Last reviewed · How we verify
Duavee (conjugated-estrogens-bazedoxifene)
DUAVEE pairs conjugated estrogens with bazedoxifene, which bind to and activate estrogen receptors α and β.
DUAVEE, a combination of conjugated estrogens and bazedoxifene marketed by Pfizer, is positioned in the moderate to severe vasomotor symptoms of menopause segment. Its key strength lies in the unique mechanism of pairing conjugated estrogens with bazedoxifene, which activates estrogen receptors α and β, distinguishing it from competitors. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | conjugated-estrogens-bazedoxifene |
|---|---|
| Sponsor | Pfizer |
| Drug class | Estrogen [EPC] |
| Target | estrogen receptors α and β |
| Therapeutic area | Bone |
| Phase | FDA-approved |
| First approval | 2013 |
Mechanism of action
Conjugated estrogens are composed of multiple estrogens and are agonists of estrogen receptors α and β. Bazedoxifene is an estrogen agonist/antagonist that acts as an agonist in some estrogen-sensitive tissues and an antagonist in others. The pairing of conjugated estrogens with bazedoxifene produces a composite effect that is specific to each target tissue.
Approved indications
- Moderate to severe vasomotor symptoms of menopause
- Prevention of 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
- muscle spasms
- neck pain
- dizziness
- oropharyngeal pain
Drug interactions
- Itraconazole
- St. John's Wort (Hypericum perforatum), Phenobarbital, Carbamazepine, Rifampin
- Rifampin, Phenobarbital, Carbamazepine, 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)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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
- Pfizer portfolio CI