Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed/refractory acute myeloid leukemia.

Start Date21 Nov 2022

Sponsor / Collaborator

Stanford University

KCT0007307 / CompletedPhase 2

A randomized, double-blind, placebo-controlled design phase 2 clinical trial to comparatively evaluate the efficacy and safety of CP-COV03 in patients with mild or moderate COVID-19

Start Date11 May 2022

Sponsor / Collaborator

HYUNDAI BIOSCIENCE Co., Ltd.

NCT05226533 / TerminatedPhase 2

A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients

Safety and efficacy of DWRX2003 combination with Remdesivir in moderate to severe COVID-19 patients will be confirmed.

Start Date31 Mar 2022

Sponsor / Collaborator

Daewoong Pharmaceutical Co., Ltd.

100 Clinical Results associated with Niclosamide

100 Translational Medicine associated with Niclosamide

100 Patents (Medical) associated with Niclosamide

1,176

Literatures (Medical) associated with Niclosamide

01 Jan 2025·Biomaterials advances

GSH responsive AuNRs@TFF nanotheranostic for NIR-II photoacoustic imaging-guided CDT/PTT synergistic cancer therapy

Article

Author: Liang, Hong ; Zhou, Yuzhu ; Huang, Ke-Bin ; Fang, Qi ; Leng, Nan ; Cai, Bingbing ; Guo, Xiaohuan ; Wen, Changchun

Gold nanorods (AuNRs) are important photothermal therapeutic agents; however, a single therapy does not achieve satisfactory outcomes, and the synthesis process often leads to the adsorption of cetyltrimethylammonium bromide on the surface of AuNRs, which reduces its biocompatibility. Natural polyphenols are abundant in natural plants and have good biocompatibility. The metal-polyphenol network is formed by the coordination of metal ions and polyphenols, which has good drug loading, surface adhesion, and biocompatibility. In this study, the metal-polyphenol network structure formed by a transition metal (iron) and natural polyphenol tannic acid was used to modify the surface of gold nanorods (AuNRs@TF). Additionally, the surfaces of AuNRs were modified using the targeted functional molecule mercapto folic acid (AuNRs@TFF). The constructed composite nanomaterials AuNRs@TFF has good biocompatibility and tumor targeting ability. Tannic acid‑iron degrades in the tumor microenvironment and releases iron ions that catalyze the Fenton reaction, thereby facilitating chemodynamic therapy. The good photo-thermal ability of AuNRs generate good photoacoustic signals to facilitate photoacoustic imaging mediation and enhances photothermal and chemodynamic therapy performance. This study expands on the application of AuNRs in the field of nanomedicine. The simple and effective design of AuNRs@TFF provides a strategy for the development of synergistic therapeutic agents for photothermal therapy and chemodynamic therapy.

01 Nov 2024·NEUROCHEMICAL RESEARCH

Wnt Signaling Modulators Exhibit Neuroprotective Effects via Combating Astrogliosis and Balancing Synaptic Density at Early and Late Stage Temporal Lobe Epilepsy

Article

Author: Kumar, Anil ; Saha, Lekha ; Sharma, Antika ; Bhatia, Alka ; Sandhu, Arushi ; Gautam, Vipasha ; Rawat, Kajal

Temporal Lobe Epilepsy (TLE) is a severe neurological condition characterized by recurrent seizures that often do not respond well to available anti-seizure medications. TLE has been associated with epileptogenesis, a process that starts during the latent period following a neurologic insult and is followed by chronic phase. Recent research has linked canonical Wnt signaling to the pathophysiology of epileptogenesis and TLE. Our previous study demonstrated differential regulation of canonical Wnt signaling during early and late stage post status epilepticus (SE) induction. Building on these findings, our current study utilized Wnt modulators: GSK-3β inhibitor 6-bromoindirubin-3'-oxime (6-Bio) and disheveled inhibitor niclosamide and investigated their impact on canonical Wnt signaling during the early (30 days) and later stages (60 days) following SE induction. We assessed several parameters, including seizure frequency, astrogliosis, synaptic density, and neuronal counts in hippocampal tissue. We used immunohistochemistry and Nissl staining to evaluate gliosis, synaptic density, and neuronal counts in micro-dissected hippocampi. Western blotting was used to examine the expression of proteins involved in canonical Wnt/β-catenin signaling, and real-time PCR was conducted to analyze their relative mRNA expression. Wnt modulators, 6-Bio and Niclosamide were found to reduce seizure frequency and various other parameters including behavioral parameters, hippocampal morphology, astrogliosis and synaptic density at different stages of TLE.

