BI Halts Phase I Trial of ADHD Asset After Safety Event

Boehringer Ingelheim (BI) has paused a Phase I study of BI 3031185, an oral small-molecule candidate for attention-deficit hyperactivity disorder (ADHD) and borderline personality disorder, following an unspecified safety event, according to Fierce Biotech. The halted trial began in July 2026 in Japan with a single-blind, randomised, placebo-controlled first part in healthy male volunteers assessing safety, tolerability, and pharmacokinetics, and an open-label second part in healthy female volunteers examining interaction with Bayer's oral contraceptive Yaz.

BI 3031185 had previously completed a 78-patient German Phase Ib study in borderline personality disorder and ADHD (started August 2025) and a separate German Phase I drug-interaction study with Johnson & Johnson's Sporanox.

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