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

Chengdu First Pharmaceutical Co. Ltd.

Merck Sharp & Dohme Corp.

Chugai Pharmaceutical Co., Ltd.

+ [1]

Inactive Organization

AbbVie, Inc.Hoffmann-La Roche, Inc.Biopartners GmbH

+ [8]

Drug Highest PhaseApproved

First Approval Date

US (31 Dec 1985),

Respiratory Syncytial Virus Infections

RegulationOrphan Drug (EU)

Structure

Molecular FormulaC8H12N4O5

InChIKeyIWUCXVSUMQZMFG-AFCXAGJDSA-N

CAS Registry36791-04-5

910

Clinical Trials associated with Ribavirin

NCT06488300 / Not yet recruitingPhase 2IIT

Assessment of Respiratory SYNcytial Virus antivirALs: A Phase 2 Multi-centre Adaptive Randomised Platform Trial For the Assessment of Antiviral Pharmacodynamics in aCute Symptomatic RSV Infection (ARSYNAL-FC)

This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated Respiratory Syncytial Virus (RSV), to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential adaptive platform trial, we will assess and compare the performance of currently licensed interventions (including repurposed drugs) with activity against RSV, and those with potential activity demonstrated in pre-clinical and early clinical studies relative to each-other, and the control (no antiviral treatment).
ARSYNAL-FC study is funded by Wellcome Trust Grant ref: 226933/Z/23/Z through the COVID-19 Therapeutics Accelerator

Start Date01 Jul 2024

Sponsor / Collaborator

University of Oxford

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-

100 Clinical Results associated with Ribavirin

100 Translational Medicine associated with Ribavirin

100 Patents (Medical) associated with Ribavirin

15,578

Literatures (Medical) associated with Ribavirin

01 Jan 2025·Brain, Behavior, and Immunity

Acute effects of interferon-alpha on cellular anabolic and catabolic processes are associated with the development of fatigue during Interferon-alpha-based therapy for Hepatitis-C: A preliminary study

Article

Author: Bullmore, Edward T. ; Periche-Tomas, Eva ; Harrison, Neil A ; Pariante, Carmine ; Bone, Claudia ; Cattane, Nadia ; Bullmore, Edward T ; Cattaneo, Annamaria ; Tibble, Jeremy ; Harrison, Neil A.

INTRODUCTIONInterferon-alpha (IFN-α) is a key mediator of antiviral immune responses used to treat Hepatitis-C virus (HCV) infection. Though clinically effective, IFN-α frequently induces functionally impairing mood and motivation symptoms, particularly fatigue. Unlike mood impairment, which typically emerges after weeks of treatment, fatigue tends to emerge and evolve rapidly, typically within hours of the first IFN-α injection. Despite being a major source of functional impairment during IFN-α and other immune-based therapies, the biological mechanisms underlying fatigue remain poorly understood. Here, we aimed to identify acute immune-response signatures to IFN-α that could predict the later development of fatigue.METHODSIn this exploratory study, we analyzed whole blood transcriptomics in a longitudinal sample of 27 HCV patients initiating IFN-α and Ribavirin therapy. Blood samples were obtained at baseline and 4½ hours after the first IFN-α dose and transcriptomic data was obtained using Affymetrix Human Gene 1.1 ST Array Strips. Gene expression data visualization and quality control were assessed using Partek Genomics Suite V6.6 and protein-protein interaction networks using STRING and Ingenuity Pathway Analysis (IPA). A Fatigue Visual Analogue Scale (fVAS) was utilized to record fatigue symptoms at baseline, 4½ hours and 4 weeks after initiation of treatment.RESULTSIFN-α was associated with an upregulation of 526 transcripts and a downregulation of 228 genes, indicating a rapid transcriptomic response in whole blood within 4½ hours of injection. 93 genes were significantly positively correlated with changes in fatigue, with gene expression changes measured from baseline to 4.5 h and increases in fatigue assessed from baseline to week 4 on the fVAS. We identified a novel network of predominantly cytosolic ribosomal units and ubiquitin proteins implicated in modulating mTOR signaling that was associated with the development of fatigue 4 weeks after initiation of IFN-α treatment (p = 0.0078).CONCLUSIONOur findings suggest that acute activation of this anabolic/catabolic network by IFN-α may predispose to the experience of fatigue similar to evidence found in cancer-related fatigue. Further investigation is warranted to confirm the exploratory nature of these observations.

