Insilico Medicine Receives FDA Fast Track Designation for ISM6331, the AI-driven Pan-TEAD Inhibitor, in Advanced Mesothelioma (IMAGE)
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This is the first Fast Track Designation granted to a program in Insilico’s AI-driven pipeline, recognizing ISM6331’s potential to provide a meaningful therapy where limited options exist or to offer improved clinical efficacy over available treatments. Previously, ISM6331 received Orphan Drug Designation (ODD) for the same indication in June 2024, following the ODD in February 2023 for Rentosertib (ISM001-055), Insilico’s lead program currently in Phase III clinical trial for the treatment of idiopathic pulmonary fibrosis (IPF).
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Insilico Medicine
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