AIBRIEF
Rentosertib, an AI designed small molecule, entered a 52 week Phase III trial in idiopathic pulmonary fibrosis on Wednesday, starting a three to four year confirmatory clock rather than an approval.
The first patient has been dosed in a large, late-stage trial of Rentosertib, an AI-designed small molecule for idiopathic pulmonary fibrosis (IPF), a progressive, often fatal scarring of the lungs with a median survival of three to four years. Insilico Medicine, a clinical-stage biotech that uses AI to design drug candidates, said the dosing happened Wednesday at Peking Union Medical College Hospital, with Shanghai Pulmonary Hospital enrolling a patient the same day, per the company.
GENESIS-IPF-3 is a 52-week, randomized, double-blind, placebo-controlled study expected to enroll 320 participants across 47 centers in China. The primary endpoint is the annual rate of decline in forced vital capacity, according to RTTNews. Rentosertib inhibits TNIK, a kinase that no currently approved IPF therapy targets. Existing antifibrotics slow progression but do not stop or reverse it.
The "world's first Phase III trial of a generative AI-driven innovative drug" framing is Insilico's own, per the company's announcement. The same release bundles a first profitable half-year for Insilico's Hong Kong-listed parent: roughly $106 million in H1 2026 revenue, up 287% year-over-year; an adjusted net profit above $51 million; and 2026 deal contract value around $7.3 billion. None of that is a trial readout. Results remain three to four years away under favorable conditions, the lead investigator told reporters.