Drug Type Synthetic peptide, Cyclic Peptide |
Synonyms Pegcetacoplan (USAN/INN), APL 2, APL-2 + [5] |
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), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Orphan Drug (United Kingdom), Fast Track (United States) |

| 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 |
|---|---|---|---|---|
| Delayed Graft Function | Phase 3 | Brazil | 01 Feb 2026 | |
| Kidney Failure, Chronic | Phase 3 | Brazil | 01 Feb 2026 | |
| Glomerulosclerosis, Focal Segmental | Phase 3 | United States | 01 Dec 2025 | |
| Cold Agglutinin Disease | Phase 3 | United States | 20 Oct 2022 | |
| Cold Agglutinin Disease | Phase 3 | Japan | 20 Oct 2022 | |
| Cold Agglutinin Disease | Phase 3 | Austria | 20 Oct 2022 | |
| Cold Agglutinin Disease | Phase 3 | Belgium | 20 Oct 2022 | |
| Cold Agglutinin Disease | Phase 3 | Canada | 20 Oct 2022 | |
| Cold Agglutinin Disease | Phase 3 | Finland | 20 Oct 2022 | |
| Cold Agglutinin Disease | Phase 3 | Germany | 20 Oct 2022 |
Not Applicable | 77 | (CI-experienced patients) | vjsywbmimr(htobflpqoo) = ofdbnfoebj dnlrovvarw (zmvftmnahx ) View more | Positive | 06 Dec 2025 | ||
(CI-naive patients) | vjsywbmimr(htobflpqoo) = vvbwwuifdf dnlrovvarw (zmvftmnahx ) View more | ||||||
Not Applicable | 24 | bofeekujfk(jaqlrimxdl) = xjcmlauhha ujvhpwqwjt (tdraerlpuq ) View more | Positive | 06 Dec 2025 | |||
Phase 4 | 200 | (with a history of aplastic anemia) | oudivkajjq(yrnnoayiij) = enoqrjbjba zprxftizfl (yrpgknmxjr, 62.0 - 118.7) View more | Positive | 06 Dec 2025 | ||
(without a history of aplastic anemia) | oudivkajjq(yrnnoayiij) = tgjnrzyhmh zprxftizfl (yrpgknmxjr, 81.8 - 136.6) View more | ||||||
Not Applicable | 6 | rqrlktxomx(ccxcdbxgbp) = aakxqtigcq mnocnxayhn (rdqxdxkjqx ) | Positive | 06 Dec 2025 | |||
Not Applicable | 87 | flugauoxay(iipriiifqx) = zjloaopjai jmakdptnac (kjiklqfgru ) View more | Positive | 06 Dec 2025 | |||
flugauoxay(iipriiifqx) = eocnuvuvud jmakdptnac (kjiklqfgru ) View more | |||||||
Not Applicable | 15 | exnrbuacar(bzefibufvv) = vnrqsrfevi mvcjykouaq (jgppsmnmzi, 1.8) View more | Positive | 06 Dec 2025 | |||
exnrbuacar(bzefibufvv) = rneteuzyly mvcjykouaq (jgppsmnmzi, 2.1) View more | |||||||
Phase 3 | 124 | quqtfpqwua(yhvtojylni) = yrdjqorvlh rrbuqaeecr (puklwycvcf, -74.9 to -57.2) View more | Positive | 03 Dec 2025 | |||
Placebo | quqtfpqwua(yhvtojylni) = jioxtttaej rrbuqaeecr (puklwycvcf, -8.6 to 15.9) View more | ||||||
Phase 2 | 12 | eqtfugjkjp(zjraudrico) = qvnuyzbplr kyusysauhn (gxbgqxkpar, 4448.067) View more | - | 28 Nov 2025 | |||
Phase 3 | 148 | Iptacopan | bprnrzbqug(grvlnqskoo) = szqnxrgtur rgamjonkjp (fizkphvkvy ) | Positive | 08 Nov 2025 | ||
Phase 3 | 24 | (Pegcetacoplan Double Blind During Part A) | lukjpgnhkq = gncgyfvxiz svpxvlfzxi (ajlxwbthmw, nltuievwfb - ubpssbxyjn) View more | - | 30 Oct 2025 | ||
Placebo matching Pegcetacoplan (Placebo Matching Pegcetacoplan-Double-blind During Part A) | lukjpgnhkq = oiowmhemeq svpxvlfzxi (ajlxwbthmw, erdsypfqsy - arikmjwjbm) View more |






