Evidence map›Paper›PMID 42638221›Full record

ArticleClinical pharmacology and therapeutics2026

Successful Translational Prediction of Bedaquiline's Phase 2a Clinical Trial Results against Tuberculosis: The Zebrafish as a New Approach Methodology.

Bart van Lieshout, Aanisah Hanuun, J G Coen van Hasselt, Rob C van Wijk

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

4 authors.

Bart van LieshoutSystems Pharmacology and Pharmacy, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.ORCID https://orcid.org/0009-0000-5031-9042
Aanisah HanuunSystems Pharmacology and Pharmacy, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.ORCID https://orcid.org/0009-0007-3071-3254
J G Coen van HasseltSystems Pharmacology and Pharmacy, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.ORCID https://orcid.org/0000-0002-1664-7314
Rob C van WijkSystems Pharmacology and Pharmacy, Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.ORCID https://orcid.org/0000-0001-7247-1360

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tuberculosis remains an urgent global health crisis that requires an accelerated development of novel regimens. Rodent and rabbit studies currently inform early translational predictions. However, the zebrafish (Danio rerio) embryo/larva, as a New Approach Methodology, provides an ethical, cost-effective, and high-throughput non-mammalian disease model to study early anti-tuberculosis drug pharmacology and bridge the gap between in vitro drug screens and (confirmatory) rodent experiments. This study aimed to translate the bedaquiline exposure-response relationship from zebrafish to humans to predict two phase 2a trial results in order to strengthen the use of zebrafish as a New Approach Methodology for translational anti-tuberculosis pharmacology. An established exposure-response relationship for bedaquiline in zebrafish against Mycobacterium marinum as a tuberculosis disease model was combined with a clinical population pharmacokinetic model to predict bacterial burden profiles from two published phase 2a clinical trials (25 to 400 mg daily). This translation incorporated the minimum inhibitory concentration ratio between Mycobacterium marinum and Mycobacterium tuberculosis to scale the zebrafish bedaquiline EC

Identifiers

PMID42638221
PMCPMC13503988

What OpenQuestion holds

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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.