IMPDH inhibitors(Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitors), RNAP inhibitors(Bacterial DNA-directed RNA polymerase inhibitors), mRNA guanylyltransferase inhibitors

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Compensated cirrhosisHepatitis CHepatitis C, Chronic+ [1]

Inactive Indication

Acute hepatitisAnemiaChronic hepatitis C genotype 1+ [16]

Originator Organization

Bausch Health Cos., Inc.

Active Organization

Merck Sharp & Dohme Corp.

Chugai Pharmaceutical Co., Ltd.Bausch Health US LLC

+ [1]

Inactive Organization

ANRS, Emerging Infectious Diseases

AbbVie, Inc.Biopartners GmbH

+ [10]

Drug Highest PhaseApproved

First Approval Date

US (31 Dec 1985),

Respiratory Syncytial Virus Infections

RegulationOrphan Drug (US)

Structure

Molecular FormulaC8H12N4O5

InChIKeyIWUCXVSUMQZMFG-AFCXAGJDSA-N

CAS Registry36791-04-5

915

Clinical Trials associated with Ribavirin

NCT06212336 / Not yet recruitingPhase 2/3IIT

Efficacy, Tolerability and Safety of New or Repurposed Drugs Against Lassa Fever in West African Countries

Lassa fever (LF) is a viral haemorrhagic fever responsible of 5000 deaths per year in West Africa, with in-hospital mortality at 12%. Transmission to humans occurs mainly via direct or indirect exposure to excreta from the rodent reservoir, mainly made up of Mastomys natalensis . Less frequently, LASV may also be transmitted from human to human and cause nosocomial outbreaks. Ribavirin is the only treatment available with worrying toxicity, questionable efficacy and low access because of its high cost. Consequently, there is an urgent need for new drugs to treat LF patients. The Research and Development (R&D) Blueprint of the World Health Organization (WHO) has included LF in the list of priority diseases for urgent research and development.
The INTEGRATE consortium is an unprecedented international collaboration on Lassa fever of 15 partners from 10 countries across West Africa, Europe and North America and across several disciplines (epidemiological researchers, social scientists, medical health facility professionals, humanitarian actors, etc.).

Start Date01 Jul 2024

Sponsor / Collaborator

Bernhard-Nocht-Institut für Tropenmedizin

[+6]

ChiCTR2400082642 / RecruitingEarly Phase 1IIT

A randomized controlled study on the safety and efficacy of a ribavirin spray for the treatment of allergic rhinitis

Start Date02 Apr 2024

Sponsor / Collaborator-

NCT06222723 / Not yet recruitingPhase 2

Safety and Tolerability of Adjunct Dexamethasone in Addition to Standard of Care Antiviral Therapy Compared to Standard of Care Antiviral Therapy Alone for the Treatment of Moderate to Severe Lassa Fever

Dexamethasone is a corticosteroid which can modulate inflammatory-mediated tissue damage associated with a wide range of infectious diseases. Dexamethasone is routinely used for treatment of tuberculous meningitis and for pneumococcal meningitis in adults. In Coronavirus Disease 2019 (COVID-19) dexamethasone is also effectively preventing immune mediated damage of the lungs. There is also indication that dexamethasone may be promising in severe LF.

Start Date01 Jan 2024

Sponsor / Collaborator

Bernhard-Nocht-Institut für Tropenmedizin

100 Clinical Results associated with Ribavirin

100 Translational Medicine associated with Ribavirin

100 Patents (Medical) associated with Ribavirin

15,209

Literatures (Medical) associated with Ribavirin

01 Mar 2024·American journal of biological anthropology

Article

Author: Kivell, Tracy L ; Dunmore, Christopher J ; Skinner, Matthew M ; Tocheri, Matthew W ; Bird, Emma E

Abstract:

Objectives:

This research examines whether the distribution of trabecular bone in the proximal capitates of extant hominids, as well as several fossil hominin taxa, is associated with the oblique path of the midcarpal joint known as the dart‐thrower's motion (DTM).

