Ospemifene (Osphena™) is an oral selective estrogen receptor modulator (SERM), 
with tissue-specific estrogenic agonist/antagonist effects. QuatRx 
Pharmaceuticals conducted the global development of the agent before licensing 
it to Shionogi for regulatory filing and commercialization worldwide. Ospemifene 
is the first non-estrogen treatment approved for moderate to severe dyspareunia 
in women with menopause-related vulvar and vaginal atrophy. The drug is approved 
in the USA, and application for EU regulatory approval is underway. This article 
summarizes the milestones in the development of ospemifene leading to this first 
approval for moderate to severe dyspareunia, a symptom of postmenopausal vulvar 
and vaginal atrophy.