Bristol Myers Squibb's experimental drug admilparant, being studied for idiopathic and progressive pulmonary fibrosis, faces heightened liver-safety scrutiny. Amended Phase 3 trial protocols classify liver injury as an "important potential risk." They require enhanced liver monitoring and specify when treatment must stop if drug-induced liver injury is detected.
The review intensified after protocol documents disclosed that a patient's death in the trial was related to acute hepatic injury. Trial data remain blinded, so it is unclear whether admilparant caused the liver events.
Bristol Myers Squibb previously discontinued a predecessor drug over similar liver-safety concerns. Analysts have projected peak sales of $2.5 billion for admilparant.