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PSX-514 is a proprietary, ultra-pure, high-potency crystalline form of epigallocatechin gallate (EGCG), a major polyphenol component of green tea. Developed by PharmassêtX, PSX-514 is being advanced as a prescription drug for the treatment of pouchitis—a rare and debilitating form of inflammatory bowel disease (IBD) that occurs in patients who have undergone surgery to remove their large intestine. There are currently no FDA-approved drugs for pouchitis. The mechanism of action involves inhibition of NF-κB, a key regulator of mucosal immunity and pro-inflammatory gene expression; additional effects may include decreased activation of the NLRP3 inflammasome, reduced secretion of pro-inflammatory interleukins, and promotion of intestinal barrier integrity. Preclinical and clinical studies have shown that EGCG can improve symptoms in IBD patients without serious adverse events. PSX-514 has received Orphan Drug Designation from the FDA for pouchitis and is expected to enter clinical trials in 2025[1][3][4][5][6].
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