Bazedoxifene

Drugbox
IUPAC_name = 1- [4-(2-azepan-1-ylethoxy)benzyl] -2-(4-hydroxyphenyl)-3-methyl-1H-indol-5-ol

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CAS_number=198481-32-2
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PubChem=154257
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C = 30 | H = 34 | N = 2 | O = 3
molecular_weight = 470.603 g/mol
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Bazedoxifene is a selective estrogen receptor modulator (SERM), under developed by Wyeth Pharmaceuticals for the prevention and treatment of postmenopausal osteoporosis and the result of an exclusive research collaboration with Ligand Pharmaceuticals (LGND). It is currently in the late phases of review by the United States' Food and Drug Administration. When approved, bazedoxifene is to be sold by Wyeth under the tradename Viviant. Bazedoxifene's combination with conjugated estrogens, Aprela, is currently undergoing Phase III studies.

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 is working with the FDA to resolve these issues, and expects an FDA action date at year end.

Fact|date=July 2007

CITATIONS

cite web
last = BROWN
first = EMILY
title = Wyeth's osteoporosis drug cut risk of new fractures
url=http://www.dailyrecord.com/apps/pbcs.dll/article?AID=/20070920/UPDATES01/70920012
accessdate = 2007-09-28cite web
title = Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
url=http://www.wyeth.com/news?nav=display&navTo=/wyeth_html/home/news/pressreleases/2007/1177442503840.html
accessdate = 2007-09-28