31 Dec 2024·Emerging Microbes & Infections

A novel BSL-2 Lassa virus reverse genetics system modelling the complete viral life cycle

Article

Author: Zhong, Jin ; Bai, Xu ; Xing, Yifan ; Hu, Xiaoyou ; Shi, Yi ; Tong, Yimin ; Tian, Fangling

Lassa virus (LASV), a risk-group 4 pathogen, must be handled in biosafety level-4 (BSL-4) conditions, thereby limiting its research and antiviral development. Here, we developed a novel LASV reverse genetics system which, to our knowledge, is the first to study the complete LASV life cycle under BSL-2 conditions. Viral particles can be produced efficiently when LASV minigenomic RNA harbouring minimal viral cis-elements and reporter genes is transfected into a helper cell line stably expressing viral NP, GP, Z and L proteins. The resulting defective virions, named LASVmg, can propagate only in the helper cell line, providing a BSL-2 model to study the complete LASV life cycle. Using this model, we found that a previously reported cellular receptor α-dystroglycan is dispensable for LASVmg infection. Furthermore, we showed that ribavirin can inhibit LASVmg infection by inducing viral mutations. This new BSL-2 system should facilitate studying the LASV life cycle and screening antivirals.

01 Dec 2024·Bioorganic Chemistry

Synthesis, structural modification, and biological activity of a novel bisindole alkaloid iheyamine A

Article

Author: Zhou, Zhenghong ; Chen, Miaomiao ; Zhang, Peiyao ; Li, Taiqing ; Xu, Li ; Que, Xinyue ; Wang, Ziwen ; Wang, Qingmin ; Hou, Cancan ; Guo, Xin

Diseases caused by plant viruses and pathogens pose a serious threat to crop yield and quality. Traditional pesticides have gradually developed drug resistance and brought certain environmental safety issues during long-term overuse. There is an urgent need to discover new candidate compounds to address these issues. In this study, we achieved the efficient synthesis of iheyamine A and its derivatives, and discovered their excellent antiviral activities against tobacco mosaic virus (TMV). Most compounds displayed higher antiviral activities against TMV than commercial ribavirin at 500 μg/mL, with compounds 3a (Inactive effect IC₅₀: 162 µg/mL), 3d (Inactive effect IC₅₀: 249 µg/mL), 6p (Inactive effect IC₅₀: 254 µg/mL), and 7a (Inactive effect IC₅₀: 234 µg/mL) exhibiting better antiviral activities than ningnanmycin at 500 μg/mL (Inactive effect IC₅₀: 269 µg/mL). Meanwhile, the structure-activity relationships of this type of compounds were systematically studied. We chose 3a for further antiviral mechanism research and found that it can directly act on viral coat protein (CP). The interaction of 3a and CP was further verified via molecular docking. These compounds also showed broad-spectrum fungicidal activities against 8 plant pathogenic fungi, especially for P. piricola. This study provides a reference for the role of iheyamine alkaloids in combating plant pathogenic diseases.

News (Medical) associated with Ribavirin

22 Oct 2024

·www.biospace.com

Gilead to Present Latest Research Across Key Liver Disease Indication at the American Association for the Study of Liver Disease (AASLD) Meeting 2024

