Boehringer Ingelheim’s Apecotrep Shows 40% Proteinuria Reduction in Phase II FSGS Trial

Event summary

  • Boehringer Ingelheim’s investigational asset apecotrep (BI 764198) demonstrated a 40% reduction in proteinuria in a 12-week Phase II trial for primary focal segmental glomerulosclerosis (FSGS).
  • The Phase III trial (NCT07220083) for primary FSGS is now recruiting adults and adolescents.
  • An additional Phase II trial (NCT07355296) for other proteinuric kidney diseases will begin in Q1 2026.
  • Apecotrep has received Breakthrough Therapy Designation in China and Orphan Drug Designations in Europe and Japan.

The big picture

Boehringer Ingelheim’s apecotrep represents a potential first-in-class, non-immunosuppressive therapy for primary FSGS, a rare kidney disease with no approved targeted treatments. The positive Phase II results position the asset as a potential game-changer in addressing a significant unmet medical need. The company’s strategic focus on cardiovascular, renal, and metabolic diseases underscores its commitment to innovation in this therapeutic area.

What we're watching

Clinical Efficacy
Whether the 40% proteinuria reduction observed in Phase II translates into long-term clinical benefits in the Phase III trial.
Regulatory Pathway
The pace at which apecotrep advances through regulatory approvals in key markets, particularly given its Breakthrough Therapy and Orphan Drug designations.
Market Potential
How Boehringer Ingelheim positions apecotrep in the broader landscape of treatments for proteinuric kidney diseases beyond primary FSGS.