01 Nov 2024·EUROPEAN JOURNAL OF PHARMACOLOGY

Repurposing of niclosamide, an anthelmintic, by targeting ERK/MAPK signaling pathway in the experimental paradigm of autism spectrum disorders

Article

Author: Bishnoi, Mahendra ; Singh, Yuvraj ; Kuhad, Anurag ; Bhandari, Ranjana ; Kumar, Hemant ; Sodhi, Rupinder Kaur

AIM:

The current study explores niclosamide's neuroprotective potential in an animal model of autism spectrum disorder (ASD) and goes further to understand how the ERK/MAPK signaling pathway is thought to contribute to this activity.

METHODS:

In order to create an autism-like phenotype in rats, 4 μl of 1 M PPA was infused intracerebroventricularly. The oral treatment with niclosamide (50 and 100 mg/kg) and risperidone (1 mg/kg) (used as standard) was given from 3rd to 30th day. Between the 14th and 28th day, behavioral assessments were made for sociability, stereotypy, anxiety, depression, novelty preference, repetitive behavior, and perseverative behavior. The animals were euthanized on the 29th day, and oxidative stress markers were assessed in the brain homogenate. The levels of neuroinflammatory cytokines such as TNF-α, IL-6, NF-κB, IFN-γ and glutamate were estimated using ELISA kits. To assess the involvement of the ERK/MAPK signaling pathway, levels of Nrf2 and ERK2 were also measured.

KEY FINDINGS:

Niclosamide therapy significantly restored behavioral, biochemical, neurological, and molecular impairments. Hence, niclosamide could be a potential neurotherapeutic candidate for further studies for use in ASD.

145

News (Medical) associated with Niclosamide

26 Sep 2024

·www.globenewswire.com

TFF Pharmaceuticals’ Technology Generates Superior Inhalational Dry Powder Formulations for Pulmonary Drug Delivery

Newly published data in the Journal of Drug Delivery Science and Technology demonstrate more uniform drug distribution in the lung compared with other technologiesFORT WORTH, Texas, Sept. 26, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc (Nasdaq: TFFP) (the “Company” or “TFF Pharmaceuticals”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, announces positive preclinical data published in the Journal of Drug Delivery Science and Technology further validating the Company’s TFF technology as superior approach to formulate dry powders for pulmonary drug delivery. The study demonstrates the superiority of TFF inhalational dry powders over jet-milling and spray-drying technologies in a rat model, with enhanced uniform drug distribution in the lungs, lower airway-to-lung distribution ratio, and rapid disaggregation of particles of the TFF powder and subsequent particle movement of the resulting TFF nanoaggregates. In the newly published study, voriconazole dry powder formulations for inhalation were prepared by three different methods: jet-milling, spray-drying, and Thin Film Freezing. The TFF processed voriconazole dry powder, consisting of brittle, easily shearable nanoaggregates, exhibited the most homogeneous distribution in lung tissue, with the lowest airway-to-lung voriconazole deposition ratio (1.27), followed by spray-dried (1.76) and jet-milled (2.73) powders. This enhanced distribution is attributed to the smaller particle size after disaggregation and rapid movement of particles on the liquid surface. The results suggest that TFF inhalational dry powders may enhance treatment efficiency and reduce toxicity for lung diseases, further supporting Thin Film Freezing as a promising technology to formulate dry powders for pulmonary drug delivery. “This is our first head-to-head comparison of TFF powder to powders made by other technologies, administered by inhalation to animals and characterized using mass spectrometry imaging to assess lung drug distribution. We are extremely pleased to confirm our hypothesis that Thin Film Freezing technology leads to the most homogeneous distribution of the drug in the lung,” said Dr. Robert O. Williams III, Co-inventor of TFF technology and Professor at The University of Texas at Austin College of Pharmacy. “These data, which examine formulations of voriconazole manufactured using different particle engineering technologies, suggest that the TFF dry powder technology for inhalation provides clear advantages over jet-milling and spray-drying methods,” said Dr. Harlan Weisman, TFF Pharmaceuticals Chief Executive Officer. “It is gratifying to have the continued support of the scientific community for our approach, and to have ongoing validation of our science. The more rapid and uniform distribution of TFF generated dry powders in the lung with their lower airway to lung deposition ratio differentiate our inhalational products from products generated by other technologies and provide the opportunity to increase efficacy and lower risk of toxicities.” ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGYTFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggest the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products. ABOUT TFF PHARMACEUTICALS TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin. SAFE HARBOR This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the expected benefits of its patented TFF technology platform over jet-milling and spray-drying methods,. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk that further testing may not be consistent with the data to date demonstrating the superiority of the TFF technology platform over jet-milling and spray-drying methods, (ii) the risk that the Company may not be able to obtain additional working capital with which to continue its current operations and clinical trials as and when needed, (iii) success in early phases of pre-clinical and clinical trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 14, 2024.. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake and specifically disclaims any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law. Investor Relations Contact:Core IRJason Nelsoninvestorinfo@tffpharma.com

