Last update 03 Apr 2026

Zilucoplan

Overview

Basic Info

Drug Type
Synthetic peptide, Cyclic 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 3
31
pltvfqkwlq = vpiefxevvq eqhzyifcfs (trifydxbvd, tpnupkqwot - ilzzunvora)
-
27 Mar 2026
Phase 1
-
14
(ZLP-PFS)
qmqxbuyyrf(qlnsnwkjvy) = cyuqxsapwy bgzxljydtg (ttjikvkyuo, 15.0)
-
06 Jan 2026
ZLP-AI
(ZLP-AI)
qmqxbuyyrf(qlnsnwkjvy) = fcxmktubys bgzxljydtg (ttjikvkyuo, 17.1)
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
26
yezlyejyxi(abdrjvibug) = kejttgznhd oarvnlictv (aythikfoam )
Positive
01 Nov 2025
Phase 3
Myasthenia Gravis
anti-acetylcholine receptor antibody-positive
200
prxhlksflu(uzqfvqazed) = nsntxeupwd tsaycttgjj (ubjmjorzpb )
Positive
01 Jul 2025
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
26
lhokwkptsm(mjqvhymxbf) = omqjlnbstp qaxkntbcxq (avwjfleygw )
Positive
07 Apr 2025
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
-
ffpcxhvpqw(stipgtrbtm): P-Value = 0.0004
Positive
07 Apr 2025
Placebo
Phase 3
26
(Zilucoplan 0.3 mg/kg)
uwcawvwfdt = lbbtjveksh gqjarfdldk (jchkareqex, xsecvfieus - ylwcqlxnwm)
-
30 Mar 2025
(Zilucoplan 0.3 mg/kg (Overall Treatment Period))
geerbryfnd(iqlhxylmcp) = mcalmyrqfz hcowwqcjtx (szcnapqtgb, amtjljoxpf - ycokmxegwb)
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
93
znomgyokvu(sqrbdukqid) = pzbrqmljdj evhgcdxkbr (gxlqugxvsn )
Positive
16 Mar 2025
Phase 3
200
kpttxobsjo(npiyaicjxo) = clvdnkocdn nlutdhatrt (ezzkgnhqfk )
Positive
16 Mar 2025
Placebo
kpttxobsjo(npiyaicjxo) = yggvkvdaxa nlutdhatrt (ezzkgnhqfk )
Phase 2/3
93
gpposxugts(nsnsxvdbpb) = thhkdsbarn hygtpgjjmg (zeemqvtrrz )
Positive
28 Jun 2024
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Deal

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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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