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PG101 is a water-soluble extract derived from the cultured mycelia of *Lentinus lepideus*, a type of mushroom. It acts as a biological response modifier by selectively activating cytokine production in human peripheral blood mononuclear cells (PBMCs), particularly increasing levels of TNF-α, IL-1β, IL-10, and IL-12. The primary responsive cell types are monocytes/macrophages rather than T or B cells. Mechanistically, PG101 activates the NF-κB transcription factor pathway to induce cytokine expression. Preclinical studies indicate that it is nontoxic at high concentrations and may serve as an immune modulator with therapeutic potential. Additionally, there is reference to a product called PG-101 (ProGen), developed by ProGen Co., Ltd., which has reached Phase 1 clinical trials for indications including neoplasms and urogenital diseases such as metastatic castration-resistant prostate cancer. There are also references to its investigation for dry eye syndrome.
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