18 Sep 2024

·www.prnewswire.com

Breakthrough in Long COVID: An investigator-initiated trial (IIT) with Hyundai Bioscience's Xafty by UCSD

SAN DIEGO, Sept. 17, 2024 /PRNewswire/ -- Hyundai Bioscience USA announced that it has signed an MOU with the University of California San Diego (UCSD) to conduct an investigator-initiated trial to evaluate the efficacy of Xafty®, a niclosamide-based antiviral developed by its Korean headquarters, in treating "Long-COVID". The trial will be led by UCSD Professor Ajay Bharti, an infectious disease specialist and clinical trialist. Dr. Bharti's particular expertise in the neurocognitive effects of viral illnesses make him perfectly suited to run the investigator initiated trial. "This is an outstanding opportunity for UC San Diego and Hyundai Bioscience to partner together to tackle Long-COVID," Professor. Davey Smith, Director of the UCSD Altman Clinical and Translational Research Institute (ACTRI) of UCSD and an authority on viral illnesses, especially COVID, said about the collaboration. "There is no therapy currently available for the condition, which affects millions of people around the world." Xafty, an oral antiviral agent, is a new drug that improved the bioavailability of niclosamide, which is known to have antiviral efficacy against more than 30 viruses. It is currently in a phase 3 clinical trial in Korea targeting high-risk groups for COVID-19 and is expected to apply for phase 3 to the U.S. FDA soon. In a previous phase 2 clinical trial, Xafty successfully met the FDA's primary endpoints, demonstrating a faster symptom improvement rate than other existing treatments, especially in high-risk groups. "Being able to reduce symptoms during acute COVID-19 is an impressive accomplishment," Dr. Smith, who has helped run numerous antiviral trials in COVID-19, HIV, and Mpox, said. "Many large recent trials testing antivirals have not had such success. This may point to Xafty's effectiveness in Long-COVID as well." Long-COVID is a complex disease that is suggested to be caused by residual virus, excessive inflammation, and consequent nerve damage. Patients suffer from various symptoms such as chronic fatigue, inflammation, and cognitive decline, but existing treatments rely on a single mechanism and fail to resolve these complex symptoms. This is one of the reasons why a clear treatment for Long-COVID has not yet been developed. Xafty is expected to resolve the complex symptoms of Long-COVID through inflammation inhibition and neuro-protection mechanisms, rather than simply suppressing the virus. It is because niclosamide, Xafty's main pharmaceutical ingredient, is anticipated to provide practical therapeutic effects to patients through multiple mechanisms such as virus removal, suppression of immune hypersensitivity, and recovery of nerve damage. In a recent Parkinson's disease preclinical study conducted by Hyundai Bioscience, Xafty demonstrated to promote dopamine production and nerve cell recovery. When Xafty was administered to a Parkinson's animal model with suppressed dopamine production, a higher dopamine level was confirmed than in the group administered with the existing Parkinson's disease treatment, dopamine precursor (Madopar®), suggesting that it can make a significant contribution to improving symptoms such as brain fog and cognitive impairment due to nerve damage in people with Long-COVID. Dr. Ajay Bharti, the PI of this study, said, "We already knew about the broad-spectrum antiviral efficacy of niclosamide, but after seeing data showing that Xafty, having improved the long-standing problem of bioavailability, showed excellent symptom improvement in a COVID-19 clinical trial, especially in the high-risk group, we came up with the idea of using the drug to treat Long COVID." He added, "In particular, the fact that Xafty recovered neurons in a preclinical study of Parkinson's disease and promoted dopamine production, resulting in higher dopamine levels than the control group that took Madopar®, was an important trigger for this clinical study." Dr. Smith added, "The goal of this study is to confirm that niclosamide can solve the complex symptoms of Long COVID through multiple mechanisms such as virus suppression, inflammation suppression, and neuroprotection. We hope that the clinical trial will be successful and provide a practical treatment option for Long COVID patients, which will be historic." About Hyundai Bioscience Hyundai Bioscience is a biotechnology company that develops drugs based on its novel drug delivery system technologies to deliver active ingredients safely and efficiently to targeted areas of the human body. Founded in 2000, Hyundai Bioscience focuses on repurposing or expanding indications of existing drugs using its proprietary organic-inorganic hybrid technologies. Hyundai Bioscience is a public company listed on KOSDAQ (symbol: 048410) in South Korea. For more information, please contact Ms. Joobin Jung, Global PR Manager ([email protected]). SOURCE Hyundai Bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultPhase 2

