Drugs / Inebilizumab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed IgG4-related kidney disease 2 milestones | |||||
| Filed | China (NMPA) | XINYUE | IgG4-related kidney disease | 2025-03-04 | “Second Biologics License Application of XINYUE (Inebilizumab Injection) has been accepted by the National Medical Products Administration (the “NMPA”), which is for the...” hspharm.com ↗ |
| Filed | US (FDA) | UPLIZNA | IgG4-related kidney disease | 2025-02-04 | “The FDA accepted the regulatory submission for the Phase 3 MITIGATE study under priority review” amgen.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | UPLIZNA | — | 2025-04-03 – 2025-12-11 | fda.gov ↗ |
| Approved | EU (EMA) | Uplizna | — | 2022-04-25 | europa.eu ↗ |
| Approved | US (FDA) | UPLIZNA | — | 2020-06-11 | fda.gov ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01861340 | May 2014 → Apr 2016 | plasma cell myeloma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT01585766 | Apr 2012 → Jan 2015 | multiple sclerosis | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT01957579 | May 2011 → Sep 2015 | neoplasm of mature B-cells | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00946699 | Mar 2010 → Mar 2012 | scleroderma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02271945 | Dec 2014 → May 2016 | aggressive B-cell non-Hodgkin lymphoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT00983619 | Apr 2010 → Mar 2019 | B-cell neoplasm, cancer | MedImmune LLC | Completed | No outcome recorded |
| Phase 28 trials · 2 missed | ||||||
| Phase 2 | NCT07222553 | Jul 2026 → Jun 2031 expected | immunoglobulin G4-related sclerosing disease | Amgen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06987539 | Jul 2026 → Mar 2030 expected | generalized myasthenia gravis | Amgen | Recruiting | No outcome recorded |
| Phase 2 | NCT06570798 | Jul 2025 → Aug 2028 expected | rheumatoid arthritis, systemic lupus erythematosus | Amgen | Recruiting | No outcome recorded |
| Phase 2 | NCT05549258 | Jul 2023 → Apr 2027 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Amgen | Recruiting | No outcome recorded |
| Phase 2 | NCT04174677 | Dec 2019 → Dec 2021 | anti-HLA hyperimmunization | Amgen | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03218163 | Sep 2017 → Apr 2018 | plasma cell myeloma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 2 | NCT01453205 | Feb 2012 → Jul 2016 | diffuse large B-cell lymphoma | MedImmune LLC | Completed | Missed primary |
| Phase 2 | NCT01466153 | Feb 2012 → Jan 2016 | chronic lymphocytic leukemia/small lymphocytic lymphoma | MedImmune LLC | Completed | Missed primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT02200770 | Apr 2015 → Oct 2018 | neuromyelitis optica | MedImmune LLC | Completed | Met primary |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT07851220 | Oct 2026 → Sep 2031 expected | membranous glomerulonephritis | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT07598825 | Sep 2026 → Jul 2031 expected | autoimmune hepatitis | Amgen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05198557 | Jul 2022 → Jul 2025 overdue | systemic sclerosis | Tanabe Pharma Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04540497 | Dec 2020 → Apr 2024 overdue | immunoglobulin G4-related sclerosing disease | Amgen | Active not recruiting | Met primary |
| Phase 3 | NCT04524273 | Oct 2020 → May 2024 overdue | generalized myasthenia gravis | Amgen | Active not recruiting | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07010302 | Sep 2026 → Jan 2030 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07862075 | Oct 2025 → Sep 2028 expected | autoimmune pancreatitis type 1 | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06180278 | Apr 2024 → Jun 2028 expected | neuromyelitis optica | Amgen | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06212245 | Feb → Dec 2024 | neuromyelitis optica | Hansoh BioMedical R&D Company | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07159893 | Sep 2025 → May 2026 overdue | CNS demyelinating autoimmune disease, neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT04372615 Comparator | Mar 2022 → Sep 2028 expected | autoimmune encephalitis | University of Utah | Recruiting | No outcome recorded |
