Insilico's Rentosertib Inhalation Solution Receives IND Clearance for World's First AI-Driven Direct-to-Lung Clinical Study

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Insilico Medicine announced on April 28, 2026, that Rentosertib (ISM001-055) inhalation solution, a first-in-class AI-identified TNIK inhibitor for IPF, received IND clearance from China's CDE.12

This is the 13th program from Insilico's AI-driven Pharma.AI pipeline to receive IND clearance.123

The Phase I study will evaluate safety, tolerability, and PK in ~80 subjects:
SAD/MAD in healthy volunteers (randomized, double-blind, placebo-controlled) and multiple doses in IPF patients (open-label).13

Inhalation formulation targets lung delivery for higher pulmonary exposure, faster onset at lower doses, and reduced systemic exposure/side effects; preclinical data showed antifibrotic/anti-inflammatory efficacy, good PK/safety.123

Oral Rentosertib had positive Phase IIa results (good tolerability, favorable PK, dose-dependent efficacy) and is on track for Phase III in H2 2026; prior designations include FDA Orphan Drug (2023) and CDE Breakthrough Therapy (2025).13

Sources:

1. https://www.prnewswire.com/news-releases/insilicos-rentosertib-inhalation-solution-receives-ind-clearance-for-the-worlds-first-ai-driven-candidate-to-enter-direct-to-lung-clinical-study-302755747.html

2. https://insilico.com/news/pdmncgky51-insilicos-rentosertib-inhalation-solutio?amp=true

3. https://www.marketscreener.com/news/insilico-s-rentosertib-inhalation-solution-receives-ind-clearance-for-the-world-s-first-ai-driven-ca-ce7f59d3da8efe2c