Drugs / Flutamide
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | EULEXIN | — | 1996-06-21 | fda.gov ↗ |
| Approved | US (FDA) | EULEXIN | — | 1989-01-27 | fda.gov ↗ |
Trials 39
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04597099 | Oct 2022 → Oct 2025 | polycystic ovary syndrome | University of Virginia | Unknown | No outcome recorded |
| Phase 0 | NCT03507608 | May 2019 → Sep 2024 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT00930228 | Jan 2009 → May 2024 | polycystic ovary syndrome | University of Virginia | Unknown | No outcome recorded |
| Phase 1 | NCT02911350 | May 2000 → Dec 2016 | prostate cancer | NYU Langone Health | Completed | No outcome recorded |
| Phase 213 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06694350 | Dec 2024 → Dec 2027 expected | head and neck squamous cell carcinoma | Zhejiang Provincial People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05899699 | Jun → Sep 2023 | acne | Mansoura University | Unknown | No outcome recorded |
| Phase 2 | NCT01889199 | Apr 2013 → Jul 2023 | polycystic ovary syndrome | University of California, Los Angeles | Completed | Met primary |
| Phase 2 | NCT00528866 | Apr 2008 → Dec 2013 | prostate cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00450463 | Feb 2007 → Apr 2017 | prostate cancer | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT00103376 | Oct 2004 → Oct 2009 | prostate cancer | Medical University of South Carolina | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00028769 | Dec 2001 → Jun 2010 | prostate cancer | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00006359 | Sep 2000 → Oct 2007 | prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00006214 | Aug 2000 → Jul 2006 | prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00003323 | May 1998 → May 2002 | prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00003124 | May 1997 → Jan 2007 | prostate cancer | Herbert Irving Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00223665 | Jan 1997 → Sep 2012 | prostate cancer | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00817739 | Dec 1996 → Sep 2005 | prostate cancer | Takeda | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06601205 | Jan 2004 → Mar 2008 | prostate cancer, prostate intraepithelial neoplasia | Ente Ospedaliero Ospedali Galliera | Completed | No outcome recorded |
| Phase 314 trials · 2 met primary · 7 missed | ||||||
| Phase 3 | NCT01368588 | Jul 2011 → Apr 2025 overdue | prostate cancer | Radiation Therapy Oncology Group | Active not recruiting | Missed primary |
| Phase 3 | NCT00936390 | Sep 2009 → Oct 2020 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00567580 | Feb 2008 → Jul 2018 | prostate cancer | Radiation Therapy Oncology Group | Unknown | Met primary |
| Phase 3 | NCT00104741 | Sep 2003 → Oct 2015 | prostate cancer | UNICANCER | Completed | No outcome recorded |
| Phase 3 | NCT00023829 | Aug 2001 → Jun 2004 | prostate cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00005044 | Feb 2000 → Sep 2012 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00003645 | Jun 1999 → Mar 2017 | prostate cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 3 | NCT00003734 | Dec 1998 → ? | prostate cancer | St. Luke's Hospital, Ireland | Unknown | Missed primary |
| Phase 3 | NCT00003026 | Apr 1997 → Sep 2001 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | Missed primary |
| Phase 3 | NCT00002881 | Oct 1996 → Apr 1998 | prostate cancer | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00002855 | Aug 1996 → Jun 2005 | prostate cancer | M.D. Anderson Cancer Center | Completed | Missed primary |
| Phase 3 | NCT00001521 | Jun 1995 → Apr 2024 | congenital adrenal hyperplasia | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | Missed primary |
| Phase 3 | NCT00769548 | Apr 1995 → Apr 2001 | prostate cancer | Radiation Therapy Oncology Group | Completed | Mixed |
| Phase 3 | NCT00002597 | Oct 1994 → Jul 2011 | prostate cancer | Radiation Therapy Oncology Group | Completed | Met primary |
| Phase 43 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT04248621 | Jan 2020 → Apr 2022 | prostate neoplasm | Wonju Severance Christian Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02918968 | Nov 2016 → Mar 2020 | prostate cancer | Astellas Pharma Inc | Completed | Met primary |
| Phase 4 | NCT00611923 | Feb 2005 → Jun 2011 | premenstrual dysphoric disorder | Weill Medical College of Cornell University | Completed | Missed primary |
