Announced details
Treatment of primary IgA nephropathy in adults
The annualized change in the 24-month eGFR slope was +0.3 in the sibeprenlimab group and −4.2 in the placebo group, for a between-group difference of 4.5 mL/min/1.73 m²/year. The between-group difference in the least-squares mean change in eGFR at 24 months was 9.2 mL/min/1.73 m² (p<0.0001).
Otsuka Pharmaceutical is a wholly owned subsidiary of Otsuka Holdings. OPDC is its U.S. subsidiary. An sBLA has been submitted to the FDA seeking full approval.
The FDA is the U.S. drug regulatory authority. GlomCon Hawaii 2026 was an international academic conference and meeting held from 3 to 7 August 2026.
VISIONARY trial registration number: NCT05248646. Certification registration number and expiry date: Not disclosed
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. VOYXACT is positioned as one of the products expected to drive future growth.
The company does not address Contract Value / Offering price.
KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV)
Perkovic et al. (2026), New England Journal of Medicine
| Item | Details |
|---|---|
| Names of Products / Services Covered | VOYXACT® (sibeprenlimab) |
| Counterparty | U.S. Food and Drug Administration (FDA), GlomCon Hawaii 2026 |
| Counterparty overview | The FDA is the U.S. drug regulatory authority. GlomCon Hawaii 2026 was an international academic conference and meeting held from 3 to 7 August 2026. |
| Relationship with the Company | Otsuka Pharmaceutical is a wholly owned subsidiary of Otsuka Holdings. OPDC is its U.S. subsidiary. An sBLA has been submitted to the FDA seeking full approval. |
| Launch date | Received accelerated approval from the U.S. FDA in November 2025 (approval obtained) |
| Applicable area | Treatment of primary IgA nephropathy in adults |
| Registration number and expiry date | VISIONARY trial registration number: NCT05248646. Certification registration number and expiry date: Not disclosed |
| Location | Otsuka Pharmaceutical: Tokyo. OPDC: Princeton, New Jersey, U.S. |
| Quantitative Effects | The annualized change in the 24-month eGFR slope was +0.3 in the sibeprenlimab group and −4.2 in the placebo group, for a between-group difference of 4.5 mL/min/1.73 m²/year. The between-group difference in the least-squares mean change in eGFR at 24 months was 9.2 mL/min/1.73 m² (p<0.0001). |
| Impact on Business Performance | There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. VOYXACT is positioned as one of the products expected to drive future growth. |
| Source | KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV), Perkovic et al. (2026), New England Journal of Medicine |
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.The company explained that sibeprenlimab selectively inhibits APRIL, a pathogenic factor in IgA nephropathy, and therefore acts directly on the cause of the disease.