Drugs / Zilucoplan
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Zilbrysq | — | 2023-12-01 | europa.eu ↗ |
| Approved | US (FDA) | ZILBRYSQ | — | 2023-10-17 | fda.gov ↗ |
Trials 17 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06961747 | Jul 2025 → Mar 2027 expected | — | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 1 | NCT06511076 | Aug → Nov 2024 | — | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT04025632 | Nov 2019 → Mar 2021 | immune-mediated necrotizing myopathy | Ra Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03315130 | Oct 2017 → Dec 2018 | generalized myasthenia gravis | Ra Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03225287 | Jul 2017 → Sep 2021 | paroxysmal nocturnal hemoglobinuria | Ra Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03030183 | Apr 2017 → Mar 2018 | paroxysmal nocturnal hemoglobinuria | Ra Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03078582 | Mar 2017 → Mar 2018 | paroxysmal nocturnal hemoglobinuria | Ra Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06055959 | Oct 2024 → Nov 2026 expected | generalized myasthenia gravis | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04436497 | Jul 2020 → Apr 2022 | amyotrophic lateral sclerosis | Merit E. Cudkowicz, MD | Completed | No outcome recorded |
| Phase 2/3 | NCT04297683 | Jun 2020 → Jul 2027 expected | amyotrophic lateral sclerosis | Merit E. Cudkowicz, MD | Recruiting | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07215949 | Jan 2026 → Dec 2027 expected | generalized myasthenia gravis | Miriam Freimer | Recruiting | No outcome recorded |
| Phase 3 | NCT06435312 | Nov 2024 → Oct 2027 expected | generalized myasthenia gravis | UCB Biopharma SRL | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06471361 | Aug 2024 → Jan 2025 | generalized myasthenia gravis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT05514873 | Oct 2022 → Mar 2024 | generalized myasthenia gravis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT04590586 | Nov 2020 → Aug 2021 | COVID-19 | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT04225871 | Dec 2019 → Jul 2026 overdue | generalized myasthenia gravis | UCB Biopharma SRL | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04115293 | Sep 2019 → Dec 2021 | generalized myasthenia gravis | Ra Pharmaceuticals | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04382755 Comparator | May → Dec 2020 | COVID-19 | University Hospital, Ghent | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zilucoplan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04225871 ↗ |
| Known as | RA101495 | “The purpose of the study is to evaluate the safety and efficacy of zilucoplan (RA101495) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).” NCT03078582 ↗5“Drug: Zilucoplan (RA101495)” NCT03030183 ↗ “Drug: zilucoplan (RA101495)” NCT05514873 ↗ “zilucoplan (RA101495)” NCT04115293 ↗ “Zilucoplan (RA101495)” NCT03225287 ↗ “zilucoplan (RA101495)” NCT04225871 ↗ |
| Action | Inhibit | “macrocyclic peptide inhibitor of complement component 5” PMID 32065623 ↗ May 2020 |
| Modality | Peptide | “subcutaneously (SC) self-administered macrocyclic peptide inhibitor” PMID 32065623 ↗ May 2020 |
| Route | Subcutaneous | “0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC” NCT03030183 ↗ |
| Target | C5 | “complement C5 inhibitor” PMID 37059508 ↗ May 2023 |