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Sitagliptin + Standard Prophylaxis
Sitagliptin + Standard Prophylaxis is a DPP-4 inhibitor Small molecule drug developed by The First Affiliated Hospital of Soochow University. It is currently in Phase 3 development for Type 2 diabetes mellitus (in combination with standard prophylaxis, likely in a specific clinical context such as perioperative or infection prevention setting). Also known as: Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin.
Sitagliptin inhibits dipeptidyl peptidase-4 (DPP-4) to increase incretin levels and stimulate insulin secretion in response to glucose.
Sitagliptin is a small molecule dipeptidyl peptidase 4 inhibitor used to treat conditions such as hyperglycemia and type 2 diabetes. It is typically used in conjunction with standard prophylaxis, which may include supplemental insulin, to manage these conditions.
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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).
| 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 | Sitagliptin + Standard Prophylaxis |
|---|---|
| Also known as | Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin |
| Sponsor | The First Affiliated Hospital of Soochow University |
| 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), thereby prolonging their action. This leads to glucose-dependent stimulation of insulin secretion and inhibition of glucagon release, resulting in improved glycemic control. The 'Standard Prophylaxis' component likely refers to standard preventive measures in the trial context, possibly infection prophylaxis or other supportive care.
Approved indications
- Type 2 diabetes mellitus (in combination with standard prophylaxis, likely in a specific clinical context such as perioperative or infection prevention setting)
Common side effects
- Nasopharyngitis
- Headache
- Upper respiratory tract infection
- Hypoglycemia
Key clinical trials
- Comparative Study Between (SGLT-2i) and (DPP-4i) in the Prevention of DIC (PHASE4)
- Sitagliptin for Prevention of aGVHD After Alternative Donor Transplation (PHASE3)
- Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery (PHASE4)
- Sitagliptin in Non-Diabetic Patients Undergoing General Surgery (PHASE4)
- Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery (PHASE4)
- Prevention and Treatment Of Diabetes Complications With Gastric Surgery or Intensive Medicines (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:
- Sitagliptin + Standard Prophylaxis CI brief — competitive landscape report
- Sitagliptin + Standard Prophylaxis updates RSS · CI watch RSS
- The First Affiliated Hospital of Soochow University portfolio CI
Frequently asked questions about Sitagliptin + Standard Prophylaxis
What is Sitagliptin + Standard Prophylaxis?
How does Sitagliptin + Standard Prophylaxis work?
What is Sitagliptin + Standard Prophylaxis used for?
Who makes Sitagliptin + Standard Prophylaxis?
Is Sitagliptin + Standard Prophylaxis also known as anything else?
What drug class is Sitagliptin + Standard Prophylaxis in?
What development phase is Sitagliptin + Standard Prophylaxis in?
What are the side effects of Sitagliptin + Standard Prophylaxis?
What does Sitagliptin + Standard Prophylaxis target?
Related
- Drug class: All DPP-4 inhibitor drugs
- Target: All drugs targeting DPP-4 (Dipeptidyl peptidase-4)
- Manufacturer: The First Affiliated Hospital of Soochow University — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus (in combination with standard prophylaxis, likely in a specific clinical context such as perioperative or infection prevention setting)
- Also known as: Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing