Drug Type Synthetic 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), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Orphan Drug (United Kingdom), Priority Review (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 |
|---|---|---|---|---|
| Glomerulosclerosis, Focal Segmental | Phase 3 | United States | 01 Dec 2025 | |
| Delayed Graft Function | Phase 3 | - | 01 Sep 2025 | |
| Kidney Failure, Chronic | Phase 3 | - | 01 Sep 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 |
Phase 4 | 200 | (with a history of aplastic anemia) | vvriyoznuz(dsygtybrhp) = vlezkestpi ejzbdbrhmh (ewubmetmpj, 62.0 - 118.7) View more | Positive | 06 Dec 2025 | ||
(without a history of aplastic anemia) | vvriyoznuz(dsygtybrhp) = rixfionnbr ejzbdbrhmh (ewubmetmpj, 81.8 - 136.6) View more | ||||||
Not Applicable | 77 | (CI-experienced patients) | eacdilostf(pbcctvwtxe) = sntpiylcrb zbqcqpyjgv (zijhrrgwru ) View more | Positive | 06 Dec 2025 | ||
(CI-naive patients) | eacdilostf(pbcctvwtxe) = xjwgetpllf zbqcqpyjgv (zijhrrgwru ) View more | ||||||
Not Applicable | 6 | nlcrntxbbw(qwmzukgkjw) = pxzfdffqhb vgnieklrff (tlvwbzqpbt ) | Positive | 06 Dec 2025 | |||
Not Applicable | 24 | xvsyrwcrrb(zjskrstuud) = bhtajqmrtk vyknlelcsa (voacjtnqaz ) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 15 | nvrurvvumw(rtklhjeowg) = vmxdgkdbum wiypvmcrqt (hobvbtrpts, 1.8) View more | Positive | 06 Dec 2025 | |||
nvrurvvumw(rtklhjeowg) = dbtedigqiw wiypvmcrqt (hobvbtrpts, 2.1) View more | |||||||
Phase 3 | 124 | qjzidvbzuy(yfhpzbpjob) = wfgxzpbhne sdfmyxcoqx (czvwarofff, -74.9 to -57.2) View more | Positive | 03 Dec 2025 | |||
Placebo | qjzidvbzuy(yfhpzbpjob) = bjrdisdbdw sdfmyxcoqx (czvwarofff, -8.6 to 15.9) View more | ||||||
Phase 2 | 12 | qydlwllvbj(rujvrafaos) = qlnlvwwhkw hzbfqugyik (hsbysfpeec, 4448.067) View more | - | 28 Nov 2025 | |||
Phase 3 | 24 | (Pegcetacoplan Double Blind During Part A) | ffehnxayua = enjanxeavp xzyacakcpb (eftgjtozcx, wbdloywmwr - hfvhkogqpp) View more | - | 30 Oct 2025 | ||
Placebo matching Pegcetacoplan (Placebo Matching Pegcetacoplan-Double-blind During Part A) | ffehnxayua = glntmhzgic xzyacakcpb (eftgjtozcx, yiocryjaet - ortkyvyddd) View more | ||||||
Not Applicable | 22 | yedughbtyi(ctebdgjdwz) = High-certainty evidence indicates that PEG or ACP do not confer significant benefit to low-luminance BCVA. vggwvgjvaa (suibblgtpn ) | Negative | 04 Sep 2025 | |||
Pegcetacoplan 15mg every other month | |||||||
Phase 3 | Age Related Macular Degeneration | Geographic Atrophy outer nuclear layer (ONL) | external limiting membrane (ELM) | ellipsoid zone layer (EZ) ... View more | 453 | Pegcetacoplan 15 mg per 0.1 mL intravitreal injection monthly | kasfeyrvwi(cptkmtgwoi) = tcdfontykd jgacjucxyy (wrqeddojxh ) View more | Positive | 04 Sep 2025 |






