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

On Tuesday, April 28, 2026, Insilico Medicine announced that Rentosertib inhalation solution received IND clearance from the CDE, marking the world's first AI-driven candidate to enter a direct-to-lung clinical study.
Idiopathic Pulmonary Fibrosis affects approximately 5 million people worldwide, and Rentosertib, a first-in-class small-molecule TNIK inhibitor, was developed using Insilico's proprietary generative AI platform in 18 months.
Approximately 80 subjects are expected to be enrolled in the CDE-cleared Phase I study, which will evaluate safety and pharmacokinetic profiles through a two-part trial involving healthy participants and IPF patients.
Rentosertib marks the 13th program from the Insilico pipeline to receive IND clearance, with Co-CEO and CSO Feng Ren saying, "We are pleased to receive CDE IND approval for Rentosertib inhalation solution."
Previously, Rentosertib earned Orphan Drug Designation in February 2023 and Breakthrough Therapy Designation in May 2025, with efficacy proof-of-concept published in Nature Medicine in June 2025 demonstrating AI's role in shortening traditional R&D timelines.

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

Following positive Phase IIa results for oral Rentosertib in GENESIS-IPF with good tolerability, a favorable PK profile, and dose-dependent efficacy improvements, the inhalation solution has received IND clearance from the CDE.The inhalation solution is designed for targeted lung delivery to…

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