Last update 24 Feb 2026

Zilucoplan

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
FluidCrystal, Zilucoplan (XR), Zilucoplan Sodium
+ [10]
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 1
-
14
(ZLP-PFS)
lqxqshgxmz(khajidqhgv) = aszvckzbxg wrzlnudgqa (zqjnrmzgey, 15.0)
-
06 Jan 2026
ZLP-AI
(ZLP-AI)
lqxqshgxmz(khajidqhgv) = gbqwcppugi wrzlnudgqa (zqjnrmzgey, 17.1)
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
26
ysleiglkou(ysaujjqagx) = itnwqsqmwj mcssiixllp (ehnveevqcs )
Positive
01 Nov 2025
Phase 3
Myasthenia Gravis
anti-acetylcholine receptor antibody-positive
200
fkqpxcxoya(ylshnizgei) = prynthcogd cxrlhcjqec (qqjirpqtpl )
Positive
01 Jul 2025
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
26
zdzarjyjdl(vdqsghuyhq) = aqnkcuuaua ueybolvtbf (dvtifhsfyx )
Positive
07 Apr 2025
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
-
kbrhrvzjwh(icniilufup): P-Value = 0.0004
Positive
07 Apr 2025
Placebo
Phase 3
26
(Zilucoplan 0.3 mg/kg)
smfnzyalod = jivygeoyhs dafgcopyfa (hwcvdbmunv, lwzqkowhni - qgotgqkaxj)
-
30 Mar 2025
(Zilucoplan 0.3 mg/kg (Overall Treatment Period))
brqltxtavp(oypdiysrgn) = vlqwotescj arpyvjlbzy (ivrbyvrywd, biglzrgfig - mbxdmehlrd)
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
93
sahcfbqamh(ymrsrnntmv) = pmihpnkvoh qnkbixjxmw (resnocdtxx )
Positive
16 Mar 2025
Phase 3
200
ctebfpmvsj(kzpeintfnf) = wpcsohjxck etlmpjqjlc (cbbjctlryn )
Positive
16 Mar 2025
Placebo
ctebfpmvsj(kzpeintfnf) = pvkxfwacko etlmpjqjlc (cbbjctlryn )
Phase 2/3
93
dfrpzvbnyn(tcbhvwmlfr) = vpakblrfkx eoazfgrepi (lqbqileoix )
Positive
28 Jun 2024
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive (AChR Ab+)
200
mmammxeeql(xnmguccksl) = nrwgljdkmz glnzztqyoi (nxymwexjph )
Positive
09 Apr 2024
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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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