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**OXY133** is a novel semi-synthetic oxysterol analogue designed as a small molecule osteogenic agent that potently induces osteogenesis via activation of the Hedgehog (Hh) signaling pathway, independent of BMP or Wnt pathways. It stimulates osteoblastic differentiation, osteomorphogenesis, and mineralization in mesenchymal stem cells (MSCs) and marrow stromal cells by upregulating key markers such as Runx2, osterix (OSX), alkaline phosphatase (ALP), bone sialoprotein (BSP), and osteocalcin (OCN), while inhibiting adipogenesis to promote denser bone formation with higher bone volume/tissue volume (BV/TV) ratio. Developed through structure-activity relationship studies among over 100 oxysterol analogues, **OXY133** demonstrates superior potency, ease of synthesis, and time to fusion compared to predecessors like Oxy34 and Oxy49, and matches or exceeds recombinant human bone morphogenetic protein-2 (rhBMP-2) efficacy in preclinical models of spine fusion, fracture repair, and cranial bone regeneration without associated complications like ectopic bone or soft tissue swelling. It is being evaluated by MAX BioPharma for orthopedic applications including spinal fusion and bone grafts.[1][2][3][4][7]
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