Diabetic nephropathy medicine [ First-in-Class ]
Diabetic nephropathy is caused by diabetic complications”→ High unmet medical needs due to limitations of existing treatments.

Diabetic Nephropathy
Diabetic Nephropathy is a complication of diabetes which occurs in the microvascular system
It is the main cause of terminal renal failure.
Results in albuminuria and decreased renal function.
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