Delving into the Latest Updates on Nipocalimab-aahu with Synapse

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)

+ [6]

Target

FcRn

Action

antagonists, modulators

Mechanism

FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [7]

Active Indication

Myasthenia GravisPolyradiculoneuropathy, Chronic Inflammatory DemyelinatingSjogren's Syndrome+ [10]

Inactive Indication-

Originator Organization

Janssen Biotech, Inc.

Active Organization

Johnson & Johnson (China) Investment Ltd.Janssen Research & Development LLCJanssen-Cilag International NV

+ [2]

Inactive Organization

Momenta Pharmaceuticals, Inc.

License Organization

Momenta Pharmaceuticals, Inc.

Johnson & Johnson

Drug Highest PhaseApproved

First Approval Date

United States (29 Apr 2025),

Myasthenia Gravis

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

Sequence Code 19395495L

Source: *****

Sequence Code 19395504H

Source: *****

Nipocalimab, a human immunoglobulin G (IgG) 1 monoclonal antibody, selectively binds the IgG-binding site on the neonatal Fc receptor (FcRn) and blocks IgG recycling, reducing IgG levels without impacting antigen presentation or T-/B-cell functions. In this phase 1, open-label study, we assessed the effect of nipocalimab on IgG response in healthy adults receiving T-cell-dependent/-independent vaccines (ie, tetanus toxoid [TT], diphtheria, and acellular pertussis vaccine [Tdap] and 23-polysaccharide pneumococcal vaccine [PPSV®23], respectively). Participants received either no drug (control) or intravenous nipocalimab (30 mg/kg at Week 0; 15 mg/kg at Weeks 2 and 4). All participants received Tdap and PPSV®23 vaccinations on Day 3 and were followed through Week 16. Twenty-nine participants completed the study (active, n=15; control, n=14). All participants mounted a response to Tdap vaccination, with 3 (20%) participants in the active arm and 7 (50%) participants in the control arm achieving a positive anti-TT response at Week 4 (primary endpoint; p=.089). Nipocalimab treatment was associated with numerically lower anti-TT and anti-pneumococcal (PCP)-specific IgG responses at Week 4 but comparable responses at Weeks 2 and 16. Overall, anti-TT IgG levels remained above the protective threshold (0.16 IU/mL) for all participants, and anti-PCP IgG levels remained above the 50 mg/L threshold and showed a 2-fold increase from baseline in both arms. Nipocalimab coadministration with Tdap and PPSV®23 was safe and well tolerated. Results suggest that nipocalimab does not impact the development of IgG responses to T-cell-dependent/-independent vaccines and participants treated with nipocalimab can follow recommended vaccination schedules.Trial registration number: NCT05827874.

31 Dec 2025·mAbs

Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties

Article

Author: Sukumaran, Siddharth ; Xu, Rui ; Abouzahr, Katie ; Ling, Leona E. ; Avery, William ; Roy, Sucharita ; Beavers, Traymon ; Choudhury, Amit ; Sihapong, Samuel ; Price, Karen ; Kumar, Sujatha ; Narayanaswami, Pushpa ; DuPrie, Matthew ; Markowitz, Lynn ; Bhattacharya, Sayak ; Brown, Julia ; Daly, Thomas ; Seth, Nilufer P. ; Tyler, Steven ; Rutitzky, Laura ; Cochran, Edward ; Meador, James ; Hubbard, Jonathan J. ; Pao, Yvonne ; Elwood, Fiona ; Duffner, Jay ; Parge, Viraj ; Wang, Yang ; Chen, Hsin

