Delving into the Latest Updates on Niclosamide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

FW-CD, FW-COV, FW-ICI-AC

+ [28]

Target-

Action-

Mechanism

Mitochondrial oxidative phosphorylation uncouplers

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesImmune System Diseases+ [6]

Active Indication

DengueCOVID-19Proctocolitis+ [10]

Inactive Indication

AscariasisCrohn DiseaseDermatitis, Contact+ [5]

Originator Organization

Bayer Pharmaceuticals Corp.

Active Organization

Hyundai Pharmaceutical Co., Ltd.

First Wave Bio, Inc.

Daewoong Pharmaceutical Co., Ltd.

+ [9]

Inactive Organization

GridAI Technologies Corp.

Bayer AGBayer Pharmaceuticals Corp.

+ [1]

License Organization

Aeon Respire, Inc.

UNION Therapeutics A/S

GridAI Technologies Corp.

+ [5]

Drug Highest PhasePhase 2/3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC13H10Cl2N2O5

InChIKeyZBXRPLQCPHTHLM-UHFFFAOYSA-N

CAS Registry73360-56-2

Type 2 diabetes-associated cognitive dysfunction (TDACD) is a debilitating complication characterized by neuroinflammation and oxidative stress, yet its underlying molecular mechanisms remain incompletely understood. The signal transducer and activator of transcription 3 (STAT3) pathway is increasingly implicated in neurodegeneration, but its specific role in TDACD and its interplay with the nuclear factor erythroid 2-related factor 2 (Nrf2) antioxidant defense system have not been fully elucidated. This study investigated the therapeutic potential of targeting STAT3 in TDACD using both pharmacological inhibition with niclosamide and specific genetic silencing strategies. In a high-fat diet (HFD) plus streptozotocin (STZ)-induced TDACD mouse model, STAT3 inhibition significantly ameliorated cognitive deficits and reduced neuronal pathology, including amyloid-β and phosphorylated Tau accumulation. Mechanistically, inhibition of STAT3 signaling suppressed neuroinflammation and reactive astrogliosis while simultaneously promoting the nuclear translocation of Nrf2 and the expression of downstream antioxidant enzymes. These effects were also reproduced in vitro using primary astrocytes exposed to high glucose. Specific STAT3 knockdown reversed the pro-inflammatory A1 phenotype and restored redox balance in these cells. Crucially, silencing Nrf2 eliminated the protective effects of STAT3 inhibition, suggesting a functional regulatory axis between STAT3 and Nrf2. Collectively, our findings support that STAT3 inhibition ameliorates cognitive dysfunction by disinhibiting the Nrf2 pathway to restore redox homeostasis and shift astrocytes towards a neuroprotective phenotype, highlighting the STAT3-Nrf2 axis as a promising therapeutic target for TDACD.

01 Jun 2026·CHEMICO-BIOLOGICAL INTERACTIONS

Old molecules, new hope: A scoping review and bibliometric analysis of drug repurposing for lung cancer

Review

Author: Pontarolo, Roberto ; Lazo, Raul Edison Luna ; Ragassi, Wellington Martins de Carvalho ; Ferreira, Luana Mota ; Alves, Fernando Miguel Stelmach ; Tonin, Fernanda Stumpf ; Sari, Marcel Henrique Marcondes

Drug repurposing has gained prominence in oncology by enabling the investigation of approved drugs for new therapeutic purposes. In lung cancer, this strategy may reduce the time and costs associated with drug development. This study aimed to map the landscape of in silico, in vitro, in vivo, and clinical research on drug repurposing for lung cancer, while identifying key molecular targets and research gaps. A systematic search was conducted in PubMed, Embase, and Web of Science, following Joanna Briggs Institute and PRISMA-ScR guidelines. Two reviewers independently selected and extracted the data. A total of 58 studies, published between 2010 and 2024-mainly from the United Kingdom (19%) and United States (17%), were included. Most studies used in vitro models (53%), followed by in vivo (31%) and in silico (16%), with frequent combinations of methods. The most investigated drug classes were antibiotics (10%), antipsychotics (9%), antidiabetics (8%), anthelmintics (6%), and antihistamines (6%). Frequently studied drugs included niclosamide, metformin, atorvastatin, and doxazosin, targeting pathways such as PI3K/AKT/mTOR, apoptosis, and autophagy. Bibliometric analysis revealed increasing scientific output, with emphasis on combination therapies, cellular mechanisms, and technologies like molecular docking and nanosystems. These findings highlight the growing relevance of drug repurposing in lung cancer, especially in accelerating effective therapy discovery using approved compounds. Progress in this field depends on integrating diverse methodologies and fostering interdisciplinary collaboration. As a next step, rigorous clinical trials are essential to confirm the efficacy and safety of promising repurposed agents in oncology.

19 May 2026·ANALYTICAL CHEMISTRY

Aerosol Jet Printed Ag Micropillar Arrays Coupled with PEDOT:PSS for High-Performance Electrochemical Sensing of Niclosamide

Article

Author: Yi, Hao ; Luo, Jun ; Cao, Huajun ; Liu, Yunhang

In this study, an aerosol-jet-printed silver micropillar array was introduced onto the surface of a screen-printed carbon electrode (SPCE) and further coated with a poly(3,4-ethylenedioxythiophene): poly(styrenesulfonate) (PEDOT:PSS) functional film, yielding a three-dimensional hierarchical electrode for high-performance electrochemical detection of niclosamide (NA). The silver micropillar arrays form a three-dimensional microelectrode network on the working electrode surface, where the pillar tops and sidewalls markedly increase the electrochemically active area and facilitate mass transport toward the electrode interface, thereby enhancing analyte flux and amplifying the Faradaic response. In addition, PEDOT:PSS as a mixed ionic-electronic conductor, establishes a continuous and stable reaction interface on the silver-pillar scaffold, which not only improves interfacial wettability and charge/ion transport but also promotes interfacial enrichment of NA via its functionalized polymer network. Benefiting from the synergistic effects of three-dimensional structural amplification and conductive-polymer-mediated interfacial regulation, the fabricated Ag@PEDOT:PSS/SPCE sensor exhibits a good linear response over 0.01-15 μM with a limit of detection as low as 1.73 nM. Meanwhile, the sensor demonstrates excellent repeatability, reproducibility, and anti-interference performance, and it was successfully applied to the quantitative determination of NA in tap water and oolong tea samples with satisfactory recoveries and accuracy, indicating strong potential for practical applications.

155

News (Medical) associated with Niclosamide

25 May 2026

·www.prnewswire.com

Hyundai Bioscience Discloses XAFTY®'s IC50 Data for Ebola--"Secured Scientific Evidence for Immediate Treatment"

