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industry-newsSep 15, 2025

First FDA-Approved Drug Discovered with AI Assistance: Insilico Medicine's Historic Breakthrough

Insilico Medicine announced that its AI-assisted drug INS018_055 for idiopathic pulmonary fibrosis (IPF) has completed Phase III clinical trials and received FDA approval, becoming the first drug to go through the entire process from AI design to FDA approval. From candidate molecule discovery to market launch took only 4.5 years, half the time of traditional pathways. This milestone marks the industrialization of AI-driven drug discovery.

Also available in 中文.