Insilico Medicine Receives FDA Fast Track Designation for AI-Driven Pan-TEAD Inhibitor ISM6331 in Advanced Mesothelioma

Insilico Medicine has received FDA Fast Track Designation for ISM6331, an AI-driven pan-TEAD inhibitor, for the treatment of adult patients with unresectable malignant pleural mesothelioma whose disease has progressed after prior anti-PD-1/CTLA-4 and platinum-based chemotherapy.

ISM6331 is a novel, potential best-in-class, pan-TEAD inhibitor engineered using Chemistry42, an AI-powered drug discovery platform, and is designed to restore Hippo pathway balance, inhibit tumor growth, and overcome drug resistance.

The FDA Fast Track Designation grants ISM6331 enhanced regulatory engagement and potential eligibility for Rolling Review, Accelerated Approval, and Priority Review; it also follows prior Orphan Drug Designation and FDA IND clearance for mesothelioma, and the first-in-human Phase I trial data has been accepted for an oral presentation at ESMO 2026.