glp-1 adjuvant muscle protection material development

Technical Feasibility 3 Ready for Immediate Execution Preparation is complete. Now, we simply need to run alongside our pharmaceutical partners. Daygen's core material, Lithospermum erythrorhizon extract, has completed all development stages, from mechanism validation to human clinical trials and regulatory approval. The new investment required for GLP-1 co-development is minimal, and by leveraging 80% of existing data, we can reduce development time from 335 years to 1.5 years. Key Mechanism: SCI-Validated Shikonin (Active Ingredient in Lithospermum) ³ Akt/mTOR Pathway Activation ³ Promotes Muscle Protein Synthesis + Inhibits Degradation Published in 3 SCI-level journals, including the Journal of Microbiology and Biotechnology Akt (Protein Kinase B) phosphorylation ³ mTOR complex activation ³ Satellite cell proliferation Dual action through inhibition of MuRF-1 and MAFbx (E3 ubiquitin ligases for muscle protein degradation) Antagonistic effect expected against GLP-1-induced muscle loss mechanisms (GLP-1R-mediated cAMP increase ³ FOXO3a activation) Obtained MFDS Individual Ingredient Approval No. 2025-52 4 First Korean natural material approved for muscle strength maintenance Approval Date: 2025 (MFDS Notification) Functional Claim: May help maintain muscle strength Safety Profile: Confirmed as natural GRAS-level safety profile Future Plans: Application for additional functionality regarding GLP-1 combined muscle preservation Key Human Clinical Trial Results (2 Trials Completed, N=169 Total) Category Key Metrics Regulatory Status GLP-1 Relevance Lithospermum Extract Monotherapy (N=87, 12 weeks) Quadriceps Extension P=0.040 / Flexion P=0.041, Muscle Power +12.8~17.7%, Albumin P=0.049 MFDS Individual Approval #2025-52 Granted Lithospermum Complex (N=82) SPPB Total Score P=0.033, 6-minute Walk +20.29m P=0.046, Ankle Peak Torque P=0.026, and 11 other biomarkers significant Physical functional age improved by 1.78 years (clinical significance confirmed) Improvement in muscle strength maintenance biomarkers ³ Expected muscle preservation effect when combined with GLP-1 SPPB, Gait, Ankle Stability ³ Directly linked to preventing falls and maintaining function in GLP-1 users