SMC021 (Novartis)

SMC021 is an oral formulation of recombinant salmon calcitonin developed by Novartis for the treatment of postmenopausal osteoporosis. The drug utilizes Emisphere Technologies' proprietary Eligen delivery system, which incorporates the absorption enhancer 5-CNAC (N-(5-chlorosalicyloyl)-8-aminocaprylic acid) to facilitate the transport of the calcitonin peptide across the gastrointestinal epithelium. Salmon calcitonin is a potent agonist of the calcitonin receptor, a G protein-coupled receptor located on osteoclasts; its activation leads to the inhibition of bone resorption and a subsequent increase in bone mineral density. Despite showing efficacy in increasing bone mass during Phase II and Phase III trials, a large-scale Phase III study (Study 2303) involving over 4,600 postmenopausal women failed to demonstrate a significant reduction in the risk of new vertebral fractures. Due to this lack of clinical efficacy in fracture prevention, Novartis terminated the development of SMC021.

Other names

Oral salmon calcitoninsalmon calcitonin + 5-CNACOral recombinant salmon calcitonin