| Phase not applicable4 trials | ||||||
| — | NCT05478330 | Jan 2021 → Jun 2022 | acne | Zagazig University | Completed | No outcome recorded |
| — | NCT00729560 | Jul 2008 → Feb 2012 | polycystic ovary syndrome | Virginia Commonwealth University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01428193 | Sep 2006 → Aug 2017 | polycystic ovary syndrome | University of Virginia | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00442689 | Jul 2006 → Nov 2012 | metabolic syndrome X, polycystic ovary syndrome | Northwestern University | Completed | No outcome recorded |
| Comparator or background therapy35 trials | ||||||
| Phase 1 | NCT00512668 Background | Sep 2007 → Jan 2008 | prostate adenocarcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT00054106 Background | Dec 2002 → Sep 2004 | prostate cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 1 | NCT00026377 Background | Nov 2001 → Mar 2002 | prostate cancer | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT02742675 Background | Sep 2015 → Mar 2021 | prostate cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT02346578 Comparator | Dec 2014 → Sep 2018 | castration-resistant prostate carcinoma | Taro Iguchi, MD, PHD | Completed | Met primary |
| Phase 2 | NCT01786265 Background | Feb 2013 → Feb 2027 expected | prostate adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00699907 Comparator | Jan 2005 → Nov 2012 | ovarian cancer | University of Arizona | Completed | No outcome recorded |
| Phase 2 | NCT00170157 Background | Jun 2004 → Apr 2011 | prostate adenocarcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT00283803 Background | Mar 2002 → Oct 2011 | prostate cancer | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00002889 Background | May 1997 → Jan 2004 | prostate cancer | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00003517 Background | — | prostate adenocarcinoma | Burzynski Research Institute | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT04787744 Background | Jul 2021 → Sep 2026 overdue | metastatic prostate carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03070886 Background | Apr 2017 → Oct 2025 overdue | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05050084 Background | Dec 2021 → Nov 2026 expected | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04513717 Background | Jan 2021 → Dec 2033 expected | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03488810 Comparator | Mar 2020 → Jun 2026 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 3 | NCT03678025 Background | Sep 2018 → Apr 2033 expected | prostate adenocarcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 3 | NCT02446405 Comparator | Mar 2014 → Dec 2026 expected | prostate cancer | University of Sydney | Active not recruiting | Met primary |
| Phase 3 | NCT01546987 Background | May 2012 → Nov 2021 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00651326 Comparator | Jun 2008 → May 2010 | prostate cancer | NCIC Clinical Trials Group | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00309985 Background | Sep 2006 → Dec 2013 | metastatic prostate carcinoma | ECOG-ACRIN Cancer Research Group | Completed | Met primary |
| Phase 3 | NCT00288080 Background | Dec 2005 → Apr 2014 | prostate cancer | Radiation Therapy Oncology Group | Completed | Met primary |
| Phase 3 | NCT00388804 Comparator | Feb 2005 → Apr 2011 | prostate cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01011751 Background | Apr 2004 → Dec 2007 | prostate adenocarcinoma | Takeda | Completed | Met primary |
| Phase 3 | NCT00030654 Background | Oct 2002 → Feb 2005 | prostate cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT01122121 Background | Mar 2000 → Dec 2008 | prostate cancer | Takeda | Completed | Met primary |
| Phase 3 | NCT00004054 Background | Jan 2000 → Apr 2010 | prostate cancer | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 3 | NCT00003653 Comparator | Jan 1999 → Oct 2010 | prostate cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 3 | NCT00116220 Comparator | Sep 1995 → Apr 2001 | prostate cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 3 | NCT00002633 Comparator | Feb 1995 → Sep 2011 | prostate cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 3 | NCT00767286 Background | ? → Nov 2003 | prostate cancer | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 4 | NCT07848828 Comparator | Aug 2026 → Jul 2028 expected | dysautonomia, hypertensive disorder, kidney disorder, prostate cancer | Virginia Commonwealth University | Recruiting | No outcome recorded |
