Nefecon (VR-205)

June 29, 2026: Viatris Inc. (NASDAQ: VTRS) reported positive top-line results from a Japan Phase 3, multicenter, interventional, open-label trial of VR-205 (targeted-release budesonide formulation; Nefecon®) in Japanese adults with primary immunoglobulin A nephropathy (IgAN) at risk of end-stage renal disease. The study (VR-205A-01-CAZ-3001; n=39) dosed VR-205 16 mg daily for nine months followed by a three-month follow-up (including a two-week taper to 8 mg at follow-up start).

VR-205 met the primary endpoint, delivering a 33.75% reduction in geometric mean urine protein-to-creatinine ratio (UPCR) at 9 months vs baseline (95% CI: -45.27 to -19.80; p<0.001). Key secondary findings included significant UPCR reductions at 6 and 12 months, improvements in eGFR, and reductions in serum creatinine and urine albumin-to-creatinine ratio (UACR) at 9 months vs baseline, plus improvements in microhematuria and sustained proteinuria reduction. No participants progressed to dialysis, kidney transplant, or severe renal impairment (eGFR ≤15 mL/min/1.73 m²) by study end. VR-205 was generally well tolerated with a safety profile consistent with non-Japanese experience.

Viatris targets submission of a Japan New Drug Application by end of 2026; it previously licensed Japanese rights from Calliditas Therapeutics AB (2022).