Materials and Methods:

We analyzed proximal capitates from extant (Pongo n = 12; Gorilla n = 11; Pan n = 10; fossil and recent Homo sapiens n = 29) and extinct (Australopithecus sediba n = 2; Homo naledi n = 1; Homo floresiensis n = 2; Neandertals n = 3) hominids using a new canonical holistic morphometric analysis, which quantifies and visualizes the distribution of trabecular bone using relative bone volume as a fraction of total volume (rBV/TV).

Results:

Homo sapiens and Neandertals had a continuous band of high rBV/TV that extended across the scaphoid, lunate, and hamate subarticular regions, but other fossil hominins and extant great apes did not. A. sediba expressed a distinct combination of human‐like and Pan‐like rBV/TV distribution. Both H. floresiensis and H. naledi had high rBV/TV on the ulnar‐side of the capitate but low rBV/TV on the radial‐side.

Conclusion:

The proximal capitates of H. sapiens and Neandertals share a distinctive distribution of trabecular bone that suggests that these two species of Homo regularly load(ed) their midcarpal joints along the full extent of the oblique path of the DTM. The observed pattern in A. sediba suggests that human‐like stress at the capito‐scaphoid articular surface was combined with Pan‐like wrist postures, whereas the patterns in H. floresiensis and H. naledi suggest their midcarpal joints were loaded differently from that of H. sapiens and Neandertals.

01 Mar 2024·Journal of ethnopharmacology

Article

Author: Chen, Xiuyun ; Yin, Mingyu ; He, Jinyang ; Huang, Wenguan ; Xie, Xinyuan ; Chen, Yuan ; Liu, Yatian ; Li, Wanxi ; Zhang, Xinyu ; Luo, Minyi ; Ai, Ying ; Li, Junlin ; Xie, Lei

ETHNOPHARMACOLOGICAL RELEVANCE:

Coronavirus Disease 2019 (COVID-19) is a grave and pervasive global infectious malady brought about by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), posing a significant menace to human well-being. Qingfei Paidu decoction (QFPD) represents a pioneering formulation derived from four classical Chinese medicine prescriptions. Substantiated evidence attests to its efficacy in alleviating clinical manifestations, mitigating the incidence of severe and critical conditions, and reducing mortality rates among COVID-19 patients.

AIM OF THE STUDY:

This study aims to investigate the protection effects of QFPD in mice afflicted with a coronavirus infection, with a particular focus on determining whether its mechanism involves the NLRP3 signaling pathway.

MATERIALS AND METHODS:

The coronavirus mice model was established through intranasal infection of Kunming mice with Hepatic Mouse Virus A59 (MHV-A59). In the dose-effect experiment, normal saline, ribavirin (80 mg/kg), or QFPD (5, 10, 20 g/kg) were administered to the mice 2 h following MHV-A59 infection. In the time-effect experiment, normal saline or QFPD (20 g/kg) was administered to mice 2 h post MHV-A59 infection. Following the assessment of mouse body weights, food consumption, and water intake, intragastric administration was conducted once daily at consistent intervals over a span of 5 days. The impact of QFPD on pathological alterations in the livers and lungs of MHV-A59-infected mice was evaluated through H&E staining. The viral loads of MHV-A59 in both the liver and lung were determined using qPCR. The expression levels of genes and proteins related to the NLRP3 pathway in the liver and lung were assessed through qPCR, Western Blot analysis, and immunofluorescence.

RESULTS:

The administration of QFPD was shown to ameliorate the reduced weight gain, decline in food consumption, and diminished water intake, all of which were repercussions of MHV-A59 infection in mice. QFPD treatment exhibited notable efficacy in safeguarding tissue integrity. The extent of hepatic and pulmonary injury, when coupled with QFPD treatment, demonstrated not only a reduction with higher treatment dosages but also a decline with prolonged treatment duration. In the dose-effect experiment, there was a notable, dose-dependent reduction in the viral loads, as well as the expression levels of IL-1β, NLRP3, ASC, Caspase 1, Caspase-1 p20, GSDMD, GSDMD-N, and NF-κB within the liver of the QFPD-treated groups. Additionally, in the time-effects experiments, the viral loads and the expression levels of genes and proteins linked to the NLRP3 pathway were consistently lower in the QFPD-treated groups compared with the model control groups, particularly during the periods when their expressions reached their zenith in the model group. Notably, IL-18 showed only a modest elevation relative to the blank control group following QFPD treatment.