- Key Insights from Viral Hepatitis, PBC, and MASH/Fibrosis Studies Highlight Gilead’s Ongoing Commitment to Advancing Life-Changing Liver Disease Research - FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced new research to be presented at The Liver Meeting ® 2024, hosted by the American Association for the Study of Liver Diseases (AASLD) from November 15-19 in San Diego, Calif. More than 40 abstracts will be presented with key data, including 11 abstracts reporting new data on primary biliary cholangitis (PBC). The data will include findings from the RESPONSE trial that demonstrate the efficacy and safety pro Livdelzi ® (seladelpar) in people living with PBC and compensated cirrhosis. Additionally, data will be presented on the effects of Livdelzi on pruritus (chronic itching), a symptom that has significant impact on the quality of life of people living with PBC, along with interim long-term efficacy and safety results from the ongoing ASSURE study. Beyond PBC, Gilead will be presenting an interim analysis of the Phase 3 MYR301 study, which is evaluating people living with hepatitis Delta virus (HDV) who received bulevirtide monotherapy (2 mg for 144 weeks; 10 mg for 144 weeks; or 10 mg for 96 weeks) for chronic HDV and have been off treatment for 48 weeks. The study is evaluating whether or not patients treated with bulevirtide monotherapy for 2-3 years maintained virological and biochemical responses one year after stopping treatment. An additional 144-week analysis of patient-reported outcomes for individuals treated with bulevirtide 2 mg will also be presented, adding to the wealth of long-term data for the treatment for chronic HDV. “We’re excited to share our latest research at The Liver Meeting, as we push the boundaries of what’s possible in liver disease treatment. The breadth of this research reflects Gilead’s unwavering dedication to advancing life-changing science and shaping healthier futures for people living with liver disease,” said Anu Osinusi, Vice President of Clinical Development for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences. “The depth and range of our data, spanning both viral and inflammatory liver diseases, underscores our commitment to making a meaningful impact at every stage of a person’s journey in liver disease. Our goals go far beyond treatment alone—our work spans awareness, education, screening, diagnosis, and long-term care, all intending to address unmet needs and enhance treatment outcomes.” Gilead will also present hepatitis C virus (HCV) data which will include safety and tolerability outcomes for Epclusa ® (velpatasvir/sofosbuvir) in pregnant individuals with chronic HCV (the STORC study). As a special population that is often excluded from clinical research, these results may help clinicians better support pregnant people living with HCV, which in turn may reduce the risk of transmission to infants. Furthermore, real-world findings from the SVR10K study on HCV will be showcased, demonstrating the effects of direct-acting antivirals against all HCV genotypes across diverse regions. Late-breaking data from a Phase 2a open-label study assessing the safety and efficacy of novel combination therapies for chronic hepatitis B virus (HBV) will also be presented by Gilead. Key Abstracts at AASLD 2024: ID Abstract Title PBC 164 Efficacy and Safety of Seladelpar in Patients with PBC and Compensated Cirrhosis in the Phase 3 Placebo-controlled RESPONSE Trial 167 Attenuation, Near Resolution, and Prevention of Pruritis in Patients with PBC Treated with Seladelpar: A Secondary Analysis of Patterns of Pruritis Change in the RESPONSE Trial 4339 Alkaline Phosphatase Changes with Seladelpar Across Subgroups of Primary Biliary Cholangitis Patients in the RESPONSE Trial 4342 Seladelpar and Reductions in Lipids in Patients with Primary Biliary Cholangitis with and without Statin use in the Phase 3 Placebo-controlled RESPONSE Study 4341 Long-term Safety of Seladelpar 10 mg with up to 5 Years of Treatment in Patients with Primary Biliary Cholangitis Primary sclerosing cholangitis (PSC) 151 Associations Between Biomarkers and Magnetic Resonance Imaging-derived ANALI Score in Patients with Primary Sclerosing Cholangitis: Analysis from the Phase 3 PRIMIS Study HDV 1147 Efficacy and Safety of BLV Monotherapy for Chronic Hepatitis Delta: Post Treatment Results through 48 Weeks after the End of Treatment from an Interim Analysis of a Randomized Phase 3 Study MYR301 1193 Patient-reported Outcomes among Patients with Chronic Hepatitis Delta Treated with Bulevirtide 2 mg: A Long-term Analysis of the Phase 3 MYR301 Trial at 144 Weeks 139 Long-term Bulevirtide Monotherapy in Patients with HDV-related Compensated Cirrhosis: Effectiveness, Safety and Clinical Outcomes from the Retrospective Multicenter European Study (SAVE-D) HCV 222 Safety, Tolerability, and Outcomes of Velpatasvir/Sofosbuvir in Treatment of Chronic Hepatitis C Virus during Pregnancy (STORC) 1455 The SVR10K Study: A Real-world Data with Pangenotypic Direct-acting Antivirals across Multiple Diverse Regions 1476 Hepatitis C Treatment Uptake Differs by Gender among a Commercially Insured Population in the United States HBV 1380 Results from a Phase 2a, Open-label Study to Evaluate the Safety and Efficacy of Novel Combination Therapies Containing VIR-2218, Selgantolimod, and Nivolumab for the Treatment of Chronic Hepatitis B 1252 Effectiveness and Safety of Tenofovir Alafenamide in Chronic Hepatitis B Patients with Suboptimal Response