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- ||||| niclosamide / Generic mfg.
Trial completion date, Trial termination: RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (clinicaltrials.gov) - Jul 23, 2024
P2, N=166, Terminated, Sponsor: Entero Therapeutics
Trial completion date: May 2023 --> Sep 2023 | Active, not recruiting --> Terminated; The termination of the study was a decision based on topline data analysis (no efficacy as per Day 43) of the study data.
- | niclosamide / Generic mfg.
Trial completion date: RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (clinicaltrials.gov) - Feb 2, 2023
P2, N=166, Active, not recruiting, Sponsor: First Wave Bio, Inc.
Trial completion date: May 2023 --> Sep 2023 | Active, not recruiting --> Terminated; The termination of the study was a decision based on topline data analysis (no efficacy as per Day 43) of the study data. Trial completion date: Dec 2022 --> Mar 2023
- | niclosamide / Generic mfg.
Trial completion date: RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (clinicaltrials.gov) - Aug 30, 2022
P2, N=166, Active, not recruiting, Sponsor: First Wave Bio, Inc.
Trial completion date: Dec 2022 --> Mar 2023 Trial completion date: Jul 2022 --> Oct 2022
- | niclosamide / Generic mfg.
Trial completion date: RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (clinicaltrials.gov) - Apr 5, 2022
P2, N=166, Active, not recruiting, Sponsor: First Wave Bio, Inc.
Trial completion date: Jul 2022 --> Oct 2022 Trial completion date: Mar 2022 --> Jul 2022
- | niclosamide (FW-1022) / First Wave Bio
Enrollment change, Trial withdrawal, Trial primary completion date: Niclosamide In Moderate COVID-19 (clinicaltrials.gov) - Feb 21, 2022
P2, N=0, Withdrawn, Sponsor: First Wave Bio, Inc.
Trial completion date: Mar 2022 --> Jul 2022 N=100 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2021 --> Jan 2022
- | niclosamide (FW-1022) / First Wave Bio
Enrollment change, Trial withdrawal, Trial primary completion date: Niclosamide in COVID-19 (clinicaltrials.gov) - Feb 21, 2022
P2, N=0, Withdrawn, Sponsor: First Wave Bio, Inc.
N=100 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2021 --> Jan 2022 N=148 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Oct 2021 --> Jan 2022
- || niclosamide / Generic mfg.
Enrollment closed: RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (clinicaltrials.gov) - Feb 7, 2022
P2, N=166, Active, not recruiting, Sponsor: First Wave Bio, Inc.
N=148 --> 0 | Not yet recruiting --> Withdrawn | Trial primary completion date: Oct 2021 --> Jan 2022 Recruiting --> Active, not recruiting
- MS1819-SD / AzurRx BioPharma, micronized niclosamide (FW-420) / First Wave Bio, AzurRx BioPharma, niclosamide (FW-1022) / First Wave Bio
[VIRTUAL] AzurRx BioPharma () - May 31, 2021 - Abstract #BIO2021BIO_258;
AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients and FW-1022, for COVID-19 gastrointestinal infections. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California.
- ||| niclosamide / Generic mfg.
Enrollment open: RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (clinicaltrials.gov) - May 3, 2021
P2, N=148, Recruiting, Sponsor: AzurRx BioPharma, Inc.
The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. Not yet recruiting --> Recruiting
- |||| niclosamide / Generic mfg.
New P2 trial: RESERVOIR: Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (clinicaltrials.gov) - Apr 25, 2021
P2, N=148, Not yet recruiting, Sponsor: AzurRx BioPharma, Inc.
- || niclosamide (FW-1022) / First Wave Bio
Trial completion date, Trial initiation date, Trial primary completion date: Niclosamide in COVID-19 (clinicaltrials.gov) - Feb 15, 2021
P2, N=148, Not yet recruiting, Sponsor: First Wave Bio, Inc.
Not yet recruiting --> Recruiting Trial completion date: May 2021 --> Dec 2021 | Initiation date: Nov 2020 --> Jun 2021 | Trial primary completion date: May 2021 --> Oct 2021
- || niclosamide (FW-1022) / First Wave Bio
Trial completion date, Trial initiation date, Trial primary completion date: Niclosamide In Moderate COVID-19 (clinicaltrials.gov) - Feb 15, 2021
P2, N=100, Not yet recruiting, Sponsor: First Wave Bio, Inc.
Trial completion date: May 2021 --> Dec 2021 | Initiation date: Nov 2020 --> Jun 2021 | Trial primary completion date: May 2021 --> Oct 2021 Trial completion date: Apr 2021 --> Dec 2021 | Initiation date: Dec 2020 --> Jun 2021 | Trial primary completion date: Apr 2021 --> Aug 2021
- |||| niclosamide (FW-1022) / First Wave Bio
New P2 trial: Niclosamide in COVID-19 (clinicaltrials.gov) - Sep 8, 2020
P2, N=148, Not yet recruiting, Sponsor: First Wave Bio, Inc.
