Diabetic nephropathy medicine [ First-in-Class ]
Diabetic nephropathy is caused by diabetic complications”→ High unmet medical needs due to limitations of existing treatments.
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Diabetic Nephropathy |
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Diabetic Nephropathy is a complication of diabetes which occurs in the microvascular system |
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It is the main cause of terminal renal failure. |
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Results in albuminuria and decreased renal function. |
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There is no fundamental treatment for this condition. |
Existing medicine and unmet medical needs
Global market perspective
Diabetic nephropathy medicine [ First-in-Class ]
Phase 2a clinical trial study design
Study overview
Design: Multi-center, randomized, double-blind, placebo-control
ObjectivesTo evaluate safety and efficacy
Number of subjects2 groups (treatment arm, placebo arm)
Development progress
PHASE 2A DIABETIC NEPHROPATHY CLINICAL TRIAL: CU01-1001-P2A (COMPLETED)
The Phase 2a clinical trial of CU01-1001 in Type 2 diabetic nephropathy patients was conducted under an MFDS approved Investigational New Drug (IND) application at 6 clinical sites in South Korea.
Further details on the Phase 2a trial can be found at https://cris.nih.go.kr, CRIS Registration Number: KCT0004233
The Phase 2a trial was designed to assess safety and tolerability, changes in GFR and ACR. We reported encouraging results from a Phase 2a clinical trial in DN patients in March 2021.
The results of this study provided important insights into the design of a late phase clinical trial in preparation.
Completed IND submission for Phase III (2021.09.29)
Diabetic nephropathy medicine
