No adequate and well-controlled studies of saxagliptin use during human pregnancy exist. Only use saxagliptin during pregnancy if clearly needed, as animal reproductive studies are not always predictive of human response. Saxagliptin does cross the placenta to the fetus in pregnant rats. Saxagliptin was not teratogenic at any dose tested when administered to pregnant rats and rabbits during periods of organogenesis. Incomplete ossification of the pelvis, a form of developmental delay, occurred in rats at a dose of 240 mg/kg, or approximately 1,503 and 66 times the human exposure to saxagliptin and the active metabolite, respectively, at the maximum recommended human dose (MRHD) of 5 mg. Maternal toxicity and reduced fetal body weights were observed at 7,986 and 328 times the human exposure at the MRHD for saxagliptin and the active metabolite, respectively. Minor skeletal variations in rabbits occurred at a maternally toxic dose of 200 mg/kg, or approximately 1,432 and 992 times the MRHD.