Drugs / Sibeprenlimab
Trials 6 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07105124 | Oct 2022 → Feb 2023 | — | Otsuka Beijing Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT03719443 | Oct 2018 → Aug 2019 | IgA glomerulonephritis | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06928142 | Apr 2025 → Mar 2027 expected | Sjogren syndrome | Otsuka Pharmaceutical Development & Commercialization, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06740526 | Nov 2024 → Apr 2029 expected | IgA glomerulonephritis | Otsuka Pharmaceutical Development & Commercialization, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04287985 | Jul 2020 → May 2023 | IgA glomerulonephritis | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05248659 | Apr 2022 → Dec 2028 expected | IgA glomerulonephritis | Otsuka Pharmaceutical Development & Commercialization, Inc. | Enrolling by invitation | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05248646 Comparator | Mar 2022 → May 2026 overdue | IgA glomerulonephritis | Otsuka Pharmaceutical Development & Commercialization, Inc. | Active not recruiting | No outcome recorded |
Press releases naming this drug 24 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-04 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Unveils Unprecedented Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT (sibeprenlimab-szsi) Stabilizes Kidney Function Decline to Baseline Physiologic Rate, Fundamentally Altering Disease Progression in IgA Nephropathy® otsuka.co.jp ↗ |
| 2026-08-03 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Unveils Unprecedented Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Stabilizes Kidney Function Decline to Baseline Physiologic Rate, Fundamentally Altering Disease Progression in IgA Nephropathy (IgAN) otsuka-us.com ↗ |
| 2026-07-02 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Reports Positive Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT(sibeprenlimab-szsi) Prevented Progression to Kidney Failure and Improved Kidney Function in IgA Nephropathy (IgAN)® otsuka.co.jp ↗ |
| 2026-07-02 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Reports Positive Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Prevented Progression to Kidney Failure and Improved Kidney Function in IgA Nephropathy (IgAN) otsuka-us.com ↗ |
| 2026-06-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Presents Positive Interim Phase 3 VISIONARY eGFR Data Showing VOYXACT (sibeprenlimab-szsi) Preserved Kidney Function Over 12 Months in IgA Nephropathy (IgAN)® otsuka.co.jp ↗ |
| 2026-06-04 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Presents Positive Interim Phase 3 VISIONARY eGFR Data Showing VOYXACT® (sibeprenlimab-szsi) Preserved Kidney Function Over 12 Months in IgA Nephropathy (IgAN) otsuka-us.com ↗ |
| 2026-03-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Showcases New Efficacy and Safety Data of VOYXACT® (sibeprenlimab-szsi) in Patients with IgA Nephropathy (IgAN) at the 2026 ISN World Congress of Nephrology Highlighting the Impact of APRIL Inhibition otsuka-us.com ↗ |
| 2025-11-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Receives FDA Accelerated Approval for VOYXACT (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression ® otsuka.co.jp ↗ |
| 2025-11-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Receives FDA Accelerated Approval for VOYXACT® (sibeprenlimab-szsi) for the Reduction of Proteinuria in Adults with Primary Immunoglobulin A Nephropathy (IgAN) at Risk for Disease Progression otsuka-us.com ↗ |
| 2025-11-10 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Sibeprenlimab Phase 3 Data Presented at American Society of Nephrology Kidney Week 2025 Showed Proteinuria Reduction through 12 Months for the Treatment of Immunoglobulin A Nephropathy (IgAN) otsuka.co.jp ↗ |
| 2025-06-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN) otsuka.co.jp ↗ |
| 2025-06-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Sibeprenlimab Phase 3 Data Show a Statistically Significant and Clinically Meaningful Proteinuria Reduction for the Treatment of Immunoglobulin A Nephropathy (IgAN) otsuka-us.com ↗ |
| 2025-05-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN) otsuka-us.com ↗ |
| 2025-05-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN) otsuka.co.jp ↗ |
| 2025-03-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy otsuka.co.jp ↗ |
| 2025-03-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy otsuka-us.com ↗ |
| 2024-11-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Provides Update on Sibeprenlimab, an Investigational Monoclonal Antibody for the Treatment of IgA Nephropathy in Adults otsuka.co.jp ↗ |
| 2024-11-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Provides Update on Sibeprenlimab, an Investigational Monoclonal Antibody for the Treatment of IgA Nephropathy in Adults otsuka-us.com ↗ |
| 2024-10-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces Positive Interim Results from the Phase 3 Trial of Sibeprenlimab for the Treatment of Immunoglobulin A Nephropathy in Adults otsuka.co.jp ↗ |
| 2024-10-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces Positive Interim Results from the Phase 3 Trial of Sibeprenlimab for the Treatment of Immunoglobulin A Nephropathy in Adults otsuka-us.com ↗ |
| 2024-02-16 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Sibeprenlimab Received U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy (IgAN) otsuka.co.jp ↗ |
| 2024-02-16 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy otsuka-us.com ↗ |
| 2023-11-06 | Otsuka Pharmaceutical Development & Commercialization, Inc. | New England Journal of Medicine Publishes Complete Results of Positive Phase 2 Trial of Sibeprenlimab in Treatment of Immunoglobulin A Nephropathy (IgAN) otsuka.co.jp ↗ |
| 2023-11-02 | Otsuka Pharmaceutical Development & Commercialization, Inc. | New England Journal of Medicine Publishes Complete Results of Positive Phase 2 Trial of Sibeprenlimab in Treatment of Immunoglobulin A Nephropathy (IgAN) otsuka-us.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sibeprenlimab | “VIS649 (sibeprenlimab), a humanized IgG2 monoclonal antibody that inhibits APRIL, is being developed as a potential treatment for IgA nephropathy (IgAN).” PMID 35570983 ↗ Feb 20226“Sibeprenlimab is a humanized IgG2 monoclonal antibody that binds to and neutralizes APRIL.” PMID 37916620 ↗ Nov 2023 |
| Known as | VIS649 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03719443 ↗ |
| Action | Inhibit | “Tumor necrosis factor ligand superfamily member 13 inhibitor” CHEMBL4594614 ↗1“inhibits APRIL” PMID 35570983 ↗ Feb 2022 |
| Modality | Monoclonal antibody | “a humanized IgG2 monoclonal antibody” PMID 35570983 ↗ Feb 2022 |
| Route | Intravenous | “VIS649 Administered Intravenously” NCT03719443 ↗ |
| Target | TNFSF13 | “Tumor necrosis factor ligand superfamily member 13 inhibitor” CHEMBL4594614 ↗ |