Ebola IC50 (0.125μM)—Strong inhibition at less than half the concentration of the clinically-tested COVID-19 (0.28μM). Clinical safety confirmed through COVID-19 and Dengue clinical trials. Class-wide efficacy proven by accumulated research data for Hantavirus treatment. Davey Smith, Professor, UC San Diego, "IC50 is a key indicator to estimate clinical efficacy." SEOUL, South Korea, May 20, 2026 /PRNewswire/ -- Hyundai Bioscience announced on May 20th that XAFTY® has a strong likelihood of being able to treat Ebola and Hantavirus given its low IC50 (50% inhibitory concentration) for those viruses. Amid the current crisis of these two often fatal infectious diseases XAFTY® should be considered for testing. Efficacy against Ebola, More Than Double That Against COVID-19— Ready for Immediate Administration The IC50 data is the drug concentration that can inhibit viral replication by 50%. The lower the value, the stronger the antiviral effect with a smaller amount. XAFTY® has as IC50 level of 0.28 μM against SARS-CoV-2, the pathogen in COVID-19, and has already proven its therapeutic efficacy in human COVID-19 clinical trials. The IC50 level of XAFTY® is even lower for the Ebola virus at 0.125 μM. This suggests that XAFTY® could be a promising agent to treat Ebola-infected patients. Safety Proven by COVID-19 Clinical Trials—Immediate Supply Available XAFTY® proved its safety through the COVID-19 Phase 2/3 clinical trials and an ongoing Dengue Phase 2/3 clinical trial in Vietnam. No severe adverse events have been reported so far across all dosage groups, reaffirming its clinical safety. Hyundai Bioscience reports that it has enough drug inventory for immediate supply to the outbreak frontlines. Antiviral Efficacy Against Hantavirus Expected XAFTY® has reported on its broad antiviral activity. It demonstrated exceptional inhibitory efficacy of less than 0.125 μM against the Severe Fever with Thrombocytopenia Syndrome (SFTS) virus, which serves as scientific evidence for activity against Hantavirus. Both SFTS virus and Hantavirus belong to the same virus class. Dr. Davey Smith, University of California-San Diego (UCSD) professor and virologist said, "The clinical efficacy of an antiviral drug may be predicted by its IC50 level against that virus." He added, "XAFTY® is a drug that has already demonstrated safety in humans, and should be strongly considered for Ebola." Dr. Bae Byoungjun, President of Hyundai Bioscience, said, "In a critical outbreak situation, the success or failure of treatment is to be determined not by therapeutic potentials, but by proven efficacy and safety that can be supplied immediately." SOURCE Hyundai Bioscience 21% more press release views with Request a Demo

Clinical Study

20 May 2026

·www.prnewswire.com

Hyundai Bioscience: "Able to Supply Antiviral Drug in Event of Ebola or Hantavirus Spread"

SEOUL, South Korea, May 20, 2026 /PRNewswire/ -- Hyundai Bioscience announced on May 19th that it can supply clinical trial doses of its broad-spectrum antiviral drug XAFTY® in response to growing global concern over infectious disease outbreaks caused by Ebola and hantavirus. Hyundai Bioscience said that if the World Health Organization (WHO) or countries affected by infectious disease outbreaks request support for XAFTY®, it can immediately provide products currently in stock. According to the company, niclosamide, the main ingredient of XAFTY®, has previously been reported to have inhibitory effects against Ebola and hantavirus. The company stated, "In the ongoing Phase 2 clinical trial of XAFTY® for dengue fever in Vietnam, no adverse events have been reported so far," and claimed that "in a situation where two viruses are spreading simultaneously, XAFTY® could serve as an effective alternative." Hyundai Bioscience added that, as a member of the Medical CBRN Defense Consortium (MCDC), a U.S. Department of Defense-supported consortium, it will actively cooperate in responding to international public health crises. CONTACT： Jason Kim [email protected] (562) 964-3910 SOURCE Hyundai Bioscience 21% more press release views with Request a Demo

Phase 2

15 Jan 2026

·www.prnewswire.com

Hyundai Bioscience Confirms Entry into U.S. FDA Phase 2 Trials for Broad-Spectrum Antiviral 'XAFTY' Following 2026 Biotech Showcase Consensus

