Patient dosing with INS018_055, the first antifibrotic small molecule inhibitor discovered and designed using generative artificial intelligence (AI) for the treatment of idiopathic pulmonary fibrosis (IPF) has started, Insilico Medicine announced.

The trial is part of a multiregional phase 2 clinical trial conducted in the United States and China.

“With demonstrated potential against both fibrosis and inflammation, INS018_055 could offer another option for patients worldwide,” said Feng Ren, PhD, co-CEO and chief scientific officer of Insilico Medicine.

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“The achievement of the first dose for INS018_055 in phase 2 clinical trial is not only an important step for Insilico but also a milestone for AI-driven drug discovery and development. Together, we are expecting more achievements powered by AI for global unmet medical needs.”

Read more about IPF experimental therapies

This randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of a 12-week oral INS018_055 dosing regimen in patients with IPF assigned to 4 cohorts. For further evaluation, 60 more patients with IPF will be recruited at 40 sites across the United States and China.

The positive topline data from the phase 1 trial demonstrated favorable safety, tolerability, and pharmacokinetics of INS018_055. The study, conducted in China and New Zealand, featured a single ascending dose and multiple ascending dose studies.

INS018_055 is a small molecule inhibitor with a novel target discovered by Insilico’s target identification engine, PandaOmics, as well as a novel molecular structure designed by its generative chemistry engine, Chemistry42.


First drug discovered and designed with generative AI enters phase II trials, with first patients dosed. News release. Insilico Medicine; June 27, 2023.