Drugs / Obexelimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | IgG4-related kidney disease | 2026-08-13 | “submitted a marketing authorization application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for obexelimab for the treatment of IgG4-RD” zenasbio.com ↗ |
| Filed | US (FDA) | — | IgG4-related kidney disease | 2026-05-28 | “today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD).” zenasbio.com ↗ “In August 2026, the FDA accepted the Company’s Biologics License Application (BLA) for obexelimab for the treatment of IgG4-RD.” zenasbio.com ↗ “In May 2026 , Zenas submitted a biologics license application (BLA) to the U.S . FDA for obexelimab in IgG4-related disease” xencor.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02867098 | Jul → Oct 2016 | — | Xencor, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT06559163 | Sep 2024 → Jun 2026 overdue | systemic lupus erythematosus | Zenas BioPharma (USA), LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT06564311 | Aug 2024 → Aug 2025 overdue | multiple sclerosis | Zenas BioPharma (USA), LLC | Active not recruiting | Met primary |
| Phase 2 | NCT02725476 | Mar 2016 → Dec 2017 | immunoglobulin G4-related sclerosing disease | Xencor, Inc. | Completed | Met primary |
| Phase 2 | NCT02725515 | Feb 2016 → Jul 2018 | systemic lupus erythematosus | Xencor, Inc. | Completed | Missed primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05786573 | Sep 2023 → Jun 2026 overdue | autoimmune hemolytic anemia, warm type | Zenas BioPharma (USA), LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05662241 | Jan 2023 → Nov 2025 overdue | immunoglobulin G4-related sclerosing disease | Zenas BioPharma (USA), LLC | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-08-13 | Zenas BioPharma (USA), LLC | Regulatory Zenas BioPharma Reports Second Quarter 2026 Financial Results and Provides Corporate Update zenasbio.com ↗
2026 continues to be a transformative year for Zenas, highlighted by FDA acceptance of the obexelimab BLA for the treatment of IgG4-RD, with a PDUFA date of May 27, 2027. |
| 2026-06-02 | Zenas BioPharma (USA), LLC | Results Zenas BioPharma Announces Data from the Registrational Phase 3 INDIGO Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD), Simultaneously Presented at the EULAR 2026 Congress and Published in the New England Journal of Medicine zenasbio.com ↗
Collectively, the results consistently demonstrated reductions in disease activity including flare burden as well as glucocorticoid use and toxicity across multiple endpoints. |
| 2026-05-28 | Zenas BioPharma (USA), LLC | Regulatory Zenas BioPharma Announces Submission of Biologics License Application (BLA) to U.S. FDA for Obexelimab in IgG4-RD zenasbio.com ↗
The BLA submission is supported by the results of the Phase 3 INDIGO registrational trial of obexelimab for the treatment of IgG4-RD. |
| 2026-05-19 | Zenas BioPharma (USA), LLC | Results Zenas BioPharma Announces Upcoming Presentation of Results from Phase 3 INDIGO Registrational Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) at EULAR 2026 Congress zenasbio.com ↗
Obexelimab was well tolerated with no new safety signals observed. |
| 2026-02-09 | Zenas BioPharma (USA), LLC | Results Zenas BioPharma Announces Late-Breaking Platform Presentation of Results from Phase 2 MoonStone Trial of Obexelimab in Relapsing Multiple Sclerosis at ACTRIMS Forum 2026 zenasbio.com ↗
Obexelimab met the primary endpoint, demonstrating a highly statistically significant 95% relative reduction in the cumulative number of new gadolinium (Gd)-enhancing (GdE) T1 hyperintense lesions over week 8 and week 12 compared with placebo (p=0.0009). |
| 2026-01-05 | Zenas BioPharma (USA), LLC | Results Zenas BioPharma Announces Positive Results from Phase 3 INDIGO Registrational Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) zenasbio.com ↗
Obexelimab met the primary endpoint, demonstrating a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo (Hazard Ratio 0.44, p=0.0005) during the 52-week randomized placebo-controlled period. |
| 2025-10-27 | Zenas BioPharma (USA), LLC | Results Zenas BioPharma Announces Positive Results from Phase 2 MoonStone Trial of Obexelimab in Relapsing Multiple Sclerosis zenasbio.com ↗
Obexelimab met the primary endpoint, demonstrating a highly statistically significant 95% relative reduction in the cumulative number of new gadolinium (Gd)-enhancing (GdE) T1 hyperintense lesions over week 8 and week 12 compared with placebo (p=0.0009). |
| 2023-08-01 | Zenas BioPharma (USA), LLC | Results Zenas BioPharma Announces Publication of Phase 2 Study of Obexelimab, an Investigational Treatment for IgG4-Related Disease (IgG4-RD), in The Lancet Rheumatology zenasbio.com ↗
