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 · 5 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 ↗ |
| Filed | US (FDA) | EVISTA | invasive breast cancer risk reduction | — | “announced today that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration's Division of Drug Oncology Products (DDOP) for EVISTA(R) (raloxifene...” lilly.com ↗ “Lilly also announced today that data supporting the breast cancer risk reduction indication for Evista has been submitted to the FDA.” lilly.com ↗ |
Trials 42
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 · 2 missed | ||||||
| Phase 2 | NCT07470606 | Jul 2026 → Jul 2030 expected | brain neoplasm | The University of Texas Health Science Center at San Antonio | 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| Phase 2 | NCT03147196 | Jun 2017 → Jun 2022 | prostate adenocarcinoma | Mayo Clinic | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00368459 | Aug 2006 → Mar 2011 | Alzheimer disease | Stanford University | Completed | Missed primary |
| 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 | Missed primary |
| 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 | Mixed |
| Phase 2/3 | NCT00065767 | Sep 2001 → Mar 2005 | Alzheimer disease | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 39 trials · 1 met primary · 2 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT00427700 | Aug 2008 → Aug 2009 | polycystic ovary syndrome | Hospital de Clinicas de Porto Alegre | Completed | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT00190593 | Jun 1998 → Nov 2005 | breast neoplasm, cardiovascular disorder | Eli Lilly and Company | Completed | Mixed |
| 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 · 1 missed | ||||||
| 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 | Missed primary |
| 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 Stop: Enrollment |
| — | 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 |
| Comparator or background therapy20 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 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2022-07-26 | Dompé Farmaceutici S.p.A | Results Two Clinical Studies to Treat Mild-to-Moderate COVID-19 at Home Reveal Value of Exscalate, Dompé’s AI Platform for Drug Design dompe.com ↗
Dompé farmaceutici S.p.A (“Dompé”) today announced positive results from two studies demonstrating that treatment with oral raloxifene, a selective estrogen receptor modulator (SERM) with a proven safety profile, may be effective against SARS-CoV-2, including its clinically relevant variants. |
| 2020-10-27 | Dompé Farmaceutici S.p.A | Regulatory EXSCALATE4COV: Italian Medicines Agency (AIFA) authorizes Raloxifene Clinical Trial for Paucisymptomatic Covid-19 Patients treated at Home and in Medical Facilities dompe.com ↗
The Italian Medicines Agency, AIFA, has greenlighted a clinical trial with a raloxifene product in patients with mild symptoms caused by the infection of the SARS-CoV-2 virus. |
| 2014-03-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Generic Evista® Tablets 60 mg in the United States tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the approval of the generic equivalent to Evista® (Raloxifene) Tablets, 60 mg, in the United States. |
| 2011-08-09 | Eli Lilly and Company | Results Lilly Announces Review of Data on Long-Term Raloxifene Treatment for Postmenopausal Osteoporosis Published in Current Medical Research & Opinion lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that data on EVISTA® (raloxifene HCl tablets) therapy for more than three years was published online in Current Medical Research & Opinion. |
| 2009-03-23 | Eli Lilly and Company | Results Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista® (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis lilly.com ↗
Arzoxifene significantly increased BMD at all sites to a greater extent than raloxifene, respectively (p<0.05 for all comparisons) |
| 2008-04-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Generic Evista® Tablets tevapharm.com ↗ |
| 2007-09-14 | Eli Lilly and Company | Regulatory FDA Approves Lilly's Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women lilly.com ↗ |
| 2007-07-24 | Eli Lilly and Company | Regulatory FDA Advisory Committee Recommends Approval of EVISTA for the Reduction of Risk for Invasive Breast Cancer in Two Populations of Postmenopausal Women lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted to recommend approval of its osteoporosis drug EVISTA(R) (raloxifene HCl) for a new use to reduce invasive breast cancer risk in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer. |
| 2006-12-07 | Eli Lilly and Company | Regulatory Eli Lilly and Company Submits New Drug Application for EVISTA for Reduction of Invasive Breast Cancer Risk in Postmenopausal Women lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration's Division of Drug Oncology Products (DDOP) for EVISTA(R) (raloxifene HCl) for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for breast cancer. |
| 2006-04-12 | Eli Lilly and Company | Results Lilly Announces Preliminary Coronary and Breast Cancer Results from Raloxifene Use for The Heart (RUTH) Study lilly.com ↗
EVISTA did not increase or decrease the combined endpoint of non-fatal heart attack, fatal heart attack, and hospitalized acute coronary syndrome compared to placebo. |
| 2005-09-21 | Eli Lilly and Company | Results New Data Provide In-Depth, Safety Information on Long-Term use of EVISTA® lilly.com ↗
The results of these studies reinforce EVISTA's safety profile over an extended period of time, providing physicians and patients with information they need to weigh the risks and benefits of treatment and decide if EVISTA is right for that person. |
All press releases naming this drug 23 releases
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” NCT01481883 ↗ “Drug: Raloxifene hydrochloride” NCT02354001 ↗ |
| 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 ↗ |