Drugs / Raloxifene
Raloxifene
also known as
raloxifene hydrochloride · Evista · Eviden · Evirex · J22.982B · Keoxifene · Keoxifene hydrochloride · LY-139481 · +11 more
Other / unclassified targets ESR1, ESR2
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | EVISTA | — | 1998-11-24 – 1999-09-30 | fda.gov ↗ |
| Approved | EU (EMA) | Optruma | — | 1998-08-05 | europa.eu ↗ |
| Approved | US (FDA) | EVISTA | — | 1997-12-09 | fda.gov ↗ |
Trials 42 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01050842 | Feb 2010 → May 2012 | hormone-resistant prostate carcinoma, prostate adenocarcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT03824171 | Feb → Mar 2019 | osteoporosis | Addpharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03764462 | Dec 2018 → Jan 2019 | osteoporosis | Addpharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03010267 | Jan → Mar 2017 | — | Alvogen Korea | Completed | No outcome recorded |
| Phase 1 | NCT02762643 | May → Jul 2016 | — | Alvogen Korea | Completed | No outcome recorded |
| Phase 1 | NCT02654093 | Jan → Mar 2016 | — | Alvogen Korea | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT07470606 | Mar 2026 → Mar 2030 expected | brain neoplasm | The University of Texas Health Science Center at San Antonio | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06944145 | Dec 2025 → Jun 2029 expected | benign prostatic hyperplasia | Beth Israel Deaconess Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03147196 | Jun 2017 → Jun 2022 | prostate adenocarcinoma | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 2 | NCT00368459 | Aug 2006 → Mar 2011 | Alzheimer disease | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT00206557 | Oct 2002 → Apr 2007 | schizoaffective disorder, schizophrenia, schizophreniform disorder | The Alfred | Completed | No outcome recorded |
| Phase 2 | NCT00332553 | Feb 2002 → May 2004 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00149604 | Mar 2000 → Feb 2006 | — | National Institute on Aging (NIA) | Completed | No outcome recorded |
| Phase 2 | NCT00019500 | Dec 1998 → Jun 2005 | breast cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00001848 | Nov 1998 → Jan 2006 | endometriosis, pelvis syndrome | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 2 | NCT00004915 | Nov 1998 → Feb 2000 | endometrial cancer | Northwestern University | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05172050 | Jan → Jun 2021 | COVID-19 | Dompé Farmaceutici S.p.A | Completed | No outcome recorded |
| Phase 2/3 | NCT00065767 | Sep 2001 → Mar 2005 | Alzheimer disease | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT01573637 | Jul 2011 → Jul 2014 | — | Fundació Sant Joan de Déu | Completed | No outcome recorded |
| Phase 3 | NCT01280305 | Mar 2011 → Dec 2012 | schizoaffective disorder, schizophrenia | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT00427700 | Aug 2008 → Aug 2009 | polycystic ovary syndrome | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| Phase 3 | NCT00687102 | Oct 2001 → Mar 2008 | — | Wake Forest University | Completed | No outcome recorded |
| Phase 3 | NCT00389740 | Apr 2001 → Jan 2003 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00003906 | May 1999 → Dec 2005 | breast cancer | NSABP Foundation Inc | Completed | No outcome recorded |
| Phase 3 | NCT00190593 | Jun 1998 → Nov 2005 | breast neoplasm, cardiovascular disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00670319 | Nov 1994 → Sep 1999 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00046137 | — | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT03006003 | Jan 2017 → Dec 2021 | depressive disorder | Taichung Veterans General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01481883 | Jan 2012 → Jan 2019 | schizoaffective disorder, schizophrenia, schizophreniform disorder | The Alfred | Completed | No outcome recorded |
| Phase 4 | NCT02354001 | Apr 2011 → Jan 2019 | schizoaffective disorder, schizophrenia | The Alfred | Completed | No outcome recorded |
| Phase 4 | NCT00079924 | Nov 2004 → May 2007 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00108238 | Apr 2003 → Dec 2006 | — | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 4 | NCT00532246 | Mar → Aug 2003 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00191425 | Aug 2002 → Nov 2005 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00030147 | Feb 2002 → Jun 2015 | depressive disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 4 | NCT00035256 | Oct 2001 → Jul 2005 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00035971 | — | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06055179 | Mar 2024 → Jun 2026 overdue | irinotecan toxicity | Guangzhou University of Traditional Chinese Medicine | Recruiting | No outcome recorded |
| — | NCT01607320 | Jun 2012 → Mar 2013 | polycystic ovary syndrome | Bruce Lessey | Terminated | No outcome recorded |
| — | NCT00723398 | Mar 2009 → Apr 2015 | breast cancer | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| — | NCT00031811 | Mar 2001 → Apr 2003 | breast cancer, osteoporosis | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| — | NCT00031850 | Mar 2000 → May 2007 | breast cancer | Institute of Cancer Research, United Kingdom | Completed | No outcome recorded |
Also used as a comparator or background therapy in 20 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 35 trials | ||||||
| Phase 3 | NCT03043820 Comparator | Aug 2016 → Jul 2021 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Iris Sommer | Completed | No outcome recorded |
| Phase 3 | NCT00383422 Comparator | Oct 2006 → Jul 2008 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00310531 Comparator | Feb 2004 → Jun 2007 | — | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00163137 Comparator | May 2003 → Oct 2005 | osteoporosis | Ligand Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00675688 Comparator | Apr 2002 → Jan 2006 | endometrial disorder, osteoporosis | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT05386784 Comparator | Dec 2020 → Jul 2022 | osteoporosis | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT03623633 Comparator | Nov 2018 → Feb 2023 overdue | postmenopausal osteoporosis | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03418831 Comparator | Jul 2018 → Apr 2019 | schizophrenia | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT01166958 Comparator | Sep 2010 → Nov 2012 | osteoporosis | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 4 | NCT01544894 Comparator | Sep 2009 → Oct 2011 | postmenopausal osteoporosis | University of Valencia | Completed | No outcome recorded |
| Phase 4 | NCT00431444 Comparator | Jan 2007 → Jul 2008 | osteoporosis | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00371956 Comparator | Sep 2006 → Feb 2010 | osteoporosis | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00361543 Comparator | Aug 2006 → Dec 2014 | schizoaffective disorder, schizophrenia, schizophreniform disorder | The Alfred | Completed | No outcome recorded |
| Phase 4 | NCT01535027 Comparator | Mar 2006 → Dec 2012 | osteoporosis | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT01041092 Comparator | Jun 2004 → Dec 2009 | schizophrenia | Fundació Sant Joan de Déu | Completed | No outcome recorded |
| Phase 4 | NCT00790101 Comparator | Jun → Oct 2004 | postmenopausal osteoporosis | Sanofi | Terminated | No outcome recorded |
| Phase 4 | NCT00532428 Comparator | Apr → Sep 2003 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00431431 Comparator | Jul 2000 → Feb 2005 | — | Organon and Co | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02982083 Comparator | Sep 2015 → Dec 2019 | rheumatoid arthritis | Sara Saeidi Shahri | Completed | No outcome recorded |
| — | NCT00200174 Comparator | Jul 1999 → Jul 2003 | breast cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-03-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Generic Evista® Tablets 60 mg in the United States tevapharm.com ↗ |
| 2009-09-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Provides Update on Generic Evista® Litigation tevapharm.com ↗ |
| 2008-04-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Generic Evista® Tablets tevapharm.com ↗ |
| 2006-07-14 | Daiichi Sankyo | Sales Agreement for EVISTA® Reached in Europe daiichisankyo.com ↗ |
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 63 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Raloxifene | “Raloxifene 60mg po, used as probe for pharmacokinetic testing, on Day 3 (the day before chemotherapy), for 3 cycles of chemotherapy.” NCT06055179 ↗60“2 years treatment with raloxifene (60 mg)” NCT00431431 ↗ |
| Known as | Eviden | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Evirex | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Evista | “Raloxifene (Evista (Trademark), Lilly), has been approved by the Food and Drug Administration for use in preventing bone loss in postmenopausal women.” NCT00001848 ↗1“Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal” NCT01607320 ↗ |
| Known as | J22.982B | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Keoxifene | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Keoxifene hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | LY-139481 | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | LY-156758 | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | NSC-706725 | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | NSC-747974 | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Optruma | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Ostiral | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Raloxifene HCL | “Raloxifene HCL 60 mg orally once daily” NCT00670319 ↗ |
| Known as | raloxifene hydrochloride | “With the recent advent of selective estrogen receptor modulators, in particular raloxifene hydrochloride, there is the potential to harness the positive estrogenic effect on...” NCT00206557 ↗6“20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.” NCT02982083 ↗ “Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis” NCT00670319 ↗ “Oral Raloxifene Hydrochloride 60 mg / Day” NCT00310531 ↗ “Drug: Raloxifene hydrochloride” NCT02354001 ↗ “Drug: Raloxifene Hydrochloride” NCT01481883 ↗ |
| Known as | Raloxifene teva | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Raloxifeno | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Raloxiphene | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Raxeto | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Known as | Razylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL81 ↗ |
| Action | Inhibit | “If Raloxifene blocks estrogen action in the lining of the uterus (endometrium) of reproductive age women, as it does in post-menopausal women, it may also limit the growth of...” NCT00001848 ↗ |
| Modality | Other / unclassified | “Selective estrogen receptor modulators (SERMS), such as raloxifene, and phytoestrogens, such as rimostil, have estrogen-like properties” NCT00030147 ↗ |
| Route | Oral | “Arm II: Participants receive oral raloxifene plus placebo daily for 5 years.” NCT00003906 ↗ |
| Target | ESR1 | “Estrogen receptor modulator” CHEMBL81 ↗ |
| Target | ESR2 | “Estrogen receptor beta modulator” CHEMBL81 ↗ |