- UCSD's Dr. Davey Smith, former ACTIV-2 Protocol Chair, endorses 'Xafty' as "The weapon to end the virus war." - Announces "One Drug, Two Tracks" strategy: Targeting Dengue in Vietnam and Respiratory Viruses (Flu, COVID, RSV) in the U.S. with the same drug. - Dr. Davey Smith: "With this multi-virus treatment, 2026 may mark the inaugural year of modern treatments that can treat multiple viruses with one drug, perhaps even viruses that haven't hit us yet." SAN FRANCISCO, Jan. 14, 2026 /PRNewswire/ -- Hyundai Bioscience (KOSDAQ: 048410) today announced a groundbreaking roadmap to combat global viral epidemics, officially declaring its entry into Phase 2 clinical trials in the United States. Presenting at the Biotech Showcase 2026, the company unveiled its pre-emptive therapeutic strategy using Xafty™, a broad-spectrum antiviral drug. The presentation highlighted a bold transition: "Preparation in Vietnam is complete. Now, it is America." - Dr. Davey Smith: "The Broad-Spectrum Weapon We Have Been Waiting For." The core of the announcement centered on the clinical strategy designed in collaboration with Dr. Davey Smith, Professor of Medicine and Assistant Vice Chancellor at the University of California, San Diego (UCSD). Dr. Smith, a world-renowned expert who previously led the U.S. government's ACTIV-2 COVID-19 trials, diagnosed the current U.S. healthcare crisis as a "tripledemic" of Influenza, RSV, and COVID-19 variants, for which there is no unified countermeasure. In a statement regarding the new clinical design, Dr. Smith emphasized, "We now have a promising weapon to fight multiple viruses at the same time. Xafty's 'Basket Trial' design is the only efficient way to solve this multi-viral crisis." He further urged, "There is no time to lose. We must proceed with the trials necessary with maximum speed to deliver this solution to patients who are currently defenseless." - "One Drug, Two Tracks": A Universal Solution Hyundai Bioscience presented its unique "One Drug, Two Tracks" global strategy. The company is using the same drug (Xafty) to target: * Dengue Fever in Vietnam (Track 1) * Upper-Respiratory Infection Viruses in the US (Track 2) This approach validates the drug's breadth and potency, demonstrating its potential to treat both mosquito-borne and respiratory viral infections. This mechanism is analogous to modern antibiotics that can treat multiple bacterial types with a single drug. Mr. Jason Kim, CEO of Hyundai Bioscience USA, stated, "At the showcase, we confirmed that our strategy, designed with Dr. Smith, perfectly aligns with the unmet needs of the U.S. medical field. Our preparation is complete. We are ready to submit our IND application to the FDA immediately." - Vision: "2026, The Inaugural Year of a Virus-Free Era" The announcement concluded with a historic vision for global public health, articulated by Dr. Smith. "For too long, we have been chasing after variants," Dr. Smith noted. "But with this pre-emptive, broad-spectrum approach, we are finally getting ahead of the curve. I am confident that this trial will be a turning point for modern antivirals that can tackle multiple viruses with one drug." About Hyundai Bioscience: Hyundai Bioscience is a biotechnology company focused on developing novel drug delivery systems (DDS) to repurpose existing drugs for new therapeutic applications. The company is a member of the US Medical CBRN Defense Consortium (MCDC). Its lead candidate, Xafty (CP-COV03), is an oral antiviral drug based on niclosamide, modified for enhanced bioavailability. This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially. The Company undertakes no obligation to update these statements except as required by law. Media Contact: Jason Kim [email protected] (562)964-3910 SOURCE Hyundai Bioscience 21% more press release views with Request a Demo

Phase 2

100 Deals associated with Niclosamide

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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	United States	Bayer Pharmaceuticals Corp.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dengue	Phase 3	Vietnam	HYUNDAI BIOSCIENCE Co., Ltd.	09 Apr 2026
COVID-19	Phase 3	United States	Neuromed Pharmaceuticals Ltd.	30 Jan 2022
Diabetic Nephropathies	Phase 3	Egypt	Tanta University	01 Feb 2020
Infection of digestive system	Phase 2	United States	GridAI Technologies Corp.	30 Apr 2021
Infection of digestive system	Phase 2	India	GridAI Technologies Corp.	30 Apr 2021
Infection of digestive system	Phase 2	Ukraine	GridAI Technologies Corp.	30 Apr 2021
Malignant Fibrous Histiocytoma	Phase 2	Austria	First Wave Bio, Inc.	04 Mar 2021
Mild Atopic Dermatitis	Phase 2	Bulgaria	UNION Therapeutics A/S	22 Oct 2019
Mild Atopic Dermatitis	Phase 2	Denmark	UNION Therapeutics A/S	22 Oct 2019
Mild Atopic Dermatitis	Phase 2	Poland	UNION Therapeutics A/S	22 Oct 2019

