ZITUVIO (sitagliptin)
Zituvio (sitagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is not recommended for use in patients with type 1 diabetes. Use in patients with a history of pancreatitis has not been studied, and it is unknown if these patients are at an increased risk for developing pancreatitis while on this medication.
How ZITUVIO Works
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that slows the inactivation of incretin hormones, including GLP-1 and GIP. By increasing and prolonging active incretin levels, the drug stimulates insulin synthesis and release from pancreatic beta cells and reduces glucagon secretion from pancreatic alpha cells. These effects are glucose-dependent, occurring primarily when blood glucose levels are normal or elevated, ultimately leading to reduced hepatic glucose production and improved glucose homeostasis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-10-18
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- TABLET
ZITUVIO Approval History
What ZITUVIO Treats
1 indicationsZITUVIO is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
ZITUVIO Target & Pathway
ProTarget
A hormone released after eating that stimulates insulin secretion, suppresses glucagon, slows gastric emptying, and promotes satiety. GLP-1 receptor agonists mimic these effects, improving blood sugar control and promoting weight loss in diabetes and obesity.
ZITUVIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZITUVIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZITUVIO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZITUVIO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
213 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07003542 | CASE2325 | Ph 2 | recruiting | A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas |
| NCT07567781 | M25-744 | Ph 1 | recruiting | A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults. |
| NCT07541781 | 202512310 | Ph 1 | not yet recruiting | Sitagliptin in Recurrent/Progressive Grade 4 Glioma |
| NCT06246799 | STUDY00000139 R01DK097554 | Ph 3 | recruiting | Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes |
| NCT06851962 EPHIC-DIA2 | EPHIC-DIA2 2025-520686-46-00 | Ph 4 | active not recruiting | Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. |
| NCT06263673 results posted | 23-008183 | Ph 4 | completed | Anti-Diabetic Medications to Fight PD and LBD |
| NCT02650427 HCC-DPPIV | C15-41 2015-002968-17 | Ph 1 | completed | A Pilot Study to Evaluate the Safety of a 3 Weeks Sitagliptin Treatment in HCC Patients Undergoing Liver Resection |
| NCT03738878 results posted | IRB#170762 | Ph 4 | terminated | Mechanism(s) Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 1 |
| NCT04409795 | 2019-76 | Ph 2, Ph 3 | completed | Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study |
| NCT02512523 | HD_TEN_PH42014 | Ph 4 | completed | Exploratory Study to Compare the Effects of Tenelia® or Januvia® on Glucose Variability in add-on to Metformin (CGMS Study) |
| NCT06054815 | DA1241_NASH_IIa | Ph 2 | completed | Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH |
| NCT04017832 PIONEER 12 results posted | NN9924-4309 U1111-1188-1256, 2018-002589-38 | Ph 3 | completed | A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes |
| NCT04304261 ESCDP | ESCDP | Ph 3 | completed | Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP) |
| NCT05895201 | CTO-IUSCCC-0778 | Ph 1, Ph 2 | withdrawn | High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of GVHD |
| NCT00936663 results posted | 0254-09-FB | Ph 4 | terminated | Using Sitagliptin as a Treatment to Prevent New Onset Diabetes After Kidney Transplantation |
| NCT05219409 SITA-one | 01/2022 | Ph 2, Ph 3 | not yet recruiting | Effects of Sitagliptin in Relatives of T1D Patients |
| NCT03790839 | HMM0111 | Ph 1 | completed | Drug Interaction Study Between Dorzagliatin and Sitagliptin |
| NCT01928199 results posted | 201306111 50669 | Ph 4 | completed | Efficacy Study of Sitagliptin to Prevent New-onset Diabetes After Kidney Transplant |
| NCT03101930 results posted | IRB# 170213 | Ph 4 | completed | Cardiovascular Effects of GLP-1 Receptor Activation |
| NCT03076112 | B-1612/375-004 | Ph 3 | completed | Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin |
| NCT01485614 results posted | 0431-083 2011-002528-42, MK-0431-083 | Ph 3 | completed | Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083) |
| NCT02607865 PIONEER 3 results posted | NN9924-4222 2015-001351-71, U1111-1168-4339 | Ph 3 | completed | Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes |
| NCT02849080 PIONEER 7 results posted | NN9924-4257 2015-005593-38, U1111-1177-5103 | Ph 3 | completed | Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus. |
| NCT05266404 | D1683C00014 2021-005104-35 | Ph 1 | completed | Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components |
| NCT02338921 | Triple_3 | Ph 4 | completed | Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy |
| NCT00790205 TECOS results posted | 0431-082 2008_523, 2008-006719-20 | Ph 3 | completed | Sitagliptin Cardiovascular Outcomes Study (MK-0431-082) |
| NCT02917031 MEASURE-HF results posted | D1680C00016 | Ph 4 | completed | Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart Failure |
| NCT02956044 results posted | THR-1442-C-453 | Ph 1 | completed | Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin |
| NCT03115112 results posted | THR-1442-C-423 | Ph 3 | completed | Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects |
| NCT03893526 NEPT2D | NEPT2D | Ph 4 | completed | Effect of Neprilysin on Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes |
| NCT03061214 SUSTAIN results posted | NN9535-4114 U1111-1149-0432, CTR20161003 | Ph 3 | completed | Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT) |
| NCT00627744 BEGAMI | BEGAMI | Ph 4 | completed | Beta-cell Function in Glucose Abnormalities and Acute Myocardial Infarction |
| NCT03646721 | DA1241_DM_Ib | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM |
| NCT02683525 results posted | IUSCC-0522 | Ph 2 | completed | Sitagliptin for Prevention of Acute Graft Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation |
| NCT00860288 | CLAF237B2224 | Ph 2, Ph 3 | completed | Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes |
| NCT00770081 | CLAF237A23138E1 | Ph 3 | completed | Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study) |
| NCT01619332 | CLEZ763X2201 | Ph 1, Ph 2 | completed | Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763 |
| NCT00616811 | CLAF237A23138 | Ph 3 | completed | Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency |
| NCT03108521 results posted | 2015SZ0182 | Ph 4 | completed | SNP Study of DPP-4 and GLP-1R in Chinese People (Including Diabetes Patients) |
| NCT01991197 DIP results posted | DPIDM-2012-01 2012-005505-51 | Ph 2 | completed | Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial. |
| NCT02536248 results posted | JANU-INF | Ph 3 | completed | Sitagliptin Therapy and Kinetics of Inflammatory Markers |
| NCT02122380 results posted | 131969 K23HL119602-01A1 | Ph 4 | completed | The Effect of Dipeptidyl Peptidase 4 Inhibition on Growth Hormone Secretion in Women With Polycystic Ovarian Syndrome |
| NCT02043054 LYDIA | 0398 2012-002422-78, U1111-1131-8802 | Ph 3 | completed | Effects of Liraglutide in Young Adults With Type 2 DIAbetes (LYDIA) |
| NCT02556918 SITA-CABGDM results posted | IRB00082180 | Ph 4 | completed | Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery |
| NCT02920918 results posted | HM20007043 28431754DIATBD | Ph 4 | completed | Treatment of Diabetes in Patients With Systolic Heart Failure |
| NCT02173457 CMAS | CGZ302 | Ph 3 | completed | Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients |
| NCT02111096 results posted | 15286 I1R-MC-GLDJ, 2013-004275-12 | Ph 2 | terminated | A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus |
| NCT02072096 IMPERIUM results posted | 14842 F3Z-MC-IOQL, 2013-001473-24 | Ph 4 | terminated | A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM) |
| NCT02743260 | PHENTRA_2015_KPUK | Ph 4 | completed | Drug Transporter Interaction Study PHENTRA_2015_KPUK |
| NCT02330406 REASON | ICE_2014_01R | Ph 4 | completed | Randomized Evaluation of Anagliptin Versus Sitagliptin On Low-density lipoproteiN Cholesterol in Diabetes Trial |
Showing 50 of 213 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZITUVIO FDA Label Details
Indications & Usage
FDA Label (PDF)ZITUVIO is indicated for the treatment of Type 2 Diabetes.
ZITUVIO Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for ZITUVIO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 9 active patents
Trial Analysis
- • 213 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment