Bazedoxifene has been evaluated across Phase 1 through Phase 4 in numerous clinical trials sponsored by pharmaceutical companies, regional developers, and academic research centers. Spanning completed, recruiting, active, terminated, and withdrawn statuses, this research encompasses healthy volunteers, postmenopausal osteoporosis, menopausal vaginal atrophy, breast cancer risk reduction, and relapsing-remitting multiple sclerosis. Key evaluations include Phase 3 trials on postmenopausal symptom management alongside Phase 2 studies exploring therapeutic potential in breast tissue proliferation and neurological conditions.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04113993 | RECRUITING | Schizophrenia; Schizophreniform Disorders; Schizo Affective Disorder |
The Alfred |
2019-10-07 | PHASE4 |
| NCT05059626 | ENROLLING_BY_INVITATION | Endometriosis |
Penn State University |
2023-12-01 | PHASE4 |
| NCT04103476 | ACTIVE_NOT_RECRUITING | Atherosclerosis; Cognitive Decline |
University of Southern California |
2021-04-13 | PHASE2 |
| NCT04821141 | ACTIVE_NOT_RECRUITING | Risk Reduction; Breast Cancer |
University of Kansas Medical Center |
2021-12-14 | PHASE2 |
| NCT04478305 | RECRUITING | Menopause; Depression, Anxiety; Sleep; Menopause Related Conditions |
St. Joseph's Healthcare Hamilton |
2024-07-03 | PHASE1 |
| NCT04002934 | COMPLETED | Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting |
Riley Bove, MD |
2019-09-10 | PHASE2 |
| NCT02694809 | COMPLETED | Ductal Breast Carcinoma In Situ; Postmenopausal |
Northwestern University |
2017-01 | PHASE2 |
| NCT04821375 | COMPLETED | Increased Risk for Development of Breast Cancer |
Carol Fabian, MD |
2021-12-02 | EARLY_PHASE1 |
| NCT05073237 | WITHDRAWN | Menopause; Prediabetes; Obesity |
VA Office of Research and Development |
2024-04-08 | PHASE2 |
| NCT04812808 | UNKNOWN | Pancreas Cancer |
Hôpital Fribourgeois |
2022-02-01 | |
| NCT03981341 | UNKNOWN | Sleep Apnea; Post Menopausal; Oxidative Stress |
Laval University |
2019-11-01 | PHASE3 |
| NCT04036929 | COMPLETED | Hand Osteoarthritis |
University of Oxford |
2019-05-09 | |
| NCT03740009 | COMPLETED | Perimenopausal Disorder; Depression |
University of North Carolina, Chapel Hill |
2019-01-02 | PHASE4 |
| NCT02448771 | COMPLETED | Breast Cancer Stage IV; Unresectable Locally Advanced Invasive Breast Cancer; Metastatic Invasive Breast Cancer |
Dana-Farber Cancer Institute |
2015-07-09 | PHASE1; PHASE2 |
| NCT02237079 | COMPLETED | Obesity; Glucose Homeostasis; Postmenopausal Symptoms |
Tulane University Health Sciences Center |
2014-12 | PHASE4 |
| NCT03475719 | Unknown status | Osteoporosis Postmenopausal |
Huons Co. Ltd. |
2018-01-11 | Phase 1 |
| NCT03382314 | COMPLETED | Osteoporosis |
Hyundai Pharmaceutical Co., LTD. |
2017-10-16 | PHASE1 |
| NCT02602704 | COMPLETED | Arthritis, Rheumatoid |
Hanyang University |
2015-12-29 | PHASE4 |
| NCT03321318 | UNKNOWN | Healthy |
Alvogen Korea |
2017-07-13 | PHASE1 |
| NCT03234244 | COMPLETED | Osteoporosis |
Hyundai Pharmaceutical Co., LTD. |
2017-04-12 | PHASE1 |
| NCT03005340 | Unknown status | Healthy |
Alvogen Korea |
2016-12 | Phase 1 |
| NCT02729701 | Completed | Breast Cancer |
University of Kansas Medical Center|Pfizer |
2016-05 | Phase 2 |
| NCT02090400 | COMPLETED | Osteoporosis, Postmenopausal |
Instituto Palacios |
2013-05 | PHASE4 |
| NCT02100553 | COMPLETED | Healthy |
Pfizer |
2014-04 | PHASE1 |
| NCT01634789 | TERMINATED | Healthy |
Pfizer |
2012-08 | PHASE1 |
| NCT01973738 | Unknown status | Selective Estrogen Receptor Modulator |
Toshihiko Kono|Tomidahama Hospital |
2012-01 | -- |
| NCT00808132 | COMPLETED | Menopause; Osteoporosis |
Pfizer |
2009-01 | PHASE3 |
| NCT00205777 | COMPLETED | Osteoporosis |
Pfizer |
2001-12 | PHASE3 |
| NCT00745173 | COMPLETED | Postmenopause |
Wyeth is now a wholly owned subsidiary of Pfizer |
2008-09 | PHASE1 |
| NCT00242710 | COMPLETED | Endometrial Hyperplasia; Osteoporosis |
Pfizer |
2005-09 | PHASE3 |
| NCT00706225 | COMPLETED | Postmenopause |
Wyeth is now a wholly owned subsidiary of Pfizer |
2008-06 | PHASE1 |
| NCT00675688 | COMPLETED | Endometrial Hyperplasia; Osteoporosis |
Wyeth is now a wholly owned subsidiary of Pfizer |
2002-04 | PHASE3 |
| NCT00481169 | COMPLETED | Osteoporosis |
Wyeth is now a wholly owned subsidiary of Pfizer |
2001-07 | PHASE3 |
| NCT00238745 | COMPLETED | Postmenopausal Osteoporosis |
Wyeth is now a wholly owned subsidiary of Pfizer |
2003-08 | PHASE2 |
| NCT00238732 | COMPLETED | Vaginal Atrophy |
Wyeth is now a wholly owned subsidiary of Pfizer |
2005-10 | PHASE3 |
| NCT00384072 | COMPLETED | Postmenopause; Osteoporosis |
Wyeth is now a wholly owned subsidiary of Pfizer |
2006-05 | PHASE3 |
| NCT00367536 | COMPLETED | Postmenopause |
Wyeth is now a wholly owned subsidiary of Pfizer |
2006-08 | PHASE1 |
| NCT00465075 | COMPLETED | Healthy |
Wyeth is now a wholly owned subsidiary of Pfizer |
2007-03 | PHASE1 |
| NCT00234819 | COMPLETED | Vasomotor Symptoms Associated With Menopause |
Wyeth is now a wholly owned subsidiary of Pfizer |
2005-10 | PHASE3 |
| NCT00464789 | COMPLETED | Menopause |
Wyeth is now a wholly owned subsidiary of Pfizer |
2007-03 | PHASE1 |
| NCT00396799 | COMPLETED | Menopause |
Wyeth is now a wholly owned subsidiary of Pfizer |
2006-11 | PHASE1 |
| NCT00479778 | COMPLETED | Postmenopause |
Wyeth is now a wholly owned subsidiary of Pfizer |
2007-04 | PHASE1 |
| NCT00550433 | COMPLETED | Postmenopause |
Wyeth is now a wholly owned subsidiary of Pfizer |
2007-09 | PHASE1 |
| NCT00550303 | COMPLETED | Healthy |
Wyeth is now a wholly owned subsidiary of Pfizer |
2007-10 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-06-03)
Check the
Bazedoxifene (WAY-140424) HCl
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Bazedoxifene (WAY-140424) HCl Solubility in DMSO
- Bazedoxifene (WAY-140424) HCl Stock Solution
- Bazedoxifene (WAY-140424) HCl Storage
- Bazedoxifene (WAY-140424) HCl Stability
- Bazedoxifene (WAY-140424) HCl Molecular Weight
- Bazedoxifene (WAY-140424) HCl SMILES
- Bazedoxifene (WAY-140424) HCl CAS Number
- Bazedoxifene (WAY-140424) HCl Chemical Structure (2D and 3D)
- Bazedoxifene (WAY-140424) HCl SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.