to Antiviral Therapy 1337 Characterization of Changes in Noninvasive Fibrosis Markers over 8 Years of Tenofovir-based Treatment in Chronic Hepatitis B Patients Enrolled in Two Phase 3 Trials Nonalcoholic steatohepatitis (NASH)/Fibrosis 1520 Prospective Validation of the Mediterranean Diet Adherence Screener (MEDAS) for Point-of-care Assessment of Diet Quality in Patients with Metabolic Dysfunction-associated Steatotic Liver Disease For more information, including a complete list of abstract titles being presented at the meeting, please visit the AASLD website . In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for bulevirtide 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide’s conditional MA license in Great Britain was converted to a full MA in August 2023 and a full MA was granted in Switzerland and Australia in 2024. In regions where it is not approved, including the U.S., bulevirtide 2 mg is an investigational product. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and has not been approved anywhere. Cilofexor and selgantolimod are investigational compounds and are not approved by the FDA or any other regulatory authority; their safety and efficacy have not been established. Please see below for the U.S. Indications and Important Safety Information, including BOXED WARNINGS, for Epclusa and Livdelzi. U.S. Important Safety Information And Indication for EPCLUSA BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated. Contraindications If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information. Warnings and Precautions Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia. Risk of Reduced Therapeutic Effect Due to Use with P-gp Inducers and/or Moderate to Strong Inducers of CYP2B6, CYP2C8 or CYP3A4 : Rifampin, St. John’s wort and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations. Adverse Reactions The most common adverse reactions (≥10%, all grades) with EPCLUSA in adults and pediatric patients 6 years of age and older were headache and fatigue; and when used with RBV in adults with decompensated cirrhosis were fatigue, anemia, nausea, headache, insomnia and diarrhea. The most common adverse reactions (≥10%, grade 1 or 2) in pediatric patients less than 6 years of age were vomiting and spitting up the drug. Drug Interactions Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan. Coadministration of EPCLUSA is not recommended with proton-pump inhibitors, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir. Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments. Indication EPCLUSA is indicated for the treatment of adult and pediatric patients 3 years of age and older with chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis and in combination with ribavirin for those with decompensated cirrhosis. U.S. Important Safety Information for LIVDELZI Warnings and Precautions Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care. Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI. Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid coadministration with LIVDELZI due to increased LIVDELZI exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment. Coadministration may result in delayed or suboptimal biochemical response of LIVDELZI. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (eg, cyclosporine): Monitor closely for adverse effects. Concomitant administration with LIVDELZI may increase LIVDELZI exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase LIVDELZI exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There are no data on the presence of LIVDELZI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI. Indication LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). About HDV HDV is considered the most aggressive or severe form of viral hepatitis, associated with more rapid progression towards liver-related death and liver cancer in people with HBV. On average, HDV progresses to cirrhosis within 5 years and to liver cancer within 10 years. Nearly 5% of people who have a chronic infection with HBV are estimated to have HDV, equating to 12-15 million people worldwide. The prevalence of HDV infection is largely underestimated due to lack of universal testing of HBV-positive individuals for HDV. About PBC PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the U.S.). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of alkaline phosphatase (ALP), alanine transaminase (ALT) and gamma-glutamyl transferase (GGT), enzymes found primarily in the liver, as well as total bilirubin. The most common symptoms of PBC are pruritus and fatigue, which can be debilitating for some people. Progression of PBC is associated with an increased risk of liver-related mortality. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with PBC. But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving Epclusa, Hepcludex (bulevirtide), Livdelzi (seladelpar), cilofexor and selgantolimod (such as the ASSURE, RESPONSE, MYR301, STORC and SVR10K studies); uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the FDA and other regulatory authorities may not approve bulevirtide for the treatment of HDV, and the risk that any such approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of investigational programs for indications that are currently under evaluation and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Epclusa, Hepcludex, Livdelzi, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Contacts Meaghan Smith, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com

