ArticleNaunyn-Schmiedeberg's archives of pharmacology2025
In silico and in vitro evaluation of the potential genotoxic impurities of vildagliptin.
Article in Naunyn-Schmiedeberg's archives of pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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
1 citing paper in PubMed.
- Vildagliptin topical ointment: an effective treatment for imiquimod-induced psoriasis in mice.Journal of molecular histology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Establishing the safety of impurities in drug substances or products is crucial. The assessment of genotoxicity for these impurities and determining the acceptable limits pose considerable challenges, as recognized in recent guidelines. While the genotoxicity profile of vildagliptin-an oral hypoglycemic drug-is well established, there is limited knowledge about the genotoxic potential of its impurities. In this study, vildagliptin cyclic amidine, vildagliptin diketopiperazine, and vildagliptin amide were assessed in silico and in vitro for mutagenic and clastogenic/aneugenic potential using Ames and micronucleus tests. None of the investigated impurities showed mutagenic or clastogenic potential, thus, are considered non-mutagenic and non-clastogenic/aneugenic in vitro. These findings are consistent with negative in silico predictions for mutagenicity and clastogenicity/aneugenicity in vitro, indicating a good correlation between in silico and in vitro data. In conclusion, this study provides valuable information for the safety assessment of vildagliptin, confirming that its impurities are neither clastogenic/aneugenic nor mutagenic.
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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.