License data EU EMA: Conbriza ATC code G03XC02 (WHO) Molar mass 470.603 g/mol | Routes of
administration Oral CAS Number 198481-32-2 CAS ID 198481-32-2 | |
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AHFS/Drugs.com International Drug Names Legal status In general: ℞ (Prescription only) | ||
Bazedoxifene, or bazedoxifene acetate, is a third generation selective estrogen receptor modulator (SERM), developed by Pfizer following the completion of their takeover of Wyeth Pharmaceuticals. In late 2013, Pfizer received approval for bazedoxifene as part of the combination drug DUAVEE in the prevention (not treatment) of postmenopausal osteoporosis. Bazedoxfiene is the result of an exclusive research collaboration between Wyeth Pharmaceuticals and Ligand Pharmaceuticals.
It is also being studied for possible treatment of breast cancer and pancreatic cancer.
History of approval
As of December 2011, the FDA have not given approval for the use of bazedoxifene in the US.
The drug was approved in the European Union by the European Medicines Agency on April 27, 2009.
On October 3, 2013 the FDA approved the combination product of bazedoxifene 20 mg with 0.45 mg Premarin (conjugated estrogens) for the treatment of menopausal osteoporosis and the treatment of moderate to severe hot flushes. This is the first approved hormone replacement therapy product that contains a SERM (bazedoxifene) and an estrogen.