| Phase 4 | NCT05700903 Comparator | Sep 2023 → Jul 2025 | dysautonomia, hypertensive disorder, kidney disorder, prostate cancer | University of Colorado, Denver | Terminated | No outcome recorded |
| — | NCT05628363 Background | Jan 2023 → Oct 2025 overdue | prostate cancer | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| — | NCT02454543 Background | May 2015 → Dec 2019 overdue | prostate cancer | Martini-Klinik am UKE GmbH | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2001-09-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Flutamide Capsules tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration (FDA) has issued final approval for the Company's ANDA for Flutamide Capsules. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2001-09-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Flutamide Capsules tevapharm.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Flutamide | “Participants were randomly assigned (1:1), using a centralised web-based system and stratified by volume of disease, planned use of concurrent docetaxel and bone antiresorptive...” PMID 36990608 ↗ Apr 202371“All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 4-6 months, and luteinizing...” NCT01368588 ↗ “Patients treated with leuprolide, goserelin, or degarelix should also receive an androgen receptor antagonist (flutamide or bicalutamide) for 30 days from the start of GnRH...” NCT05628363 ↗ “Combination therapy of topical anti-inflammatory agent (Dapsone 5%) and anti-androgenic agent (Flutamide 2.5%) with anti-bacterial agent of micro-emulsion component (tea tree oil 5%)” NCT05899699 ↗ “Non-steroidal anti-androgen (e. g. flutamide, bicalutamide) PO daily for 4 weeks, started 2 weeks before the first LHRH agonist injection” NCT03488810 ↗ “Antiandrogen (AA) therapy can be either 250 mg flutamide by mouth three times a day or 50 mg bicalutamide by mouth once a day.” NCT00567580 ↗ “Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens.” NCT00103376 ↗ “oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months).” NCT00288080 ↗ “Flutamide dosed at 250mg orally three times a day for 14 days prior to the initiation of Leuprolide Acetate.” NCT00223665 ↗ “Either flutamide (orally 250 mg three times a day) or bicalutamide (orally 50 mg once a day).” NCT01546987 ↗ “flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks” NCT00006359 ↗ |
| Known as | Chimax | ChEMBL registry synonym — accepted as the source's own label CHEMBL806 ↗ |
| Known as | Drogenil | ChEMBL registry synonym — accepted as the source's own label CHEMBL806 ↗ |
| Known as | Eulexin | “Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens.” NCT00003026 ↗3“an antiandrogen such as Eulexin or Casodex” NCT00283803 ↗ “Flutamide (Eulexin) and Lupron or Zoladex” NCT00116220 ↗ |
| Known as | FLUT | “Flutamide, FLUT, NSC-147834; and Zoladex, ZDX, NSC-606864; plus external-beam irradiation using megavoltage equipment with energies of at least 4 MV (at least 6 MV preferred).” NCT00767286 ↗2“Flutamide, FLUT, NSC-147834; Goserelin, Zoladex, ZDX, NSC-606864; with irradiation of the whole pelvis followed by a boost to the prostate using photons of at least 6 MV.” NCT00769548 ↗ “an antiandrogen (nilutamide [ANAN], flutamide [FLUT], bicalutamide [CDX], or cyproterone acetate [CPTR])” NCT00003653 ↗ |
| Known as | Flutamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL806 ↗ |
| Known as | NSC-147834 | “Flutamide, FLUT, NSC-147834; and Zoladex, ZDX, NSC-606864; plus external-beam irradiation using megavoltage equipment with energies of at least 4 MV (at least 6 MV preferred).” NCT00767286 ↗1“Flutamide, FLUT, NSC-147834; Goserelin, Zoladex, ZDX, NSC-606864; with irradiation of the whole pelvis followed by a boost to the prostate using photons of at least 6 MV.” NCT00769548 ↗ |
| Known as | NSC-215876 | ChEMBL registry synonym — accepted as the source's own label CHEMBL806 ↗ |
| Known as | SCH 13521 | ChEMBL registry synonym — accepted as the source's own label CHEMBL806 ↗ |
| Action | Inhibit | “Non steroidal anti-androgen that prevents the action of androgens by blocking receptor sites in target tissue.” NCT00001521 ↗ |
| Modality | Small molecule | — CHEMBL806 ↗ |
| Route | Oral | “flutamide 10mg/kg/day orally” NCT00001521 ↗ |
| Target | AR | “androgen receptor (AR) ligands (e.g., dihydrotestosterone and flutamide)” PMID 38104131 ↗ Dec 2023 |