Nipocalimab is a human immunoglobulin G (IgG)1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) with high specificity and high affinity at both neutral (extracellular) and acidic (intracellular) pH, resulting in the reduction of circulating IgG levels, including those of pathogenic IgG antibodies. Here, we present the molecular, cellular, and nonclinical characteristics of nipocalimab that support the reported clinical pharmacology and potential clinical application in IgG-driven, autoantibody- and alloantibody-mediated diseases. The crystal structure of the nipocalimab antigen binding fragment (Fab)/FcRn complex reveals its binding to a unique epitope on the IgG binding site of FcRn that supports the observed pH-independent high-binding affinity to FcRn. Cell-based and in vivo studies demonstrate concentration/dose- and time-dependent FcRn occupancy and IgG reduction. Nipocalimab selectively reduces circulating IgG levels without detectable effects on other adaptive and innate immune functions. In vitro experiments and in vivo studies in mice and cynomolgus monkeys generated data that align with observations from clinical studies of nipocalimab in IgG autoantibody- and alloantibody-mediated diseases.

01 Sep 2025·DRUGS

Nipocalimab: First Approval

Review

Author: Fung, Simon

Nipocalimab (nipocalimab-aahu; IMAAVY™) is a fully human monoclonal antibody that binds to and blocks the neonatal fragment crystallizable (Fc) receptor (FcRn) resulting in the reduction of circulating IgG levels. It is being developed by Johnson & Johnson for the treatment of a number of autoimmune disorders. On 29 April 2025, nipocalimab received its first approval in the USA for the treatment of generalized myasthenia gravis in adult and pediatric patients ≥ 12 years of age who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. Regulatory review of nipocalimab is underway for generalized myasthenia gravis in Japan and the European Union. This article summarizes the milestones in the development of nipocalimab leading to this first approval for generalized myasthenia gravis.

152

News (Medical) associated with Nipocalimab-aahu

29 Aug 2025

·www.fiercepharma.com

After trial failure, J&J ditches Imaavy as combo agent for rheumatoid arthritis

Adding Johnson & Johnson's Imaavy to an anti-TNFα therapy in patients with refractory rheumatoid arthritis did not provide any significant benefits over anti-TNFα therapy alone, the company said. Flying high after an FDA approval four months ago to treat generalized myasthenia gravis (gMG), Johnson & Johnson’s much-touted Imaavy (nipocalimab) has taken a hit, coming up short as part of a combination therapy in a rheumatoid arthritis (RA) trial.Without revealing data from the phase 2a Daisy proof-of-concept study, J&J said that after 12 weeks, Imaavy provided no added benefit when added to an anti-TNFα therapy in patients with refractory RA.“Based on these findings, Johnson & Johnson has decided not to proceed with the clinical development of nipocalimab in combination with an anti-TNFα therapy for RA,” the company said in its release.Despite the setback, J&J added that it is still “confident” that Imaavy can live up to the $5 billion-plus peak sales potential the company has pegged for the FcRn-blocking monoclonal antibody. J&J is investigating Imaavy in a host of immunology disorders, including Sjogren’s disease (SjD). Last year, the company presented data from a phase 2 study that demonstrated the effectiveness of an FcRn blocker for the first time in SjD. The results helped earn a fourth FDA fast-track designation for Imaavy, with the others coming in gMG and two maternal fetal diseases.J&J picked up Imaavy as the primary piece of its $6.5 billion acquisition of Momenta Pharmaceuticals in 2020. The infused treatment isn’t the first FcRn binder on the market for gMG. Argenx got there first in 2021 with an FDA nod for its blockbuster Vyvgart. Two years later, UCB scored with its FcRn drug Rystiggo. Imaavy could become the top seller in the indication as it has the broadest label.Imaavy works by blocking the protein FcRn, which is responsible for circulating the immunoglobulin G (IgG) antibodies that are known culprits in several autoimmune diseases. Data have shown that Imaavy is able to substantially reduce IgG levels, including IgG autoantibodies, while sparing the body’s other immune functions.

Clinical ResultPhase 2ImmunotherapyFast TrackAcquisition

29 Aug 2025

·endpoints.news

J&J's megablockbuster hopeful Imaavy fails Phase 2a rheumatoid arthritis study

Johnson & Johnson is expecting its newly-approved Imaavy to be a multibillion-dollar blockbuster across several conditions. But a stumble in a major disease category could hurt those plans. Imaavy (nipocalimab) failed a Phase 2a rheumatoid arthritis study, the company reported Thursday afternoon . Researchers were testing the drug as part of a regimen with an anti-TNF alpha therapy, and the trial showed that the combination did not have a “significant added benefit” compared with the control group. J&J will not move forward with this combination in rheumatoid arthritis as a result of the study. But J&J emphasized that they “remain confident in the nipocalimab product having $5B+ potential,” according to the release, and it’s testing it in several autoimmune and neurological diseases. The drug received its first approval in a rare disease called generalized myasthenia gravis in April. It’s expected to compete with argenx’s Vyvgart franchise, a pair of drugs from UCB, and other programs from Amgen, AstraZeneca and Regeneron. Elsewhere, J&J is testing Imaavy in an array of smaller rare disease populations, including a burgeoning area of competition called chronic inflammatory demyelinating polyneuropathy, or CIDP. Imaavy is also in Phase 3 for Sjögren’s disease, another autoimmune condition, and Phase 2 for lupus. But it may be a while before Imaavy’s next data update. The drug has no expected readouts for the rest of this year, according to J&J’s most recent earnings presentation.

Phase 2Drug ApprovalPhase 3

29 Aug 2025

·firstwordpharma.com

J&J scraps Imaavy combo with anti-TNFα in rheumatoid arthritis after mid-stage flop

Johnson & Johnson on Thursday said it has halted clinical development of its FcRn blocker Imaavy (nipocalimab) in combination with UCB’s anti-TNFα therapy Cimzia (certolizumab pegol) for rheumatoid arthritis after a mid-stage proof-of-concept study showed underwhelming results.The Phase IIa DAISY study enrolled 103 adult patients with moderate to severe active rheumatoid arthritis for ≥3 months who were refractory to biologic disease-modifying anti-rheumatic drugs or anti-TNF agents. The participants were randomised to receive either Imaavy plus Cimzia or placebo plus Cimzia for up to 22 weeks; the study’s primary endpoint measured change in Disease Activity Index Score 28 using C-reactive Protein (DAS28-CRP) from baseline to week 12.The company noted that Imaavy plus Cimzia failed to demonstrate adequate evidence of significant added benefit over Cimzia monotherapy at 12 weeks in patients with refractory disease. However, no new safety concerns emerged, with Imaavy's established safety profile maintained throughout the study period extending to week 30.“We are excited to continue the ongoing clinical development program evaluating [Imaavy] in potential indications across rheumatic, rare autoantibody and maternal foetal diseases,” the drugmaker stated, adding that they “remain confident in the…product having $5B+ potential.”Imaavy, gained through J&J's $6.5-billion buyout of Momenta Pharmaceuticals in 2020, secured its first FDA approval for generalised myasthenia gravis in adults and adolescents earlier this year. The anti-FcRn antibody is also being investigated for other autoimmune conditions, including haemolytic disease of the foetus and newborn, warm autoimmune haemolytic anaemia and Sjögren's disease.

