ArticleNAM journal2025
Botulinum neurotoxin: Tracking the transition from lethal dose to
Article in NAM journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Botulinum neurotoxin (BoNT), commonly referred to as 'Botox', is widely used in medical and aesthetic applications across the globe. As a biological product, BoNT requires rigorous batch potency testing to ensure safety, and is currently reliant on the ethically and scientifically contentious Mouse Lethality Bioassay (MLB). Despite severe suffering of the mice, the reproducibility crisis, and translatability issues of this Lethal Dose (LD50) test, its use persists due to regulatory inertia and other systemic barriers. Recent advancements in new approach methodologies (NAMs), particularly cell-based assays (CBAs), offer promising non-animal alternatives for regulatory potency testing. This paper seeks to provide an update on the transition to non-animal NAMs with a primary focus on Europe as a key player in the production of BoNT products. Namely, it describes the (accepted) alternatives to the MLB, the distribution of BoNT products and use of mice in the European Union and United Kingdom, and attempts to understand the number of mice used per year for BoNT alone, by analyzing Non-Technical Summaries (NTSs) from known testing facilities across the UK, Germany, and Ireland. This paper synthesizes findings from publicly available resources to provide actionable insights into overcoming barriers to implementing ethical and scientifically robust alternatives for regulatory testing of BoNT products. Based on NTS data, the MLB has likely ceased in Germany but persists in the UK and Ireland. Our findings show that even when companies have developed CBAs, MLB use may continue for various factors such as testing for reference standards, comparability testing/validation of CBAs, a lack of universal alternatives, and compliance with regulations for market authorizations of new BoNT products. Finally, predicting the number of mice used for BoNT potency testing was strikingly difficult, especially given the severity of the LD50 test, demonstrating the need for greater transparency in actual animal use for (severe) procedures and the limited applicability of public data to predict actual animal use for more specific research questions.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.