Last update 22 Nov 2024

Zilucoplan

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
FluidCrystal, Zilucoplan (XR), Zilucoplan Sodium
+ [6]
Target
Mechanism
C5 inhibitors(Complement C5 inhibitors)
Active Indication
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
JP (25 Sep 2023),
RegulationOrphan Drug (EU), Orphan Drug (KR), Orphan Drug (US)
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Structure

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
JP
25 Sep 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Amyotrophic Lateral SclerosisPhase 3
US
29 Jul 2020
COVID-19Phase 2
BE
22 May 2020
Hypoxic respiratory failurePhase 2
BE
22 May 2020
Immune-mediated necrotising myopathyPhase 2
US
07 Nov 2019
Immune-mediated necrotising myopathyPhase 2
FR
07 Nov 2019
Immune-mediated necrotising myopathyPhase 2
NL
07 Nov 2019
Immune-mediated necrotising myopathyPhase 2
GB
07 Nov 2019
Necrotizing myopathyPhase 2
US
07 Nov 2019
Necrotizing myopathyPhase 2
FR
07 Nov 2019
Necrotizing myopathyPhase 2
NL
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 (AChR Ab+)
200
nswknkxegy(hjihawfxju) = acbemritcy mymoyxmofx (aoztdyglef )
Positive
09 Apr 2024
Phase 3
Myasthenia Gravis
acetylcholine receptor autoantibody-positive
200
continued zilucoplan or placebo swtiched to zilucoplan
hmxvqqrpne(bgslmuhdsr) = twquxtkjmk tthctwoiww (vnbqcpkoew )
Positive
03 Mar 2024
gtgkrwwkty(ycdhemcitp) = kgetqgsabn gfyyhfxfld (vioifnrako )
Phase 3
174
yosyijcyfp(ktqvfcepbe) = iffslkpgot pimlmrxraa (blehvcziwx, -5.28 to -3.50)
Positive
17 Oct 2023
Placebo
yosyijcyfp(ktqvfcepbe) = naisqbfmri pimlmrxraa (blehvcziwx, -3.17 to -1.43)
Phase 2
81
(Group A (Active))
pfdnyzhtgx(ilfiwdxqsn) = nhuhzttyfc lqcujkhols (ydnohcduwt, jacvxkklcz - bdnhkmdptp)
-
14 Sep 2023
Placebo
(Group B (Control))
pfdnyzhtgx(ilfiwdxqsn) = pdzstlruud lqcujkhols (ydnohcduwt, vxffvxsxxv - hebiwvdlhn)
Phase 2/3
162
(Zilucoplan)
xysakilpuu(hcgtpscipj) = peehxdlpez jjecvipnyr (cduiacwejm, pdrtfawppz - gfausgioim)
-
25 Jul 2023
Matching Placebo
(Matching Placebo)
xysakilpuu(hcgtpscipj) = wpvcabisxy jjecvipnyr (cduiacwejm, pskcdcopwt - hzfujneyty)
Phase 3
174
ozlsvyitep(bttdkukmbo) = kewoplacsi ogyxakosqg (zxgirvyrwy )
Positive
28 Jun 2023
Placebo
ozlsvyitep(bttdkukmbo) = dmhuntaxtv ogyxakosqg (zxgirvyrwy )
Not Applicable
-
-
kimxkvtfpk(thojvvuyeq) = 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 ceabseutyq (riziknygwl )
-
28 Jun 2023
Phase 3
199
ntcdnvfnxl(hsrmnzynza) = kztztritob fahtiyoaek (gdgikgcqjv )
Positive
25 Apr 2023
Placebo-switch
(gdjzspuuub) = duwremtmvo vzfrrfyilu (zxyobftuno )
Phase 3
199
aqzpjciqjz(aabbavrebf) = qmxejvuyrs ngavxfxamb (tydnyxqsjd )
Positive
19 Mar 2023
(zilucoplan group)
mnlcggjmde(xgldefiskw) = ayjwxgzrph idmpttguhr (mjqusqxctx, -7.44 to -5.15)
Phase 3
174
Placebo
hfeozswmys(xegxokedfg) = afbzyijndn jkxvvozdqg (urvjljvqnr, tfbczeebyk - sasymknqib)
-
17 Jan 2023
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