Drugs / Bazedoxifene
Bazedoxifene
also known as
Bazedoxifene Acetate · BZA · Bazedoxifen acetate · Bazedoxifene acetate component of duavee · Bazedoxifene component of ak r215 · Bazedoxifeno · BZA-20 · BZE · +4 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | DUAVEE | — | 2013-10-03 | fda.gov ↗ |
| Approved | EU (EMA) | Conbriza | — | 2009-04-17 | europa.eu ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04821375 | Dec 2021 → May 2024 | — | Carol Fabian, MD | Completed | No outcome recorded |
| Phase 0 | NCT04379024 | Jun 2020 → Jul 2021 | — | Carol Fabian, MD | Terminated | No outcome recorded |
| Phase 0 | NCT02274571 | Sep 2015 → Apr 2017 | — | Pennington Biomedical Research Center | Completed | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT04478305 | Jul 2024 → Dec 2025 overdue | mixed anxiety and depressive disorder | St. Joseph's Healthcare Hamilton | Recruiting | No outcome recorded |
| Phase 1 | NCT03321318 | Jul → Sep 2017 | — | Alvogen Korea | Unknown | No outcome recorded |
| Phase 1 | NCT03005340 | Dec 2016 → Mar 2017 | — | Alvogen Korea | Unknown | No outcome recorded |
| Phase 1 | NCT01634789 | Aug → Nov 2012 | — | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00706225 | Jun → Jul 2008 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00550303 | Oct → Nov 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00479778 | Apr → Jul 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00464789 | Mar → May 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00465075 | Mar → Apr 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00367536 | Aug 2006 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT02448771 | Jul 2015 → Aug 2019 | invasive breast carcinoma | Dana-Farber Cancer Institute | Completed | Met primary |
| Phase 25 trials | ||||||
| Phase 2 | NCT04821141 | Dec 2021 → Jul 2026 overdue | breast cancer | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04103476 | Apr 2021 → Oct 2026 expected | atherosclerosis, subjective cognitive decline | University of Southern California | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04002934 | Sep 2019 → May 2025 | relapsing-remitting multiple sclerosis | Riley Bove, MD | Completed | No outcome recorded |
| Phase 2 | NCT02729701 | May 2016 → Jan 2019 | breast cancer | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00238745 | Aug 2003 → Mar 2007 | postmenopausal osteoporosis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 38 trials · 2 met primary | ||||||
| Phase 3 | NCT03981341 | Nov 2019 → Dec 2023 | sleep apnea syndrome | Laval University | Unknown | No outcome recorded |
| Phase 3 | NCT00808132 | Jan 2009 → Feb 2011 | osteoporosis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00384072 | May 2006 → Sep 2007 | osteoporosis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00234819 | Oct 2005 → Feb 2007 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00238732 | Oct 2005 → Mar 2007 | postmenopausal atrophic vaginitis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00242710 | Sep 2005 → Sep 2008 | endometrial disorder, osteoporosis | Pfizer | Completed | Met primary |
| Phase 3 | NCT00675688 | Apr 2002 → Jan 2006 | endometrial disorder, osteoporosis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00481169 | Jul 2001 → Jul 2004 | osteoporosis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT05059626 | Dec 2023 → Dec 2025 overdue | endometriosis | Penn State University | Recruiting | No outcome recorded |
| Phase 4 | NCT04113993 | Oct 2019 → Dec 2026 expected | schizoaffective disorder, schizophrenia, schizophreniform disorder | The Alfred | Recruiting | No outcome recorded |
| Phase 4 | NCT03740009 | Jan 2019 → May 2021 | major depressive disorder, menstrual disorder | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT02237079 | Dec 2014 → Apr 2018 | glucose metabolism disease, obesity disorder | Tulane University Health Sciences Center | Completed | No outcome recorded |
| Phase 4 | NCT02090400 | May 2013 → Jul 2015 | postmenopausal osteoporosis | Instituto Palacios | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04812808 | Feb 2022 → Jan 2024 | pancreatic adenocarcinoma | Hôpital Fribourgeois | Unknown | No outcome recorded |
