Announced details
Primary IgA nephropathy in adults at risk of disease progression
97.1% reduction in the risk of composite renal events. 61.3% reduction in uPCR at 24 months.
510 patients in the VISIONARY trial (259 in the sibeprenlimab group and 251 in the placebo group)
Otsuka Pharmaceutical is a wholly owned subsidiary of the company. Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is a U.S. subsidiary. An sBLA was submitted to the FDA for full approval. The ASN is the conference venue and scientific society.
The FDA is the U.S. drug regulatory authority. The ASN is the American Society of Nephrology.
NCT 05248646 (VISIONARY trial registration number)
There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. The company positions this as important progress toward enhancing corporate value over the medium to long term and as one of the product groups expected to drive future growth.
The company does not address Contract Value / Offering price.
American Society of Nephrology (ASN) Annual Meeting Kidney Week 2026, The New England Journal of Medicine (NEJM), KDIGO 2025 Clinical Practice Guideline, and the VISIONARY trial (NCT 05248646)
| Item | Details |
|---|---|
| Names of Products / Services Covered | VOYXACT® (sibeprenlimab) |
| Counterparty | U.S. Food and Drug Administration (FDA), American Society of Nephrology (ASN) |
| Counterparty overview | The FDA is the U.S. drug regulatory authority. The ASN is the American Society of Nephrology. |
| Relationship with the Company | Otsuka Pharmaceutical is a wholly owned subsidiary of the company. Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is a U.S. subsidiary. An sBLA was submitted to the FDA for full approval. The ASN is the conference venue and scientific society. |
| Applicable area | Primary IgA nephropathy in adults at risk of disease progression |
| Registration number and expiry date | NCT 05248646 (VISIONARY trial registration number) |
| Quantitative Effects | 97.1% reduction in the risk of composite renal events. 61.3% reduction in uPCR at 24 months. |
| Usage history | 510 patients in the VISIONARY trial (259 in the sibeprenlimab group and 251 in the placebo group) |
| Impact on Business Performance | There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. The company positions this as important progress toward enhancing corporate value over the medium to long term and as one of the product groups expected to drive future growth. |
| Source | American Society of Nephrology (ASN) Annual Meeting Kidney Week 2026, The New England Journal of Medicine (NEJM), KDIGO 2025 Clinical Practice Guideline, and the VISIONARY trial (NCT 05248646) |
Items this document does not state (8)
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.The final 24-month analysis of the VISIONARY trial showed preservation of kidney function, reduced risks of declining kidney function and kidney failure, and a favorable safety profile.