A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Pimodivir in Adult Subjects

The purpose of this study is to evaluate the pharmacokinetics (PK) of pimodivir after a single oral dose of 600 milligrams (mg) in adult participants with severe renal impairment who are not on dialysis and in adult participants with end-stage renal disease (ESRD) who are not yet on dialysis compared to adult participants with normal renal function (Part A). Optionally, to evaluate the PK in adult participants with mild and/or moderate renal impairment compared to adult participants with normal renal function (Part B).

Start Date02 Jul 2019

Sponsor / Collaborator

Janssen-Cilag International NV

NCT03816631

/ CompletedPhase 1

A Phase 1, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Orally Administered Pimodivir in Adult Subjects

The purpose is to evaluate the pharmacokinetics (PK) of a single oral dose of 600 milligram (mg) pimodivir in adult participants with impaired hepatic function compared to adult participants with normal hepatic function.

Start Date28 May 2019

Sponsor / Collaborator

Janssen-Cilag International NV

NCT03768609

/ CompletedPhase 1

A Randomized, Open-label, Single-dose, 2-period, 2-sequence, Crossover, Phase 1 Study to Evaluate the Effect of Cyclosporine, a P-glycoprotein, Breast Cancer Resistance Protein, and Organic-anion-transporting Polypeptide Inhibitor, on the Pharmacokinetics of Pimodivir in Healthy Adult Subjects

The purpose of this study is to evaluate the effect of a single oral dose of cyclosporine on the pharmacokinetics of a single oral dose of pimodivir when coadministered to healthy adult participants under fasted conditions.

Start Date06 Dec 2018

Sponsor / Collaborator

Janssen-Cilag International NV

100 Clinical Results associated with Pimodivir

100 Translational Medicine associated with Pimodivir

100 Patents (Medical) associated with Pimodivir

Literatures (Medical) associated with Pimodivir

04 Feb 2025·JOURNAL OF INFECTIOUS DISEASES

Efficacy and Safety of Pimodivir Combined With Standard of Care in Hospitalized and Nonhospitalized High-Risk Adolescents and Adults With Influenza A Infection

Article

Author: Nalpas, Catherine ; Deleu, Sofie ; van Dromme, Ilse ; Weber, Karin ; Leopold, Lorant ; Michiels, Bart ; van Duijnhoven, Wilbert ; Vingerhoets, Johan ; Lowson, David

Abstract:

Background:

An unmet need exists for effective antivirals to treat patients hospitalized with influenza. The results of 2 phase 3 studies that evaluated the efficacy and safety of pimodivir in combination with investigator-chosen standard of care (SoC) treatment are presented.

Methods:

Hospitalized patients (hospital study; NCT03376321) and high-risk outpatients (outpatient study; NCT03381196) with laboratory-confirmed influenza A infection were randomized 1:1 to 600 mg pimodivir twice daily + SoC or placebo twice daily + SoC for 5 days. For most patients, SoC included oseltamivir. Primary end points were Hospital Recovery Scale (HRS) at day 6 (hospital study) and median time to resolution (TTR) of influenza-related symptoms (outpatient study).

Results:

Pimodivir + SoC (oseltamivir) treatment showed no clinical benefit over placebo + SoC on HRS at day 6 (common odds ratio, 0.943; 95% confidence interval [CI], .609–1.462; P = .397; hospital study). A shorter median TTR of 7 symptoms was estimated with pimodivir + SoC versus placebo (92.6 hours; 95% CI, 77.6–104.2 vs 105.1 hours; 95% CI, 92.7–128.6; P = .0216; outpatient study).

Conclusions:

Pimodivir + SoC showed no additional clinical benefit versus SoC treatment alone in hospitalized patients. Pimodivir + SoC demonstrated shorter TTR of influenza symptoms versus placebo + SoC in high-risk outpatients.

Clinical Trial Registration:

NCT03376321 and NCT03381196.

01 Feb 2025·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

The evaluation of DNA-linked inhibitor antibody and AlphaScreen assays for high-throughput screening of compounds targeting the cap-binding domain in influenza a polymerase

Article

Author: Bechynský, Vít ; Konvalinka, Jan ; Kožíšek, Milan ; Navrátil, Václav ; Karlukova, Elena ; Čermáková, Kateřina ; Machara, Aleš ; Albiñana, Carlos Berenguer ; Reiberger, Róbert ; Gregor, Jiří ; Kráľ, Michal ; Majer, Pavel