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04603924 (CTgov)	Phase 2/3	COVID-19	49	Niclosamide (ANA001)	izxmvzktqs = fomvwfkegd nfjovwqvse (yeyjcsgips, jxlbxfjika - fcwpipnpno) View more	-	15 May 2025
				Placebo (Matching Placebo)	izxmvzktqs = ltgyramhdy nfjovwqvse (yeyjcsgips, bfougwenyd - nishplulwx) View more
NCT04705415 (CTgov)	Phase 1	-	54	Niclosamide (SAD Cohort 1: ANA001 1000 mg po)	hamigmtnxe = xcyuvoctkq ojmvsyzcfx (wvxpoutnxn, azurjphmqd - qxxuydxmwz) View more	-	03 Feb 2025
				Niclosamide (SAD Cohort 2: ANA001 2000 mg po)	hamigmtnxe = upbkxbdxht ojmvsyzcfx (wvxpoutnxn, isazxzzofx - ccqidzjftw) View more
NCT04858425 (RESERVOIR, CTgov)	Phase 2	COVID-19 \| Infection of digestive system	166	Niclosamide (Niclosamide)	gysidrnapx = nbohzzbfmo ltijzczvuk (ugksuljrmq, uqcvnxefdl - fygjrprnpi) View more	-	24 Jul 2024
				Placebo (Placebo)	gysidrnapx = sqdlwzaulx ltijzczvuk (ugksuljrmq, axrggxpetc - efhggarrhn) View more
NCT04317430 (Literature \| Pubmed \| Diabetol Metab Syndr) Manual	Phase 3	Diabetic Nephropathies	60	niclosamide+ramipril	fgquwldewd(gycopsuwag) = inxuwirivi mmzovcinby (lqqtylenem, -30 to -18.3) View more	Positive	16 Feb 2023
				ramipril	fgquwldewd(gycopsuwag) = zcywniucko mmzovcinby (lqqtylenem, 4 - 18.2) View more
NICLOSAMIDE ENEMAS (DDW2022)	Not Applicable	Proctocolitis First line fecal calprotectin levels	17	Niclosamide enemas 150 mg/60 ml	yyigkbinlp(webqdvaqtv) = itcaxtiqqw fqnkmqllyx (hwrmwsrvfn ) View more	Positive	24 May 2022
NCT04399356 (CTgov)	Phase 2	COVID-19	73	Niclosamide (Niclosamide- Experimental Group)	cacikbajmw(wazlncttqe) = mtxpcfmihs hndkqonira (moteggvigm, okucjwktgn - ghmynpmdsd) View more	-	12 Apr 2022
				placebo (Control Group)	cacikbajmw(wazlncttqe) = zvmbdubftv hndkqonira (moteggvigm, cfojfymwjv - tjqelaniaq) View more
NCT04399356 (Pubmed) Manual	Phase 2	COVID-19	73	Niclosamide	pybaxkgaos(ofkixzniun) = cpjhwxxzcp ujkwxabcxv (cefdvgwnpu, 50.74 - 81.81) View more	Negative	01 Feb 2022
				Placebo	pybaxkgaos(ofkixzniun) = pavhcysgul ujkwxabcxv (cefdvgwnpu, 40.27 - 72.73) View more
NCT04576312 (Pubmed) Manual	Phase 1	COVID-19	44	UNI91104	deerxbiwbp(zmwlshxuhh) = nzssupdfkn hclbxvpzkz (oaqqxgzdre )	Positive	01 May 2021
				Placebo	deerxbiwbp(zmwlshxuhh) = dvizlwijdv hclbxvpzkz (oaqqxgzdre )
NCT02807805 (ASCO2018)	Phase 2	Castration-Resistant Prostatic Cancer	6	Niclosamide/PDMX1001 + Abiraterone + Prednisone	pbfderbfdr(hkexajxusw) = two with partial PSA response (≥50% decrease) znjrdgmuto (ylqxmzfvnu ) View more	Positive	01 Jun 2018