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CU01 is a solubilized oral formulation of tranilast being developed by Curacle for the treatment of diabetic nephropathy (DN). Tranilast is a small molecule mast cell stabilizer that has been repositioned for its potent anti-fibrotic and anti-inflammatory properties. The drug acts primarily by inhibiting the signaling and expression of transforming growth factor-beta 1 (TGF-β1), a key driver of renal fibrosis and collagen synthesis. By utilizing a proprietary solubilization technology, CU01 aims to overcome the low bioavailability of conventional tranilast, thereby improving its efficacy in reducing albuminuria and preserving renal function in patients with chronic kidney disease associated with diabetes. Clinical development has progressed through Phase 2 trials in South Korea.
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