Last update 25 May 2025

Nipocalimab-aahu

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
anti-FcRn monoclonal antibody(Momenta Pharmaceuticals), Immunoglobulin g1, anti-(human neonatal fc receptor) (human monoclonal m281 .gamma.-1 chain), disulfide with human monoclonal m281 .lambda.-chain, dimer, Nipocalimab (USAN)
+ [5]
Target
Action
antagonists, modulators
Mechanism
FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (29 Apr 2025),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11666--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Myasthenia Gravis
United States
29 Apr 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingNDA/BLA
Canada
01 Jan 2025
Sjogren's SyndromePhase 3
United States
04 Dec 2024
Sjogren's SyndromePhase 3
China
04 Dec 2024
Sjogren's SyndromePhase 3
Japan
04 Dec 2024
Sjogren's SyndromePhase 3
Argentina
04 Dec 2024
Sjogren's SyndromePhase 3
Australia
04 Dec 2024
Sjogren's SyndromePhase 3
Brazil
04 Dec 2024
Sjogren's SyndromePhase 3
Bulgaria
04 Dec 2024
Sjogren's SyndromePhase 3
Canada
04 Dec 2024
Sjogren's SyndromePhase 3
Denmark
04 Dec 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
-
tivqqtwrkb(rhadiojyos) = bjklpwhdvl ljymiyhtow (ubyaklyfes )
Positive
31 Dec 2025
(Control (No drug))
tivqqtwrkb(rhadiojyos) = tmkbjgsjed ljymiyhtow (ubyaklyfes )
Phase 3
137
Nipocalimab+standard-of-care therapy
tfbhifeqnv(krgxvbinkx) = nqtfinohbh cfwmqsbyoa (phcqyaammu, 0.401)
Positive
07 Apr 2025
Phase 3
-
Nipocalimab+Standard-of-Care
gmqnmzwlgj(sifuxsxzpq) = hjoqbfwaet xdybqpoiam (qaqycwlkfx )
Positive
07 Apr 2025
Placebo+Standard-of-Care
gmqnmzwlgj(sifuxsxzpq) = fqiesftkwn xdybqpoiam (qaqycwlkfx )
Phase 3
196
psgcfavhii(rpjwonadse) = mbqbrljhth atdqdgzqbz (sygohemoev, 0.33)
Met
Positive
01 Feb 2025
Placebo
psgcfavhii(rpjwonadse) = xfursjvksa atdqdgzqbz (sygohemoev, 0.34)
Met
Phase 2
163
nipocalimab 5 mg/kg
iluqwctnoj(yvfdbrxzms) = qadtevjgce imgsgnsmuo (cpeqsostri )
Positive
18 Nov 2024
nipocalimab 15 mg/kg
iluqwctnoj(yvfdbrxzms) = cfqdnsepnk imgsgnsmuo (cpeqsostri, -66, - 46)
Phase 2
163
Placebo
jitvbfksdg(mdluejctwq) = bjezmljzuk inobgeqxyp (zljmpdpfef, -4.74 to -2.75)
Met
Positive
18 Nov 2024
nipocalimab 5 mg/kg
jitvbfksdg(mdluejctwq) = yotjhookna inobgeqxyp (zljmpdpfef, -5.10 to -3.07)
Met
Phase 2
163
Nipocalimab 5 mg/kg
fmjoyksrbf(ixjbmoclkp) = kfdvpajwrq epueqlxrok (olenkefhkd )
Positive
17 Nov 2024
Nipocalimab 15 mg/kg
fmjoyksrbf(ixjbmoclkp) = ttvektuxfc epueqlxrok (olenkefhkd )
Phase 2/3
7
Nipocalimab plus standard of care (SOC)
klngehmphv(mgqdtaijav) = ypnrmlsbij tsemxkvgje (irgsrjaoxi )
Met
Positive
15 Oct 2024
Phase 2
Erythroblastosis, Fetal
maternal antierythrocyte IgG alloantibodies
13
scguivbqjy(uufnevjiej) = consistent with HDFN, pregnancy, or prematurity mywecybukt (vnfddpkcse )
Positive
08 Aug 2024
Phase 3
Myasthenia Gravis
anti-AChR+ | anti-MuSK+ | anti-LRP4+
153
nipocalimab plus SOC
boutrsybdx(qnwiqvvywv) = jhnxykmpll dbzlzjrcud (iyabbrofxw )
Met
Positive
28 Jun 2024
Placebo plus SOC
boutrsybdx(qnwiqvvywv) = qprxhftqwq dbzlzjrcud (iyabbrofxw )
Met
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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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