11 Sep 2024

·endpts.com

Xencor’s $175M offering; Viridian to raise $150M

Plus, news about Hyundai Bioscience, Clear Scientific and Terns Pharmaceuticals: Xencor prices $175M offering: The Pasadena, CA-based biotech made the financing move after announcing drug candidates in autoimmune diseases earlier in the week. — Kyle LaHucik Viridian’s $150M offering: The Waltham, MA-based company kicked off the stock sale the same day as disclosing Phase 3 data in thyroid eye disease. — Kyle LaHucik Hyundai Bioscience touts broad-spectrum antiviral: The Korean biotech said its candidate, Xafty, has shown promise against several viral infections in animal, cell and clinical studies. The niclosamide reformulation, which was developed using Hyundai’s proprietary drug delivery technology, is currently in a Phase 3 trial for high-risk Covid-19 patients. — Ayisha Sharma Clear Scientific reveals safety data for overdose drug: The Cambridge, MA-based biotech said CS-1103 demonstrated a “favorable safety and tolerability profile” in a Phase 1 trial of 32 healthy volunteers. The company is planning to advance the small molecule sequestrant into Phase 2 development for meth and fentanyl overdose, set to start in early 2025. — Ayisha Sharma Terns Pharmaceuticals upsizes share sale : The drugmaker priced a $150 million offering after originally planning to raise $125 million on the back of Phase 1 obesity data revealed earlier this week. — Kyle LaHucik

Phase 1Phase 3Clinical ResultPhase 2

100 Deals associated with Niclosamide

External Link

KEGG	Wiki	ATC	Drug Bank
D00436	Niclosamide	P02DA01	DB06803

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ascariasis	US	Bayer Pharmaceuticals Corp.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	US	Neuromed Pharmaceuticals Ltd.	30 Jan 2022
Diabetic Nephropathies	Phase 3	EG	Tanta University	01 Feb 2020
Gastrointestinal infection	Phase 2	US	Entero Therapeutics, Inc.	30 Apr 2021
Gastrointestinal infection	Phase 2	IN	Entero Therapeutics, Inc.	30 Apr 2021
Gastrointestinal infection	Phase 2	UA	Entero Therapeutics, Inc.	30 Apr 2021
Proctocolitis	Phase 2	IT	Entero Therapeutics, Inc.	15 May 2018
Ulcerative proctitis	Phase 2	IT	Entero Therapeutics, Inc.	15 May 2018
Crohn Disease	Phase 1	-	First Wave Bio, Inc.	-
Dengue	Preclinical	KR	Hyundai Pharmaceutical Co., Ltd.	11 Sep 2024
Monkeypox	Preclinical	KR	Hyundai Pharmaceutical Co., Ltd.	11 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04858425 (RESERVOIR, CTgov)	Phase 2	COVID-19 \| Gastrointestinal infection	166	Niclosamide (Niclosamide)	gmjbqvavvm(fcccodpanj) = vrklvyhbmx qlzaxctmrc (ovyscoobqj, eumhhyckrs - zpxuxbslpu) View more	-	24 Jul 2024
				Placebo (Placebo)	gmjbqvavvm(fcccodpanj) = axyaibhhem qlzaxctmrc (ovyscoobqj, mwqiqtqgiu - dyxunzeafw) View more
NCT04317430 (Literature) Manual	Phase 3	Diabetic Nephropathies	60	niclosamide+ramipril	hjukneknpt(bpnqipaawa) = pfpxnxszwn mdlnkplqph (xkxbgotobj, -30 to -18.3) View more	Positive	16 Feb 2023
				ramipril	hjukneknpt(bpnqipaawa) = mqtzjvpubv mdlnkplqph (xkxbgotobj, 4 - 18.2) View more
NCT04399356 (Pubmed) Manual	Phase 2	COVID-19	73	Niclosamide	vfyzvgppxu(nzkvzyaywa) = jpiaigkcjz xzslprsdkx (lyhsffiagw, 50.74 - 81.81) View more	Negative	01 Feb 2022
				Placebo	vfyzvgppxu(nzkvzyaywa) = vizljookid xzslprsdkx (lyhsffiagw, 40.27 - 72.73) View more
NCT02807805 (ASCO2018)	Phase 2	Castration-Resistant Prostatic Cancer	6	Niclosamide/PDMX1001 + Abiraterone + Prednisone	hartokxfwg(gxdugjgcgo) = two with partial PSA response (≥50% decrease) twtijnvsut (emqkizmmrh ) View more	Positive	01 Jun 2018
ASN2016	Not Applicable	Reperfusion Injury	-	Niclosamide	zxenfdppvk(oevzjgjvuy) = I/R-induced fatty acid deposition in tubular epithelium was almost diminished in niclosamide-treated mice ghenoylvfe (cdsybzkykv ) View more	Positive	15 Nov 2016

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