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bazedoxifene BZA-20
bazedoxifene BZA-20 is a Selective estrogen receptor modulator (SERM) Small molecule drug developed by Wyeth is now a wholly owned subsidiary of Pfizer. It is currently in Phase 3 development for Treatment and prevention of postmenopausal osteoporosis.
Bazedoxifene acts as a selective estrogen receptor modulator (SERM) with agonist activity on the estrogen receptor beta and antagonist activity on the estrogen receptor alpha.
Bazedoxifene, specifically the 20 mg dose, is being studied in combination with conjugated estrogens for the risk reduction of breast cancer, osteoporosis, and postmenopausal conditions. This combination is being investigated in a Phase IIb trial, as per the study NCT04821141 conducted by the University of Kansas Medical Center.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Wyeth is now a wholly owned subsidiary of Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | bazedoxifene BZA-20 |
|---|---|
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Drug class | Selective estrogen receptor modulator (SERM) |
| Target | Estrogen receptor beta (ERβ) |
| Modality | Small molecule |
| Therapeutic area | Osteoporosis |
| Phase | Phase 3 |
Mechanism of action
This dual activity allows bazedoxifene to modulate the effects of estrogen in various tissues, potentially reducing the risk of osteoporosis and other estrogen-related conditions. By selectively activating estrogen receptor beta, bazedoxifene may also have beneficial effects on bone density and cardiovascular health.
Approved indications
- Treatment and prevention of postmenopausal osteoporosis
Common side effects
- Hot flashes
- Vaginal discharge
- Headache
- Dizziness
- Nausea
Key clinical trials
- Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens (PHASE2)
- Study Evaluating Changes In Mammographic Breast Density
- Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women (PHASE3)
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 |
|---|---|
| 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:
- bazedoxifene BZA-20 CI brief — competitive landscape report
- bazedoxifene BZA-20 updates RSS · CI watch RSS
- Wyeth is now a wholly owned subsidiary of Pfizer portfolio CI
Frequently asked questions about bazedoxifene BZA-20
What is bazedoxifene BZA-20?
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What drug class is bazedoxifene BZA-20 in?
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What does bazedoxifene BZA-20 target?
Related
- Drug class: All Selective estrogen receptor modulator (SERM) drugs
- Target: All drugs targeting Estrogen receptor beta (ERβ)
- Manufacturer: Wyeth is now a wholly owned subsidiary of Pfizer — full pipeline
- Therapeutic area: All drugs in Osteoporosis
- Indication: Drugs for Treatment and prevention of postmenopausal osteoporosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing