Product Description
Bazedoxifene is an indole derivative and third-generation selective estrogen receptor modulator (SERM) with potential antineoplastic activity. Upon administration, bazedoxifene specifically binds to estrogen receptors in responsive tissues, including liver, bone, breast, and endometrium. The resulting ligand-receptor complex is translocated to the nucleus where, depending on the tissue type, it either promotes or suppresses the transcription of estrogen-regulated genes. Bazedoxifene acts as an estrogen antagonist in uterine and breast tissue, thereby blocking the proliferative effects of estrogen-binding to ER-positive cells in these tissues. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Bazedoxifene)
Mechanisms of Action: ER Modulator
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | Greece | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Mexico | New Zealand | Norway | Poland | Portugal | Serbia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Thailand | Ukraine | United Kingdom | United States
Approved Indications: Osteoporosis | Osteoporosis, Postmenopausal | Menopause
Known Adverse Events: Abdominal Pain | Dizziness | Neck Pain | Pain Unspecified | Spasm | Diarrhea | Dyspepsia
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 2
Highest Development Phases
Phase 2: Breast Cancer|COVID-19|Ductal Breast Carcinoma|Ductal Carcinoma|Intraductal Noninfiltrating Carcinoma|Pneumonia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
The PROMISE Study | P2 |
Recruiting |
Ductal Carcinoma|Intraductal Noninfiltrating Carcinoma|Ductal Breast Carcinoma|Breast Cancer |
2023-08-01 |
|
2021-005247-78 | P2 |
Active, not recruiting |
COVID-19|Pneumonia |
2023-01-19 |