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Developed by 
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Supported by 
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Niclosamide
Developer(s)
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Bayer https://www.bayer.com/en/Germany Bayer AG is a multinational pharmaceutical company that develops a wide range of chemical products and medicines for consumer healthcare, industrial biotechnology and agricultural purposes. Headquartered in Leverkusen, Bayer was originally founded in 1863 and is currently listed on the EURO STOXX 50 index. |
Drug structure
Niclosamide Chemical Structure
Sourced from Drugbank
Drug information
Associated long-acting platforms
Aqueous drug particle suspension
Administration route
Intramuscular
Therapeutic area(s)
Use case(s)
Use of drug
Ease of administration
User acceptance
Not provided
Dosage
Available dose and strength
Not provided
Frequency of administration
Not provided
Maximum dose
Not provided
Recommended dosing regimen
Not provided
Additional comments
Not provided
Dosage link(s)
Not provided
Drug information
Drug's link(s)
Not provided
Generic name
Brand name
Compound type
Summary
Approval status
Regulatory authorities
Delivery device(s)
No delivery device
Scale-up and manufacturing prospects
Scale-up prospects
Formulations for long-acting NCL are currently in preclinical development. Researchers from the Centre of Excellence for Long-acting Therapeutics (CELT) at the University of Liverpool have recently developed a highly innovative redispersible solid drug nanoparticle (SDN) formulation that utilises nanoprecipitation methods similar to those already utilised in commercial-scale production of beta-carotene particles for foodstuffs and agriculture. Successful industrial scale-up of the spray-dried dispersion may require potential optimisation of the mixing process using high shear mixer geometries.
Tentative equipment list for manufacturing
Detailed information regarding industrial manufacturing requirements and/or equipment lists is currently not available as long-acting niclosamide formulations have been only been produced at small-scale for research use.
Manufacturing
The previously mentioned formulation developed by researchers from CELT at the University of Liverpool can be stored as a solid dry powder and reconstituted into an aqueous solution through the addition of water prior to administration.
Specific analytical instrument required for characterization of formulation
Dynamic light scattering equipment (Malvern Panalytical ZetaSizer Ultra Photon Correlation Spectroscope) to characterise the dry powder formulation. 1H nuclear magnetic spectroscopy to determine drug loading at 60 wt% relative to excipients using BzMA internal standard.
Clinical trials
Not providedExcipients
Proprietary excipients used
No proprietary excipient used
Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration
Not provided
Residual solvents used
No residual solvent used
Patent info
Description
Gastropod combating compositions
Brief description
Gastropod combating compositions
Representative patent
GB824345
Category
compound
Patent holder
Bayer AG
Exclusivity
Not provided
Expiration date
September 19, 1976
Status
Expired
Supporting material
Publications
Hobson JJ , Savage AC , Dwyer AB , Unsworth C , Massam J , Arshad U , Pertinez H , Box H , Tatham L , Rajoli RKR , Neary M , Sharp J , Valentijn A , David C , Curley P , Liptrott NJ , McDonald TO , Owen A , Rannard SP . Scalable nanoprecipitation of niclosamide and in vivo demonstration of long-acting delivery after intramuscular injection. Nanoscale. 2021 Apr 7;13(13):6410-6416. DOI: https://doi.org/10.1039/d1nr00309g. Epub 2021 Mar 25. PMID: 33885522.
The control of COVID-19 across the world requires the formation of a range of interventions including vaccines to elicit an immune response and immunomodulatory or antiviral therapeutics. Here, we demonstrate the nanoparticle formulation of a highly insoluble drug compound, niclosamide, with known anti SARS-CoV-2 activity as a cheap and scalable long-acting injectable antiviral candidate.
Additional documents
No documents were uploaded
Useful links
There are no additional links
Access principles
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Collaborate for developmentConsider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology Not provided |
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Share technical information for match-making assessmentProvide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit Not provided |
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Work with MPP to expand access in LMICsIn the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing Not provided |
Comment & Information
Not provided