Overview of the clinical pharmacokinetics of eldecalcitol, a new active vitamin D₃ derivative

Eldecalcitol, which was developed by Chugai Pharmaceutical Co., Ltd. as a treatment with the potential of becoming the drug of first choice for osteoporosis, is a new derivative of active vitamin D₃ (1,25(OH) ₂D₃) with a hydroxypropyloxy group introduced at the 2β position. The clinical development of this product has included a Phase I multiple dose study, early and late Phase II studies, a Phase III study, a clinical pharmacology study to investigate pharmacokinetics in postmenopausal women, a drug interaction study, a bioequivalence formulation study and a clinical pharmacology study to investigate pharmacokinetics in patients with impaired liver function. Using data from all these studies, we sought to characterize the pharmacokinetic profile of eldecalcitol.