Phase 2Clinical ResultDrug ApprovalPhase 3

28 Nov 2023

·www.biospace.com

The Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company’s Broad-Spectrum Antiviral Drug, Has Successfully Completed the First Part (Phase 1a), Reports NanoViricides

SHELTON, CT / ACCESSWIRE / November 28, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the Single-Ascending Dose part of the Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's broad-spectrum antiviral drug, was completed successfully. Recruitment for the Multiple-Ascending Dose part was also completed. The drug NV-CoV-2 contains the Company's nanoviricide active agent, NV-387, which has shown strong broad-spectrum antiviral activity not only against multiple coronaviruses, but also against RSV and in a model for Smallpox therapeutics. The Phase 1a Clinical Trial Part, namely Single-Ascending-Dose in Healthy Volunteers, Was Completed Successfully: The Company reports that its Indian collaborator and drug sponsor, Karveer Meditech Pvt. Ltd., India, has communicated that all 36 healthy volunteers in the various cohorts in the Phase 1a Single-Ascending-Dose ("SAD") clinical trial have now completed the study. Follow-up visit was also concluded for all of the Phase 1a volunteers. Previously, we reported on August 21, 2023 that 26 of the 36 healthy volunteers had completed the Phase 1a study. No Adverse Events Found in the Healthy Volunteers Cohorts to Date: No adverse events or serious adverse events were found at any of the three dose levels studied, in either of the two formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies, in the completed Phase 1a (Single Ascending Dose) part of the study. To note, we have previously reported that no adverse events or serious adverse events were found in either of the two formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies, in the 26 out of 36 healthy volunteers that had completed the Phase 1b part (Multiple-Ascending Dose) of the study. Recruitment for Multiple-Ascending-Dose Clinical Trial (Phase 1b) in Healthy Volunteers Was Completed: Additionally, the remaining 10 healthy volunteers have been recruited into the Multiple-Ascending Dose part of the Phase 1b study, completing the targeted 36 volunteers recruitment. "The excellent safety of NV-CoV-2 formulations is expected to enable use of the drug across all patient population, from young children, otherwise healthy persons, to immune-compromised persons, persons with advanced age with or without co-morbidities," said Anil R. Diwan, Ph.D., Executive Chairman and President of the Company, adding, "We await completion of the multiple-ascending dose portion of this trial in healthy volunteers which is expected soon. Thereafter we plan on advancing NV-387 for the treatment of several different viruses that this drug has shown strong activity against." NV-387 Has Shown Broad-Spectrum Antiviral Activity Across Multiple Virus Families: NV-387 was found to be as effective as ribavirin, the toxic last resort drug, against RSV infection in a lethal lung infection animal model, as reported previously. RSV is a virus particularly threatening to vulnerable infants, young children, older adults, and immunocompromised populations. There is no approved drug for the treatment of RSV infection, except the toxic drug ribavirin which is only indicated for very severe cases due to its severe hemotoxicity. The market size for RSV therapeutics has been estimated to be approximately $2 Billion rising to $8 Billion. Additionally, we recently reported that NV-387 was as effective as the approved drug tecovitrimat (TPOXX®, SIGA), in a lethal intra-digital infection by ectromelia virus in mice. Importantly, a combined drug made from NV-387 and tecovirimat was more effective than either drug alone, indicating NV-387 "plays well" with tecovirimat and acts by a different mechanism. Smallpox poses a significant biodefense threat. Ectromelia virus is a native virus of mice in the poxvirus family and is one of the key animal model viruses for developing smallpox therapeutics. Tecovirimat is an approved drug for treating smallpox infection based on the FDA "Animal Rule", and is stockpiled by the US "Strategic National Stockpile". It was mobilized during the recent monkeypox epidemic. It is important to develop additional smallpox therapeutics that work well with tecovirimat and by themselves, since viruses pose the threat of drug escape by mutation; further, in a bio-terrorism scenario, a human-engineered smallpox virus resistant to existing drugs could be a potential threat. NV-387 Acts by a Novel Mechanism: We developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It is designed to "look like a cell" to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering the virus incapable of infecting another cell. We call this novel antiviral mechanism "Re-Infection Blocker". NV-387 Could Revolutionize Antiviral Treatment Just As Antibiotics Did Against Bacteria: In particular, NV-387 was designed to emulate an "attachment receptor family" called sulfated proteoglycans (S-PG), that over 90% of human pathogenic viruses are known to use for infecting cells. Therefore, in addition to Coronaviruses, RSV and Smallpox, we anticipate that NV-387 may have effectiveness against many other viruses. We plan on continuing to study the antiviral spectrum of NV-387 with a view to expand its applications. NV-387 could usher in a new era in the treatment of antiviral infections, if it is found to be broadly effective against additional viruses that use S-PG, evoking a comparison to how antibiotics changed the treatment of bacterial infections. NV-387 Addresses an Unmet Medical Need for Broad-Spectrum, Safe and Effective Antiviral Drug That Works Against Multiple Viral Threats: There is a significant unmet medical need for a broad-spectrum antiviral drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug. We believe that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection. NV-387 Addresses Large Market Sizes: In addition to the well-known strong and continuing market size for COVID drugs, GrowthPlus Reports, in June 2023, has said that the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031. About NanoViricides NanoViricides, Inc. (the "Company") ( ) is a clinical 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. Our lead drug candidate is NV-CoV-2, that contains the active pharmaceutical ingredient ("API") NV-387, for the treatment of COVID caused by SARS-CoV-2 coronavirus. NV-CoV-2 in Phase 1a/1b human clinical trials for evaluation of safety and tolerability in healthy volunteers and COVID patients, as well as initial indications of effectiveness in COVID patients. The same API, NV-387, was recently demonstrated to be active against RSV as well as against ectromelia virus, a mouse model virus used for smallpox drug development. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 through Phase I/II clinical trials. NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently. The Company is also developing a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, Inc., which TheraCour licenses from AllExcel, Inc. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms 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 Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, RSV and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. 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. Disclosure Statement 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 that are, in some cases, beyond the Company's control and that 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. In particular, 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 in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program. CONTACT: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: MJ Clyburn TraDigital IR clyburn@tradigitalir.com SOURCE: NanoViricides, Inc. View source version on accesswire.com:

Phase 1License out/in

14 Nov 2023

·www.biospace.com

Broad-Spectrum Antiviral NV-387 (NV-CoV-2) in Phase 1a/1b Clinical Trial is Highly Effective in an Animal Model for MPox and Smallpox Drug Development

