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SK-09 is a novel Category 1 small molecule drug developed by Consun Pharmaceutical Group for the treatment of podocyte injury-related renal diseases, specifically focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD). It is designed as a targeted therapy to provide podocyte protection, addressing a significant unmet need in kidney disease management where specific treatments are currently lacking. The drug is administered orally as a tablet. As of early 2024, SK-09 has received IND approval from China's National Medical Products Administration (NMPA) and is undergoing Phase 1 clinical evaluation in healthy volunteers to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics through single and multiple ascending dose studies.
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