CONCLUSIONS:

To sum up, our current study demonstrated that QFPD treatment has the capacity to alleviate infection-related symptoms, mitigate tissue damage in infected organs, and suppress viral replication in coronavirus-infected mice. The protective attributes of QFPD in coronavirus-infected mice are plausibly associated with its modulation of the NLRP3 signaling pathway. We further infer that QFPD holds substantial promise in the context of coronavirus infection therapy.

01 Mar 2024·Semergen

Análisis de las notificaciones de úlceras cutáneas inducidas por medicamentos en España

Article

Author: Marín Murillo, P ; Esteban Jiménez, Ó ; Ioakeim Skoufa, I ; Navarro Pemán, C ; Esteban Jiménez, J J

AIM:

To study the role of drugs in the aetiology of skin ulcers.

MATERIAL AND METHOD:

A comprehensive study of all spontaneous reports related to skin ulcers that appear in the Spanish Pharmacovigilance System of Medicines for Human Use database.

RESULTS:

A total of 292 reports were identified containing suspected adverse drug reactions (ADRs) of ulcer lesion type. Three hundred sixty-nine medications with 427 active ingredients were identified. The ulcers appeared mainly in women with a mean age of 56.6 years. The most frequently reported suspected drugs were SGLT-2, vaccines against COVID-19, methotrexate, hydroxycarbamide, trimethoprim-sulfamethoxazole, foscarnet trisodium hexahydrate, ribavirin, docetaxel, acenocumarol and imiquimod, and the combination of lidocaine Hcl-pentosan polysulfate sodium-triamcinolone acetonide.

DISCUSSION:

Numerous medications may cause ulcers as an adverse reaction. This possibility should not be ruled out when a new skin lesion appears after the administration of new drugs since 25% of the ADRs were unknown at the time of their notification, as were the cases of ulcers associated with i-SGLT2 and vaccines against COVID at the beginning of their commercialization. However, informative health alerts can be generated by continuously notifying suspected ADRs, so we strongly advise reporting any suspected ADRs to the regional pharmacovigilance system.

News (Medical) associated with Ribavirin

10 Jun 2024

·www.sciencedaily.com

How human derived RNA fragments help the Hepatitis E virus

Why does Hepatitis E become chronic in some patients, and why do medications not work? To find out, an international research team led by scientists from Bochum observed a patient with chronic Hepatitis E infection over a year. Repeated sequencing of the virus RNA showed that the virus incorporated various parts of the host's messenger RNA into its genome. This resulted in a replication advantage, which may have contributed to the infection becoming chronic. Why does Hepatitis E become chronic in some patients, and why do medications not work? To find out, an international research team led by scientists from Bochum observed a patient with chronic Hepatitis E infection over a year. Repeated sequencing of the virus RNA showed that the virus incorporated various parts of the host's messenger RNA into its genome. This resulted in a replication advantage, which may have contributed to the infection becoming chronic. "The so-called insertion of host RNA can possibly predict the transition of an acute infection to a chronic condition," says Dr Daniel Todt, head of the Computational Virology research group in the Department of Medical and Molecular Virology at Ruhr University Bochum, Germany. The researchers report in the journal Nature Communications on June 6, 2024. Sequencing of the virus population Around 20 million people worldwide contract Hepatitis E every year. Normally, the infection heals without consequences, but it can be life-threatening for pregnant women or people with suppressed immune systems. In some cases, it becomes chronic. There are no specific effective medications. The broad-spectrum antiviral drug Ribavirin is also used against Hepatitis E, but it does not always work. How can the virus evade the immune system? Why does the infection become chronic and not heal? The researchers wanted to find out and analyzed for the first time all virus populations of a chronically infected patient over a period of more than a year. They examined more than 180 individual sequences from blood samples in detail. Replication in Cell Culture Benefits from Host RNA "The Hepatitis E virus has a so-called hypervariable region in its genetic information, into which it can incorporate various RNA sequences from host cells," describes Daniel Todt. His team was able to show that the composition of this region changed massively during the observation period. Additionally, many different compositions occurred simultaneously. In cell culture experiments, it was shown that incorporating host RNA provided a replication advantage: The altered viruses could replicate better than others. "We assume that this is partly responsible for the infection becoming chronic and the therapy failing," says Daniel Todt. The researchers examined the composition of the host RNA incorporated into the virus to determine if there were any common features characterizing the gene segments. "However, we could not detect any meaningful similarities," says Todt. The incorporated gene sequences are predominantly those that are very common in host cells, indicating a random selection. "Possibly, during Hepatitis E infection, a race between the virus and the immune system occurs in the body," speculates Daniel Todt. If the virus manages to incorporate host RNA before the immune system successfully combats the infection, it may lead to a chronic course. "Host RNA in the viral genome could, in any case, serve as a biomarker in the acute phase of an infection, indicating early on that it is likely to become chronic." The researchers plan to expand their studies to larger cohorts of patients.