| — | NCT04036929 | May 2019 → Aug 2021 | osteoarthritis, hand | University of Oxford | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT03475719 Comparator | Jan → Feb 2018 | postmenopausal osteoporosis | Huons Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03382314 Comparator | Oct → Dec 2017 | osteoporosis | Hyundai Pharmaceutical Co., LTD. | Completed | No outcome recorded |
| Phase 1 | NCT03234244 Comparator | Apr → Aug 2017 | osteoporosis | Hyundai Pharmaceutical Co., LTD. | Completed | No outcome recorded |
| Phase 3 | NCT00205777 Comparator | Dec 2001 → Sep 2010 | osteoporosis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT02602704 Comparator | Dec 2015 → Oct 2017 | rheumatoid arthritis | Hanyang University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2020-02-17 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for 15 generic drugs with 31 strengths. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-02-17 | Upsher-Smith Laboratories | Sawai Receives Approvals for 15 Generic Drugs with 31 Strengths upsher-smith.com ↗ |
| 2014-12-19 | Ligand Pharmaceuticals | Ligand Partner Pfizer Receives European Marketing Authorization for DUAVIVE® (Conjugated Estrogens/Bazedoxifene) for Treatment of Estrogen Deficiency Symptoms in Postmenopausal Women with a Uterus ligand.com ↗ |
| 2011-06-21 | Almirall, S.A. | Nuevos datos avalan la seguridad y la eficacia del bazedoxifeno para prevenir fracturas vertebrales almirall.com ↗ |
| 2010-10-13 | Ligand Pharmaceuticals | Ligand Announces Market Launch of Bazedoxifene in Japan and Spain for the Treatment of Postmenopausal Osteoporosis ligand.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bazedoxifene | “Duavee. One capsule daily for 6 months (+/- 1 month) of Duavee (Bazedoxifene 20 mg plus conjugated estrogens 0.45 mg)” NCT04379024 ↗37“Dose consisting of 1 pill of 0.45mg conjugated estrogens and 20mg bazedoxifene as bazedoxifene acetate.” NCT04478305 ↗ “Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))” NCT02729701 ↗ “Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)” NCT02274571 ↗ “Bazedoxifene 20 mg” NCT03005340 ↗ |
| Known as | Bazedoxifen acetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL46740 ↗ |
| Known as | Bazedoxifene Acetate | “A Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Delayed-Start Trial to Assess the Efficacy, Safety, and Tolerability of Bazedoxifene Acetate (BZA) as a...” NCT04002934 ↗3“Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)” NCT03475719 ↗ “Bazedoxifene Acetate (TSE-424)” NCT00481169 ↗ “Drug: Bazedoxifene Acetate” NCT04113993 ↗ |
| Known as | Bazedoxifene acetate component of duavee | ChEMBL registry synonym — accepted as the source's own label CHEMBL46740 ↗ |
| Known as | Bazedoxifene component of ak r215 | ChEMBL registry synonym — accepted as the source's own label CHEMBL46740 ↗ |
| Known as | Bazedoxifeno | ChEMBL registry synonym — accepted as the source's own label CHEMBL46740 ↗ |
| Known as | BZA | “A Phase II Randomized, Double-Blind, Parallel-Group, Placebo Controlled Delayed-Start Trial to Assess the Efficacy, Safety, and Tolerability of Bazedoxifene Acetate (BZA) as a...” NCT04002934 ↗3“The combination of bazedoxifene 20 mg (BZA) and conjugated estrogens 0.45 mg (CE) marketed as Duavee® is approved for vasomotor symptom relief and osteoporosis prevention.” PMID 39293780 ↗ Sep 2024 “Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA)” NCT00706225 ↗ “Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)” NCT02274571 ↗ |
| Known as | BZA-20 | “bazedoxifene BZA-20” NCT00384072 ↗ |
| Known as | BZE | “bazedoxifene + conjugated estrogen; BZE+CE” NCT05059626 ↗ |
| Known as | Conbriza | “Bazedoxifene (Conbriza®) will be prescribed and administered for the duration of the study.” NCT04812808 ↗ |
| Known as | Duavive | ChEMBL registry synonym — accepted as the source's own label CHEMBL46740 ↗ |
| Known as | TSE-424 | “Bazedoxifene Acetate (TSE-424)” NCT00481169 ↗ |
| Known as | WAY-140424 | ChEMBL registry synonym — accepted as the source's own label CHEMBL46740 ↗ |
| Modality | Other / unclassified | “a novel selective estrogen receptor modulator” PMID 20569451 ↗ Jun 2010 |
| Route | Oral | “BZA 20mg, daily, oral” NCT00205777 ↗ |