Astellas has discovered Minodronic acid hydrate, an oral bisphosphonate, which has been co-developed by Ono and Astellas.
Minodronic acid hydrate increases the bone mineral density and strength by inhibiting osteoclastic bone resorption.
Recalbon tablets 1mg/Bonoteo tablets 1mg, a daily formulation of Minodronic acid hydrate, launched in Japan in April 2009, has showed efficacy in bone fractures prevention.
Recalbon tablets 50mg/Bonoteo tablets 50mg, a monthly formulation of Minodronic acid hydrate, demonstrated non-inferiority to the daily formulation 1mg in average bone mineral density change in lumbar spines, the primary endpoint in a Phase 2/3 study in Japan.
Additionally, the Phase 2/3 study showed that a monthly formulation 50mg is expected to have an equivalent effect in bone fractures prevention to the daily formulation and boost the patients’ convenience by reducing the dose frequency.