SHELTON, CT / ACCESSWIRE / November 14, 2023 / NanoViricides, Inc. (AMEX:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reports that its broad-spectrum antiviral drug candidate, NV-387 was highly effective in an animal model that is used in drug development for MPox and Smallpox virus infections in humans. NV-387 is currently in Phase 1a/1b human clinical trials for COVID-19 indication in India, under sponsorship by our licensee and collaborator, Karveer Meditech, Pvt. Ltd. In addition to broad-spectrum activity against Seasonal Coronaviruses and SARS-CoV-2, NV-387 was previously found to have strong activity against the Respiratory Syncytial Virus (RSV) that was comparable to the last-resort toxic drug Ribavirin. The current study indicates that NV-387 is active against viruses in the genus of Orthopoxviruses as well. We believe that this broad-spectrum antiviral activity of NV-387 is observed because NV-387 is designed to mimic a host cell membrane bearing "Sulfated Proteoglycans" ("S-PG") family of virus attachment receptors. S-PG receptors taken together are involved in the re-infection lifecycle of more than 90% of human pathogenic viruses. Thus, we believe that NV-387 has a broad spectrum of antiviral activity that is reminiscent of the antibacterial activity of antibiotics. We believe that the Nanoviricides Platform Technology is poised to revolutionize the fight against viruses just as antibiotics revolutionized the fight against bacterial infections. Oral NV-387 treatment led to 14 days of survival, matching the 14 days survival on oral Tecovorimat treatment. In contrast, untreated and vehicle-treated animals died in only 8 days, indicating an increase of 6 days, or 75%, in the lifespan for both NV-387 and Tecovirimat, in this lethal model comprising intra-digital infection by the Ectromelia virus into the footpads of mice. Moreover, a formulation combining NV-387 and Tecovirimat, that we call NV-387-m-T, led to a significantly greater survival of 17 days, indicating an impressive increase of 9 days, or 112%, in survival lifespan, in this study. The increase in lifespan in comparison to the untreated animals in such lethal virus infection models serves as a clear primary endpoint indicative of the relative effectiveness of different drugs. Tecovirimat ("TPOXX®", SIGA Pharmaceuticals) is an approved smallpox therapeutic. It was mobilized from the US Government stockpile for the treatment of Mpox infection during the recent MPox epidemic. Additional therapeutics that work with Tecovirimat such as NV-387 may reduce the required dosage and dosing period enabling rapid patient recovery. "We believe that non-dilutive government funding may be possible for the development of a NV-387-based drug for the treatment of Smallpox and Mpox, given these excellent results," said Anil R. Diwan, PhD. Smallpox-causing Variola virus is considered a significant biodefense threat. While smallpox vaccines are available, their general public health usage has stopped after Smallpox was declared eradicated in 1980, leaving persons under the age of about 45 vulnerable. Tecovirimat is stockpiled by the Biomedical Advanced Research and Development Authority (BARDA) under Project BioShield. BARDA awarded an original development and procurement contract worth approximately $435 million to SIGA in 2011, followed by another procurement contract in 2018 upon regulatory approval worth approximately $629 million. SIGA announced in July 2023 that it has received new procurement orders of approximately $138 Million for TPOXX from the U.S. Government. There is significant interest in the development of a smallpox therapeutic drug that works well by itself, as well as in combination with the known drug, Tecovirimat. Tecovirimat has a low barrier of escape; a single mutation in one protein can enable the virus to escape this drug, adding to the significance of additional smallpox drug development. Since human clinical trials are not feasible for the deadly Variola virus, infection of the related animal viruses in their native species is used for evaluation of drug effectiveness under the FDA "Animal Rule". Variola (Humans), Mpox (Monkeys), Ectromelia (Mice), and Rabbitpox (Rabbits) are some of the closely related pathogenic viruses belonging to the Orthopoxvirus genus (with their native hosts listed in parentheses). The animal-rule based efficacy studies conducted under GLP conditions substitute for the usual Phase 2/3 human clinical efficacy trials for regulatory approval under the Animal Rule. Additional human safety clinical studies are expected to be required. This pathway may enable rapid regulatory development of NV-387 as a smallpox therapeutic towards approval. Previously, the Company has reported that NV-387 was highly effective for the treatment of lethal lung infection by the Respiratory Syncytial Virus (RSV). Currently there