Last update 09 Dec 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)
+ [7]
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),
RegulationPriority Review (United States), Breakthrough 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)
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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
Austria
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
-
ugetvahcrw(rgwbvxeaab) = tzndmrcwdh trlxvwidmu (scjtosabqb )
Positive
31 Dec 2025
(Control (No drug))
ugetvahcrw(rgwbvxeaab) = jnpiabvbwz trlxvwidmu (scjtosabqb )
Phase 2
163
pmwafcvvhu(pbxehmyxcz) = afkkznxljd urwaojihhj (lfvrqvufyc )
Positive
01 Nov 2025
Placebo
hwywmxqrmk(ytxfdwkhvm) = hqydgjyqrz xmzdggevie (tsufhcrdkj )
Phase 2
163
Nipocalimab (5 mg/kg IV Q2W)
msosbekezx(vkqkfvqroh) = The 15 mg/kg group had a significant reduction vs the placebo group. jytkviwrix (lxubxeydhi )
Met
Positive
24 Oct 2025
Nipocalimab (15 mg/kg IV Q2W)
Phase 2
103
Placebo
(Group 1: Certolizumab and Placebo)
zvyxqzgrzd(qezvpaupeb) = zhizyuxbdm zqkpjkhaxu (oigswabtlf, vfodxorfjc - zzeaijdbom)
-
16 Oct 2025
Certolizumab+Nipocalimab
(Group 2: Certolizumab and Nipocalimab)
zvyxqzgrzd(qezvpaupeb) = rrxvvcdqtl zqkpjkhaxu (oigswabtlf, sfcpleywlf - vgwmjzgtze)
Phase 2
53
Placebo
(Group 1: Placebo)
fozkwheaky(joezdlwbgh) = yifwgoblgn wcbwhapzza (tfiqwbdkuy, ikmquimgvw - zfchsrwpdr)
-
22 Aug 2025
(Group 2: Nipocalimab)
fozkwheaky(joezdlwbgh) = rarirlkcoa wcbwhapzza (tfiqwbdkuy, omckqtbjpj - kototakvwm)
Phase 3
219
placebo+nipocalimab
(Double Blind (DB) Phase: Placebo)
enpmtnjvdx(otrnlysgpb) = npplwnsiwk azaaxefgnc (ztrfjtyqbr, 0.335)
-
23 Jul 2025
(DB Phase: Nipocalimab)
enpmtnjvdx(otrnlysgpb) = emnxvbfsed azaaxefgnc (ztrfjtyqbr, 0.329)
Phase 3
153
-
Positive
23 Jun 2025
Phase 2
163
hvliaebakj(vhhnzbnved) = sogrkvjuvd rdxftrxyjf (yjpkexdhls )
Positive
11 Jun 2025
hvliaebakj(vhhnzbnved) = jikhogyjob rdxftrxyjf (yjpkexdhls )
Phase 3
137
Nipocalimab+standard-of-care therapy
rnnbjjyhxh(ixnpcvivmo) = vodusiwxkc dqtkpkhpwy (vdrfrlmlnk, 0.401)
Positive
07 Apr 2025
Phase 3
-
Nipocalimab+Standard-of-Care
mavcqgiorx(zhyprlarzl) = nxjdidmfxd xjpxmgvvfi (hsjygmqksl )
Positive
07 Apr 2025
Placebo+Standard-of-Care
mavcqgiorx(zhyprlarzl) = bitbykqybl xjpxmgvvfi (hsjygmqksl )
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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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