Drugs / PRUXELUTAMIDE
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04103853 | Sep 2017 → May 2019 | breast cancer | Suzhou Kintor Pharmaceutical Inc | Completed | No outcome recorded |
| Phase 1 | NCT02826772 | Feb 2016 → May 2019 | prostate carcinoma | Suzhou Kintor Pharmaceutical Inc | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05076851 | Jun → Dec 2021 | — | Hongqian Guo | Unknown | No outcome recorded |
| Phase 2 | NCT03899467 | May 2019 → Mar 2022 | castration-resistant prostate carcinoma | Suzhou Kintor Pharmaceutical Inc | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05009732 | Sep 2021 → Feb 2023 | COVID-19 | Suzhou Kintor Pharmaceutical Inc | Terminated | No outcome recorded |
| Phase 3 | NCT04869228 | Aug 2021 → Sep 2022 | COVID-19 | Suzhou Kintor Pharmaceutical Inc | Terminated | No outcome recorded Stop: Business |
| Phase not applicable1 trial · 1 met primary | ||||||
| — | NCT04446429 | Oct → Dec 2020 | COVID-19, androgenetic alopecia, benign prostatic hyperplasia, prostate cancer +1 | Applied Biology, Inc. | Completed | Met primary |
| Comparator or background therapy5 trials | ||||||
| Phase 3 | NCT05126628 Comparator | Mar 2021 | COVID-19 | Corpometria Institute | Completed | No outcome recorded |
| Phase 3 | NCT04870606 Comparator | Mar 2021 → Jan 2022 | — | Suzhou Kintor Pharmaceutical Inc | Completed | No outcome recorded |
| Phase 3 | NCT04853927 Comparator | Feb → Oct 2021 | COVID-19, severe acute respiratory syndrome | Applied Biology, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT04728802 Comparator | Feb → Apr 2021 | COVID-19, severe acute respiratory syndrome | Applied Biology, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04853134 Comparator | Nov 2020 → Dec 2021 | COVID-19 | Applied Biology, Inc. | Withdrawn | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PRUXELUTAMIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594417 ↗ |
| Known as | GT0918 | “The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease” NCT04869228 ↗7“The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) as a treatment for outpatients COVID-19 subjects.” NCT04870606 ↗ “Proxalutamide (GT0918) demonstrates a dual mechanism of action.” NCT04853927 ↗ “Proxalutamide (GT0918) demonstrates a dual mechanism of action.” NCT04853134 ↗ “Proxalutamide (GT0918) demonstrates a dual mechanism of action.” NCT04446429 ↗ |
| Known as | proxalutamide | “Subjects will continue treatment with GT0918 (proxalutamide) at their assigned dose on an empty stomach until disease progression, intolerable toxicities (AEs), or withdrawn consent.” NCT03899467 ↗9“The purpose of this study is to assess the efficacy and safety of Proxalutamide (GT0918) in male outpatients with mild to moderate COVID-19 disease” NCT04869228 ↗ |
| Action | Inhibit | “androgen receptor antagonist” NCT03899467 ↗ |
| Modality | Small molecule | — CHEMBL4594417 ↗ |
| Route | Oral | “Patients received orally administered GT0918 once daily at the indicated doses for 28 consecutive days (4 weeks), followed by a 7-day off-treatment period for PK analysis.” NCT02826772 ↗ |
| Target | AR | “for its AR down-regulation activity” PMID 34392453 ↗ Aug 2021 |