- || niclosamide (FW-1022) / First Wave Bio
Trial primary completion date: Niclosamide In Moderate COVID-19 (clinicaltrials.gov) - Sep 7, 2020
P2, N=100, Not yet recruiting, Sponsor: First Wave Bio, Inc.
Trial completion date: Apr 2021 --> Dec 2021 | Initiation date: Dec 2020 --> Jun 2021 | Trial primary completion date: Apr 2021 --> Aug 2021 Trial primary completion date: Jan 2021 --> Apr 2021
- niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
[VIRTUAL] Effects of Steroid Hormones on Lipogenesis and Insulin Sensitivity - an Insight into the Involvement of the Wnt Signaling Pathway () - Jun 20, 2020 - Abstract #ENDOI2020ENDO-I_954;
No such observation was made with respect to the effect of P4 on lipogenesis. Understanding the mechanistic actions of these steroids may play an important role in devising methods to prevent conditions like GDM before its onset.
- | doxorubicin hydrochloride / Generic mfg.
Journal, Cancer stem cells: Stress Conditions Induced by Locoregional Therapies Stimulate Enrichment and Proliferation of Liver Cancer Stem Cells. (Pubmed Central) - Jun 18, 2020
Stress conditions induced by locoregional therapies stimulated hCSC enrichment and proliferation, which could be suppressed by niclosamide and inhibitors of pathways important for hCSC renewal. Future studies will determine whether combining locoregional therapies with adjuvant hCSC inhibitors reduces HCC recurrence.
- |||| niclosamide (FW-1022) / First Wave Bio
New P2 trial: Niclosamide In Moderate COVID-19 (clinicaltrials.gov) - Jun 18, 2020
P2, N=100, Not yet recruiting, Sponsor: First Wave Bio, Inc.
- ||| niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Any chance we can get some of those trials locally? Niclosamide perhaps? I mean with ~300 diagnosed per day I bet the sign up will be enough... (Twitter) - Jun 17, 2020
- | niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Journal: Inhibition of human immunodeficiency virus type 1 by niclosamide through mTORC1 inhibition. (Pubmed Central) - Jun 13, 2020
Likewise, MHY-1485 could partially reverse the inhibitory effect of niclosamide by increasing the phosphorylation in the mTORC1 pathway and HIV-1 viral protein synthesis. Our findings, therefore, demonstrated the antiviral mechanism of niclosamide is via the AMPK-mTORC1 pathway, which could be a common therapeutic target for various viruses.
- | niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Journal: Repositioning of niclosamide ethanolamine (NEN), an anthelmintic drug, for the treatment of lipotoxicity. (Pubmed Central) - Jun 10, 2020
We also demonstrated that NEN protects cells and mouse liver from acute lipotoxic stress through activating p62-dependent Keap1-Nrf2 pathway. Taken together, NEN can be used for clinical applications and has the potential to provide a new therapeutic option for NASH.
- ||| niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Among the potential endosomal trafficking blockers, niclosamide has better inhibitory activity in vitro, yet there’s only 1 study planned to look at it vs placebo in COVID-19. It’s frustrating to think how many other potential antivirals are being overshadowed by HCQ. (Twitter) - Jun 5, 2020
- | niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Journal: STAT3 operates as a novel transcription factor that regulates NEDD4 in Keloid. (Pubmed Central) - Jun 4, 2020
No direct protein-protein interactions between STAT3 and NEDD4 can be identified in our setting. The data we provided herein enrich the knowledge regarding the molecular mechanism of NEDD4 involved in the pathogenesis of keloid, defining a new regulatory role for STAT3 in keloid.
- | niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Journal: Contributions of Hepatic and Intestinal Metabolism to the Disposition of Niclosamide, A Repurposed Drug with Poor Bioavailability. (Pubmed Central) - May 29, 2020
SIGNIFICANCE STATEMENT: These results suggest that efforts to increase the bioavailability of niclosamide by blocking its metabolism by P450 enzymes will unlikely be fruitful. In contrast, inhibition of niclosamide glucuronidation in both liver and intestine may prove effective for increasing niclosamide's bioavailability, thereby making it practical to repurpose this drug for treating systemic diseases.
- niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
NICLOSAMIDE SUPPRESSES MACROPHAGE INDUCED INFLAMMATION IN PRIMARY HUMAN ENDOMETRIOTIC STROMAL CELLS () - May 27, 2020 - Abstract #WCE2020WCE_460;
- niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
THE EFFICACY OF NICLOSAMIDE ON ABERRANT INFLAMMATORY DYSFUNCTION CAUSED BY PERITONEAL MACROPHAGES IN ENDOMETRIOSIS () - May 27, 2020 - Abstract #WCE2020WCE_459;
- | niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Journal: Maternal-to-zygotic transition as a potential target for niclosamide during early embryogenesis. (Pubmed Central) - May 21, 2020
Based on this study, we found that (1) niclosamide exposure during early zebrafish embryogenesis resulted in a decrease in yolk sac integrity with a concomitant decrease in the presence of yolk sac actin networks and increase in cell size; (2) within whole embryos, niclosamide exposure did not alter non-polar metabolites and lipids, but significantly altered amino acids specific to aminoacyl-tRNA biosynthesis; (3) niclosamide significantly altered transcripts related to translation, transcription, and mRNA processing pathways; and (4) niclosamide did not significantly alter levels of rRNA and tRNA. Overall, our findings suggest that niclosamide may be causing a systemic delay in embryonic development by disrupting the translation of maternally-supplied mRNAs, an effect that may be mediated through disruption of aminoacyl-tRNA biosynthesis.
- | niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Journal: A New Method to Test Molluscicides against the Philippine Schistosomiasis Snail Vectors. (Pubmed Central) - May 16, 2020
Taken together, the results point out that mpt generates accurate and reproducible lethal concentration values. Hence, mpt may be used as an alternative method to screen molluscicides that are active against schistosome snail vectors.
- niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
[VIRTUAL] SELECTIVE KILLING MULTIPLE MYELOMA CELLS BY TARGETING FREE LIGHT CHAIN SECRETION, ENDOPLASMIC RETICULUM STRESS AND UNFOLDED PROTEIN RESPONSE USING THE COMBINATION OF VALPROATE AND NICLOSAMIDE (VAN) () - May 16, 2020 - Abstract #EHA2020EHA_1480;
As expected of activators of the UPR, VaN combined with proteasome inhibitors bortezomib or carfilzomib induced greater MM killing at low doses of PI. Combined together, these data have identified an oral drug-combination with anti-MM activity which rapidly reduces FLC secretion and has activity against PI-resistant MM cells.
- | niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Review, Journal: Broad Spectrum Antiviral Agent Niclosamide and Its Therapeutic Potential. (Pubmed Central) - May 13, 2020
Through a series of drug repurposing screening campaigns, niclosamide, an FDA-approved anthelminthic drug, was found to be effective against various viral infections with nanomolar to micromolar potency such as SARS-CoV, MERS-CoV, ZIKV, HCV and human adenovirus, indicating its potential as an antiviral agent. In this brief article, we summarize the broad antiviral activities of niclosamide and highlight its potential clinical use for treatment of COVID-19.
- | niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Journal: Plausible mechanisms of Niclosamide as an antiviral agent against COVID-19. (Pubmed Central) - May 4, 2020
Niclosamide (NIC) is an approved anti-helminthic drug with diverse antiviral mechanisms. In this work we hypothesize, the potential antiviral mechanisms of NIC against COVID-19.
- |||| niclosamide / Generic mfg., MK-2206 / Merck (MSD), niclosamide (FW-1022) / First Wave Bio
Preclinical: Corona-infected cell cultures were treated with 2 drugs (niclosamide and an anti-breast CAD, MK-2206) and spermidine. All 3 are known to activate autophagy. The experiment showed that the rate of multiplication of the novel SARS could be reduced by 99%, 88% and 85%, respectively. (Twitter) - Apr 25, 2020
- | niclosamide / Generic mfg., niclosamide (FW-1022) / First Wave Bio
Journal: Inhibition of LEF1-mediated DCLK1 by Niclosamide Attenuates Colorectal Cancer Stemness. (Pubmed Central) - Apr 22, 2020
Disruption of the LEF1/DCLK1-B axis by niclosamide eradicates cancer stemness and elicits therapeutic effects on CRC initiation, progression, and resistance. These findings provide a preclinical rationale to broaden the clinical evaluation of niclosamide for the treatment of CRC.
- | Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA
Journal: Identifying targets of potential concern by a screening level ecological risk assessment of human use pharmaceuticals in China. (Pubmed Central) - Apr 17, 2020
Of the 22 APIs with low risks (0.1 < RQ < 1), 17 have never been monitored previously in China and even worldwide. This study has yielded some probable antibiotics that should be considered as monitoring targets in China in the future.
- | niclosamide (FW-1022) / First Wave Bio
Journal: Niclosamide inhibits ovarian carcinoma growth by interrupting cellular bioenergetics. (Pubmed Central) - Apr 15, 2020
Collectively, these data highlight a novel anti-tumor mechanism of Niclosamide that involves an interruption of cell metabolism. The finding also indicates a potential for the application of Niclosamide in ovarian carcinoma therapy.
- || Review, Journal: Systematic review of the effectiveness of selected drugs for preventive chemotherapy for Taenia solium taeniasis. (Pubmed Central) - Apr 14, 2020
Evidence indicated that praziquantel 10mg/kg, niclosamide 2g, and triple dose albendazole 400mg were effective as taenicides and could be considered for use in mass drug administration programs for the control of T. solium taeniasis. Evidence was not found that any of these drugs caused severe side effects at the indicated doses, although the extent of the available evidence was limited.