BI 765423

Table of contents

• What is BI 765423?
• How does BI 765423 work?
• Which conditions is it studied for?
• How is BI 765423 given?
• What do the clinical trials show?
• What side effects are known?

What is BI 765423?

BI 765423 is a protein-based investigational substance being developed by Boehringer Ingelheim International for the treatment of idiopathic pulmonary fibrosis (IPF).^[1] The substance is classified in the therapeutic area of respiratory tract diseases.^[1] BI 765423 has no marketing authorisation in the product records, meaning it is still an investigational substance and has not been approved as a medicine.^[1] The name BI 765423 is the development code used in the clinical trial registry; no trade name has been assigned to the substance.^[1]

How does BI 765423 work?

The registry records do not describe the molecular target or mechanism of action of BI 765423. The trial is designed to measure whether BI 765423 has an effect on lung function in people with IPF, with or without standard treatment.^[1] The primary objective is to estimate the absolute difference in means of forced vital capacity (FVC) change from baseline after 12 weeks between BI 765423 and placebo.^[1] FVC is the total amount of air a person can exhale after taking the deepest breath possible, and it is a key measure of lung function in IPF.^[1]

Which conditions is it studied for?

• Idiopathic pulmonary fibrosis (IPF) — a chronic lung disease in which the tissue in the lungs becomes thickened and scarred over time, making it progressively harder to breathe. The word "idiopathic" means the cause is unknown.^[1]

How is BI 765423 given?

BI 765423 is prepared as a solution for infusion and is given by intravenous use, meaning it is administered directly into a vein.^[1] The trial also includes a placebo to BI 765423, which is a comparison arm that does not contain the active substance.^[1] The dose of BI 765423 used in the trial is reported as 00 mg in the registry, which means the dose was not reported.^[1]

What do the clinical trials show?

There is one registered clinical trial for BI 765423. It is a Phase 2 interventional study in idiopathic pulmonary fibrosis (IPF).^[1] The trial is authorised but not yet recruiting, meaning the study has received the necessary approvals but has not started enrolling participants.^[1]

The trial plans to enrol 65 participants.^[1] The main thing the trial measures is the absolute change from baseline in forced vital capacity (FVC) in millilitres at 12 weeks.^[1] The study will compare the change in FVC between people who receive BI 765423 and people who receive placebo, with or without standard treatment for IPF.^[1]

The trial is registered in the EU Clinical Trials Information System (CTIS) with the number 2025-520658-12-00.^[1] Because the study has not yet reported results, there are no published findings from this trial at this time.^[1]

What side effects are known?

No side effect information for BI 765423 is available in the registry records or the product records used for this page. Because the substance is still investigational and the trial has not yet started, no safety data from this trial have been published.^[1]