Study found obexelimab produced rapid, strong, and sustained clinical improvement, including complete clinical remission, in most patients with active IgG4-RD |
| 2018-10-05 | Xencor, Inc. | Results Xencor Announces Topline Results from Phase 2 Study of XmAb®5871 in Systemic Lupus Erythematosus and Selection of Late-Breaking Abstract for Presentation at the 2018 ACR Annual Meeting xencor.com ↗
These encouraging results support further study of XmAb5871 in SLE. |
| 2017-11-04 | Xencor, Inc. | Results Xencor Presents Final Results from Phase 2 Study of XmAb®5871 in IgG4-Related Disease (IgG4-RD) at the American College of Rheumatology 2017 Annual Meeting xencor.com ↗
Data show that 12 of 15 patients completed the study, and all 12 achieved the primary endpoint of at least a two-point reduction in the IgG4-RD Responder Index (IgG4-RD RI) on Day 169. |
| 2017-06-16 | Xencor, Inc. | Results Xencor Presents Interim Data from an Ongoing, Open-label, Phase 2 Study of XmAb®5871 in IgG4-Related Disease at EULAR 2017 xencor.com ↗ |
| 2017-05-11 | Xencor, Inc. | Regulatory Xencor's Lead Drug Candidate, XmAb5871, Receives Orphan Drug Designation from FDA for Treatment of IgG4-Related Disease xencor.com ↗ |
| 2017-05-09 | Xencor, Inc. | Results Xencor Reports First Quarter 2017 Financial Results xencor.com ↗
Today, we are pleased to announce data from our Phase 1 trial of subcutaneously administered XmAb5871, which support use of this formulation as a simpler, more flexible treatment option for patients and doctors. |
| 2017-02-18 | Xencor, Inc. | Results IgG4-Related Disease Biomarker Development Update Presented From an Ongoing, Open-label, Phase 2 Study of XmAb®5871 in IgG4-RD at the 3rd International Symposium on IgG4-Related Diseases & Fibrosis xencor.com ↗
A rapid reduction of circulating plasmablasts was seen following XmAb5871 treatment. |
| 2016-11-13 | Xencor, Inc. | Results Xencor Presents Preliminary Data from an Ongoing, Open-label, Phase 2 Study of XmAb®5871 in IgG4-Related Disease (IgG4-RD) at the American College of Rheumatology 2016 Annual Meeting xencor.com ↗
Data show that 82% of patients achieved an initial response to therapy within two weeks of their first dose. |
| 2015-11-09 | Xencor, Inc. | Results Xencor Presents Data on XmAb5871 Program at American College of Rheumatology (ACR) 2015 Annual Meeting xencor.com ↗ |
| 2015-06-10 | Xencor, Inc. | Results Xencor Reports Complete Data Results on XmAb5871 Program at European League Against Rheumatism (EULAR) 2015 Annual Meeting xencor.com ↗
XmAb5871 was generally well tolerated and showed trends in improvement in RA disease activity by multiple disease activity measures and across multiple dose groups. |
| 2015-01-29 | Xencor, Inc. | Results Xencor Reports Top-line XmAb®5871 Phase 1b/2a Results Showing Promising Clinical Activity in Rheumatoid Arthritis xencor.com ↗
Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, today reported top-line results from a Phase 1b/2a study for XmAb ® 5871. |
| 2011-03-09 | Xencor, Inc. | Results Xencor's Fc Engineered Antibody Suppresses Autoimmunity in Preclinical Systemic Lupus Erythematosus Models; Data Published in Journal of Immunology xencor.com ↗
Researchers concluded that XmAb5871 may be an effective immunosuppressant in multiple in vivo settings including systemic lupus erythematosus (SLE), and can globally suppress autoimmune response without B cell depletion. |
| 2007-12-07 | Xencor, Inc. | Results Xencor Presents Findings on New Aspect of its Fc Technology Targeting Autoimmune Disease xencor.com ↗
Engineered antibodies strongly inhibited B cell receptor-induced proliferation and showed minimal B cell depletion by comparison to anti-CD19 antibodies that had not been engineered. |
All press releases naming this drug 29 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Obexelimab | “Obexelimab is a bifunctional, non-cytolytic, humanised monoclonal antibody that binds CD19 and Fc gamma receptor IIb to inhibit B cells, plasmablasts, and CD19-expressing plasma cells.” PMID 38251576 ↗ Jul 2023 |
| Known as | XmAb5871 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02725515 ↗ |
| Action | Inhibit | “Low affinity immunoglobulin gamma Fc region receptor II-b inhibitor” CHEMBL4298134 ↗1“to inhibit B cells, plasmablasts, and CD19-expressing plasma cells” PMID 38251576 ↗ Jul 2023 |
| Modality | Monoclonal antibody | “Obexelimab is a bifunctional, non-cytolytic, humanised monoclonal antibody” PMID 38251576 ↗ Jul 2023 |
| Route | Intravenous | “Patients received 5 mg/kg of obexelimab intravenously every 2 weeks for 24 weeks.” PMID 38251576 ↗ Jul 2023 |
| Target | CD19 | “binds CD19” PMID 38251576 ↗ Jul 2023 |
| Target | FCGR2B | “Low affinity immunoglobulin gamma Fc region receptor II-b inhibitor” CHEMBL4298134 ↗ |