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Placebo, MK-0431/ONO-5435
MK-0431/ONO-5435 is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases incretin hormone levels to improve blood glucose control in type 2 diabetes.
MK-0431/ONO-5435 is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases incretin hormone levels to improve blood glucose control in type 2 diabetes. Used for Type 2 diabetes mellitus.
At a glance
| Generic name | Placebo, MK-0431/ONO-5435 |
|---|---|
| Sponsor | Ono Pharmaceutical Co. Ltd |
| Drug class | DPP-4 inhibitor |
| Target | DPP-4 (Dipeptidyl peptidase-4) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
DPP-4 inhibitors block the enzyme that degrades glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby prolonging the action of these incretin hormones. This leads to increased insulin secretion and decreased glucagon secretion in a glucose-dependent manner, resulting in improved glycemic control without causing hypoglycemia.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nasopharyngitis
- Headache
- Upper respiratory tract infection
- Hypoglycemia
Key clinical trials
- Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105) (PHASE2)
- Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136) (PHASE3)
- MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104) (PHASE3)
- MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes (PHASE3)
- MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus (PHASE3)
- Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus (PHASE3)
- Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus (PHASE3)
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:
- Placebo, MK-0431/ONO-5435 CI brief — competitive landscape report
- Placebo, MK-0431/ONO-5435 updates RSS · CI watch RSS
- Ono Pharmaceutical Co. Ltd portfolio CI