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Comparator: Sitagliptin
Comparator: Sitagliptin is a DPP-4 inhibitor Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Type 2 diabetes mellitus. Also known as: GLUCOPHAGE®, MK0431, Januvia.
Sitagliptin inhibits dipeptidyl peptidase-4 (DPP-4), prolonging the activity of incretin hormones to increase insulin secretion and decrease glucagon in response to meals.
Sitagliptin is a small molecule dipeptidyl peptidase 4 inhibitor used to treat Type 2 Diabetes Mellitus. It has been compared to a placebo and insulin glargine in clinical trials for this indication.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Comparator: Sitagliptin |
|---|---|
| Also known as | GLUCOPHAGE®, MK0431, Januvia |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | DPP-4 inhibitor |
| Target | DPP-4 (dipeptidyl peptidase-4) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Sitagliptin is a DPP-4 inhibitor that prevents the degradation of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). By extending the half-life of these incretin hormones, the drug enhances glucose-dependent insulin secretion and suppresses glucagon release, thereby lowering blood glucose levels in a glucose-dependent manner with minimal hypoglycemia risk.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nasopharyngitis
- Headache
- Upper respiratory tract infection
- Hypoglycemia
Key clinical trials
- Emulation of the STEP-HFpEF DM Heart Failure Trial in Healthcare Claims Data
- Emulation of the SUMMIT Heart Failure Trial in Healthcare Claims Data
- Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients (PHASE4)
- Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk
- Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
- A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
- Polypill Versus Metformin in New Onset Type 2 Diabetes (PHASE2)
- Impact of Sitagliptin on Cardiovascular Exercise Performance in Type 2 Diabetes (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Comparator: Sitagliptin CI brief — competitive landscape report
- Comparator: Sitagliptin updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Comparator: Sitagliptin
What is Comparator: Sitagliptin?
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What is Comparator: Sitagliptin used for?
Who makes Comparator: Sitagliptin?
Is Comparator: Sitagliptin also known as anything else?
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Related
- Drug class: All DPP-4 inhibitor drugs
- Target: All drugs targeting DPP-4 (dipeptidyl peptidase-4)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Also known as: GLUCOPHAGE®, MK0431, Januvia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing