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Bazedoxifene Acetate (TSE-424)
Bazedoxifene is a selective estrogen receptor modulator (SERM) that acts as an estrogen agonist in bone and lipid metabolism while functioning as an antagonist in breast and uterine tissue.
Bazedoxifene is a selective estrogen receptor modulator (SERM) that acts as an estrogen agonist in bone and lipid metabolism while functioning as an antagonist in breast and uterine tissue. Used for Prevention of postmenopausal osteoporosis, Treatment of postmenopausal osteoporosis.
At a glance
| Generic name | Bazedoxifene Acetate (TSE-424) |
|---|---|
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Drug class | Selective Estrogen Receptor Modulator (SERM) |
| Target | Estrogen receptor alpha (ERα) and estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Bone Health / Osteoporosis |
| Phase | Phase 3 |
Mechanism of action
Bazedoxifene binds to estrogen receptors with tissue-selective activity, promoting bone formation and favorable lipid profiles similar to estrogen while blocking estrogen signaling in reproductive tissues to avoid proliferative effects. This dual action makes it suitable for postmenopausal women seeking osteoporosis prevention without increased risk of endometrial or breast cancer.
Approved indications
- Prevention of postmenopausal osteoporosis
- Treatment of postmenopausal osteoporosis
Common side effects
- Hot flashes
- Leg cramps
- Musculoskeletal pain
- Venous thromboembolism
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
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |