Drugs / Toremifene
Toremifene
also known as
Fareston · Toremifene citrate · Acapodene · Chlortamoxifen · Farestone · FC-1157A · GTX-006 · J33.157K · +4 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed osteoporosis 1 milestone | |||||
| Filed | US (FDA) | — | osteoporosis | — | “In December, GTx Inc. submitted a New Drug Application in the United States for toremifene 80 mg.” orionpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | FARESTON | — | 1997-05-29 | fda.gov ↗ |
| Approved | EU (EMA) | Fareston | — | 1996-02-14 | europa.eu ↗ |
Trials 26
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02271282 | Dec 2014 → May 2016 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary | ||||||
| Phase 2 | NCT04383275 | Aug 2021 → May 2025 overdue | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT02788201 | Mar 2017 → Oct 2019 | urinary bladder cancer, urothelial carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT03204734 | Jan 2016 → Dec 2020 | breast cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02353429 | Nov 2012 → Jun 2015 | desmoid tumor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Unknown | Met primary |
| Phase 2 | NCT00437359 | May 2007 → May 2017 | breast neoplasm | Japan Breast Cancer Research Network | Terminated | No outcome recorded |
| Phase 2 | NCT00028353 | Apr 2001 → Jul 2003 | prostate intraepithelial neoplasia | GTx | Completed | No outcome recorded |
| Phase 2 | NCT00020735 | Apr 2001 → Jan 2005 | prostate cancer | Joel Nelson, MD | Completed | No outcome recorded |
| Phase 2 | NCT00003865 | Jul 1999 → Feb 2017 | ovarian cancer | George Washington University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00002595 | Jul 1991 → May 2003 | desmoid tumor | Advocate Lutheran General Hospital | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02132000 | Apr 2014 → May 2020 | hormone receptor-positive breast cancer | Fengxi Su | Unknown | No outcome recorded |
| Phase 312 trials · 2 missed | ||||||
| Phase 3 | NCT07153757 | Sep 2025 → Sep 2033 expected | female breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02132390 | May 2014 → May 2024 | breast cancer, chemotherapy-induced toxicity | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02097459 | Mar 2014 → Mar 2024 | breast cancer | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01214291 | Mar → Sep 2011 | osteoporosis | GTx | Withdrawn | No outcome recorded |
| Phase 3 | NCT01417754 | Sep → Nov 2010 | — | Satakunta Central Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00267553 | Nov 2005 → Jun 2006 | breast neoplasm | Intarcia Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT00106691 | Jan 2005 → Feb 2010 | prostate intraepithelial neoplasia | GTx | Completed | Missed primary |
| Phase 3 | NCT00097344 | Dec 2004 → Aug 2006 | breast neoplasm | Intarcia Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT00129142 | Oct 2003 → Nov 2007 | osteoporosis, prostate cancer | GTx | Completed | Missed primary |
| Phase 3 | NCT00044291 | Jun 2002 → Jan 2006 | breast neoplasm | Intarcia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00010322 | Oct 2000 → May 2001 | breast cancer | Intarcia Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT00002529 | May 1993 → Aug 2010 | breast cancer | ETOP IBCSG Partners Foundation | Completed | No outcome recorded |
| Phase 43 trials · 1 missed | ||||||
| Phase 4 | NCT03238703 | Sep 2018 → Mar 2023 | Her2-receptor negative breast cancer, breast carcinoma in situ, female breast carcinoma, invasive breast carcinoma | Fred Hutchinson Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02344940 | Dec 2014 → Aug 2018 | breast cancer | Shanghai Jiao Tong University School of Medicine | Completed | Missed primary |
| Phase 4 | NCT02089854 | Nov 2014 → Apr 2019 | breast cancer | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT05472792 Comparator | May 2022 → Apr 2027 expected | breast cancer | UNC Lineberger Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04531748 Comparator | Dec 2021 → Sep 2022 | COVID-19 | Reena Mehra, MD | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02506790 Background | Jul 2015 → Aug 2020 | breast cancer | N.N. Petrov National Medical Research Center of Oncology | Unknown | No outcome recorded |
| Phase 3 | NCT05891093 Background | Jun 2023 → May 2028 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT03351062 Comparator | Nov 2017 → Dec 2025 | female breast carcinoma | Chinese Anti-Cancer Association | Unknown | No outcome recorded |
| Phase 3 | NCT00534846 Comparator | Apr 2007 → May 2008 | breast disorder | Satakunta Central Hospital | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2004-12-14 | Orion Corporation, Orion Pharma | Orion grants GTx exclusive rights in the US for toremifene orionpharma.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Toremifene | “Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or...” NCT03204734 ↗29“Premenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 5 years) or Toremifene (60 mg, orally, once daily, for 5 years)” NCT07153757 ↗ “premenopausal: tamoxifen or toremifene; postmenopausal: letrozole or anastrozole or exemestane” NCT04383275 ↗ “Topotecan, Toremifene, Tretinoin” NCT02788201 ↗ |
| Known as | Acapodene | “GTX-006 (Acapodene)” NCT00028353 ↗ |
| Known as | Chlortamoxifen | ChEMBL registry synonym — accepted as the source's own label CHEMBL1655 ↗ |
| Known as | Fareston | “The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene...” NCT00044291 ↗2“the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer.” NCT00267553 ↗ “an FDA-approved drug, toremifene (Fareston®)” NCT00097344 ↗ |
| Known as | Farestone | ChEMBL registry synonym — accepted as the source's own label CHEMBL1655 ↗ |
| Known as | FC-1157A | ChEMBL registry synonym — accepted as the source's own label CHEMBL1655 ↗ |
| Known as | GTX-006 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00028353 ↗ |
| Known as | J33.157K | ChEMBL registry synonym — accepted as the source's own label CHEMBL1655 ↗ |
| Known as | NSC-613680 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1655 ↗ |
| Known as | TOR | “Toremifene (TOR) is a selective oestrogen receptor modulator (SERM) and has comparable efficacy to that of tamoxifen (TAM) in breast cancer patients.” PMID 32677982 ↗ Jul 2020 |
| Known as | Toremifene citrate | “Toremifene citrate: 40-mg tablets by mouth once daily.” NCT00437359 ↗ |
| Known as | Toremifeno | ChEMBL registry synonym — accepted as the source's own label CHEMBL1655 ↗ |
| Known as | Toremiphene | ChEMBL registry synonym — accepted as the source's own label CHEMBL1655 ↗ |
| Action | Inhibit | “Hormone therapy using toremifene may fight ovarian cancer by reducing the production of estrogen.” NCT00003865 ↗ |
| Modality | Small molecule | — CHEMBL1655 ↗ |
| Route | Oral | “oral toremifene daily for 5 years” NCT00002529 ↗ |