Bazedoxifene

Generic Name: Bazedoxifene

Brand Names: Duavee, Duavive, Conbriza

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₃₄N_₂O_₃

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

Clinical Trials

Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

Phase 4

Recruiting

Conditions: Endometriosis

Interventions: Drug: simvastatin 10mg
Drug: Bazedoxifene 20/Estrogens,Con 0.45Mg Tb

First Posted Date: 2021-09-28

Last Posted Date: 2024-11-05

Lead Sponsor: Penn State University

Target Recruit Count: 28

Registration Number: NCT05059626

Locations: 🇺🇸
The John B. Pierce Laboratory, New Haven, Connecticut, United States

Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens

Phase 2

Recruiting

Conditions: Risk Reduction
Breast Cancer

Interventions: Drug: Bazedoxifene and Conjugated Estrogens

First Posted Date: 2021-03-29

Last Posted Date: 2024-12-18

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 120

Registration Number: NCT04821141

Locations: 🇺🇸
Northwestern Medical Center, Chicago, Illinois, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
City of Hope Medical Center, Duarte, California, United States

and more 2 locations

Pilot Study of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers

Early Phase 1

Completed

Conditions: Increased Risk for Development of Breast Cancer

Interventions: Drug: bazedoxifene plus conjugated estrogens

First Posted Date: 2021-03-29

Last Posted Date: 2025-03-26

Lead Sponsor: Carol Fabian, MD

Target Recruit Count: 16

Registration Number: NCT04821375

Locations: 🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States

Bazedoxifene as a Concomitant Treatment of Patients With Metastatic Pancreatic Adenocarcinoma

Not Applicable

Conditions: Pancreas Cancer

Interventions: Drug: Bazedoxifene 20 mg

First Posted Date: 2021-03-24

Last Posted Date: 2022-02-25

Lead Sponsor: Hôpital Fribourgeois

Target Recruit Count: 10

Registration Number: NCT04812808

Locations: 🇨🇭
HFR Fribourg - cantonal hospital, Fribourg, Switzerland

Bazedoxifene -Treatment for Women With Schizophrenia

Phase 4

Recruiting

Conditions: Schizophrenia
Schizophreniform Disorders
Schizo Affective Disorder

Interventions: Drug: Bazedoxifene Acetate
Drug: Placebo

First Posted Date: 2019-10-03

Last Posted Date: 2023-11-28

Lead Sponsor: The Alfred

Target Recruit Count: 160

Registration Number: NCT04113993

Locations: 🇦🇺
Monash Alfred Psychiatry Research Centre, Melbourne, Victoria, Australia

Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis

Phase 2

Active, not recruiting

Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting

Interventions: Drug: Bazedoxifene Acetate

First Posted Date: 2019-07-01

Last Posted Date: 2025-04-04

Lead Sponsor: Riley Bove, MD

Target Recruit Count: 62

Registration Number: NCT04002934

Locations: 🇺🇸
Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, California, United States

HDDO-1614 Bio Equivalence Study

Phase 1

Completed

Conditions: Osteoporosis

Interventions: Drug: Bazedoxifene / Cholecalciferol
Combination Product: HDDO-1614

First Posted Date: 2017-12-22

Last Posted Date: 2018-02-26

Lead Sponsor: Hyundai Pharmaceutical Co., LTD.

Target Recruit Count: 38

Registration Number: NCT03382314

Locations: 🇰🇷
Inha University Hospital, Junggu, Incheon, Korea, Republic of

AK-R215 Pharmacokinetic Study Phase I

Phase 1

Conditions: Healthy

Interventions: Drug: AK-R215
Drug: Bazedoxifene 20 mg
Drug: Cholecalciferol 800IU

First Posted Date: 2017-10-25

Last Posted Date: 2017-10-25

Lead Sponsor: Alvogen Korea

Target Recruit Count: 52

Registration Number: NCT03321318

Locations: 🇰🇷
Dong-A University Hospital, Busan, Korea, Republic of

HDDO-1614 Intervention Trial

Phase 1

Completed

Conditions: Osteoporosis

Interventions: Drug: Bazedoxifene 20 mg
Drug: Bazedoxifene 20mg and Cholecalciferol
Drug: Cholecalciferol

First Posted Date: 2017-07-31

Last Posted Date: 2017-12-11

Lead Sponsor: Hyundai Pharmaceutical Co., LTD.

Target Recruit Count: 37

Registration Number: NCT03234244

Locations: 🇰🇷
Inha University Hospital, Junggu, Incheon, Korea, Republic of

The PROMISE Study: Duavee in Women With DCIS

Phase 2

Completed

Conditions: Ductal Breast Carcinoma In Situ
Postmenopausal

Interventions: Drug: Conjugated Estrogens/Bazedoxifene
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Placebo
Procedure: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2016-03-01

Last Posted Date: 2025-01-28

Lead Sponsor: Northwestern University

Target Recruit Count: 142

Registration Number: NCT02694809

Locations: 🇺🇸
University of Colorado at Denver/ Department of Surgery, Aurora, Colorado, United States
🇺🇸
Northwestern University, Lake Forest, Illinois, United States
🇺🇸
Northwestern Medicine - Delnor/Warrenville Cancer Centers/Central DuPage Hospital, Geneva, Illinois, United States

and more 6 locations

Drug Development Updates

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