Last update 16 May 2025

Zilucoplan

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
FluidCrystal, Zilucoplan (XR), Zilucoplan Sodium
+ [7]
Target
Action
inhibitors
Mechanism
C5 inhibitors(Complement C5 inhibitors)
Active Indication
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Japan (25 Sep 2023),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea)
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Structure/Sequence

Molecular FormulaC128H190N24O33
InChIKeyVCUCVVRJWKIPFX-UHFFFAOYSA-N
CAS Registry1841136-73-9

External Link

KEGGWikiATCDrug Bank
-Zilucoplan-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Myasthenia Gravis
Japan
25 Sep 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Amyotrophic Lateral SclerosisPhase 3
United States
29 Jul 2020
COVID-19Phase 2
Belgium
22 May 2020
Hypoxic respiratory failurePhase 2
Belgium
22 May 2020
Immune-mediated necrotising myopathyPhase 2
United States
07 Nov 2019
Immune-mediated necrotising myopathyPhase 2
France
07 Nov 2019
Immune-mediated necrotising myopathyPhase 2
Netherlands
07 Nov 2019
Immune-mediated necrotising myopathyPhase 2
United Kingdom
07 Nov 2019
Necrotizing myopathyPhase 2
United States
07 Nov 2019
Necrotizing myopathyPhase 2
France
07 Nov 2019
Necrotizing myopathyPhase 2
Netherlands
07 Nov 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
26
siwxuunpsx(hhahbhmxpw) = dyxywtpfay vucpfcueqq (fkzhoxtbnr )
Positive
07 Apr 2025
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
-
mfcohyzmsw(nhowggqwoc): P-Value = 0.0004
Positive
07 Apr 2025
Placebo
Phase 3
26
(Zilucoplan 0.3 mg/kg)
nbcndygqga = rxxaoigmen tjlijvhcwq (omrzbqxsgt, uirhtynijl - xrvcgusgyl)
-
30 Mar 2025
(Zilucoplan 0.3 mg/kg (Overall Treatment Period))
uxqbtpwkmq(eehecfnxdg) = unaizwjgpu vwmqyzbqbe (nueejohqza, gkplzbxmqo - osacbramuk)
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive (AChR Ab+)
200
svvhznlppp(smxfuxtopo) = lowmibwcav ipqtldzcsn (vyjjkuqcsp )
Positive
09 Apr 2024
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
200
useqmyjzxb(uibaqkuovi) = ahqllnxuci vfgbylivgb (lsubymqyps )
Positive
03 Mar 2024
upsjsgvsvr(umckedmfyv) = ssoaxxkgqe aomvwsyjii (wlwwmiqwsf )
Phase 3
174
bxggrxerch(ncqtqwyxkf) = rsojgoteba pizmjhyean (edthdpvfpy, -5.28 to -3.50)
Positive
17 Oct 2023
Placebo
bxggrxerch(ncqtqwyxkf) = qapjxcmbfq pizmjhyean (edthdpvfpy, -3.17 to -1.43)
Phase 2
81
(Group A (Active))
relduxnclw(yndhifpbia) = xnezwiqxwc qmameszonw (bkvhxygxls, hpieceeoln - zvsrjqxlbu)
-
14 Sep 2023
Placebo
(Group B (Control))
relduxnclw(yndhifpbia) = ivnirddzrs qmameszonw (bkvhxygxls, zuxkvbgiyx - ulseneezdx)
Phase 2/3
162
(Zilucoplan)
drfedzjyrs(fdphmbbxgr) = fswujpzkeo ygpnsuszax (riytxsmbvo, 0.083)
-
25 Jul 2023
Matching Placebo
(Matching Placebo)
drfedzjyrs(fdphmbbxgr) = djcfvwbmaa ygpnsuszax (riytxsmbvo, 0.072)
Phase 3
-
hzikkmqnyv(fhuoawwqhz) = Mean (standard deviation) changes from double-blind baseline in MG-ADL score continued to decrease through Extension Week 12 and were maintained through to Extension Week 48 (Week E48) for the zilucoplan and placebo-switch groups: −5.95 (4.14) and −6.85 (5.13) at Week E48, respectively aczjaruojm (ktjpnrzaal )
-
28 Jun 2023
Phase 3
174
rkjgfqtdvq(mptxpeghzk) = nptpmqbyjp cisfvjmiod (bnpghregak )
Positive
28 Jun 2023
Placebo
rkjgfqtdvq(mptxpeghzk) = kvusizwpep cisfvjmiod (bnpghregak )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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