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Bazedoxifene

Generic Name
Bazedoxifene
Brand Names
Duavee, Duavive, Conbriza
Drug Type
Small Molecule
Chemical Formula
C30H34N2O3
CAS Number
198481-32-2
Unique Ingredient Identifier
Q16TT9C5BK
Background

Bazedoxifene 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. It is approved in the European Union (marketed in Italy and Spain) and Japan as monotherapy. In 2013, the combination product containing conjugated estrogens and bazedoxifene was approved by the FDA for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as the prevention of postmenopausal osteoporosis in women.

Indication

用于预防和治疗妇女绝经后的骨质疏松症。

Associated Conditions
Postmenopausal Osteoporosis, Moderate Menopausal Vasomotor Symptoms, Severe Vasomotor Symptoms Associated With Menopause

Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women

Phase 3
Completed
Conditions
Osteoporosis
First Posted Date
2007-06-01
Last Posted Date
2009-08-21
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
1742
Registration Number
NCT00481169

Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

Phase 3
Completed
Conditions
Postmenopause
Osteoporosis
First Posted Date
2006-10-04
Last Posted Date
2007-12-28
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
500
Registration Number
NCT00384072

Study Evaluating Bazedoxifene Dose-Response in Japanese Patients With Postmenopausal Osteoporosis.

Phase 2
Completed
Conditions
Postmenopausal Osteoporosis
First Posted Date
2005-10-13
Last Posted Date
2007-12-20
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
375
Registration Number
NCT00238745

Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women

Phase 3
Completed
Conditions
Osteoporosis
Interventions
First Posted Date
2005-09-20
Last Posted Date
2013-04-10
Lead Sponsor
Pfizer
Target Recruit Count
7609
Registration Number
NCT00205777
Locations
🇪🇸

Pfizer Investigational Site, Madrid, Spain

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