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Life sciences · Journal article
Pharmaceutics · September 7, 2026
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This is a first-in-concept preclinical study of a novel PEGylated cerosome formulation of niflumic acid tested in a murine subcutaneous Ehrlich carcinoma model. The optimized topical gel formulation showed improved skin permeation (2.02-fold over pure drug) and modulation of EGFR/ERK/miR-21 signaling with markers of tumor suppression and apoptosis in mice, but the work remains exploratory and does not include human subjects or direct comparator efficacy data.
Single-arm preclinical in vivo study in murine subcutaneous Ehrlich carcinoma model. Subcutaneous solid Ehrlich carcinoma mice model; in vitro ex vivo rat skin permeation studies.. Intervention: NIF-loaded PEGylated cerosomes (optimal formula C5) incorporated into a topical gel.
Optimal formula C5 showed 96.71 ± 0.0% encapsulation efficiency and vesicular size 292.95 ± 0.78 nm NIF-loaded PEG-CER gel exhibited 2.02-fold higher skin permeation compared to pure NIF gel Significant decrease in tumor volume and marked improvement in survival rate in SEC mice confirmed by downregulation of EGFR, ERK1, ERK2, and miR-21-5p expression
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This preclinical work suggests potential for nanoformulated niflumic acid in topical cancer therapy through MAPK pathway targeting, but extensive further development—including toxicology, pharmacokinetics, and clinical trials—would be needed before any therapeutic claim can be made in humans.
First-in-concept preclinical study in a murine xenograft model using a novel nanoformulation; lacks human data, comparator arm, and hard clinical outcomes to support practice change.
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Quoted from the source exactly as published.
This preclinical work suggests potential for nanoformulated niflumic acid in topical cancer therapy through MAPK pathway targeting, but extensive further development—including toxicology, pharmacokinetics, and clinical trials—would be needed before any therapeutic claim can be made in humans.
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Background/Objectives: Repurposing existing drugs may represent a promising strategy for effective cancer therapy. This study was the first to investigate the augmented antitumor therapeutic effect achieved by co-incorporating the NSAID Niflumic acid (NIF) with ceramides into PEGylated cerosomes (NIF-loaded PEG-CERs) in a novel platform that targets specifically the MAPK-ERK signaling pathway and miR-21-5p modulation. Methods: The prepared formulae were statistically optimized utilizing a full factorial design and the optimal formula (C5) was further incorporated into a topical gel and evaluated for ex vivo rat skin permeation, and tested in vivo in a subcutaneous solid Ehrlich carcinoma (SEC) mice model. Results: The optimal formula (C5) showed tubular elongated morphology with higher EE% (96.71 ± 0.0), lower vesicular size (VS) and PDI values, 292.95 ± 0.78 nm and 0.47 ± 0.0 respectively. A high ZP value (−37.5 ± 0.57 mV) was in accordance with stability results showing good stability of the optimal formula (C5). Permeability studies exhibited 2.02-fold higher skin permeation compared to pure NIF gel. A significant decrease in tumor volume and marked improvement in survival rate in SEC mice were confirmed by downregulation of EGFR, ERK1, ERK2, and miR-21-5p expression. Furthermore, an increase in total antioxidant capacity and caspase-3 levels was observed, accompanied by significant suppression in cyclin D1, MMP-2, COX-2, and MDA levels. Finally, histopathological analysis revealed the superior antitumor effect of C5 gel together with immunohistochemical assay showing the lowest BCL-2-positive staining, indicating the restoration of physiological apoptotic balance. Conclusions: Based on the previous findings, NIF-loaded PEG-CERs offer augmented therapeutic potential for efficient topical skin cancer management in an SEC mice model.
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