siRNA

04 Jun 2024

·www.biospace.com

The Sustained, Slow Declining, Blood Concentration Profile of NV-387 Enables Infrequent Dosing for Strong Antiviral Effect

A First-In-Class, Broad-Spectrum Antiviral Agent Intending To Revolutionize Treatment of Viral Infections Including RSV, COVID, Influenzas and More SHELTON, CT / ACCESSWIRE / June 4, 2024 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports on the highly desirable blood concentration pro its lead clinical stage broad-spectrum antiviral agent NV-387 upon intravenous (I.V.) administration in a non-human primate (NHP) animal model. The Company has found that its lead nanoviricide broad-spectrum antiviral drug candidate NV-387, when given as a slow bolus intravenous infusion, resulted in a relatively flat plateau of blood concentration of the drug with very slow decline over a 24 hour period in a cynomolgus monkey model. The maximum concentration as well as the plateau concentration increased in a dose-dependent manner, as expected. This sustained drug level in the blood stream for a relatively long period of time enables infrequent dosing. It is the result of the unique polymeric design of NV-387. NV-387 is a "chemical nanomachine". It is made up of polymer with its size chosen to minimize loss by renal filtration. The observed pharmacokinetic pro NV-387 supports a once-daily or less frequent dosing regimen. The Company has already developed an injectable formulation of NV-387, namely NV-387 Solution for Injection, Infusion, and Inhalation. An injection of NV-387 would be useful for moderate to severe illness, especially because of the sustained blood pro requires infrequent dosing. An infusion would be suitable for severely ill hospitalized patients. Importantly, this NV-387 Solution can be readily delivered directly into the lungs of a patient using a simple handheld nebulizer over a period of a few minutes. Such delivery can enable direct attack on the virus where such attack is most needed in the cases of severe lung infection. The utility of NV-387 is extremely broad, reminiscent of the utility of antibiotics. We have found that NV-387 could cure lethal lung infection in RSV infected animals even with an oral dose. There is no approved drug for RSV treatment other than the toxic, last resort drug ribavirin, which was not very effective in this lethal study compared to NV-387. We have also found that NV-387 IV administration as well as PO (Oral) administration was substantially superior to each of the approved drugs Tamiflu, Rapivab and Xofluza in an Influenza A/H3N2 lethal lung infection model. We believe that NV-387 is expected to possess similar strong antiviral activity against Influenza A/H5N1 "Bird Flu" viruses as well. Our belief is based on the putative mechanism of NV-387. NV-387 is a host-mimetic, direct acting antiviral designed as decoy, to look like a cell decorated with sulfated proteoglycans, to which over 90% of human pathogenic viruses including H5N1 are known to bind. We have found that NV-387 has strong antiviral activity against all tested coronaviruses, including SARS-CoV-2 pseudovirions. NV-387 was substantially more effective than remdesivir in a lethal coronavirus infection animal study. We believe that NV-387 has a strong potential for the treatment of COVID as well as "Long COVID". COVID continues to cause substantially more fatalities annually than Influenza viruses. Long COVID has substantial personal as well as societal costs. Available drug, Paxlovid (Pfizer) has significant limitations for patient suitability. Thus a new drug against COVID and Long COVID is sorely needed. About NanoViricides NanoViricides, Inc. (the "Company") ( ) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs. Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. This trial was conducted by the drug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores" and HSV-2 "genital ulcers". The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. "NOAEL" means "No-Observed-Adevrese-Event-Level", which is the maximum dosage employed at which there were no adverse events found in animal studies. "MTD" means "Maximum Tolerated Dose", which is the maximum dosage employed that does not compromise survival of the animals. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". API means active pharmaceutical ingredient. Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: MJ Clyburn, TraDigital IR clyburn@tradigitalir.com SOURCE: NanoViricides, Inc. View the original press release on accesswire.com