is no approved treatment for RSV other than ribavirin which is only conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure. RSV therapeutics is estimated to be a multi-billion-dollar market, as we have previously reported. We believe that NV-387 works by a novel mechanism of action, that of blocking the re-infection lifecycle of the virus. We believe that NV-387 not only binds to the virus, but fuses with the virus surface, uprooting the glycoproteins that are required for the virus to bind to the human cell (for example, the S protein, and its products S1 and S2 proteins for coronaviruses), thereby rendering the virus incapable of infecting a cell. In contrast, antibodies are only capable of incompletely decorating the virus. We believe that NV-387 mimics the "Sulfated Proteoglycans" ("S-PG") family of virus attachment receptors. This family includes heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), and keratan sulfate (KSPG). Over 90% of known pathogenic viruses bind to one or more of these S-PG class attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, Poxviruses, among others. Therefore, NV-387 may be anticipated to exhibit strong antiviral activity against at least some, if not many, of these viruses. We believe that the successes of NV-387 as a broad-spectrum antiviral bode well for validating the multiple modalities in which our Nanoviricides Platform Technology can be employed to revolutionize the treatment of viral infections as well as pandemic preparedness response. We have found that NV-387 is highly active against tested coronaviruses including SARS-CoV-2 in pre-clinical studies. We are continuing to expand our pre-clinical studies to evaluate the antiviral activity of NV-387 against other viruses. We believe that this work would expand the range of indications for NV-387. Such expansion of use of NV-387 would significantly expand the market size and substantially improve the return on investments (ROI). NV-387 is in Phase 1 human clinical trial as two oral formulations: (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies in India. The drug sponsor, Karveer Meditech Pvt. Ltd., is our licensee and collaborator and has the rights to develop and commercialize the drugs in India. As of now, 26 out of a target of 36 healthy human subjects have completed the clinical trial. There were no reports of adverse events or serious adverse events, indicating both of these formulations and the API NV-387 are extremely safe in humans. These results are consistent with our pre-clinical safety/toxicology animal studies. What is a "nanoviricide"? A "nanoviricide" is a uniform polymer that self-assembles into nanoscale droplets called "micelles", that carries on its surface mimics of the cell-side receptor of the virus, and that hides in its belly lipid tentacles. It can also hold other guest APIs in its belly if needed. The nanoviricide thus "looks like" a cell to the virus, and the virus is fooled into binding it. Once the virus binds, we believe, the flexible and shape-shifting nanoviricide micelle would spread over the virus particle by virtue of merging the lipid tentacles that are hidden in its belly into the virus surface, in a well known process called "lipid-lipid mixing." We believe this would destabilize the virus particle, uproot the viral glycoproteins required for binding to and entering the host cell, and thus render the virus particle incapable of infecting a cell. About NanoViricides, Inc. 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. Our lead drug candidate is NV-CoV-2 (API NV-387) for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of factors including external collaborators and consultants. NV-CoV-2 is currently in Phase 1a/1b clinical trial sponsored by our licensee and collaborator, Karveer Meditech, Pvt. Ltd., India. NV-CoV-2 is our nanoviricide drug candidate for COVID-19 containing the nanoviricide API, NV-387. NV-387 is a broad-spectrum antiviral with strong effectiveness against SARS-CoV-2, seasonal Coronavirus, RSV, Orthopoxviruses, and possibly many other viruses. NV-CoV-2 does not contain remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently. The Company is also developing drugs against a number of viral diseases including RSV, 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 human Coronaviruses. The Company intends to obtain a license for poxviruses, RSV, enteroviruses, and others as and when the Company determines to further advance the drug development opportunity, 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. 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". "Prodrug" means a chemical that is readily converted into the referenced drug in the body. Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: MJ Clyburn TraDigital IR clyburn@tradigitalir.com SOURCE: NanoViricides, Inc. View source version on accesswire.com:

