BI-3804379: An Early-Stage Investigational New Molecular Entity

I. Executive Summary

BI-3804379 is an early-stage investigational new molecular entity (NME) currently under development by the global pharmaceutical company Boehringer Ingelheim. As of late 2024 and early 2025, this compound is advancing through Phase 1 clinical trials. These initial first-in-human studies are primarily focused on evaluating its safety, tolerability, and pharmacokinetic profile in healthy volunteers. A notable aspect of its early clinical assessment is the consistent use of subcutaneous administration.[1]

The precise mechanism of action (MoA) for BI-3804379 remains undisclosed and is consistently reported as "Unknown" or "Undefined" in publicly available databases.[1] However, one information source suggests that while the specific MoA is unknown, the underlying mechanism is "not novel," implying that BI-3804379 may target an established biological pathway rather than pioneering an entirely new therapeutic approach.[1] Fundamental scientific details, including its definitive chemical structure (such as CAS number and molecular formula), the specific molecular target(s) it interacts with, and its intended therapeutic area, are not available in the provided research materials.

The development status indicates multiple Phase 1 clinical trials, including NCT06575400, CTIS2024-513549-36-01, and U1111-1306-8874, were either initiated or planned to commence in the latter half of 2024.[2] These studies are characterized by their focus on subcutaneous administration in healthy volunteer populations. Parallel to these human trials, preclinical studies involving subcutaneous administration were also noted as ongoing or planned in Germany as of August 2024.[2]