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Insilico Medicine Completes First Patient First Dose in BETHESDA: A Phase II Trial for Garutadustat (ISM5411), the Gut-restricted AI-driven PHD Inhibitor for the Treatment of Inflammatory Bowel Disease
Insilico Medicine ("Insilico"), a clinical-stage, generative AI-driven drug discovery company, today announced the completion of first patient first dose in BETHESDA: a Phase IIa clinical trial of ISM5411 (NCT07265570), which has recently been granted the generic name of Garutadustat by the United States Adopted Names (USAN) Council. Garutadustat (originally ISM5411) is a novel, gut-restricted PHD inhibitor developed with Pharma.AI, Insilico's generative platform, for the treatment of Inflammato
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[{"type":"text","content":"CAMBRIDGE, Mass., Jan. 12, 2026 /PRNewswire/ -- Insilico Medicine ("Insilico"), a clinical-stage, generative AI-driven drug discovery company, today announced the completion of first patient first dose in BETHESDA: a Phase IIa clinical trial of ISM5411 (NCT07265570), which has recently been granted the generic name of Garutadustat by the United States Adopted Names (USAN) Council. Garutadustat (originally ISM5411) is a novel, gut-restricted PHD inhibitor developed with Pharma.AI, Insilico's generative platform, for the treatment of Inflammatory Bowel Disease (IBD).","length":585,"tagName":"p"},{"type":"text","content":"Named Barrier Enhancement Therapy for Healing Enteric Structural Defects & Anomalies (BETHESDA), this ongoing multicenter, randomized, double-blind, placebo-controlled Phase IIa trial of Garutadustat is led by Professor Minhu Chen, one of the most renowned Gastroenterology experts in China and the subject leader of Department of Gastroenterology at the First Affiliated Hospital of Sun Yat-sen University. In approximately 80 participants with ulcerative colitis, BETHESDA plans to assess the safety, tolerability, and pharmacokinetics (PK) of Garutadustat, and efficacy signals will be monitored through clinical remission/response, endoscopy, histopathology, and biomarker exploration.","length":693,"tagName":"p"},{"type":"text","content":""Given the encouraging results from our Phase I studies on Garutadustat's safety and gut-restricted profile, we look forward to seeing how these benefits will be translated into ulcerative colitis patient population," says Carol Satler, MD, PhD, Senior Vice President for Clinical Development, Non-Oncology, Insilico Medicine. "This program is the output of an AI-driven breakthrough that sets a new benchmark in the field. We are excited to advance Garutadustat into Phase II trial and anticipate that its innovative, AI-identified mechanism will offer new hope for patients living with inflammatory bowel disease."","length":640,"tagName":"p"},{"type":"text","content":"Inflammatory Bowel Disease (IBD) encompasses chronic, relapsing inflammatory conditions of the gastrointestinal tract, most notably ulcerative colitis and Crohn's disease. These diseases affect millions of people worldwide and can increase the risk of developing colitis-associate...