Drugs / Nilutamide
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NILANDRON | — | 1996-09-19 | fda.gov ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT00028769 | Dec 2001 → Jun 2010 | prostate cancer | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00020254 | Jun 2000 → Oct 2004 | prostate cancer | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT00002855 | Aug 1996 → Jun 2005 | prostate cancer | M.D. Anderson Cancer Center | Completed | Missed primary |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT00512668 Background | Sep 2007 → Jan 2008 | prostate adenocarcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT01786265 Background | Feb 2013 → Feb 2027 expected | prostate adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00918385 Comparator | May 2009 → Feb 2012 | prostate cancer | Duke University | Terminated | No outcome recorded Stop: Enrollment |
| 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 | 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 | NCT00003653 Comparator | Jan 1999 → Oct 2010 | prostate cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 3 | NCT00002633 Comparator | Feb 1995 → Sep 2011 | prostate cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nilutamide | “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 2023 |
| Known as | Anadron | ChEMBL registry synonym — accepted as the source's own label CHEMBL1274 ↗ |
| Known as | ANAN | “an antiandrogen (nilutamide [ANAN], flutamide [FLUT], bicalutamide [CDX], or cyproterone acetate [CPTR])” NCT00003653 ↗ |
| Known as | Nilandron | ChEMBL registry synonym — accepted as the source's own label CHEMBL1274 ↗ |
| Known as | Nilutamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1274 ↗ |
| Known as | NSC-758683 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1274 ↗ |
| Known as | RU 23908 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1274 ↗ |
| Action | Inhibit | “Hormone therapy using nilutamide may fight prostate cancer by reducing the production of androgens.” NCT00020254 ↗ |
| Modality | Small molecule | — CHEMBL1274 ↗ |
| Route | Oral | “Nilutamide 100 mg po TID x 1 mo; then 150 mg po QD” NCT00002633 ↗ |
| Target | AR | “nilutamide, an approved oral agent used in metastatic CRPC to target the AR.” NCT00918385 ↗ |