License out/in

29 May 2024

·www.biospace.com

A First-In-Class, Broad-Spectrum Antiviral Agent Intending To Revolutionize Treatment of Viral Infections Including RSV, COVID, Influenzas and More

Novel Host-Mimetic, Virus Killing Technology Platform SHELTON, CT / ACCESSWIRE / May 29, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, elaborates on its development of a first-in-class, broad-spectrum antiviral agent that could revolutionize treatment of viral infections including RSV, COVID, Influenzas and other viruses. "Resistance is Futile" - Host-Mimetic Technology To Solve the Greatest Pain for Antiviral Medicines, i.e. Virus Escape No matter how much a virus changes in the field, it uses the same "landing sites" in the host body to gain access to cells, attach to and then fuse into the cells, causing an infection. A drug using the same landing sites and acting as a "decoy" would remain effective against the virus even as the virus changes, because the host side does not change. NV-387 is designed to employ such advanced "host-mimetic" technology, built into the nanoviricide™ nanomedicine that is further designed to "look like a cell" to the virus. In contrast, vaccines, antibodies and small chemical drugs all lose their effectiveness as the virus changes in the field. The virus is constantly changing due to various natural mechanisms such as mutations, recombinations, and/or re-assortments that are native to the virus lifecycle. Extremely Broad Antiviral Spectrum of NV-387 Resulted Because Many Diverse Viruses Use Common Host-Side Landing Sites Over 90% of human pathogenic viruses are known to use one or more "landing sites" that are in the Sulfated Proteoglycans ("SPG") family. A successful host-mimetic nanoviricide drug using SPG as the key feature to attract viruses could theoretically be able to attack most if not all such viruses. NV-387 is designed to mimic SPG and attack the virus as a cell-mimicking decoy. We have accumulated substantial evidence that in lethal viral infection animal studies, NV-387 demonstrated strong antiviral activity against a range of different virus families, exceeding or matching the activity of known approved drug agents. NV-387 was substantially superior to remdesivir in coronavirus infections, using a model for SARS-CoV-2 (COVID) virus, as reported earlier. We believe that NV-387 continues to be one of the most active antiviral drugs against multiple coronaviruses, and that it is a viable clinical candidate for drug development to treat COVID, Long COVID, as well as potentially MERS, SARS, and seasonal coronavirus infections. NV-387 was substantially superior to the three approved drugs, namely Tamiflu®, Rapivab® , and Xofluza® against an Influenza H3N2 lethal lung viral infection study, as previously reported. We believe that NV-387 is expected to possess strong antiviral activity against H5N1 "Bird Flu" as well, given that H5N1 viruses are known to bind to heparan sulfate proteoglycans, and based on the observed broad-spectrum activity of NV-387. NV-387 was at least as good as TPOXX® in a model animal study for the development of Smallpox/Mpox drugs, in two different ways of acquiring infection, as reported earlier. Further, we found that NV-387 is capable of completely curing a lethal RSV lung virus infection in animals, leading to indefinite survival of the animals, as reported recently. There is no cure for RSV, and no approved drug for treatment of RSV infection other than the toxic last-resort drug ribavirin. Moreover, even novel viruses, whether from natural sources or bio-engineered, are expected to be susceptible to NV-387 if they employ SPG for gaining access to human cells to infect and cause disease. Thus, NV-387 could be highly valuable for preparedness against novel viral epidemics and pandemics. NV-387 could thus be a single drug to treat all of the "tripledemic" viruses, and more, when so approved. Safety of NV-387 Studied Successfully in Phase I Human Clinical Trials with No Adverse Events NV-387 is inherently designed to be safe, by careful choice of the components of the nanoviricide polymeric chemical, and this was borne out in our studies. Leading to the human clinical trials, we had found that the safety of NV-387 was demonstrated by the very large NOAEL value of 1,200mg/Kg and MTD value of 1,500mg/Kg in rats. We had also found that NV-387 was non-mutagenic, non-genotoxic, non-immunogenic, and studies indicated that allergenicity was not an issue; all parameters that indicate excellent safety. A Phase I clinical trial of NV-387 Oral Syrup and NV-387 Oral Gummies was completed successfully with no adverse events reported. We are awaiting reports from the CRO to further elaborate on the findings. "An antiviral agent with an extra-ordinarily broad spectrum of antiviral activity, coupled with strong safety, is a ‘holy grail' of antiviral medicines," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding, "Our host-mimetic, direct-acting, nanoviricide™ platform technology capable of destroying virus particles has made this possible, we believe. NV-387 is now ready for Phase II studies towards the goal of regulatory approvals worldwide." He further commented, "If and when approved, NV-387 could be as revolutionary an antiviral agent as penicillin was as an anti-bacterial agent." About NanoViricides NanoViricides, Inc. (the "Company") ( ) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs. Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. This trial was conducted by the drug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores" and HSV-2 "genital ulcers". The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. "NOAEL" means "No-Observed-Adevrese-Event-Level", which is the maximum dosage employed at which there were no adverse events found in animal studies. "MTD" means "Maximum Tolerated Dose", which is the maximum dosage employed that does not compromise survival of the animals. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". API means active pharmaceutical ingredient. Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: MJ Clyburn, TraDigital IR clyburn@tradigitalir.com SOURCE: NanoViricides, Inc. View the original press release on accesswire.com

