Comprehensive Report on the Investigational Compound BI-3031185

1. Executive Summary

BI-3031185 is an orally administered small molecule investigational drug, classified as a New Molecular Entity (NME), currently under development by the global pharmaceutical company Boehringer Ingelheim. The compound is in the early stages of Phase 1 clinical development, with studies primarily focused on evaluating its safety, tolerability, and pharmacokinetic profile in healthy male volunteers. Completed and ongoing trials are assessing single ascending doses, multiple ascending doses, the influence of food on bioavailability, and potential drug-drug interactions, notably with Midazolam, a CYP3A4 probe substrate.

To date, the specific mechanism of action and the intended therapeutic target(s) for BI-3031185 have not been publicly disclosed by the developer. Preclinical development was reportedly completed in Germany prior to February 2024, enabling the transition to human trials. While associated patent information is indicated in some databases, specific details are not publicly available. The compound does not currently hold Orphan Drug Status. The successful outcome of the current Phase 1 program, particularly regarding safety and pharmacokinetic characterization, will be crucial in determining the future development pathway for BI-3031185, including its potential progression into patient-based studies and the eventual elucidation of its therapeutic utility.

2. Introduction to BI-3031185

Overview