Boehringer Ingelheim’s apecotrep has led to a 40% reduction in proteinuria, a key indicator associated with kidney damage, in patients with primary focal segmental glomerulosclerosis (FSGS).
The data from the 12-week, Phase II trial (NCT05213624) of the oral, non-immunosuppressive transient receptor potential channel 6 (TRPC6) inhibitor were published in The Lancet and presented at the 2025 American Society of Nephrology (ASN)’s Kidney Week.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Response to treatment was defined as a ≥25% reduction in urine protein-creatinine ratio (UPCR), which was achieved by 35% of patients receiving apecotrep, compared to 7.1% in the placebo arm. The highest proportion of response was seen in the high-dose cohort. The drug was also well-tolerated in the study.
Primary FSGS is a rare, progressive kidney disease that can end in kidney failure, with no approved targeted therapies. TRPC6 is believed to be overactivated on podocytes, which are cells responsible for the kidney’s filtration system, allowing for excessive calcium to enter the cells, causing progressive podocyte injury and loss, and ultimately, proteinuria and kidney disease progression.
Boehringer Ingelheim is enrolling patients with primary FSGS in a Phase III trial (NCT07220083), with a Phase II trial (NCT07355296) evaluating the safety and efficacy of apecotrep in other proteinuric kidney diseases set to begin in Q1 2026.
Paola Casarosa, head of the Innovation Unit at Boehringer Ingelheim, said: “With the Phase III trial now underway, we are advancing apecotrep driven by the potential to deliver the first disease-modifying treatment for primary FSGS and redefine the standard of care for patients.”
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataApecotrep has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China and Orphan Drug Designations from the European Medicines Agency (EMA) and the Japanese Ministry for Health, Labour and Welfare (MHLW).
Travere Therapeutics has filed with the US Food and Drug Administration (FDA) for the approval of Filspari (sparsentan) in FSGS, with a decision due by 13 April. According to a GlobalData report, there are other drugs in Phase III trials for FSGS – Vertex Pharmaceuticals’ inaxaplin (NCT05312879) and Dimerix’s propagermanium (NCT05183646).
GlobalData is the parent company of Clinical Trials Arena.
