Overview
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/09/28 | Phase 4 | Recruiting | |||
2021/03/29 | Phase 2 | Recruiting | |||
2021/03/29 | Early Phase 1 | Completed | Carol Fabian, MD | ||
2021/03/24 | Not Applicable | UNKNOWN | |||
2019/10/03 | Phase 4 | Recruiting | The Alfred | ||
2019/07/01 | Phase 2 | Completed | Riley Bove, MD | ||
2017/12/22 | Phase 1 | Completed | |||
2017/10/25 | Phase 1 | UNKNOWN | Alvogen Korea | ||
2017/07/31 | Phase 1 | Completed | |||
2016/03/01 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| U.S. Pharmaceuticals | 63539-122 | ORAL | 20 mg in 1 1 | 7/1/2022 | |
| Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1123 | ORAL | 20 mg in 1 1 | 12/21/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/17/2009 | ||
Authorised | 12/16/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DUAVIVE 0.45/20 conjugated estrogens/bazedoxifene (as acetate) 0.45 mg/20 mg modified release tablet blister pack | 262525 | Medicine | A | 12/15/2016 |
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