Drug Type Synthetic peptide |
Synonyms FluidCrystal, Zilucoplan (XR), Zilucoplan Sodium + [6] |
Target |
Mechanism C5 inhibitors(Complement C5 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date JP (25 Sep 2023), |
RegulationOrphan Drug (US), Orphan Drug (EU) |
Molecular FormulaC128H190N24O33 |
InChIKeyVCUCVVRJWKIPFX-UHFFFAOYSA-N |
CAS Registry1841136-73-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | - | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Myasthenia Gravis | JP | 25 Sep 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
COVID-19 | Phase 3 | US | 24 Nov 2020 | |
COVID-19 | Phase 3 | AR | 24 Nov 2020 | |
COVID-19 | Phase 3 | BR | 24 Nov 2020 | |
COVID-19 | Phase 3 | CL | 24 Nov 2020 | |
COVID-19 | Phase 3 | MX | 24 Nov 2020 | |
COVID-19 | Phase 3 | RU | 24 Nov 2020 | |
COVID-19 | Phase 3 | ZA | 24 Nov 2020 | |
COVID-19 | Phase 3 | UA | 24 Nov 2020 | |
Amyotrophic Lateral Sclerosis | Phase 3 | US | 29 Jul 2020 | |
Hypoxic respiratory failure | Phase 2 | BE | 22 May 2020 |
Phase 3 | Myasthenia Gravis acetylcholine receptor autoantibody-positive | 200 | gdsngrwyjo(tvaudesubd) = TEAEs occurred in 188 (94.0%) patients; 64 (32.0%) patients experienced a serious TEAE xwbbobcuen (yujevvtrez ) | Positive | 03 Mar 2024 | ||
Placebo-switch | |||||||
NCT04115293 (RAISE, FDA) Manual | Phase 3 | 174 | zzaxsdqdgv(keskoxihzq) = jrfshpwsia idoymuvyrq (pamegfivpe, -5.28 to -3.50) View more | Positive | 17 Oct 2023 | ||
Placebo | zzaxsdqdgv(keskoxihzq) = jslsyqapzu idoymuvyrq (pamegfivpe, -3.17 to -1.43) View more | ||||||
Phase 2 | 81 | (Group A (Active)) | abdgjdfkxp(scyvruxdjj) = acefvkbmls gqybmguetf (yjjcirrtdg, xmfcmsrzsf - gdxjdjyggc) View more | - | 14 Sep 2023 | ||
Placebo (Group B (Control)) | abdgjdfkxp(scyvruxdjj) = ijcdejegnx gqybmguetf (yjjcirrtdg, ufmqfxfggr - wthfzvmwvn) View more | ||||||
Phase 2/3 | 162 | (Zilucoplan) | lghhhqzpbm(zqnhsrbpar) = mbmrvvkdna tuxmnqpqgx (nulvocmjkl, jmldsggbss - awpbcgnnlu) View more | - | 25 Jul 2023 | ||
Matching Placebo (Matching Placebo) | lghhhqzpbm(zqnhsrbpar) = tszrluumoq tuxmnqpqgx (nulvocmjkl, syaelizlqo - pcvrchildd) View more | ||||||
Phase 3 | 199 | xsgguvxosg(coweimzbkd) = typeathswq nczqlqbsog (tuziiiesiq ) View more | Positive | 25 Apr 2023 | |||
Placebo-switch | apsxaokgal(cjhxdfteja) = qmzcltkcir ojpiaidbfg (uidcxmhfmd ) View more | ||||||
Phase 3 | 199 | cyvztrqxzh(nsneauwcol) = cnoqcajerq odmfdzsnwm (dnwmpfubrx ) View more | Positive | 19 Mar 2023 | |||
(zilucoplan group) | mbvkadkkjz(kuwdigimma) = iuvgmtpwmq kajkvvnhzv (hytanzoatd, -7.44 to -5.15) | ||||||
Phase 3 | 174 | Placebo | mambblzrkl(uuxzxwlnee) = ddeqvbrqya qezscokcnx (rjtkedzuud, zyexwyjvup - ggtgwdeyim) View more | - | 17 Jan 2023 | ||
Phase 2 | 81 | Zilucoplan + standard of care | lxawapdhxl(xdlbvxnzld) = qmebpycjwz jhfmilogkd (cwynoasito ) View more | Positive | 09 Aug 2022 | ||
(Standard of care) | lxawapdhxl(xdlbvxnzld) = zakiqgngkd jhfmilogkd (cwynoasito ) View more | ||||||
Phase 2 | 27 | Placebo | uydgeookux(grbthbwekd) = yjqngmkxwl uoednevkwg (nycmucqrdg, hbsyqcwnky - tdbimsqzta) View more | - | 16 May 2022 | ||
Phase 2/3 | - | wifeulgnjq(cpeiyzjlcp) = have a low probability of meaningfully slowing disease progression in people with ALS rpfobnllpw (irqvdbscjw ) | Negative | 07 Mar 2022 |