trial

Sitagliptin in Renal Transplant Recipients

Completed·UUniversity of Oslo School of Pharmacy·Phase 4·NCT00740363·25 enrolled

Systolic Heart Failure1 trial

Treatment of Diabetes in Patients With Systolic Heart Failure

Completed·VVirginia Commonwealth University·Phase 4·NCT02920918·36 enrolled

Unspecified2 trials

Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00944450·12 enrolled

Glycemic Holter Study (Continuous Glucose Monitoring) -

Completed· Novartis logo

Novartis·Phase 4·NCT01193296·36 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 16, 2006

JANUVIA

NDA NDA021995

Oct 16, 2006

JANUVIA

NDA NDA021995

Oct 12, 2007

JANUVIA

NDA NDA021995

Oct 12, 2007

JANUVIA

NDA NDA021995

Oct 12, 2007

JANUVIA

NDA NDA021995

Oct 12, 2007

JANUVIA

NDA NDA021995

Jul 22, 2008

JANUVIA

NDA NDA021995

Oct 20, 2008

JANUVIA

NDA NDA021995

Dec 28, 2009

JANUVIA

NDA NDA021995

Feb 26, 2010

JANUVIA

NDA NDA021995

Feb 26, 2010

JANUVIA

NDA NDA021995

Feb 26, 2010

JANUVIA

NDA NDA021995

Feb 26, 2010

JANUVIA

NDA NDA021995

Sep 24, 2010

JANUVIA

NDA NDA021995

Sep 24, 2010

JANUVIA

NDA NDA021995

Apr 14, 2011

JANUVIA

NDA NDA021995

Jun 10, 2011

JANUVIA

NDA NDA021995

Feb 27, 2012

JANUVIA

NDA NDA021995

Mar 24, 2012

JANUVIA

NDA NDA021995

Oct 18, 2012

JANUVIA

NDA NDA021995

Dec 7, 2012

JANUVIA

NDA NDA021995

Feb 11, 2013

JANUVIA

NDA NDA021995

Aug 19, 2013

JANUVIA

NDA NDA021995

Oct 17, 2013

JANUVIA

NDA NDA021995

Mar 10, 2015

JANUVIA

NDA NDA021995

Apr 27, 2015

JANUVIA

NDA NDA021995

Aug 28, 2015

JANUVIA

NDA NDA021995

Jan 11, 2016

JANUVIA

NDA NDA021995

Jan 18, 2017

JANUVIA

NDA NDA021995

Aug 10, 2017

JANUVIA

NDA NDA021995

Feb 9, 2018

JANUVIA

NDA NDA021995

Jul 1, 2019

JANUVIA

NDA NDA021995

Aug 12, 2019

JANUVIA

NDA NDA021995

Dec 4, 2020

JANUVIA

NDA NDA021995

Jun 21, 2022

JANUVIA

NDA NDA021995

Oct 18, 2023

ZITUVIO

NDA NDA211566

Dec 28, 2023

JANUVIA

NDA NDA021995

Jan 16, 2025

BRYNOVIN

NDA NDA219122

Sources

References

[1]
ClinicalTrials.gov — 433 trial records for Sitagliptin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Januvia drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Sitagliptin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Sitagliptin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219122). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Januvia. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Zydus Therapeutics Inc. company filings. U.S. Securities and Exchange Commission.

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

Patent #Expires

7326708*PEDMay 24, 2027

10925871Feb 25, 2035

12295953Oct 23, 2040

11944621Oct 23, 2040

Januvia

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Type 2 Diabetes Mellitus44 trials

Type 2 Diabetes41 trials

Metformin20 trials

Lip6 trials

Type 1 Diabetes4 trials

Diabetes Mellitus3 trials

Type 2 Diabetic Patients3 trials

Kidney Transplant2 trials

MPA2 trials

Cystic Fibrosis2 trials

Fasting Conditions2 trials

Prevention2 trials

Dapagliflozin2 trials

Efficacy and Safety2 trials

Treatment2 trials

TIA2 trials

Acute Myocardial Infarction2 trials

Efficacy2 trials

Tics2 trials

Concentration2 trials

Diabetes2 trials

Islet Transplantation2 trials

Oral2 trials

Function2 trials

Growth1 trial

Interaction1 trial

Non-Diabetic Patients1 trial

Insulin resistance1 trial

Gestational Diabetes1 trial

Liraglutide1 trial

Albuminuria1 trial

Randomized1 trial

Wolfram syndrome1 trial

Monotherapy1 trial

Costs1 trial

Hyperglycemia1 trial

Hepatic Insufficiency1 trial

Adolescent1 trial

Adult Subject1 trial

Weight loss1 trial

Recovery1 trial

Hypoglycemia1 trial

GLP-11 trial

Autoimmune Diabetes1 trial

Observational Study1 trial

COVID-191 trial

Drug Transporter1 trial

Coronary Artery Disease1 trial

Metabolic Syndrome1 trial

ESS1 trial

Renal insufficiency1 trial

Cancer1 trial

Humans1 trial

LAM1 trial

Immune Thrombocytopenia1 trial

TED1 trial

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Interleukin1 trial

Non-Alcoholic Fatty Liver Disease1 trial

T2DM1 trial

Heart Failure1 trial

Outcome1 trial

Empagliflozin1 trial

Endothelial Function1 trial

Inflammatory Response1 trial

Renal Transplant Recipients1 trial

Systolic Heart Failure1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News