Niclosamide has been evaluated across multiple clinical trials spanning Phase 1 through Phase 4 for various indications, including COVID-19, acute myeloid leukemia, advanced prostate carcinoma, ulcerative colitis, and intestinal parasitism. Spearheaded by both academic institutions and pharmaceutical entities, these protocols reflect a range of recruitment statuses, including active recruitment, completed safety evaluations, and terminated or withdrawn studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05188170 | RECRUITING | Acute Myeloid Leukemia (AML) |
Stanford University |
2022-11-21 | PHASE1 |
| NCT02807805 | ACTIVE_NOT_RECRUITING | Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer |
Mamta Parikh |
2016-10 | PHASE2 |
| NCT04870333 | COMPLETED | Covid19 |
Cambridge University Hospitals NHS Foundation Trust |
2021-02-19 | PHASE2; PHASE3 |
| NCT04372082 | WITHDRAWN | Sars-CoV2 |
University Hospital, Lille |
2020-05 | PHASE3 |
| NCT04296851 | UNKNOWN | Familial Adenomatous Polyposis |
Yonsei University |
2020-02-14 | PHASE2 |
| NCT05188170 | Recruiting | Acute Myeloid Leukemia (AML) |
Stanford University |
2022-11-21 | Phase 1 |
| NCT03521232 | TERMINATED | Ulcerative Colitis; Ulcerative Proctitis; Ulcerative Proctosigmoiditis |
Entero Therapeutics |
2018-05-15 | PHASE1; PHASE2 |
| NCT05087381 | COMPLETED | Treatment Efficacy |
Chulalongkorn University |
2021-10-01 | PHASE4 |
| NCT04858425 | TERMINATED | Covid19 |
Entero Therapeutics |
2021-04-30 | PHASE2 |
| NCT04317430 | COMPLETED | Diabetic Nephropathies |
Tanta University |
2020-02-01 | PHASE3 |
| NCT04603924 | COMPLETED | COVID-19 |
NeuroBo Pharmaceuticals Inc. |
2020-10-07 | PHASE2; PHASE3 |
| NCT05168644 | COMPLETED | Healthy |
TFF Pharmaceuticals, Inc. |
2021-11-14 | PHASE1 |
| NCT04436458 | WITHDRAWN | COVID |
Entero Therapeutics |
2022-01-20 | PHASE2 |
| NCT04542434 | WITHDRAWN | Covid19 |
Entero Therapeutics |
2022-01-20 | PHASE2 |
| NCT03123978 | COMPLETED | Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer |
University of California, Davis |
2017-01-09 | PHASE1 |
| NCT04932915 | TERMINATED | Covid19 |
UNION therapeutics |
2021-09-03 | PHASE2 |
| NCT04436458 | Withdrawn | COVID |
First Wave BioPharma Inc. |
2022-01-20 | Phase 2 |
| NCT04753619 | UNKNOWN | Covid-19; SARS Pneumonia |
University of Baghdad |
2021-01-03 | PHASE2 |
| NCT05168644 | Completed | Healthy |
TFF Pharmaceuticals Inc. |
2021-11-14 | Phase 1 |
| NCT04750759 | TERMINATED | Covid19 |
Charité Research Organisation GmbH |
2021-02-03 | PHASE2 |
| NCT04705415 | COMPLETED | Healthy |
NeuroBo Pharmaceuticals Inc. |
2020-11-17 | PHASE1 |
| NCT04749173 | COMPLETED | Covid19 |
Daewoong Pharmaceutical Co. LTD. |
2020-11-21 | PHASE1 |
| NCT04644705 | COMPLETED | Healthy Volunteers |
Charité Research Organisation GmbH |
2020-11-02 | PHASE1 |
| NCT04399356 | COMPLETED | COVID-19 |
Tufts Medical Center |
2020-10-01 | PHASE2 |
| NCT04541485 | TERMINATED | COVID-19 Patients |
Daewoong Pharmaceutical Co. LTD. |
2020-12-04 | PHASE1 |
| NCT04558021 | UNKNOWN | Covid19 |
Imuneks Farma ilac San. Tic. A.S. |
2020-10-08 | PHASE3 |
| NCT04592835 | UNKNOWN | COVID-19 Patients |
Daewoong Pharmaceutical Co. LTD. |
2020-10-19 | PHASE1 |
| NCT04524052 | UNKNOWN | Healthy |
Daewoong Pharmaceutical Co. LTD. |
2020-08 | PHASE1 |
| NCT04644705 | Completed | Healthy Volunteers |
Charité Research Organisation GmbH|Bayer |
2020-11-02 | Phase 1 |
| NCT04592835 | Unknown status | COVID-19 Patients |
Daewoong Pharmaceutical Co. LTD.|Novotech (Australia) Pty Limited |
2020-10-19 | Phase 1 |
| NCT04524052 | Unknown status | Healthy |
Daewoong Pharmaceutical Co. LTD. |
2020-08 | Phase 1 |
| NCT02519582 | UNKNOWN | Colorectal Cancer |
Charite University, Berlin, Germany |
2015-08 | PHASE2 |
| NCT03160001 | COMPLETED | Rheumatoid Arthritis (RA) |
Faiq Gorial |
2017-08-15 | PHASE1; PHASE2 |
| NCT02687009 | TERMINATED | Colon Cancer |
Michael Morse, MD |
2017-11-07 | PHASE1 |
| NCT02532114 | COMPLETED | Castration Levels of Testosterone; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Adenocarcinoma |
University of Washington |
2015-12-31 | PHASE1 |
| NCT01296958 | COMPLETED | Taenia Solium Taeniasis |
Oregon Health and Science University |
2011-05 | |
| NCT00138359 | TERMINATED | Intestinal Parasitism |
National Institute of Allergy and Infectious Diseases (NIAID) |
2004-12 |
(data from https://clinicaltrials.gov, updated on 2026-08-12)
Check the
Niclosamide
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.