Phase 1License out/inClinical Result

100 Deals associated with Ribavirin

External Link

KEGG	Wiki	ATC	Drug Bank
D00423	Ribavirin	J05AP01	DB00811

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Compensated cirrhosis	JP	Merck Sharp & Dohme Corp.	29 Jul 2015
Hepatitis C	JP	Chugai Pharmaceutical Co., Ltd.	26 Jan 2007
Hepatitis C, Chronic	US	Merck Sharp & Dohme Corp.	03 Jun 1998
Respiratory Syncytial Virus Infections	US	Bausch Health US LLC	31 Dec 1985

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	Phase 3	-	AbbVie, Inc.	01 Jul 2015
Decompensated cirrhosis of liver	Phase 3	-	AbbVie, Inc.	24 Nov 2014
Kidney Failure, Chronic	Phase 3	-	AbbVie, Inc.	23 Sep 2014
Chronic hepatitis C genotype 1b	Phase 3	-	AbbVie, Inc.	01 Sep 2014
Anemia	Phase 3	-	Merck Sharp & Dohme Corp.	07 Dec 2009
Fibrosis, Liver	Phase 3	BE	Merck Sharp & Dohme Corp.	01 May 2006
Fibrosis, Liver	Phase 3	FR	Merck Sharp & Dohme Corp.	01 May 2006
Chronic hepatitis C genotype 3	Phase 3	DE	Hoffmann-La Roche, Inc.	01 Nov 2005
Chronic hepatitis C genotype 1	Phase 3	-	Merck Sharp & Dohme Corp.	01 Jul 2005
HIV Infections	Phase 3	CA	Hoffmann-La Roche, Inc.	01 Jul 2005