| Phase 3 | NCT07132398 Comparator | Sep 2025 → Aug 2027 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Tianjin Medical University General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06590051 Background | — | — | Amgen | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-09-16 | Tanabe Pharma Corporation | Regulatory Tanabe Pharma Receives Approval in Japan for additional indication of generalized Myasthenia Gravis Anti-CD19 monoclonal antibody UPLIZNA® for I.V. Infusion 100 mg tanabe-pharma.com ↗
Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative Director, CEO: Akihisa Harada; hereinafter "Tanabe Pharma") announced today that it has received approval from Japan’s Ministry of Health, Labour and Welfare for an additional indication for UPLIZNA® for intravenous infusion 100 mg (generic name: Inebilizumab (Genetical Recombination), hereinafter "UPLIZNA®") for the treatment of generalized Myasthenia Gravis (gMG) in patients who do not respond adequately to corticosteroids or non- steroidal immunosuppressants. |
| 2026-06-03 | Amgen | Results AMGEN TO PRESENT NEW DATA ACROSS RARE AUTOIMMUNE AND INFLAMMATORY DISEASES AT EULAR 2026 amgen.com ↗
New data from the Phase 3 MITIGATE trial of UPLIZNA ® (inebilizumab) provide insights into the biology of immunoglobulin G4-related disease (IgG4-RD), 1 while additional analyses support its long-term safety profile and sustained results in IgG4-RD. |
| 2026-04-03 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA – XINYUE’S THIRD INDICATION APPROVED FOR MARKETING FOR THE TREATMENT OF GENERALIZED MYASTHENIA GRAVIS IN ADULT PATIENTS hspharm.com ↗
XINYUE (Inebilizumab Injection) has been approved by the National Medical Products Administration (NMPA) for marketing |
| 2026-03-30 | Hansoh BioMedical R&D Company | Regulatory 翰森制药 | 昕越®第三项适应症获批上市，用于治疗全身型重症肌无力成人患者 hansoh.cn ↗
此次获批gMG为昕越®在中国获批的第三项罕见病适应症. |
| 2026-02-12 | Amgen | Regulatory EUROPEAN COMMISSION APPROVES AMGEN'S UPLIZNA® FOR GENERALIZED MYASTHENIA GRAVIS amgen.com ↗ |
| 2025-12-11 | Amgen | Regulatory FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS amgen.com ↗
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA ® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. |
| 2025-11-20 | Tanabe Pharma Corporation | Regulatory Anti-CD19 monoclonal antibody UPLIZNAⓇ for I.V. Infusion 100mg Approval for additional indication of suppression of relapse of immunoglobulin G4-related disease in Japan ～Japan’s First Drug Approved for IgG4-Related Disease～ tanabe-pharma.com ↗
UPLIZNA is the first pharmaceutical product approved in Japan for IgG4-RD. |
| 2025-10-14 | Tanabe Pharma Corporation | Regulatory Anti-CD19 monoclonal antibody UPLIZNA® for I.V. Infusion 100mg Application for additional indication of generalized Myasthenia Gravis in Japan tanabe-pharma.com ↗
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative Director, CEO: Akihisa Harada, “MTPC”) filed an application with the Ministry of Health, Labour and Welfare for an additional indication of the anti-CD19 monoclonal antibody UPLIZNA Ⓡ for intravenous infusion 100mg (generic name: Inebilizumab (Genetical Recombination), hereinafter UPLIZNA) for the treatment of generalized Myasthenia Gravis (gMG) on October 14, 2025. |
