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Despite its therapeutic potential, poor aqueous solubility, physicochemical instability, and low oral bioavailability severely limit its clinical application. This review provides an integrative overview of the physicochemical properties, biosynthesis, biological activities, underlying molecular mechanisms, pharmacokinetics, and safety profiles of ergosterol and its major derivatives. A structured literature search was conducted in PubMed, Web of Science, Scopus and CNKI up to February 2026, with findings critically synthesized across preclinical models. Current evidence links ergosterol-related interventions to changes in signaling pathways such as PI3K\/Akt, NF-\u03baB, and Wnt\/\u03b2-catenin, although direct target-engagement evidence remains limited for many disease models. The review concludes that while ergosterol represents a promising natural scaffold for drug development, translational progress is constrained by limited human pharmacokinetic data and insufficient exposure\u2013response validation. Future research should prioritize metabolite profiling, clinically relevant dosing strategies, and formulation optimization to better define the translational potential of ergosterol-based compounds.<\/jats:p>","DOI":"10.3390\/ijms27104198","type":"journal-article","created":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T19:10:52Z","timestamp":1778267452000},"page":"4198","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Ergosterol: Biological Activities, Mechanistic Evidence, Pharmacokinetic Barriers, and Delivery Strategies"],"prefix":"10.3390","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-9180-6788","authenticated-orcid":false,"given":"Mingkai","family":"Yao","sequence":"first","affiliation":[{"name":"Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cui","family":"Li","sequence":"additional","affiliation":[{"name":"Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mengya","family":"Dang","sequence":"additional","affiliation":[{"name":"Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Na","family":"Zhang","sequence":"additional","affiliation":[{"name":"Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoyun","family":"Yang","sequence":"additional","affiliation":[{"name":"Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuping","family":"Wang","sequence":"additional","affiliation":[{"name":"Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mengru","family":"Cai","sequence":"additional","affiliation":[{"name":"Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong","family":"Bai","sequence":"additional","affiliation":[{"name":"Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,5,8]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"17832","DOI":"10.18632\/oncotarget.4026","article-title":"Ergosterol Purified from Medicinal Mushroom Amauroderma rude Inhibits Cancer Growth in Vitro and in Vivo by Up-Regulating Multiple Tumor Suppressors","volume":"6","author":"Li","year":"2015","journal-title":"Oncotarget"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1979","DOI":"10.1007\/s10753-015-0178-1","article-title":"Effects of Ergosterol, Isolated from Scleroderma Polyrhizum Pers., on Lipopolysaccharide-Induced Inflammatory Responses in Acute Lung Injury","volume":"38","author":"Zhang","year":"2015","journal-title":"Inflammation"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1700444","DOI":"10.1002\/mnfr.201700444","article-title":"Antidiabetic Activity of Ergosterol from Pleurotus Ostreatus in KK-Ay Mice with Spontaneous Type 2 Diabetes Mellitus","volume":"62","author":"Xiong","year":"2018","journal-title":"Mol. 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