The PB2 subunit of the influenza virus polymerase complex is essential for viral replication, primarily through a mechanism known as cap-snatching. In this process, PB2 binds to the 5' cap structure of host pre-mRNAs, enabling the viral polymerase to hijack the host transcriptional machinery. This binding facilitates the cleavage and integration of the capped RNA fragment into viral mRNA, thereby promoting efficient viral replication. Inhibiting the PB2-cap interaction is therefore crucial, as it directly disrupts the viral replication cycle. Consequently, targeting PB2 with specific inhibitors is a promising strategy for antiviral drug development against influenza. However, there are currently no available methods for the high-throughput screening of potential inhibitors. The development of new inhibitor screening methods of potential PB2 binders is the focus of this study. In this study, we present two novel methods, DIANA and AlphaScreen, for screening influenza PB2 cap-binding inhibitors and evaluate their effectiveness compared to the established differential scanning fluorimetry (DSF) technique. Using a diverse set of substrates and compounds based on the previously described PB2 binder pimodivir, we thoroughly assessed the capabilities of these new methods. Our findings demonstrate that both DIANA and AlphaScreen are highly effective for PB2 inhibitor screening, offering distinct advantages over traditional techniques such as isothermal titration calorimetry (ITC) and surface plasmon resonance (SPR). These advantages include improved scalability, reduced sample requirements, and the capacity for label-free detection. Notably, DIANA's ability to determine K_i values from a single-well measurement significantly enhances its practicality and efficiency in inhibitor screening. This research represents a significant step forward in the development of more efficient and scalable screening strategies, helping advance efforts in the discovery of antiviral drugs against influenza.

21 Dec 2023·Journal of biomolecular structure & dynamics

Dynamics and binding affinity of nucleoside and non-nucleoside inhibitors with RdRp of SARS-CoV-2: a molecular screening, docking, and molecular dynamics simulation study

Article

Author: Chinnamadhu, Archana ; Ramadurai, Prakash ; Suresh, Suganya ; Poomani, Kumaradhas ; Ramakrishnan, Jaganathan

In this COVID-19 pandemic situation, an appropriate drug is urgent to fight against this infectious disease to save lives and prevent mortality. Repurposed drugs and vaccines are the immediate solutions for this medical emergency until discover a new drug to treat this disease. As of now, no specific drug is available to cure this disease completely. Several drug targets were identified in SARS-CoV-2, in which RdRp protein is one of the potential targets to inhibit this virus infection. In-Silico studies plays a vital role to understand the binding nature of the drugs at the atomic level against the disease targets. The present study explores the binding mechanism of reported 53 nucleoside and non-nucleoside RdRp inhibitors and Ivermectin which are in clinical trials. These molecules were screened by molecular docking simulation; in which, the molecules are showing high binding affinity and forming interactions with the key amino acids of active site of RdRp protein are chosen for molecular dynamics simulation (MD) and binding free energy analysis. The results of molecular docking and MD simulation studies reveal that IDX184 is a stable molecule and forms strong interactions with the key amino acids and shows high binding affinity towards RdRp. Hence, IDX184 may also be considered as a potential inhibitor of RdRp after clinical study.Communicated by Ramaswamy H. Sarma.

