Drugs / Niclosamide
Niclosamide
also known as
DWRX2003 · CP-PCA07 · Niclosamide Ethanolamine · Niclosamide Pill · PDMX1001 · UNI911 · UNI91103
targets AR
Trials 27 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT07683013 | Jul 2026 → Sep 2027 expected | castration-resistant prostate carcinoma | Hyundai Bioscience Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05188170 | Nov 2022 → Jul 2026 overdue | acute myeloid leukemia | Stanford University | Recruiting | No outcome recorded |
| Phase 1 | NCT05168644 | Nov 2021 → Jan 2022 | — | TFF Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04749173 | Nov 2020 → Jun 2021 | COVID-19 | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT04705415 | Nov 2020 → Oct 2021 | — | NeuroBo Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04592835 | Oct → Dec 2020 | — | Daewoong Pharmaceutical Co. LTD. | Unknown | No outcome recorded |
| Phase 1 | NCT04576312 | Jun → Dec 2020 | COVID-19 | UNION therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02687009 | Nov → Dec 2017 | colorectal cancer | Michael Morse, MD | Terminated | No outcome recorded |
| Phase 1 | NCT03123978 | Jan 2017 → Jan 2022 | metastatic prostate carcinoma | University of California, Davis | Completed | No outcome recorded |
| Phase 1 | NCT02532114 | Dec 2015 → Nov 2017 | castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate adenocarcinoma | University of Washington | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03521232 | May 2018 → Sep 2022 | proctitis, ulcerative colitis, ulcerative proctosigmoiditis | Entero Therapeutics | Terminated | No outcome recorded |
| Phase 1/2 | NCT03160001 | Aug 2017 → Aug 2018 | rheumatoid arthritis | Faiq Gorial | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT05226533 | Mar → Dec 2022 | COVID-19 | Daewoong Pharmaceutical Co. LTD. | Terminated | No outcome recorded |
| Phase 2 | NCT04436458 | Jan 2022 | COVID-19 | Entero Therapeutics | Withdrawn | No outcome recorded |
| Phase 2 | NCT04542434 | Jan 2022 | COVID-19 | Entero Therapeutics | Withdrawn | No outcome recorded |
| Phase 2 | NCT04932915 | Sep 2021 → Jan 2022 | COVID-19 | UNION therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT04858425 | Apr 2021 → Jun 2022 | COVID-19 | Entero Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT04753619 | Jan → Dec 2021 | COVID-19, severe acute respiratory syndrome | University of Baghdad | Unknown | No outcome recorded |
| Phase 2 | NCT04296851 | Feb 2020 → Dec 2022 | classic familial adenomatous polyposis | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT02807805 | Oct 2016 → May 2025 overdue | metastatic prostate carcinoma | Mamta Parikh | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02519582 | Aug 2015 → Dec 2019 | colorectal cancer | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04603924 | Oct 2020 → Feb 2022 | COVID-19 | NeuroBo Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04558021 | Oct 2020 → Jan 2021 | COVID-19 | Imuneks Farma ilac San. Tic. A.S. | Unknown | No outcome recorded |
| Phase 3 | NCT04372082 | May 2020 → May 2023 | COVID-19 | University Hospital, Lille | Withdrawn | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05087381 | Oct 2021 → Jun 2022 | — | Chulalongkorn University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01296958 | May 2011 → Jan 2013 | taeniasis | Oregon Health and Science University | Completed | No outcome recorded |
| — | NCT00138359 | Dec 2004 → Jan 2005 | parasitic intestinal disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04644705 Comparator | Nov 2020 → May 2021 | — | Charité Research Organisation GmbH | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04750759 Comparator | Feb → Oct 2021 | COVID-19 | Charité Research Organisation GmbH | Terminated | No outcome recorded |
| Phase 2 | NCT04399356 Comparator | Oct 2020 → Apr 2021 | COVID-19 | Tufts Medical Center | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04870333 Comparator | Feb 2021 → Apr 2025 | COVID-19 | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04317430 Comparator | Feb 2020 → Apr 2022 | diabetic kidney disease | Tanta University | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Niclosamide | “A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide...” NCT04749173 ↗30“Niclosamide is a broad spectrum, host tageting antiviral that inhibits viral replication” NCT04576312 ↗ “Niclosamide 432mg (intramuscular injection) + Remdesivir” NCT05226533 ↗ “Niclosamide Injectable (DWRX2003)” NCT04592835 ↗ |
| Known as | CP-PCA07 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07683013 ↗ |
| Known as | DWRX2003 | “A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide...” NCT04749173 ↗1“Niclosamide Injectable (DWRX2003)” NCT04592835 ↗ |
| Known as | Niclosamide Ethanolamine | “INN: Niclosamide Ethanolamine Chemical name (IUPAC): 5-chloro-N-(2-chloro-4-nitrophenyl)-2-hydroxybenzamide.2 aminoethanol CAS registry number: 1420-04-8 Lab code: UNI911” NCT04870333 ↗ |
| Known as | Niclosamide Pill | “Drug: Niclosamide Pill” NCT05087381 ↗ |
| Known as | PDMX1001 | “niclosamide (PDMX1001/niclosamide)” NCT03123978 ↗ |
| Known as | UNI911 | “Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers” NCT04576312 ↗ |
| Known as | UNI91103 | “Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19” NCT04932915 ↗ |
| Action | Inhibit | “Niclosamide is a drug that may block another signal that can cause prostate cancer cell growth.” NCT02807805 ↗ |
| Route | Oral | “Single oral dose of niclosamide determined by weight” NCT01296958 ↗ |
| Target | AR | “Potential mechanisms of action include degrading constitutively active androgen receptor splice variants (AR-Vs)” PMID 29856824 ↗ Jun 2018 |