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Insilico Medicine Doses First Patient in GENESIS-IPF-3, the World's First Phase III Trial of a Generative AI-Driven Innovative Drug

The 52-week study will enroll 320 participants across 47 centers in China to test whether the AI-discovered drug slows or reverses lung fibrosis.

  • On Wednesday, Insilico Medicine dosed the first patient with Rentosertib in the GENESIS-IPF-3 Phase III clinical trial at Peking Union Medical College Hospital, with Shanghai Pulmonary Hospital enrolling its first participant simultaneously.
  • Rentosertib, the world's first drug candidate discovered using generative AI, targets TNIK to treat idiopathic pulmonary fibrosis , a chronic, scarring lung disease affecting approximately 5 million people worldwide.
  • This 52-week, multi-center Phase III study will enroll 320 participants across 47 centers in China, with the primary endpoint measuring the annual rate of decline in forced vital capacity over 52 weeks.
  • Carol Satler, Senior Vice President for Clinical Development at Insilico Medicine, called Rentosertib "transformative to patient care," though the drug remains investigational and has not received approval from any regulatory authority.
  • Insilico Medicine reported approximately $106 million in revenue during the first half of 2026, a 287% year-over-year increase, achieving its first profitable half-year since listing on the Hong Kong Stock Exchange.
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The Courier-TribuneThe Courier-Tribune
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Insilico Medicine Doses First Patient in GENESIS-IPF-3, the World's First Phase III Trial of a Generative AI-Driven Innovative Drug

CAMBRIDGE, Mass., Sept. 9, 2026 /PRNewswire/ -- Insilico Medicine ("Insilico," HKEX: 3696), a clinical-stage biotechnology company powered by generative AI, today announced that it has dosed the first patient with Rentosertib (known as ISM001-055 / INS018_055) in GENESIS-IPF-3, a Phase…

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In addition to lung disease, an active substance developed with generative AI against idiopathic pulmonary fibrosis could also influence age-related processes. In a small clinical sub-study, the biological age estimated by six blood protein models decreased under reindeertib. However, whether the body actually ages more slowly is still open. Cambridge (U.S.A.). The calendar age describes only how many years a person [...] The article AI-active s…

The first phase III study for the human test of a drug against idiopathic pulmonary fibrosis is initiated. The entry Molecules conceived integrally by AI enter a clinical trial was first published in Diario La R.

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PR Newswire broke the news in Chicago, United States on Thursday, September 10, 2026.
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