Drugs / Pegcetacoplan
Pegcetacoplan
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | EMPAVELI | — | 2023-02-08 – 2025-07-28 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Syfovre | — | 2024-12-16 | europa.eu ↗ |
| Approved | EU (EMA) | Aspaveli | — | 2021-12-13 | europa.eu ↗ |
| Approved | US (FDA) | EMPAVELI | — | 2021-05-14 | fda.gov ↗ |
Trials 29 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT07215390 Background | Jun 2025 → Jun 2027 expected | retinal degeneration | Apellis Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06722157 Comparator | Jan 2025 → Oct 2026 expected | age-related macular degeneration | Boehringer Ingelheim | Active not recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07020832 Comparator | May 2026 → Jun 2029 | end stage renal failure | Apellis Pharmaceuticals, Inc. | Suspended | No outcome recorded |
| Phase 3 | NCT05096403 Comparator | Oct 2022 → May 2024 | cold agglutinin disease | Swedish Orphan Biovitrum | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pegcetacoplan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04579666 ↗24 |
| Known as | APL-2 | “A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination...” NCT07215390 ↗9“Pegcetacoplan (APL-2)” NCT04579666 ↗ “PEGCETACOPLAN (APL-2)” NCT03777332 ↗ “APL-2, Pegcetacoplan” NCT07214740 ↗ |
| Known as | Aspaveli | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298211 ↗ |
| Known as | Empaveli | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298211 ↗ |
| Known as | Syfovre | “A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination...” NCT07215390 ↗ |
| Action | Inhibit | “Complement (C3) Inhibitor” NCT02264639 ↗ |
| Modality | Peptide | “Pegcetacoplan, a pegylated peptide targeting proximal complement protein C3” PMID 33730455 ↗ Mar 2021 |
| Route | Intravitreal | “will be administered via intravitreal injection” NCT02503332 ↗ |
| Target | C3 | “inhibits C3” PMID 35869170 ↗ Jul 2022 |