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

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

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.

01 Jun 2023·Antiviral Therapy

Genotypic and phenotypic characterization of influenza A viral variants in study participants treated with pimodivir in the phase 2b TOPAZ study

Article

Author: Vingerhoets, Johan ; De Meyer, Sandra ; Van Dromme, Ilse ; van Duijnhoven, Wilbert ; Leopold, Lorant ; Anderson, David

Background Pimodivir is a first-in-class polymerase basic protein 2 (PB2) subunit inhibitor of the influenza A polymerase complex. The randomized double-blinded placebo-controlled phase 2b TOPAZ study demonstrated antiviral activity and safety of twice daily pimodivir alone (300 mg, 600 mg) or in combination with oseltamivir (pimodivir 600 mg, oseltamivir 75 mg) in adult study participants with acute uncomplicated influenza A. The detailed genotypic and phenotypic characterization of viral variants observed in this study are reported. Methods Population sequencing of PB2 and neuraminidase genes, and phenotypic susceptibility testing, were performed using baseline and last virus-positive post-baseline nasal swab samples. Results Sequencing of baseline samples in 206 of 223 (92.4%) randomized study participants with confirmed influenza A infection identified no polymorphisms at any predefined PB2 positions of interest for pimodivir and no phenotypic reduced susceptibility to pimodivir was observed. Post-baseline sequencing data for 105/223 (47.1%) participants identified emergence of PB2 mutations at amino acid positions of interest in 10 (9.5%) participants (pimodivir 300 mg: n = 3; 600 mg: n = 6; combination: n = 1; placebo: n = 0) and included positions S324, F325, S337, K376, T378, and N510. These emerging mutations were typically associated with decreased pimodivir susceptibility, but not viral breakthrough. No reduced phenotypic susceptibility was observed in the one (1.8%) participant with emerging PB2 mutations from the pimodivir plus oseltamivir group. Conclusions Participants with acute uncomplicated influenza A treated with pimodivir in the TOPAZ study infrequently developed reduced susceptibility to pimodivir and combining pimodivir with oseltamivir further decreased the risk of reduced susceptibility development.

12 Aug 2022·The Journal of Infectious DiseasesQ2 · MEDICINE

A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study

Q2 · MEDICINE

Article

Author: Wilburn, John M ; Torres, Antoni ; O’Neil, Brian ; Vingerhoets, Johan ; Nilsson, Anna C ; Anderson, David ; Hallouin-Bernard, Marie Charlotte ; Kosoglou, Teddy ; Van Dromme, Ilse ; Rossenu, Stefaan ; Leopold, Lorant ; Ison, Michael G ; van Duijnhoven, Wilbert ; Deleu, Sofie

AbstractBackgroundBoth the elderly and individuals with comorbidities are at increased risk of developing influenza-related complications. Novel influenza antivirals are required, given limitations of current drugs (eg, resistance emergence and poor efficacy). Pimodivir is a first-in-class antiviral for influenza A under development for these patients.MethodsHospitalized patients with influenza A infection were randomized 2:1 to receive pimodivir 600 mg plus oseltamivir 75 mg or placebo plus oseltamivir 75 mg twice daily for 7 days in this phase 2b study. The primary objective was to compare pimodivir pharmacokinetics in elderly (aged 65–85 years) versus nonelderly adults (aged 18–64 years). Secondary end points included time to patient-reported symptom resolution.ResultsPimodivir pharmacokinetic parameters in nonelderly and elderly patients were similar. Time to influenza symptom resolution was numerically shorter with pimodivir (72.45 hours) than placebo (94.15 hours). There was a lower incidence of influenza-related complications in the pimodivir group (7.9%) versus placebo group (15.6%). Treatment was generally well tolerated.ConclusionsNo apparent relationship was observed between pimodivir pharmacokinetics and age. Our data demonstrate the need for a larger study of pimodivir in addition to oseltamivir to test whether it results in a clinically significant decrease in time-to-influenza-symptom alleviation and/or the frequency of influenza complications.Clinical trials registrationNCT02532283.

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	LT	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	AR	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	LT	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	LV	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	SK	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	SK	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	LV	Janssen Research & Development LLC	03 Jan 2018
Influenza A virus infection	Phase 3	AU	Janssen Research & Development LLC	03 Jan 2018

Clinical Result

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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)	eoxhuhnwsg(krznkqedmb) = gqxrwgblbr mibuxvokly (asafzqvusx, avqwtkehvc - vyfyrkwycn) View more	-	24 May 2021
				Placebo (Placebo + SOC)	eoxhuhnwsg(krznkqedmb) = yughyuqmil mibuxvokly (asafzqvusx, maltdimtdc - dxyleitxks) View more
NCT03376321 (CTgov)	Phase 3	Influenza A virus infection	334	Pimodivir (Pimodivir + SOC)	lffpmsmxsd(kctaiinfqf) = fchphdfbjr gfqugygtpf (vedrpkfybj, cqibmviyuh - mqijdnbpzq) View more	-	14 Apr 2021
				Placebo (Placebo + SOC)	lffpmsmxsd(kctaiinfqf) = rmtjnxbsjf gfqugygtpf (vedrpkfybj, qqwfpflbdi - mpvorauopl) View more
NCT02532283 (CTgov)	Phase 2	Influenza A virus infection	102	oseltamivir+pimodivir (Elderly Adults (65 to Less Than or Equal to [<=] 85 Years))	ttkiyyshbj(bqmjfuufpn) = wwrncqjrzp hbimaijtpv (ddtkjfhday, xehktcxqty - pdrvpcxgfu) View more	-	27 Mar 2020
				oseltamivir+pimodivir (Non-elderly Adults (18 to <=64 Years))	ttkiyyshbj(bqmjfuufpn) = oufxovldcb hbimaijtpv (ddtkjfhday, cukatwozzv - rqmpccmybq) View more

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