News (Medical) associated with Pimodivir

25 Mar 2015

·www.bioportfolio.com

H3N2 Infection - Pipeline Review, H1 2015

Recently added to the BioPortfolio report store, H3N2 Infection - Pipeline Review, H1 2015 is a new report from Global Markets Direct published on 2015-02-23. This 62-page report is available in PDF from $2000. H3N2 Infection - Pipeline Review, H1 2015 Summary Global Markets Direct’s, ‘H3N2 Infection - Pipeline Review, H1 2015’, provides an overview of the H3N2 Infection’s therapeutic pipeline. This report provides comprehensive information on the therapeutic development for H3N2 Infection, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for H3N2 Infection and special features on late-stage and discontinued projects. Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope - The report provides a snapshot of the global therapeutic landscape of H3N2 Infection - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for H3N2 Infection and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the H3N2 Infection products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the H3N2 Infection pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Reasons to buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop strategic initiatives by understanding the focus areas of… Table of Contents Table of Contents 2 List of Tables 5 List of Figures 5 Introduction 6 Global Markets Direct Report Coverage 6 H3N2 Infection Overview 7 Therapeutics Development 8 Pipeline Products for H3N2 Infection - Overview 8 Pipeline Products for H3N2 Infection - Comparative Analysis 9 H3N2 Infection - Therapeutics under Development by Companies 10 H3N2 Infection - Pipeline Products Glance 12 Clinical Stage Products 12 Early Stage Products 13 H3N2 Infection - Products under Development by Companies 14 H3N2 Infection - Companies Involved in Therapeutics Development 15 AlphaVax, Inc. 15 Colby Pharmaceutical Company 16 Crucell N.V. 17 Cure Lab, Inc. 18 Inovio Pharmaceuticals, Inc. 19 Johnson & Johnson 20 NanoViricides, Inc. 21 REPLICor Inc. 22 Takeda Pharmaceutical Company Limited 23 Vaxart, Inc. 24 H3N2 Infection - Therapeutics Assessment 25 Assessment by Monotherapy Products 25 Assessment by Combination Products 26 Assessment by Target 27 Assessment by Mechanism of Action 29 Assessment by Route of Administration 31 Assessment by Molecule Type 33 Drug Profiles 35 Aspidasept - Drug Profile 35 Product Description 35 Mechanism of Action 35 R&D Progress 35 AVX-502 - Drug Profile 36 Product Description 36 Mechanism of Action 36 R&D Progress 36 bordetella pertussis [strain BPZE1] vaccine - Drug Profile 37 Product Description 37 Mechanism of Action 37 R&D Progress 37 C-05 - Drug Profile 38 Product Description 38 Mechanism of Action 38 R&D Progress 38 CLVax-1.0 - Drug Profile 39 Product Description 39 Mechanism of Action 39 R&D Progress 39 CR-9114 - Drug Profile 41 Product Description 41 Mechanism of Action 41 R&D Progress 41 Gamma-Flu - Drug Profile 42 Product Description 42 Mechanism of Action 42 R&D Progress 42 ID-38 - Drug Profile 43 Product Description 43 Mechanism of Action 43 R&D Progress 43 influenza [H3N2] vaccine - Drug Profile 44 Product Description 44 Mechanism of Action 44 R&D Progress 44 influenza vaccine - Drug Profile 45 Product Description 45 Mechanism of Action 45 R&D Progress 45 JVRS-100 + influenza [H1N1/H3N2] vaccine - Drug Profile 46 Product Description 46 Mechanism of Action 46 R&D Progress 46 NVINF-1 - Drug Profile 47 Product Description 47 Mechanism of Action 47 R&D Progress 47 NVINF-2 - Drug Profile 49 Product Description 49 Mechanism of Action 49 R&D Progress 49 REP-9 - Drug Profile 50 Product Description 50 Mechanism of Action 50 R&D Progress 50 seasonal influenza [H3N2] vaccine - Drug Profile 51 Product Description 51 Mechanism of Action 51 R&D Progress 51 VX-787 … For more information open H3N2 Infection - Pipeline Review, H1 2015. SKU: GMDHC6284IDB

First in ClassVaccine

100 Deals associated with Pimodivir

External Link

KEGG	Wiki	ATC	Drug Bank
D11287	Pimodivir	-	DB14974

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza A virus infection	Phase 3	US	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	CN	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	AR	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	AU	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	AT	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	BE	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	BR	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	BG	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	CA	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	CL	Janssen Research & Development LLC	03 Jan 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03381196 (CTgov)	Phase 3	Influenza A virus infection	553	Pimodivir (Pimodivir + SOC)	kamdtvuvoo(biiwptjdaq) = dpigkggsej qunvtlxjui (ezqbkyzwhd, mwxzqenxgc - gcukfhbjjo) View more	-	24 May 2021
				Placebo (Placebo + SOC)	kamdtvuvoo(biiwptjdaq) = oklkzdpbfu qunvtlxjui (ezqbkyzwhd, ldwkloxuzk - tlplzwmqwf) View more
NCT03376321 (CTgov)	Phase 3	Influenza A virus infection	334	Pimodivir (Pimodivir + SOC)	ziatjrytht(kapfiqfrdj) = vagilhqmmj dfnilizcdi (jyptwmvewu, aljhykklav - bqwbkhhcrz) View more	-	14 Apr 2021
				Placebo (Placebo + SOC)	ziatjrytht(kapfiqfrdj) = sfaiyjylxc dfnilizcdi (jyptwmvewu, ltuytfyioo - hrpiwyalbp) View more
NCT02532283 (CTgov)	Phase 2	Influenza A virus infection	102	oseltamivir+pimodivir (Elderly Adults (65 to Less Than or Equal to [<=] 85 Years))	fiqqvsrxgq(jhjhjxeres) = hrebqthutz johggjnabl (ekljvtmklm, zyijfxzwrz - nbyatuaxwo) View more	-	27 Mar 2020
				oseltamivir+pimodivir (Non-elderly Adults (18 to <=64 Years))	fiqqvsrxgq(jhjhjxeres) = nmlhjmfmwn johggjnabl (ekljvtmklm, byfxvwypba - muffozoyta) View more

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