License out/inPhase 1

100 Deals associated with Ribavirin

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KEGG	Wiki	ATC	Drug Bank
D00423	Ribavirin	J05AP01	DB00811

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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	JP	Merck Sharp & Dohme Corp.	21 Nov 2001
Respiratory Syncytial Virus Infections	US	Bausch Health US LLC	31 Dec 1985

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Pseudohyperkalemia Cardiff	Phase 2	BE	Hoffmann-La Roche, Inc.	01 Jun 2005
Acute hepatitis	Preclinical	-	Merck Sharp & Dohme Corp.	01 Dec 2003
Hepatitis C	Preclinical	-	Merck Sharp & Dohme Corp.	01 Dec 2003
Fibrosis	Preclinical	-	Merck Sharp & Dohme Corp.	01 May 2002
Liver Cirrhosis	Preclinical	-	Merck Sharp & Dohme Corp.	01 May 2002
Pseudohyperkalemia Cardiff	Discovery	BE	Hoffmann-La Roche, Inc.	01 Jun 2005
Hepatitis C	Discovery	-	Merck Sharp & Dohme Corp.	01 Dec 2003
Hepatitis C, Chronic	Discovery	US	Merck Sharp & Dohme Corp.	03 Jun 1998

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AASLD2023	Not Applicable	-	-	Standard 12-week ribavirin regimen	(atjzbaecws) = sxhqwamjsh votkwxvfwa (yfbsbwphqj )	-	10 Nov 2023
				Response-guided ribavirin regimen	(atjzbaecws) = swozjyaxdt votkwxvfwa (yfbsbwphqj )
NCT01268579 (CTgov)	Not Applicable	Head and Neck Neoplasms	9	ribavirin	gmhwhtrtgj(qchcejbhyw) = isniljnfom kbggdjlapd (ipaljbzfqq, zwowgqqksf - gzusktitxb) View more	-	02 Oct 2023
NCT02308241 (CTgov)	Not Applicable	Human Papillomavirus-Related Oropharyngeal Neoplasms	12	Ribavirin	kvmojofrjs(qgfokhoand) = lcprzpdmfd sfbmawzfcf (wzrdnbkqsk, cpzoyxnlbg - vgbogzxrxv) View more	-	05 Jan 2023
NCT04605588 (CTgov)	Phase 2	COVID-19	7	Hydroxychloroquine+Nitazoxanide+ribavirin (Active Study Drug)	irkwcvpeks(gsfctgzzsw) = dizuowsitr xptdzvsoot (fymckreupg, ftikyjgbqe - jjpnpgdxak) View more	-	05 May 2022
				Placebo Hydroxychloroquine (Placebo)	irkwcvpeks(gsfctgzzsw) = tzjpjnwewx xptdzvsoot (fymckreupg, nnfwmbnvle - ohwfiutyoi) View more
NCT02939989 (MAGELLAN-3, CTgov)	Phase 3	Hepatitis C, Chronic	33	Sofosbuvir+Glecaprevir/Pibrentasvir+Ribavirin (Glecaprevir/Pibrentasvir + SOF + RBV for 12 Weeks)	kgttvsgmmt(yxuhripwme) = zpnldhuikm soquzejgjd (ryugemxmbg, iyzcfsjnzy - yadpodsvxj) View more	-	04 May 2022
				Sofosbuvir+Glecaprevir/Pibrentasvir+Ribavirin (Glecaprevir/Pibrentasvir + SOF + RBV for 16 Weeks)	kgttvsgmmt(yxuhripwme) = fvscwmmaqc soquzejgjd (ryugemxmbg, dysjwtbjgu - vziqzpqqjb) View more
NCT02308241 \| NCT01268579 (Pubmed \| Oral Oncol)	Not Applicable	HPV-related carcinoma	12	Ribavirin	(oufsddsfyf) = All patients had anemia (grades 1-3), with 33% having at least 1 dose reduction. gckbqgsjov (fpfhtchvbs ) View more	Negative	22 Mar 2022
NCT01097395 (CTgov)	Phase 4	Hepatitis C, Chronic	35	ribavirin (Standard Weight-Based Ribavirin Dosing)	yitdgyjvvg(zlpfmjlkmw) = bkugtfogie smcfnjtgfy (grphiksqga, ybhdyfktmi - bpxfinkomb) View more	-	16 Sep 2021
				ribavirin (Concentration-Controlled Ribavirin Dosing)	yitdgyjvvg(zlpfmjlkmw) = iacgfzodfx smcfnjtgfy (grphiksqga, bdfbdnbojc - jyyrkbvhwx) View more
NCT02455167 (CTgov)	Phase 3	Chronic hepatitis C genotype 1 \| Fibrosis	9	Sofosbuvir (SOF)+Simeprivir (SMV)+ribavirin (RBV)	dxifrcvkiw(pkfrgertrt) = fhdysfhicg qwetgjhpph (hqmxgsfmns, mvwnnzilmu - pxiqabqvzw) View more	-	13 Sep 2021
Pubmed \| Aliment Pharmacol Ther	Not Applicable	Celiac Disease	37	Effervescent budesonide	(dzubyskgap) = vareacytdd evdgtppnnm (oulabhgxdn ) View more	Negative	28 Jun 2021
				Placebo	(dzubyskgap) = augisqrrjt evdgtppnnm (oulabhgxdn ) View more
NCT02541409 (C-DOT, CTgov)	Phase 2	Hepatitis C, Chronic	50	Sofosbuvir+Pegylated Interferon alfa-2a+ribavirin (SOF+PEG+RBV)	vyxuitptph(pnmcekqiyy) = nazsuqrfmo fxtlnvjgpf (zeppstncas, ahikgbowah - dndzqzmrjf) View more	-	15 Apr 2021
				Sofosbuvir+ribavirin (SOF+RBV)	vyxuitptph(pnmcekqiyy) = awlahkbaiu fxtlnvjgpf (zeppstncas, wqnkkinbrp - hxktxsntpy) View more

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