Drugs / Eculizumab
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | SOLIRIS | — | 2011-09-23 – 2025-02-28 | fda.gov ↗ |
| Approved | EU (EMA) | Soliris | — | 2007-06-20 | europa.eu ↗ |
| Approved | US (FDA) | SOLIRIS | — | 2007-03-16 | fda.gov ↗ |
Trials 86 · started per year
today
US approved 2007
EU approved 2007
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Also used as a comparator or background therapy in 22 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07519005 Background | Jan → Feb 2026 overdue | liver failure | Xijing Hospital | Active not recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT05863442 Comparator | Apr 2023 → Jul 2024 | — | Turgut Ardika PTY LTD | Unknown | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT05646563 Background | Jan 2027 → Jul 2029 expected | paroxysmal nocturnal hemoglobinuria | NovelMed Therapeutics | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06673394 Comparator | Sep 2025 → Jun 2026 | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Tianjin Medical University General Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT05116774 Comparator | Dec 2021 → Sep 2023 | paroxysmal nocturnal hemoglobinuria | BioCryst Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT04702568 Background | Dec 2020 → Oct 2023 | paroxysmal nocturnal hemoglobinuria | BioCryst Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03472885 Background | May 2018 → Sep 2019 | paroxysmal nocturnal hemoglobinuria | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03439839 Background | Apr 2018 → Apr 2020 | paroxysmal nocturnal hemoglobinuria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02493725 Comparator | Jul 2015 → May 2016 | Guillain-Barre syndrome | Chiba University | Completed | No outcome recorded |
| Phase 2 | NCT00935883 Comparator | Jul 2009 → Jun 2012 | age-related macular degeneration | Philip J. Rosenfeld, MD, PhD | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT07177859 Comparator | Nov 2025 → Nov 2026 expected | paroxysmal nocturnal hemoglobinuria | Nanjing Chia-tai Tianqing Pharmaceutical | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06799546 Comparator | Feb → Nov 2025 | paroxysmal nocturnal hemoglobinuria | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06932744 Comparator | Aug 2024 → Dec 2025 overdue | paroxysmal nocturnal hemoglobinuria | Wuhan Createrna Science and Technology Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT04935177 Background | Oct 2021 → Jun 2025 | — | Hansa Biopharma AB | Completed | No outcome recorded |
| Phase 3 | NCT04558918 Comparator | Jan 2021 → Sep 2022 | paroxysmal nocturnal hemoglobinuria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04469465 Background | Dec 2020 → Jun 2022 | paroxysmal nocturnal hemoglobinuria | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04434092 Comparator | Oct 2020 → Nov 2022 overdue | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04432584 Comparator | Sep 2020 → Sep 2027 expected | paroxysmal nocturnal hemoglobinuria | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03056040 Comparator | May 2017 → Feb 2022 | paroxysmal nocturnal hemoglobinuria | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02946463 Comparator | Dec 2016 → Feb 2023 | paroxysmal nocturnal hemoglobinuria | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07410039 Comparator | Feb 2026 → Jun 2027 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Chinese PLA General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04320602 Background | Apr 2021 → Dec 2022 | paroxysmal nocturnal hemoglobinuria | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
Press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Samsung Bioepis Announce Biosimilar EPYSQLI® (eculizumab-aagh) Injection Now Available in the United States tevapharm.com ↗ |
| 2025-04-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Samsung Bioepis Announce Biosimilar EPYSQLI® (eculizumab-aagh) Injection Now Available in the United States tevapharm.com ↗ |
| 2025-01-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Samsung Bioepis Enter into a Strategic Partnership for Commercialization of EPYSQLI® (eculizumab-aagh) in the United States tevapharm.com ↗ |