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AASLD2023	Not Applicable	-	-	Standard 12-week ribavirin regimen	gmeaiuonpm(gzsoqwwrqt) = dbpupbsyjg zdrrzxkozz (wwqflhxifl )	-	10 Nov 2023
				Response-guided ribavirin regimen	gmeaiuonpm(gzsoqwwrqt) = ujmiwtpumz zdrrzxkozz (wwqflhxifl )
AASLD2023	Not Applicable	Hepatitis C, Chronic	65	Sofosbuvir/Velpatasvir with Ribavirin	cqlrzexsjz(tfvqbfpuzc) = kpzwolusdq ynimxswwhk (bsipvlacro ) View more	-	10 Nov 2023
				Sofosbuvir/Velpatasvir without Ribavirin	cqlrzexsjz(tfvqbfpuzc) = kypejfegnk ynimxswwhk (bsipvlacro ) View more
AASLD2023	Not Applicable	Hepatitis C	452	Sofosbuvir/Velpatasvir	swyrduyojg(aglwycsvte) = showed a significant decrease from baseline to SVR12(-2.91 vs. -3.11 P < 0.001) kyhyvndmvz (glgmpiftnb ) View more	-	10 Nov 2023
				Sofosbuvir/Velpatasvir with Ribavirin
NCT01268579 (CTgov)	Not Applicable	Head and Neck Neoplasms	9	ribavirin	buolwstznb(enpkpxefwe) = nzynhzdohc xsbyxvdzeb (sefekvovsf, szcuvostra - rqfrdkdcbq) View more	-	02 Oct 2023
EASL2023	Not Applicable	Hepatitis B \| Fibrosis \| HIV Infections ... View more	285	Sofosbuvir/Velpatasvir plus RibavirinSofosbuvir/Velpatasvir plus RibavirinSofosbuvir/Velpatasvir plus Ribavirin	glvirwfkpl(wepilqrots) = ggtgdyqlkd rdoovsfxha (jhoscznafv ) View more	-	21 Jun 2023
NCT02308241 (CTgov)	Not Applicable	Human Papillomavirus-Related Oropharyngeal Neoplasms	12	Ribavirin	avnmelfouq(xbslhsxufy) = yujfeoewsi ohtyyotyhm (lbxklhwgqb, ukatvtbepc - qdynldkugg) View more	-	05 Jan 2023
NCT04551768 (Pubmed) Manual	Phase 1	COVID-19 \| Respiratory Distress Syndrome	51	Kanamycin Sulfate	aiodskcojd(wssmghllul) = Improvement of ≥1 level in clinical status severity was observed in 31.4% (16/51) and 78.4% (40/51) of patients at end-of-treatment and day 30, respectively. bosvhkneon (bvvmatrlyb )	Positive	03 Nov 2022
NCT04605588 (CTgov)	Phase 2	COVID-19	7	Hydroxychloroquine+Nitazoxanide+ribavirin (Active Study Drug)	gdewinjwsh(maofirlkii) = aimhopclhj nvxlxkmkdc (glcncnyjgf, cngorryzrm - myhltmtpgb) View more	-	05 May 2022
				Placebo Hydroxychloroquine (Placebo)	gdewinjwsh(maofirlkii) = drmduljasc nvxlxkmkdc (glcncnyjgf, crwamwrzpx - anjpnxqnvm) View more
NCT02939989 (MAGELLAN-3, CTgov)	Phase 3	Hepatitis C, Chronic	33	Sofosbuvir+Glecaprevir/Pibrentasvir+Ribavirin (Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks)	skdbdvmfbh(hmwxlrvovy) = ergnojimgf weywqziyyt (jhkhfuhqds, cctiudeaxv - kptuhvmpkl) View more	-	04 May 2022
				Sofosbuvir+Glecaprevir/Pibrentasvir+Ribavirin (Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks)	skdbdvmfbh(hmwxlrvovy) = lkfooqqxwo weywqziyyt (jhkhfuhqds, osppgylyxs - omqgczbltc) View more
Pubmed Manual	Not Applicable	Hepatitis C	299	Sofosbuvir+Velpatasvir+Kanamycin Sulfate	bfjldvaziu(wmxwxpigcd) = hytsqyodbd nwqqehrahl (dxdukmlalj, 95.4 - 99.3) View more	Positive	20 Apr 2022

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