Announced details
Treatment of IgA nephropathy in adults
At 12 months, mean eGFR changed by +0.7 mL/min/1.73 m² in the sibeprenlimab group and −4.8 mL/min/1.73 m² in the placebo group, for a treatment difference of 5.5 mL/min/1.73 m². The treatment difference in eGFR slope was 4.6 mL/min/1.73 m² per year.
The VISIONARY trial included 320 participants: 152 in the sibeprenlimab group and 168 in the placebo group.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co.,Ltd. Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is Otsuka Pharmaceutical's U.S. subsidiary. Otsuka Pharmaceutical and OPDC conducted and announced the VISIONARY trial.
The ERA is described as the organization holding the congress in Glasgow, UK. The FDA is described as the U.S. regulatory authority.
NCT05248646 (VISIONARY trial registration number)
Otsuka Pharmaceutical: Tokyo. OPDC: Princeton, New Jersey, U.S.
There is no change to the consolidated earnings forecast for the fiscal year ending December 2026.
The company does not address Contract Value / Offering price.
Presentation at the European Renal Association (ERA). The New England Journal of Medicine (2025, “Sibeprenlimab in IgA Nephropathy — Interim Analysis of a Phase 3 Trial”). KDIGO international guidelines.
| Item | Details |
|---|---|
| Names of Products / Services Covered | VOYXACT® (sibeprenlimab) |
| Counterparty | U.S. Food and Drug Administration (FDA), European Renal Association (ERA) |
| Counterparty overview | The ERA is described as the organization holding the congress in Glasgow, UK. The FDA is described as the U.S. regulatory authority. |
| Relationship with the Company | Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co.,Ltd. Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is Otsuka Pharmaceutical's U.S. subsidiary. Otsuka Pharmaceutical and OPDC conducted and announced the VISIONARY trial. |
| Applicable area | Treatment of IgA nephropathy in adults |
| Registration number and expiry date | NCT05248646 (VISIONARY trial registration number) |
| Location | Otsuka Pharmaceutical: Tokyo. OPDC: Princeton, New Jersey, U.S. |
| Quantitative Effects | At 12 months, mean eGFR changed by +0.7 mL/min/1.73 m² in the sibeprenlimab group and −4.8 mL/min/1.73 m² in the placebo group, for a treatment difference of 5.5 mL/min/1.73 m². The treatment difference in eGFR slope was 4.6 mL/min/1.73 m² per year. |
| Usage history | The VISIONARY trial included 320 participants: 152 in the sibeprenlimab group and 168 in the placebo group. |
| Impact on Business Performance | There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. |
| Source | Presentation at the European Renal Association (ERA). The New England Journal of Medicine (2025, “Sibeprenlimab in IgA Nephropathy — Interim Analysis of a Phase 3 Trial”). KDIGO international guidelines. |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Selective APRIL inhibition may suppress the production of pathogenic IgA and slow the decline in renal function. The company explained that the results demonstrate a relationship between the clinical benefit of maintaining renal function and the drug's mechanism of action.