| 2025-01-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Samsung Bioepis Enter into a Strategic Partnership for Commercialization of EPYSQLI® (eculizumab-aagh) in the United States tevapharm.com ↗ |
| 2024-04-23 | AstraZeneca | Voydeya approved in the EU as add-on treatment to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia astrazeneca.com ↗ |
| 2024-04-08 | AstraZeneca | Alexion data at AAN 2024 demonstrate how Ultomiris and Soliris can transform outcomes for rare neurological diseases astrazeneca.com ↗ |
| 2024-04-01 | AstraZeneca | Voydeya approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular haemolysis in adults with the rare disease PNH astrazeneca.com ↗ |
| 2024-02-26 | AstraZeneca | Voydeya recommended for approval in the EU by CHMP as add-on treatment to ravulizumab or eculizumab for adults with PNH who have residual haemolytic anaemia astrazeneca.com ↗ |
| 2023-12-11 | AstraZeneca | Long-term ALPHA Phase III trial data showed danicopan as add-on to Ultomiris or Soliris sustained clinical improvements in subset of patients with PNH experiencing clinically significant extravascular haemolysis astrazeneca.com ↗ |
| 2022-08-23 | Amgen | AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 959, BIOSIMILAR CANDIDATE TO SOLIRIS® (ECULIZUMAB) amgen.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 108 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | eculizumab | “IVMP+Eculizumab arm: eculizumab (900 mg) will be administered intravenously once per week for a total of four doses (days 1, 8, 15, and 22) in conjunction with IVMP and oral...” NCT07184840 ↗101“Participants will continue to receive their ongoing C5 inhibitor (eculizumab or ravulizumab) therapy according to their usual dose and schedule.” NCT04469465 ↗ “At the time of study start, eculizumab was the only available SoC; eculizumab will be hereafter referred to as SoC.” NCT03439839 ↗ “Investigational arm: eculizumab (900 mg) will be administered intravenously once per week for a total of four doses” NCT06673394 ↗ “Active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5.” NCT04060264 ↗ “Eculizumab (ECZ) will be administrated intravenously as a 30-minute injection.” NCT02205541 ↗ “Eculizumab (900 mg, 24 hours pre-perfusion) for complement inhibition” NCT07519005 ↗ “International nonproprietary name: eculizumab” NCT04463056 ↗ “Soliris (eculizumab)” NCT04058158 ↗ |
| Known as | BCD-148 | “Active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5.” NCT04060264 ↗ |
| Known as | Eculizumab (Soliris) | “Eculizumab (Soliris®)” NCT01221181 ↗ |
| Known as | ECZ | “Eculizumab (ECZ) will be administrated intravenously as a 30-minute injection.” NCT02205541 ↗ |
| Known as | Elizaria | “efficacy and safety of Elizaria® (eculizumab, GENERIUM JSC, Russia) versus Soliris® (Alexion Pharma GmbH, Switzerland)” NCT04463056 ↗1“At the present time Eculizumab (JSC GENERIUM, Russia) have already been authorized as Elizaria® in Russia.” NCT04679103 ↗ |
| Known as | h5G1.1-mAb | “Eculizumab (h5G1.1-mAb) is a humanized monoclonal antibody that like CD59 inhibits terminal complement.” NCT00130000 ↗ |
| Known as | Soliris | “Active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5.” NCT04060264 ↗10“Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection” NCT04346797 ↗ “Eculizumab (SB12, EU Sourced Soliris®, and US Sourced Soliris®)” NCT03722329 ↗ “Eculizumab (Soliris) in Covid-19 Infected Patients” NCT04288713 ↗ “Eculizumab (Soliris®)” NCT01410916 ↗ “Eculizumab (Soliris®)” NCT07010302 ↗ |
| Action | Inhibit | “Eculizumab is a humanized monoclonal antibody that like CD59 inhibits terminal complement.” NCT00098280 ↗ |
| Modality | Monoclonal antibody | “Eculizumab is a humanized monoclonal antibody” NCT00098280 ↗ |
| Route | Intravenous | “The drug or placebo will be given intravenously (through a thin tube inserted into a vein)” NCT00005571 ↗ |
| Target | C5 | “This is a randomized, third-party, placebo-controlled pilot study of h5G1.1-mAb, an antibody directed at the complement component C5” NCT00005571 ↗ |