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DWP16001
DWP16001 is a long-acting GLP-1 receptor agonist that enhances insulin secretion and reduces glucagon levels to improve glycemic control in diabetes.
DWP16001 is a long-acting GLP-1 receptor agonist that enhances insulin secretion and reduces glucagon levels to improve glycemic control in diabetes. Used for Type 2 diabetes mellitus.
At a glance
| Generic name | DWP16001 |
|---|---|
| Also known as | DWP16001 tablet, DWP16001 Placebo tablet, DWP16001 0.3mg |
| Sponsor | Daewoong Pharmaceutical Co. LTD. |
| Drug class | GLP-1 receptor agonist |
| Target | GLP-1R |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Diabetes |
| Phase | Phase 3 |
Mechanism of action
DWP16001 binds to and activates the glucagon-like peptide-1 (GLP-1) receptor on pancreatic beta cells, stimulating glucose-dependent insulin secretion. It also suppresses glucagon secretion and slows gastric emptying, collectively reducing postprandial and fasting blood glucose levels. The long-acting formulation allows for less frequent dosing compared to short-acting GLP-1 agonists.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Injection site reactions
Key clinical trials
- Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults (PHASE1)
- Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults (PHASE1)
- Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients (PHASE3)
- To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function (PHASE1)
- A Study to Investigate the Effect of DWP16001 as add-on Therapy to Drug A in Patients With Type 2 Diabetes Mellitus (PHASE3)
- The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin (PHASE3)
- Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus (PHASE3)
- To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |