Evidence map›Paper›PMID 41826491›Full record

ArticleThe AAPS journal2026

PBPK Modelling of Antisense Oligonucleotide Therapeutics: Application for Predicting Plasma and Tissue Pharmacokinetics of Bepirovirsen.

Farzaneh Salem, Felix Stader, Amir S Youssef, Abdallah Derbalah, Ahmed Nader, Steve Hood, Kunal Taskar

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Article in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Farzaneh SalemDrug Metabolism and Pharmacokinetics, GSK R&D, Gunnels Wood Rd, Stevenage, SG1 2NY, UK. farzaneh.x.salem@gsk.com.ORCID 0000-0003-1791-9390
Felix StaderCertara UK Limited, Simcyp Division, Level 2 Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK.ORCID 0000-0002-4223-6754
Amir S YoussefClinical Pharmacology Modeling and Simulation, GSK R&D, Collegeville, Pennsylvania, USA.ORCID 0000-0003-4413-066X
Abdallah DerbalahCertara UK Limited, Simcyp Division, Level 2 Acero, 1 Concourse Way, Sheffield, S1 2BJ, UK.ORCID 0000-0003-1841-9646
Ahmed NaderClinical Pharmacology Modeling and Simulation, GSK R&D, Collegeville, Pennsylvania, USA.
Steve HoodDrug Metabolism and Pharmacokinetics, GSK R&D, Gunnels Wood Rd, Stevenage, SG1 2NY, UK.
Kunal TaskarDrug Metabolism and Pharmacokinetics, GSK R&D, Gunnels Wood Rd, Stevenage, SG1 2NY, UK.ORCID 0000-0001-9979-8267

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antisense oligonucleotide (ASO) therapeutics present new opportunities for treating challenging-to-treat diseases. Prediction of concentration-time course in systemic circulation and tissues within the context of large molecule physiologically based pharmacokinetic (PBPK) modelling has proven to be useful in animal-to-human extrapolation and first-in-human dose selection. A human PBPK model was developed and verified using bepirovirsen clinical data to predict plasma pharmacokinetics (PK) and tissue concentrations. Liver and kidney partition coefficient ratios from monkey studies, corrected for plasma unbound fraction in monkeys and humans, informed bepirovirsen concentration predictions in the human liver and kidney. Liver and kidney partition coefficients were calculated to be 2147 and 2822, respectively. All predicted PK parameters in healthy volunteers (except t

Indexed as

Models, BiologicalOligonucleotides, AntisenseAdultAnimalsArea Under CurveFemaleHumansKidneyLiverMaleTissue DistributionYoung AdultOligonucleotides, Antisensebepirovirsenhepatitis BoligonucleotidePBPK

Identifiers

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.