Boehringer Ingelheim Advances Apecotrep to Phase 3 for Rare Kidney Disease FSGS Despite Mixed Mid-Stage Data

Boehringer Ingelheim announced positive Phase II results for apecotrep (BI 764198), an oral TRPC6 inhibitor, showing a 40% reduction in proteinuria vs. placebo in the 20 mg dose group after 12 weeks in primary focal segmental glomerulosclerosis (FSGS) patients.23

Despite a lower 14% response rate in the middle dose dragging down the overall response rate to 35% vs. 7% on placebo, Boehringer proceeded to Phase 3, which is now recruiting 286 adults and adolescents with primary FSGS, with primary endpoint of urine protein-creatinine ratio change after 104 weeks.3

Results were published in The Lancet and presented at the 2025 American Society of Nephrology Kidney Week.23

Apecotrep targets TRPC6 overactivation in podocytes to reduce proteinuria and slow FSGS progression; it has received Breakthrough Therapy Designation in China and Orphan Drug Designations in EU and Japan.2

An additional Phase II study in other proteinuric kidney diseases is planned for Q1 2026, and no FDA-approved therapies exist for FSGS currently.23

Sources:

2. https://news.europawire.eu/boehringers-apecotrep-demonstrates-significant-proteinuria-reduction-in-phase-ii-study-supporting-phase-iii-development-in-primary-fsgs/eu-press-release/2026/01/28/11/39/26/168596/

3. https://www.fiercebiotech.com/biotech/boehringer-channels-mid-stage-momentum-pivotal-kidney-disease-trial