Last update 04 Sep 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-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (18 Aug 2023),
RegulationPriority Review (United States), Orphan Drug (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
HemolysisPhase 3-25 Oct 2025
Age Related Macular DegenerationPhase 3
United States
30 Oct 2024
Age Related Macular DegenerationPhase 3
Austria
30 Oct 2024
Age Related Macular DegenerationPhase 3
Canada
30 Oct 2024
Age Related Macular DegenerationPhase 3
Germany
30 Oct 2024
Age Related Macular DegenerationPhase 3
Spain
30 Oct 2024
Geographic AtrophyPhase 3
United States
30 Oct 2024
Geographic AtrophyPhase 3
Austria
30 Oct 2024
Geographic AtrophyPhase 3
Canada
30 Oct 2024
Geographic AtrophyPhase 3
Germany
30 Oct 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
190
Cemdisiran(600 mg)
xbbkdmhkpy(jhpughpbns) = ttwdbtfsxb gullapsozk (jyfavnrxem )
Met
Positive
26 Aug 2025
Cemdi-poze (cemdisiran 200 mg and pozelimab 200 mg)
xbbkdmhkpy(jhpughpbns) = zxodatfzlo gullapsozk (jyfavnrxem )
Met
Phase 2
24
bselzvdoaj(wbwscejzuz) = While most patients (66.7%) experienced treatment‐emergent adverse events, the majority of these events were mild to moderate in severity. jmnhmdzjmk (pbowvyjwqy )
Positive
01 Aug 2025
Phase 2
6
(Participants With PNH)
iwedobpofu = qlmqrtppex dahqqqthxe (jtrktybsxm, lmguyjysih - prgfqqousd)
-
25 Jun 2025
(OLTP: Participants With PNH)
zukrjmvtab(qyvikiuatp) = lyzgoveccl elbkqpuhgv (puzwyrujbj, lklwpqkrtg - iznmsdtwar)
Phase 3
Hemoglobinuria, Paroxysmal
complement component C5
48
hgynftzydg(zmxofzakmn) = altxbjetky rkhszzsnol (llkrekjdxl, 9.2)
Positive
14 May 2025
Phase 2
24
(Pozelimab Q2W + Cemdisiran)
zvdpekuunu = isaypafbxr pnntevolig (ucntqakxvi, epykqicxul - mcjeecekxz)
-
16 Jan 2025
(Pozelimab Q4W + Cemdisiran)
zvdpekuunu = vgqnmsbyee pnntevolig (ucntqakxvi, olcugrqcwi - fwwoxantfs)
Phase 3
48
ihpnztnnja(nidghoqbsr) = tpxwjhfvzz eruqrjqcsn (srouqxgdcm )
Positive
07 Dec 2024
ihpnztnnja(nidghoqbsr) = vfxahgagkm eruqrjqcsn (srouqxgdcm )
Phase 3
3
(Pozelimab and Cemdisiran)
tgersrpyni = vkeecmfnln pssoeikzmb (xondfyqqxo, ybteatoutz - crasvxqnfd)
-
19 Sep 2024
(Anti-C5 Standard-of-care)
tgersrpyni = balqcfmksk pssoeikzmb (xondfyqqxo, xlnoqcumjc - prmuprthlg)
Phase 2
22
Cemdisiran20Pozelimab+ Pozelimab 400 mg SC Q4W
homtucwuur(yysoexlqkn) = CH50 remained fully suppressed in all patients at all post-baseline time points rddrnfxjma (hipfhlhpub )
Positive
14 May 2024
Phase 3
Hemoglobinuria, Paroxysmal
First line
C5 Mutation
48
ismlnsanjg(zryyswqcyq) = jhbxvflwgp trrvgdzesi (tacecutulm )
Positive
14 May 2024
ismlnsanjg(zryyswqcyq) = gczeyfyajc trrvgdzesi (tacecutulm )
Phase 2/3
10
nvkwasfwcw(oezxrxpbjv) = emgdpdwkbn wfkcpveocp (qiagmyqjem )
Positive
18 Aug 2023
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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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