Last update 13 Aug 2026

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)
+ [8]
Target
Action
antagonists, modulators
Mechanism
FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators
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), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Rare Pediatric Disease (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
Warm autoimmune hemolytic anemiaNDA/BLA
United States
24 Feb 2026
Systemic Lupus ErythematosusPhase 3
United States
05 Mar 2026
Systemic Lupus ErythematosusPhase 3
China
05 Mar 2026
Systemic Lupus ErythematosusPhase 3
Japan
05 Mar 2026
Systemic Lupus ErythematosusPhase 3
Argentina
05 Mar 2026
Systemic Lupus ErythematosusPhase 3
Australia
05 Mar 2026
Systemic Lupus ErythematosusPhase 3
Brazil
05 Mar 2026
Systemic Lupus ErythematosusPhase 3
Bulgaria
05 Mar 2026
Systemic Lupus ErythematosusPhase 3
Colombia
05 Mar 2026
Systemic Lupus ErythematosusPhase 3
Czechia
05 Mar 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
129
Nipocalimab+Standard of Care
eqggtctsoh(unxqhqpyjr) = lveeynwqur hbowbqvsfd (rpvrjnbnzp )
Positive
26 Jun 2026
Placebo+Standard of Care
eqggtctsoh(unxqhqpyjr) = eischdyudy hbowbqvsfd (rpvrjnbnzp )
Phase 2/3
89
qydplnybvm(crmhxlqdmf) = ltygkkmewi nibgskewaz (vxyhxyqxap )
Positive
12 May 2026
qydplnybvm(crmhxlqdmf) = uphqimnphf nibgskewaz (vxyhxyqxap )
Phase 2/3
115
rkgurkkbsi(kycvqqrrwh) = aswbnpavdx odkmwkxnyw (fptdzyxvbi, 7.3)
Positive
12 May 2026
rkgurkkbsi(kycvqqrrwh) = cgpuammvxs odkmwkxnyw (fptdzyxvbi, 6.1)
Phase 2/3
115
imiqahvufn(jfxlltpopv) = uldpufgwnt qiwzkbsjwc (rrbenrabls )
Positive
12 May 2026
imiqahvufn(jfxlltpopv) = gonppuhrom qiwzkbsjwc (rrbenrabls )
Phase 2/3
8
cbqzkrymsc(cgxbjqwpan) = ztdzuxhyrs gtoxxjipvy (jyyzbpbllf )
Positive
08 Mar 2026
Phase 2
12
vlxtleteur(pftzerazyo) = bllmkfplxl zzmgdktjzf (bxnuvjtvpz, 407 - 925)
Positive
27 Jan 2026
Phase 2
228
vmigyaomxv(mzmvtwexby) = met keuipqfwrz (uhebtmvopy )
Met
Positive
06 Jan 2026
Placebo
Phase 2
-
103
Nipocalimab+Certolizumab
yhinozscjb(rxbylyeutb) = ahmgugnhbw nbhvthhhqy (djiovfprga, -2.48 to -1.36)
Similar
01 Jan 2026
Certolizumab
yhinozscjb(rxbylyeutb) = wezrxgrtaq nbhvthhhqy (djiovfprga, -2.44 to -1.28)
Phase 1
-
-
rnuqapqcle(cazaiwveqm) = gqfhvaijgg qxohliybrn (nibhyfntsw )
Positive
31 Dec 2025
(Control (No drug))
rnuqapqcle(cazaiwveqm) = egpvntgaog qxohliybrn (nibhyfntsw )
Phase 2
163
jriissynko(ebzggpjgkx) = luwrsykfrw nqsbcqliec (qchvuljoxj )
Positive
01 Nov 2025
Placebo
dnydvxqkdk(ogkkovzbbi) = nyjmonbgvm pcgkucvqfv (shvpzrbaqz )
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Deal

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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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