Drugs / Niclosamide
Trials 26
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT04542434 | Jan 2022 | COVID-19 | Entero Therapeutics | Withdrawn | No outcome recorded |
| Phase 2 | NCT04436458 | Jan 2022 | COVID-19 | Entero Therapeutics | Withdrawn | No outcome recorded |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 Stop: Enrollment |
| 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 · 1 met primary | ||||||
| Phase 4 | NCT05087381 | Oct 2021 → Jun 2022 | — | Chulalongkorn University | Completed | Met primary |
| 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 |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT04644705 Comparator | Nov 2020 → May 2021 | — | Charité Research Organisation GmbH | Completed | No outcome recorded |
| 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 2/3 | NCT04870333 Comparator | Feb 2021 → Apr 2025 | COVID-19 | Cambridge University Hospitals NHS Foundation Trust | Completed | Missed primary |
| Phase 3 | NCT04317430 Comparator | Feb 2020 → Apr 2022 | diabetic kidney disease | Tanta University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-06-16 | UNION therapeutics | Results Announcement of topline results from the PROTECT-V platform study investigating niclosamide nasal spray to prevent COVID-19 infection in vaccinated but highly vulnerable patients uniontherapeutics.com ↗
The study did not meet its primary endpoint, as no difference was detected between risk of infection in the niclosamide and placebo groups. |
| 2021-04-06 | UNION therapeutics | Results UNION therapeutics’ COVID-19 candidates found to be well tolerated in Phase 1 Lancet publication uniontherapeutics.com ↗
With no serious adverse effects reported, the study showed a strong safety profile of inhaled and intranasal niclosamide which was the primary endpoint for the trial. |
| 2021-03-29 | UNION therapeutics | Regulatory The PROTECT-V trial investigating UNIONs COVID-19 candidate receives Urgent Public Health Prioritization from the UK government uniontherapeutics.com ↗ |
| 2020-11-30 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains approval from Australia for clinical trial of niclosamide, a treatment for COVID-19 daewoong.co.kr ↗
Daewoong Pharmaceutical obtains approval from Australia for clinical trial of niclosamide, a treatment for COVID-19 |
| 2020-11-23 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains approval from South Korea for clinical trial of niclosamide, a treatment for COVID-19 daewoong.co.kr ↗
Daewoong Pharmaceutical obtains approval from South Korea for clinical trial of niclosamide, a treatment for COVID-19 |
| 2020-11-17 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical’s Long-Acting Niclosamide Shows High Promise Against Upcoming COVID-19 ‘Twindemic’ daewoong.co.kr ↗
According to Daewoong, niclosamide successfully reduced the IVA-driven mortality rate in an animal efficacy test alongside its previous success in a COVID-19 ferret model. |
| 2020-10-14 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical confirms effect of niclosamide on influenza following COVID-19 daewoong.co.kr ↗
As a result, the mortality rate was confirmed as 40% in the control group and 0% in the niclosamide group. |
| 2020-10-14 | Daewoong Pharmaceutical Co. LTD. | Results Daewoong Pharmaceutical and Daewoong Therapeutics smoothly conducting a global clinical trial for niclosamide as COVID-19 treatment daewoong.co.kr ↗
Safety has been confirmed so far in healthy subjects in the first treatment group, and the clinical trial is going well. |
| 2020-09-16 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains approval for phase 1 clinical trials of COVID-19 drug niclosamide for patients in the Philippines daewoong.co.kr ↗
Daewoong obtained approval for phase 1 clinical trials of the COVID-19 drug DWRX2003 (niclosamide) from the Food and Drug Administration (FDA) of the Philippines on the 4th. |
| 2020-09-16 | Daewoong Pharmaceutical Co. LTD. | Regulatory Daewoong Pharmaceutical obtains approval for phase 1 clinical trials of COVID-19 drug Niclosamide daewoong.co.kr ↗
Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) obtained approval for phase 1 clinical trials of the drug DWRX2003 (Niclosamide) for coronavirus disease 2019 (COVID-19) from the Indian Central Drugs Standard Control Organisation (CDSCO) on the 11th. |
| 2020-08-25 | UNION therapeutics | Results UNION therapeutics A/S completes dosing of healthy volunteers with UNI911 (inhaled niclosamide) for COVID-19 uniontherapeutics.com ↗
UNION has successfully completed inhalation dosing of 44 healthy volunteers, confirming the safety and tolerability of UNI911 |
| 2020-07-01 | UNION therapeutics | Regulatory UNION receives approval from Danish Medicines Agency to initiate clinical study with niclosamide for treatment of COVID-19 uniontherapeutics.com ↗
The Danish Medicines Agency has approved UNIONs Clinical Trial Application to initiate study with niclosamide in healthy volunteers |
All press releases naming this drug 16 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 32 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 | 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 |