Last reviewed 2026-04-20 · How we verify

Duavee (BAZEDOXIFENE)

DUAVEE combines conjugated estrogens and bazedoxifene to activate estrogen receptors while reducing endometrial hyperplasia risk.

Duavee (Bazedoxifene) is a small molecule estrogen agonist/antagonist developed by Wyeth Pharms Pfizer, targeting the estrogen receptor. It is FDA-approved for treating menopausal flushing and postmenopausal osteoporosis. Duavee works by modulating the estrogen receptor, providing relief from menopausal symptoms while also helping to maintain bone density. The commercial status of Duavee is patented, and its half-life is approximately 30 hours. Key safety considerations include its potential effects on the uterus and cardiovascular system.

At a glance

Mechanism of action

DUAVEE uses conjugated estrogens and bazedoxifene to bind and activate estrogen receptors in various tissues. Conjugated estrogens act as agonists, while bazedoxifene acts as both an agonist and antagonist, depending on the tissue, helping to reduce the risk of endometrial hyperplasia.

Approved indications

• Menopausal flushing
• Postmenopausal osteoporosis

Boxed warnings

• WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA • Women taking DUAVEE should not take additional estrogens [see Warnings and Precautions (5.1) ] • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. DUAVEE has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.3) ] • Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.2 , 5.4) ] • The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (0.625 mg)-alone, relative to placebo [see Warnings and Precautions (5.2) ] • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily conjugated estrogens (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.4) ] Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile. Estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA See full prescribing information for complete Boxed Warning. • Women taking DUAVEE should not take additional estrogens ( 5.1 ) • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens ( 5.1 , 5.3 ) • Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia ( 5.2 , 5.4 ) • The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) ( 5.2 ) • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older ( 5.4 )

Common side effects

• Nausea
• Diarrhea
• Dyspepsia
• Abdominal pain upper
• Oropharyngeal pain
• Muscle spasms
• Dizziness
• Neck pain

Drug interactions

• Itraconazole
• St. John's Wort (Hypericum perforatum)
• Phenobarbital
• Carbamazepine
• Rifampin
• Phenytoin
• Atorvastatin

Key clinical trials

• Pilot Study of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers (EARLY_PHASE1)
• Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens (PHASE2)
• Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis (PHASE2)
• Raising Insulin Sensitivity in Post Menopause (EARLY_PHASE1)
• The PROMISE Study: Duavee in Women With DCIS (PHASE2)
• Advancing Postmenopausal Preventive Therapy (PHASE2)
• Affect of Duavive on Mood & Anxiety Symptoms (PHASE1)
• Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee (PHASE4)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Duavee CI brief — competitive landscape report
• Duavee updates RSS · CI watch RSS
• Wyeth Pharms Pfizer portfolio CI