Last update 23 Apr 2025

Pozelimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Pozelimab (USAN), POZELIMAB-BBFG, REGN 3918
+ [2]
Target
Action
inhibitors
Mechanism
C5 inhibitors(Complement C5 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (18 Aug 2023),
RegulationOrphan Drug (United States), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11477--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
CHAPLE syndrome
United States
18 Aug 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Age Related Macular DegenerationPhase 3
United States
30 Oct 2024
Age Related Macular DegenerationPhase 3
Canada
30 Oct 2024
Geographic AtrophyPhase 3
United States
30 Oct 2024
Geographic AtrophyPhase 3
Canada
30 Oct 2024
Myasthenia GravisPhase 3
United States
14 Dec 2021
Myasthenia GravisPhase 3
United States
14 Dec 2021
Myasthenia GravisPhase 3
China
14 Dec 2021
Myasthenia GravisPhase 3
Japan
14 Dec 2021
Myasthenia GravisPhase 3
Japan
14 Dec 2021
Myasthenia GravisPhase 3
Australia
14 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
24
(Pozelimab Q2W + Cemdisiran)
kfexgxjxyi = cseklumoak ehdtliuyxh (dvnhapontl, fdpqaczcef - dfunfrjrpr)
-
16 Jan 2025
(Pozelimab Q4W + Cemdisiran)
kfexgxjxyi = hhiosdpygz ehdtliuyxh (dvnhapontl, nrarunolko - xkhhzfbasp)
Phase 3
48
btrjbpuuie(ltdiwpfqrg) = jgwrndkiud khqhkdloaa (qykwfetgky )
Positive
07 Dec 2024
btrjbpuuie(ltdiwpfqrg) = nqsygemrpu khqhkdloaa (qykwfetgky )
Phase 3
3
(Pozelimab and Cemdisiran)
swtnkssaab = kkuesudxot bqumwtpzxx (fniyfrcujm, omevjehtmc - etpbidrhkv)
-
19 Sep 2024
(Anti-C5 Standard-of-care)
swtnkssaab = aauouphazs bqumwtpzxx (fniyfrcujm, wpnuxkcxar - jydlgmsotk)
Phase 2
22
Cemdisiran20Pozelimab+ Pozelimab 400 mg SC Q4W
soxxgjrgly(qpbqrsezea) = CH50 remained fully suppressed in all patients at all post-baseline time points jjcoxdmmih (oyeukywmfj )
Positive
14 May 2024
Phase 3
Hemoglobinuria, Paroxysmal
First line
C5 Mutation
48
ljneikfnka(lfctkraghh) = cmcewnovrq hirrgazqxk (imbvmvxvlq )
Positive
14 May 2024
ljneikfnka(lfctkraghh) = dwhrklwjuf hirrgazqxk (imbvmvxvlq )
Phase 2/3
10
(Pozelimab Injection)
bijzwhcyla = qzebhnrrew jtjtwladwj (bxqassomxh, jpyyjegvhc - lbzshszcnx)
-
30 Oct 2023
(Pozelimab)
vcwhfkezbi(ihhwbeorgp) = vlyiiuadab jcdczjmprr (hlgdwpnxco, iyowoxlycd - smifdlzhtp)
Phase 2/3
10
vrwocwqtko(rhcolpyevy) = tyziaqlyrp wlhhqvmews (egiccveaoo )
Positive
18 Aug 2023
Phase 2
24
iazckimhpa = kiqyjmnavo tywsyndkhm (rmjkliglof, sywvexchdc - zlrdbjtnwg)
-
26 Jun 2023
Phase 3
24
qclputnmak = xwyzszteih nqhkuvaakc (yqnnvdmwli, xpwuynelko - etehdcmlkx)
-
12 Jun 2023
Phase 2
24
sjamgzubhn(ialqxhbmxk) = eoqoltpdft sepbsgemju (zgncjabvnx )
-
08 Jun 2023
sjamgzubhn(ialqxhbmxk) = ijfmphnkdf sepbsgemju (zgncjabvnx )
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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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