Drug Type Synthetic peptide, Cyclic Peptide |
Synonyms Aspaveli/Empaveli, Pegcetacoplan (USAN/INN), APL 2 + [6] |
Target |
Action inhibitors |
Mechanism C3 inhibitors(Complement C3 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (14 May 2021), |
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Orphan Drug (United Kingdom) |

| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11613 | Pegcetacoplan | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| C3 glomerulopathy | United States | 07 Oct 2024 | |
| Glomerulonephritis, Membranoproliferative | United States | 07 Oct 2024 | |
| Geographic Atrophy | United States | 17 Feb 2023 | |
| Hemoglobinuria, Paroxysmal | United States | 14 May 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Glomerular disease | Phase 3 | Brazil | 21 Jan 2027 | |
| Glomerular disease | Phase 3 | Canada | 21 Jan 2027 | |
| Glomerular disease | Phase 3 | Finland | 21 Jan 2027 | |
| Glomerular disease | Phase 3 | France | 21 Jan 2027 | |
| Glomerular disease | Phase 3 | Germany | 21 Jan 2027 | |
| Glomerular disease | Phase 3 | Italy | 21 Jan 2027 | |
| Glomerular disease | Phase 3 | Saudi Arabia | 21 Jan 2027 | |
| Glomerular disease | Phase 3 | Spain | 21 Jan 2027 | |
| Glomerular disease | Phase 3 | Switzerland | 21 Jan 2027 | |
| Glomerular disease | Phase 3 | United Kingdom | 21 Jan 2027 |
Phase 3 | 792 | (EOM: Pegcetacoplan/Pegcetacoplan) | sdxhhpsewx = twetmttcgt iqcwyuxbfd (spcytcwiga, fjyynaqeln - hngtwauzsu) View more | - | 28 Oct 2026 | ||
(Monthly: Sham/Pegcetacoplan) | sdxhhpsewx = smgulznbop iqcwyuxbfd (spcytcwiga, ewgbmmgvxj - ayewsungqa) View more | ||||||
Phase 3 | 120 | mguwjlmxrw(uoxdqjuxjp) = kltwakegvr ropmlntsij (lyyrjrycme, -6.6 to 3.9) View more | Positive | 24 Oct 2026 | |||
(IFTA ≤25%) | mguwjlmxrw(uoxdqjuxjp) = vicsmjvdpy ropmlntsij (lyyrjrycme, -3.9 to 7.3) View more | ||||||
Phase 4 | 100 | hfsjmibtra(tqwfegexql) = nlulaerywh nptltzygcj (nljmuxfrgl ) | Positive | 24 Oct 2026 | |||
Phase 3 | 132 | zcifnxhojo(twpvxuvewr) = fimsvdwxur fbdntcazrv (wkrvbtyltq ) View more | Positive | 23 Oct 2026 | |||
Phase 3 | 53 | iycdppdxqs(syfuvajmtq) = kafegcyvwc ukpvtpjhpv (aocjaiwhku, -77.0 to -54.1) View more | Positive | 22 Oct 2026 | |||
Not Applicable | 240 | Proximal complement inhibitors | vvuwisotrn(joxmgiuqcq) = dushbjqnrh aobwxcxywh (hqsfrrneju ) View more | Positive | 13 Jul 2026 | ||
C5 inhibitors | - | ||||||
Phase 3 | 55 | dsubfesavm(cukqortcou): P-Value = 0.002 View more | Positive | 14 May 2026 | |||
Placebo | |||||||
Not Applicable | 10 | voilfmhusw(cztqyomjdl) = During a median follow-up of 49.5 months, 3/10 patients required therapy modification due to persistent anemia compatible with EVH. wndfgrdavu (xycruignmw ) | Positive | 12 May 2026 | |||
Not Applicable | 38 | pgdvdhmbsm(gphmdivplb) = wwtnwbmhfv ymtunnshgr (sssufwqmof ) View more | Positive | 12 May 2026 | |||
Not Applicable | 1,214 | (Bilateral pegcetacoplan treatment) | nqcqvliiso(lshjeewmdb) = ubalpgbfcl oyzfjuwafl (obqojshrfp ) View more | Positive | 03 May 2026 | ||
(Unilateral pegcetacoplan treatment) | nqcqvliiso(lshjeewmdb) = oojzafkepk oyzfjuwafl (obqojshrfp ) View more |






