Bazedoxifene

Bazedoxifene

File:Bazedoxifene.svg
Systematic (IUPAC) name
1-{4-[2-(azepan-1-yl)ethoxy]benzyl}-2- (4-hydroxyphenyl)-3-methyl-1H-indol-5-ol
Clinical data
[[Regulation of therapeutic goods |Template:Engvar data]]	EU EMA: Conbriza
Routes of administration	Oral
Legal status
Legal status	℞ (Prescription only)
Identifiers
CAS Number	198481-32-2
ATC code	G03XC02 (WHO)
PubChem	CID 154257
ChemSpider	135921
Chemical data
Formula	C30H34N2O3
Molar mass	470.603 g/mol[[]]
(verify)

Bazedoxifene is a third generation selective estrogen receptor modulator (SERM), under development by Pfizer following the completion of their takeover of Wyeth Pharmaceuticals. Pfizer are seeking approval for bazedoxifene in the prevention and treatment of postmenopausal osteoporosis. Bazedoxfiene is the result of an exclusive research collaboration between Wyeth Pharamceuticals and Ligand Pharmaceuticals.

It is approved in the European Union, and is currently in the late phases of review by the United States' Food and Drug Administration. When approved, bazedoxifene is to be sold by Pfizer under the tradename Viviant in the US and Conbriza in the EU. Bazedoxifene's combination with conjugated estrogens, Aprela, is currently undergoing Phase III studies.

History of approval

Wyeth received an approvable letter for bazedoxifene in late April 2007. The FDA called for final safety and efficacy data from Phase III studies, and acceptable valuation of manufacturing and testing facilities where problems were found earlier in the year. Wyeth was working with the FDA to resolve these issues, and expected an FDA action date at the end of 2007.

As of July 2009, 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.

Synthesis

500px

Miller, C.P.; Harris, H.A.; Komm, B.S. (2002). "Bazedoxifene Acetate". Drugs of the Future. 27: 117. doi:10.1358/dof.2002.027.02.637843. 

References

nl:Bazedoxifen