| 2025-09-06 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory DRUG REGISTRATION APPROVAL OF THE SECOND INDICATION OF XINYUE (INEBILIZUMAB INJECTION) WAS GRANTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION hspharm.com ↗
This is the second indication of XINYUE which has been approved in China, this indication was included in the Priority Review and Approval Procedure by the NMPA on February 8, 2025. |
| 2025-05-31 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA ANNOUNCES THE THIRD BIOLOGICS LICENSE APPLICATION OF XINYUE(INEBILIZUMAB INJECTION) ACCEPTED BY NMPA FOR THE TREATMENT OF GENERALIZED MYASTHENIA GRAVIS IN ADULT PATIENTS hspharm.com ↗
Third Biologics License Application of XINYUE (Inebilizumab Injection) has been accepted by the National Medical Products Administration (the “NMPA”), |
| 2025-05-30 | Hansoh BioMedical R&D Company | Regulatory 翰森制药 | 昕越®第三项上市许可申请获受理，用于治疗全身型重症肌无力成人患者 hansoh.cn ↗
2025年5月30日，翰森制药集团有限公司（以下简称“翰森制药”，03692. HK）宣布，昕越®（伊奈利珠单抗注射液）第三项上市许可申请（BLA）获国家药品监督管理局（NMPA）受理，用于治疗全身型重症肌无力(gMG)成人患者. |
| 2025-04-08 | Hansoh BioMedical R&D Company | Results AAN 2025 | 翰森制药昕越®十余项研究成果入选全球神经病学盛会，中国罕见病治疗实践获全球关注 hansoh.cn ↗ |
| 2025-04-04 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory UPLIZNA (INEBILIZUMAB) IS NOW THE FIRST AND ONLY FDA-APPROVED TREATMENT FOR IGG4-RELATED DISEASE hspharm.com ↗
Hansoh Pharma’s collaborator Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved inebilizumab as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). |
| 2025-04-04 | Hansoh BioMedical R&D Company | Regulatory 伊奈利珠单抗获FDA批准成为首个IgG4相关性疾病治疗药物 hansoh.cn ↗
美国时间2025年4月3日，本公司合作方安进公司（AMGEN）宣布，美国食品药品监督管理局（FDA）已批准伊奈利珠单抗用于治疗成人免疫球蛋白G4（IgG4）相关性疾病. |
| 2025-04-03 | Amgen | Regulatory UPLIZNA® (INEBILIZUMAB-CDON) IS NOW THE FIRST AND ONLY FDA-APPROVED TREATMENT FOR IGG4-RELATED DISEASE amgen.com ↗
Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). |
| 2025-03-21 | Tanabe Pharma Corporation | Regulatory Anti-CD19 monoclonal antibody UPLIZNA® for I.V. Infusion 100mg Application for additional indication of immunoglobulin G4-related disease in Japan tanabe-pharma.com ↗
MTPC filed an application with the Ministry of Health, Labour and Welfare for an additional indication of the anti-CD19 monoclonal antibody UPLIZNAⓇ for intravenous infusion 100mg (generic name: Inebilizumab (Genetical Recombination), hereinafter UPLIZNA) for the treatment of immunoglobulin G4-related disease (IgG4-RD) on March 19, 2025. |
| 2025-03-13 | Amgen | Results UPLIZNA® (INEBILIZUMAB-CDON) SIGNIFICANTLY IMPROVES GENERALIZED MYASTHENIA GRAVIS SYMPTOMS IN ACETYLCHOLINE RECEPTOR AUTOANTIBODY-POSITIVE PATIENTS OVER 52 WEEKS amgen.com ↗
Among the AChR+ patients in the UPLIZNA group, 72.3% had a ≥3 point improvement in the MG-ADL score, compared to 45.2% in placebo. |
| 2025-03-04 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA ANNOUNCES THE SECONDBIOLOGICS LICENSE APPLICATION OF XINYUE(INEBILIZUMAB INJECTION) ACCEPTED BY NMPA FOR THE TREATMENT OF IGG4-RD hspharm.com ↗ |
| 2025-02-10 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA ANNOUNCES XINYUE(INEBILIZUMAB) PRIORITY REVIEW GRANTED BY NMPA FOR THE TREATMENT OF IGG4-RD hspharm.com ↗
the new indication of the treatment of immunoglobulin G4-related disease (IgG4-RD) has been included in the Priority Review and Approval Procedure by the National Medical Products Administration (“NMPA”). |
| 2025-02-10 | Hansoh BioMedical R&D Company | Regulatory 翰森制药昕越®（伊奈利珠单抗）新适应症纳入优先审评，用于IgG4相关性疾病治疗 hansoh.cn ↗
2025年2月10日，翰森制药集团有限公司（以下简称“翰森制药”，03692. HK）宣布，昕越®（伊奈利珠单抗注射液）用于免疫球蛋白G4相关性疾病（IgG4-RD）新适应症正式纳入国家药品监督管理局（NMPA）优先审评审批程序. |
| 2024-11-28 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory FOUR INNOVATIVE DRUGS OF HANSOH PHARMACEUTICAL GROUP HAVE BEEN RENEWED IN THE NATIONAL REIMBURSEMENT DRUG LIST (2024 VERSION) hspharm.com ↗ |
