Boehringer’s Apecotrep Demonstrates Significant Proteinuria Reduction in Phase II Study, Supporting Phase III Development in Primary FSGS

Boehringer’s Apecotrep Demonstrates Significant Proteinuria Reduction in Phase II Study, Supporting Phase III Development in Primary FSGS

(IN BRIEF) Boehringer Ingelheim has reported encouraging Phase II trial results for apecotrep (BI 764198), a potential first-in-class oral TRPC6 inhibitor being developed for primary focal segmental glomerulosclerosis. Published in The Lancet, the study showed a 40% reduction in proteinuria in the 20 mg dose group compared with placebo after 12 weeks, with a favourable tolerability profile. The Phase III trial is now recruiting adults and adolescents with primary FSGS, alongside plans for an additional Phase II study in other proteinuric kidney diseases. These findings highlight apecotrep’s potential as a targeted, non-immunosuppressive therapy for a rare kidney condition with significant unmet medical need.

(PRESS RELEASE) INGELHEIM, 28-Jan-2026 — /EuropaWire/ — Boehringer Ingelheim has announced positive results from a 12-week Phase II clinical trial evaluating apecotrep (BI 764198), an investigational, oral, potential first-in-class TRPC6 inhibitor for people living with primary focal segmental glomerulosclerosis (FSGS). The study demonstrated a clinically meaningful reduction in proteinuria, a key marker of kidney damage, with patients in the 20 mg dose group experiencing a 40% reduction compared with placebo after 12 weeks of treatment.

The trial results were published in The Lancet and presented at the 2025 American Society of Nephrology Kidney Week, underscoring the scientific and clinical relevance of the findings. Based on these outcomes, the Phase III trial of apecotrep is now open and actively recruiting adults and adolescents with primary FSGS. In parallel, an additional Phase II study investigating the safety and efficacy of apecotrep in other proteinuric kidney diseases is scheduled to begin in the first quarter of this year.

Apecotrep reflects Boehringer Ingelheim’s strategic focus on addressing high unmet medical needs across kidney diseases, particularly conditions for which no approved disease-modifying therapies currently exist. Primary FSGS is a rare and progressive kidney disorder characterised by damage and loss of podocytes, the specialised cells that maintain the kidney’s filtration barrier. Over time, this damage leads to proteinuria and can progress to kidney failure, affecting both children and adults.

In the Phase II study, a treatment response defined as at least a 25% reduction in urine protein-creatinine ratio was observed in 35% of participants receiving apecotrep across all dose groups, compared with 7.1% in the placebo arm. The strongest response was seen in the 20 mg dose group, where nearly half of patients met the response criteria. Apecotrep was generally well tolerated, supporting its continued clinical development.

The therapeutic approach behind apecotrep targets the overactivation of the Transient Receptor Potential Channel 6 (TRPC6) protein on podocytes, which is believed to play a central role in the progression of primary FSGS. Excessive activation of TRPC6 allows increased calcium influx into podocytes, leading to cellular injury, protein leakage and gradual loss of kidney function. By selectively inhibiting TRPC6, apecotrep is designed to protect podocytes and slow disease progression by reducing proteinuria.

The compound’s potential has been recognised by regulatory authorities, with apecotrep receiving Breakthrough Therapy Designation from China’s National Medical Products Administration and Orphan Drug Designations from both the European Medicines Agency and Japan’s Ministry of Health, Labour and Welfare. These designations highlight the urgent need for innovative treatments in primary FSGS and support the accelerated development of targeted therapies.

With the Phase III programme now underway, Boehringer Ingelheim continues to advance apecotrep as a potential disease-modifying option that could redefine the treatment landscape for people living with primary FSGS and related proteinuric kidney diseases.

About apecotrep (BI 764198) and the Phase II trial

Apecotrep is an investigational, potential first-in-class, oral, once daily, non-immunosuppressive TRPC6 inhibitor that is being developed as a potential treatment for people living with primary FSGS.⁹ Its mechanism of action intends to counter the overactivation of TRPC6, a protein channel essential for the structure and function of podocytes, which are specialized cells responsible for the kidney’s filtration system.⁹ The compound was discovered and developed by Boehringer Ingelheim, and is part of its Cardiovascular-Renal-Metabolic portfolio. 

In the Phase II trial, a response to treatment defined as greater than or equal to 25% reduction in urine protein-creatinine ratio (UPCR) was observed in 35% of participants receiving apecotrep across all dose groups after 12 weeks, compared to 1 out of 14 (7.1%) in the placebo arm. The greatest proportion of patients responding to apecotrep were in the 20mg dose (44.4%). Furthermore, a 40% (p=0.0024) reduction in UPCR compared to placebo was observed with 20 mg dose.¹ Finally, apecotrep was generally well-tolerated.

About FSGS

Focal segmental glomerulosclerosis (FSGS) is a type of podocytopathy in which podocyte injury and loss result in excess protein in the urine (proteinuria). Approximately, 50% of people with primary FSGS progress to end-stage kidney disease (ESKD) within 5-10 years.¹⁰ FSGS is a leading cause of nephrotic syndrome in adults and is estimated to affect up to 0.8 per 100,000 population globally.⁷ The condition is associated with scarring in the kidney’s filtering units called glomeruli and causes swelling of legs and other parts of the body, foamy urine, fatigue, weight gain, high blood pressure, and cholesterol increase.¹¹ Primary FSGS means that the disease occurs without a known cause, while secondary FSGS is caused by another known cause such as infection, diabetes or obesity.¹¹ Additionally, genetic FSGS results from mutations in podocyte or glomerular basement membrane proteins or specific susceptibility genes such as TRPC6.^12,13 

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-Ingelheim.com.  

References

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SOURCE: Boehringer Ingelheim