- Apecotrep (BI 764198) is a TRPC6 inhibitor for primary FSGS.
- Phase II trial showed 40% proteinuria reduction after 12 weeks.
- Phase III trial is recruiting adults and adolescents with FSGS.
- Additional Phase II trial for other kidney diseases starts Q1.
Overview
Apecotrep (BI 764198) is an oral, selective TRPC6 inhibitor being developed as a non-immunosuppressive therapy for primary focal segmental glomerulosclerosis (FSGS), a rare kidney condition.
Phase II Trial Results
The Phase II trial demonstrated a 40% reduction in proteinuria in the 20 mg dose group compared to placebo after 12 weeks of treatment. These results were published in The Lancet and presented at the 2025 American Society of Nephrology's Kidney Week.
Future Trials
The Phase III trial is currently recruiting adults and adolescents with primary FSGS. Additionally, a new Phase II trial will begin in the first quarter of this year to evaluate apecotrep's safety and efficacy in other proteinuric kidney diseases.
Mechanism of Action
In primary FSGS, TRPC6 is believed to be overactivated on podocytes, leading to excessive calcium entry, podocyte injury, and proteinuria. Apecotrep aims to protect podocytes and slow disease progression by reducing proteinuria.
Regulatory Designations
Apecotrep has received Breakthrough Therapy Designation from China's Center for Drug Evaluation and Orphan Drug Designations from the European Medicines Agency and Japan's Ministry for Health, Labour and Welfare.