| 2024-11-19 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory INEBILIZUMAB (BRAND NAME IN CHINA: 昕越 ® XINYUE) GRANTED US FDA BREAKTHROUGH THERAPY DESIGNATION IN IGG4-RD AND NEW DATA TO BE PRESENTED AT ACR 2024 hspharm.com ↗
Hansoh Pharma Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announced Inebilizumab has been granted Breakthrough Therapy Designation (BTD) by the US FDA following positive results from the Global Phase 3 MITIGATE study for the treatment of Immunoglobulin G4-related disease (IgG4-RD). |
| 2024-11-14 | Amgen | Results AMGEN PRESENTS NEW DATA ACROSS RARE INFLAMMATORY DISEASES AT ACR 2024 amgen.com ↗
New data showcase reduction in disease activity by UPLIZNA® (inebilizumab-cdon) in Immunoglobulin G4-Related Disease (IgG4-RD) and support shorter infusion times for KRYSTEXXA® (pegloticase) co-administered with weekly oral methotrexate 15 mg. |
| 2024-10-15 | Amgen | Results AMGEN PRESENTS POSITIVE PHASE 3 DATA FOR UPLIZNA® (INEBILIZUMAB-CDON) IN GENERALIZED MYASTHENIA GRAVIS (GMG) AT AANEM 2024 amgen.com ↗
The trial met its primary endpoint, with a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA (-4.2) compared with placebo (-2.2) (difference: –1.9, p<0.0001) at Week 26 for the combined study population. |
| 2024-06-05 | Amgen | Results AMGEN ANNOUNCES POSITIVE RESULTS FOR PHASE 3 REGISTRATIONAL TRIAL EVALUATING UPLIZNA® (INEBILIZUMAB-CDON) FOR TREATMENT OF IMMUNOGLOBULIN G4-RELATED DISEASE (IgG4-RD) amgen.com ↗
Amgen (NASDAQ:AMGN) today announced positive topline results from its randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial ( NCT04540497 ) evaluating the efficacy and safety of UPLIZNA ® (inebilizumab-cdon) for the treatment of Immunoglobulin G4-related disease (IgG4-RD). |
| 2023-01-18 | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Regulatory HANSOH PHARMA'S SEVERAL INNOVATIVE DRUGS AND NEW INDICATIONS WERE ADDED TO THE 2022 NATIONAL REIMBURSEMENT DRUG LIST hspharm.com ↗
The first-line indication of Ameile (Aumolertinib Mesylate Tablets) and the rare disease drug Xinyue (Inebilizumab Injection) were successfully added to the National Reimbursement Drug List, and two other innovative were successfully renewed. |
| 2017-03-29 | AstraZeneca | Regulatory AstraZeneca’s potential medicine for neuromyelitis optica spectrum disorder receives orphan designation in Europe astrazeneca.com ↗
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Medicines Agency (EMA) has granted orphan designation to inebilizumab (formerly MEDI-551) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). |
| 2016-03-09 | AstraZeneca | Regulatory AstraZeneca’s potential medicine for neuromyelitis optica receives FDA Orphan Drug Designation astrazeneca.com ↗ |
All press releases naming this drug 32 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inebilizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07851220 ↗ |
| Known as | Inebilizumab cdon | ChEMBL registry synonym — accepted as the source's own label CHEMBL2109334 ↗ |
| Known as | Medi-551 | “Inebilizumab (MEDI-551), an anti-CD19 antibody with enhanced antibody-dependent cell-mediated cytotoxicity against B cells, is currently being evaluated in MS and neuromyelitis optica.” PMID 27886126 ↗ Nov 201610“Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120” NCT03218163 ↗ |
| Known as | UPLIZNA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06590051 ↗ |
| Action | Deplete | “mediates antibody-dependent, cell-mediated cytotoxicity of B cells” PMID 27267753 ↗ Jun 2016 |
| Modality | Monoclonal antibody | “MEDI-551 is an investigational humanized monoclonal antibody” PMID 27267753 ↗ Jun 2016 |
| Route | Intravenous | “A single intravenous dose of MEDI-551 was administered” PMID 27267753 ↗ Jun 2016 |
| Target | CD19 | “targets the B cell surface antigen CD19” PMID 27267753 ↗ Jun 2016 |