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Fexapotide triflutate is a first-in-class injectable protein drug developed for the treatment of benign prostatic hyperplasia (BPH) and low-grade localized prostate cancer. It is administered via transrectal intraprostatic injection under ultrasound guidance, typically in an outpatient urology setting. The drug acts by selectively inducing apoptosis (programmed cell death) in proliferating prostate glandular epithelial cells, leading to shrinkage of the enlarged prostate tissue while sparing surrounding nerves and structures. Mechanistically, it activates caspase pathways, tumor necrosis factor pathways, and BCL family pathways to trigger cell death specifically within the transition zone of the prostate. Clinical trials have demonstrated significant improvements in BPH symptoms, reduced need for surgical intervention or catheterization, and a favorable safety profile with minimal sexual side effects compared to existing therapies[1][2][3][5][6][7].
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