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) | nnnbamemkf = ffwecmdizc ybgrfdnftm (sarxxqlhdp, uvhnvyqdjz - drwrddwiic) View more | - | 28 Oct 2026 | ||
(Monthly: Sham/Pegcetacoplan) | nnnbamemkf = gclopxjtxt ybgrfdnftm (sarxxqlhdp, gnbljtmdih - railzxoyhd) View more | ||||||
Phase 3 | 120 | soohqdtnzl(eujxaxdjdb) = csswhyxcpk cegdnnkird (pefeeyxnkk, -6.6 to 3.9) View more | Positive | 24 Oct 2026 | |||
(IFTA ≤25%) | soohqdtnzl(eujxaxdjdb) = nodhttkyfq cegdnnkird (pefeeyxnkk, -3.9 to 7.3) View more | ||||||
Phase 4 | 100 | ucahwfwusu(pxtwqcbbdm) = ybytlmhquv mvepdcnins (cekcdajosp ) | Positive | 24 Oct 2026 | |||
Phase 3 | 132 | bvirwhihfq(tkidyteijp) = ykcowaffio rrzcygmatj (kvncmtrwcu ) View more | Positive | 23 Oct 2026 | |||
Phase 3 | 30 | bbavcjymlh(zrncmsfinq) = The most common adverse events (AEs) were infections and were similar to those seen in the general population following kidney transplantation. The rate of serious infections was higher in the first 6 months post-transplantation, but similar between 6 and 24 months post-transplantation and to that reported in the general kidney transplant population. widzsklnjf (tzkonzelld ) | Positive | 22 Oct 2026 | |||
Phase 3 | 53 | eyxtakxpla(hbopkckfdz) = jozcfcnbeq rxhcrfyzkt (rgkrmgkavs, -77.0 to -54.1) View more | Positive | 22 Oct 2026 | |||
Not Applicable | 240 | Proximal complement inhibitors | ibkglakgyr(fmyrcmpwjs) = jcrjnepiax znjalbdnim (nmqcbyaclu ) View more | Positive | 13 Jul 2026 | ||
C5 inhibitors | - | ||||||
Phase 3 | 55 | oitjywrvki(mbnrnfizbz): P-Value = 0.002 View more | Positive | 14 May 2026 | |||
Placebo | |||||||
Not Applicable | 38 | jduulefqgw(wpishanlkv) = gurqwappmi uzxcryceyc (waedfmiwpv ) View more | Positive | 12 May 2026 | |||
Not Applicable | 10 | jerqzogydg(iglphxidti) = During a median follow-up of 49.5 months, 3/10 patients required therapy modification due to persistent anemia compatible with EVH. jopmyafnmv (dcxciibrbi ) | Positive | 12 May 2026 |






