Drugs / Inebilizumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 23 · a red edge is where a trial was stopped
| 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 | ||||||
| Phase 2 | NCT06987539 | Aug 2026 → Mar 2030 expected | generalized myasthenia gravis | Amgen | Recruiting | No outcome recorded |
| Phase 2 | NCT07222553 | Jul 2026 → Jun 2031 expected | immunoglobulin G4-related sclerosing disease | Amgen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06570798 | Jul 2025 → Jul 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| Phase 2 | NCT04174677 | Dec 2019 → Dec 2021 | anti-HLA hyperimmunization | Amgen | Withdrawn | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT01466153 | Feb 2012 → Jan 2016 | chronic lymphocytic leukemia/small lymphocytic lymphoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02200770 | Apr 2015 → Oct 2018 | neuromyelitis optica | MedImmune LLC | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT04524273 | Oct 2020 → May 2024 overdue | generalized myasthenia gravis | Amgen | Active not recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07010302 | Aug 2026 → Jan 2030 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Massachusetts General Hospital | Not yet 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 |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04372615 Comparator | Mar 2022 → Sep 2028 expected | autoimmune encephalitis | University of Utah | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| 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 |
| Phase not stated1 trial | ||||||
| — | NCT06590051 Background | — | — | Amgen | Available | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-12 | Amgen | EUROPEAN COMMISSION APPROVES AMGEN'S UPLIZNA® FOR GENERALIZED MYASTHENIA GRAVIS amgen.com ↗ |
| 2025-12-11 | Amgen | FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS amgen.com ↗ |
| 2025-04-03 | Amgen | UPLIZNA® (INEBILIZUMAB-CDON) IS NOW THE FIRST AND ONLY FDA-APPROVED TREATMENT FOR IGG4-RELATED DISEASE amgen.com ↗ |
| 2025-03-13 | Amgen | UPLIZNA® (INEBILIZUMAB-CDON) SIGNIFICANTLY IMPROVES GENERALIZED MYASTHENIA GRAVIS SYMPTOMS IN ACETYLCHOLINE RECEPTOR AUTOANTIBODY-POSITIVE PATIENTS OVER 52 WEEKS amgen.com ↗ |
| 2024-10-15 | Amgen | AMGEN PRESENTS POSITIVE PHASE 3 DATA FOR UPLIZNA® (INEBILIZUMAB-CDON) IN GENERALIZED MYASTHENIA GRAVIS (GMG) AT AANEM 2024 amgen.com ↗ |
| 2024-06-05 | Amgen | AMGEN ANNOUNCES POSITIVE RESULTS FOR PHASE 3 REGISTRATIONAL TRIAL EVALUATING UPLIZNA® (INEBILIZUMAB-CDON) FOR TREATMENT OF IMMUNOGLOBULIN G4-RELATED DISEASE (IgG4-RD) amgen.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 29 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Inebilizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07598825 ↗ |
| 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 |