New updates have been reported about Insilico Medicine.
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Insilico Medicine has secured CDE IND clearance for an inhaled formulation of Rentosertib (ISM001-055), its first-in-class, AI-discovered TNIK inhibitor for idiopathic pulmonary fibrosis, marking the 13th program from its AI-driven pipeline to reach this milestone. The approval enables a Phase I trial in roughly 80 subjects, including a randomized, placebo-controlled single and multiple ascending dose study in healthy volunteers and an open-label multiple-dose cohort in IPF patients to assess safety, tolerability, and pharmacokinetics.
Management says prior Phase IIa data for oral Rentosertib in GENESIS-IPF showed good tolerability, favorable PK, and dose-dependent efficacy trends, and the inhaled version is engineered to deliver higher lung exposure with faster onset at lower doses, while limiting systemic exposure and side effects. The program reinforces Insilico’s Pharma.AI platform, which has generated 30 preclinical candidates and 13 IND-cleared assets across fibrosis, oncology, immunology, and CNS, and materially compresses discovery timelines to 12–18 months with far fewer molecules synthesized, positioning the Hong Kong–listed company to advance Rentosertib into Phase III orally in the second half of the year while opening a direct-to-lung route that could enhance efficacy, differentiation, and partnering options in the high-need IPF market.