Boehringer Ingelheim has suspended a phase 1 trial of an investigational small molecule drug while it seeks to understand a “safety event,” though the German pharma isn't shedding light on the nature of the incident for now.
The company had been evaluating BI 3031185, an oral small molecule drug, in a study at a hospital in Fukuoka, Japan, that kicked off in early July. The trial is split into two parts, with the first consisting of a single-blind, randomized, placebo-controlled evaluation of the safety, tolerability and pharmacokinetics of single and multiple doses of the drug in healthy males.
The second part of the study is a non-randomized, open-label assessment of the effect of multiple oral doses of BI 3031185 on the pharmacokinetics of Bayer’s approved oral contraceptive pill, Yaz, in healthy female participants.
“Patient safety is central to Boehringer Ingelheim and the enrolment in the study is currently on voluntary hold for the evaluation of a safety event,” a spokesperson told Fierce.
“The assessment is ongoing, and we will provide an update when an outcome is known,” they added.
The pharma didn't provide more details in response to Fierce's questions about the nature of the safety event or BI 3031185's specific mechanism of action, which remains under wraps.
However, the spokesperson did point out that BI 3031185 had already completed three separate studies—including a phase 1b trial in Germany in 78 patients with borderline personality disorder or attention deficit/hyperactivity disorder (ADHD). The trial began in August 2025 and was recently marked complete on the U.S. federal trials database.
Boehringer also ran a phase 1 study in Germany between October 2025 and January 2026 that evaluated the effect of multiple oral doses of Johnson & Johnson's antifungal medication Sporanox on the pharmacokinetics of a single oral dose of BI 3031185.
The German drugmaker has been inking large deals over the past year to expand its profile in multiple disease areas and in artificial intelligence. They included a 407 million euros ($478 million) deal for Immunitas Therapeutics’ antibody for chronic inflammatory and autoimmune diseases, a 1.05 billion euro ($1.26 billion) biobucks agreement for Simcere’s preclinical inflammatory bowel disease antibody, and a $120 million biobucks pact for Variant Bio’s AI-powered Inference platform.
Boehringer has also been pushing into the obesity space, with recent phase 3 data showing that its Zealand Pharma-partnered glucagon/GLP-1 dual agonist drove 16.6% weight loss at 76 weeks, while not quite measuring up to the bar set by existing drugs.