VR-205 Met Primary Endpoint and Key Secondary Endpoints and Was Well Tolerated

VR-205 Efficacy and Safety Profile in Japanese Patients Was Consistent with the Profile Observed in Global Studies 

Japanese New Drug Application Submission Targeted by End of 2026

PITTSBURGH and TOKYO, June 29, 2026 /PRNewswire/ -- Viatris Inc. (NASDAQ:VTRS), a global healthcare company, today announced positive top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of VR-205 (targeted-release budesonide formulation) (Nefecon®) in Japanese adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of developing end-stage renal disease.

The Phase 3 clinical trial was a multicenter, interventional, open-label study designed to evaluate the efficacy and safety of 16 mg of VR-205 in Japanese adult patients with primary IgAN. Patients were treated for nine months, followed by a three-month follow-up period.

The study achieved its primary endpoint, with VR-205 demonstrating a 33.75 percent reduction in geometric mean urine protein-to-creatinine ratio (UPCR) at 9 months compared to baseline [95% CI: -45.27 to -19.80; p < 0.001]. These results were statistically significant and clinically meaningful, and were consistent with those observed in the global Phase 3 program for the product. Key findings included:

  • In addition to a statistically significant and clinically meaningful reduction in UPCR at 6 and 12 months, VR-205 demonstrated a significant improvement in estimated glomerular filtration rate (eGFR) and reductions in serum creatinine and urine albumin-to-creatinine ratio (UACR) at 9 months compared to baseline.
  • The overall therapeutic benefit of VR-205 was further supported by improvements in microhematuria and a sustained proteinuria reduction.
  • No study participants progressed to dialysis, kidney transplant or severe renal impairment (eGFR ≤15 mL/min per 1.73 m2) by the end of the study.
  • VR-205 was generally well tolerated over the nine-month treatment period, with a safety profile consistent with the known safety profile of targeted-release budesonide in non-Japanese patients.