Tarsa Therapeutics is developing the first oral formulation of calcitonin for the treatment of postmenopausal osteoporosis. Calcitonin is a naturally occurring hormone used by the body to regulate bone and cartilage. Calcitonin has a long history of safety and efficacy as an osteoporosis therapy but currently is only available in injectable and intranasal formulations.
Tarsa’s pivotal phase III clinical trial, the ORACAL study, yielded positive safety and efficacy results with Tarsa’s oral formulation providing superior increases in bone mineral density compared to both placebo and nasal calcitonin. Tarsa is currently preparing its submission for drug approval to the U.S. Food & Drug Administration.