UK Approves First AI-Designed Drug to Enter Human Clinical Trials

The UK Medicines and Healthcare products Regulatory Agency approved the first drug molecule designed entirely by artificial intelligence — developed by Insilico Medicine using its generative chemistry platform — to enter Phase 2 human clinical trials for idiopathic pulmonary fibrosis. The molecule, designated INS018_055, was designed, synthesised, and optimised entirely by AI without human chemists selecting the molecular structure. Phase 1 safety data from 80 volunteers showed no significant adverse events and confirmed the molecule reaches target tissue at therapeutic concentrations. The approval is considered a watershed in drug discovery, demonstrating that AI can identify new chemical entities faster than any human-driven research programme. India Sun Pharmaceutical Industries has licensed co-development rights for INS018_055 for Asian markets and will co-fund the Phase 2 trials expected to begin in Q3 2025.