Phase 2Drug ApprovalClinical ResultAcquisition

100 Deals associated with Nipocalimab-aahu

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External Link

KEGG	Wiki	ATC	Drug Bank
D11666	-	-	DB16257

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Myasthenia Gravis	United States	Janssen Biotech, Inc.	29 Apr 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	NDA/BLA	Canada	Janssen Research & Development LLC	01 Jan 2025
Sjogren's Syndrome	Phase 3	United States	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	China	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Japan	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Argentina	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Australia	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Austria	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Brazil	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Bulgaria	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Canada	Janssen Research & Development LLC	04 Dec 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05827874 (Pubmed \| Hum Vaccin Immunother)	Phase 1	-	-	Nipocalimab	xahcusjjje(ozllllmnli) = croiawvdir wxnfuckxyl (aszmimfhpi )	Positive	31 Dec 2025
				nipocalimab (Control (No drug))	xahcusjjje(ozllllmnli) = zyfoddbtfs wxnfuckxyl (aszmimfhpi )
NCT04991753 (IRIS-RA, CTgov)	Phase 2	Rheumatoid Arthritis	53	Placebo (Group 1: Placebo)	zlpznmfoux(tptehozoit) = fjkheddccu uizbsoarbt (mvfdtedjom, vnwbtcxfun - aniriokrsl) View more	-	22 Aug 2025
				Nipocalimab (Group 2: Nipocalimab)	zlpznmfoux(tptehozoit) = cyqyblamqq uizbsoarbt (mvfdtedjom, xvxyvcgnqm - gvrjqqxfpc) View more
NCT04951622 (VIVACITY \| Vivacity-MG3, CTgov)	Phase 3	Myasthenia Gravis	219	placebo+nipocalimab (Double Blind (DB) Phase: Placebo)	xjcphdjjjk(dtafnzftnn) = hojoqbbvba xuewstelkj (aoteuqcvgn, 0.335) View more	-	23 Jul 2025
				nipocalimab (DB Phase: Nipocalimab)	xjcphdjjjk(dtafnzftnn) = qkkildzebp xuewstelkj (aoteuqcvgn, 0.329) View more
NCT04951622 (Vivacity-MG3, Company_Website \| EAN2025) Manual	Phase 3	Myasthenia Gravis	153	nipocalimab +SOC	-	Positive	23 Jun 2025
NCT04968912 (DAHLIAS, EULAR2025)	Phase 2	Sjogren's Syndrome	163	Nipocalimab 5 mg/kg	zwzwgpomhx(iykavkxuay) = bbaejznfjd pfxkbmpdby (irdyepouhh )	Positive	11 Jun 2025
				Nipocalimab 15 mg/kg	zwzwgpomhx(iykavkxuay) = xychnbhgza pfxkbmpdby (irdyepouhh )
NCT04951622 (Vivacity-MG3, AAN 12025 \| AAN 22025) Manual	Phase 3	Myasthenia Gravis	137	Nipocalimab+standard-of-care therapy	nmvzpyltpl(wwftfzokmf) = druvysrbdm ssmxxpulrf (yovcwkbvbn, 0.401) View more	Positive	07 Apr 2025
NCT04951622 (Vivacity-MG3, AAN2025)	Phase 3	Myasthenia Gravis	-	Nipocalimab+Standard-of-Care	dxkvvygoke(yhnvxtphat) = ayhpplckre umvdbwxnyo (vsngwjrjfg ) View more	Positive	07 Apr 2025
				Placebo+Standard-of-Care	dxkvvygoke(yhnvxtphat) = dkoyelofsg umvdbwxnyo (vsngwjrjfg ) View more
NCT04951622 (Vivacity-MG3, Lancet \| FDA_CDER) Manual	Phase 3	Myasthenia Gravis	196	Nipocalimab	vehetawmqe(hzvitjrrvg) = optvcieahw tcvbhysiha (khnbbsulkw, 0.33) Met View more	Positive	01 Feb 2025
				Placebo	vehetawmqe(hzvitjrrvg) = xlpnulgbyo tcvbhysiha (khnbbsulkw, 0.34) Met View more
NCT04968912 (DAHLIAS, ACR2024) Manual	Phase 2	Sjogren's Syndrome	163	Placebo	sqmxuuwlnr(vmapyuchup) = jremwdnana dnmriamzml (hwbksqmrif, -4.74 to -2.75) Met View more	Positive	18 Nov 2024
				nipocalimabnipocalimab 5 mg/kg	sqmxuuwlnr(vmapyuchup) = ywhbccygck dnmriamzml (hwbksqmrif, -5.10 to -3.07) Met View more
NCT04968912 (DAHLIAS, ACR2024) Manual	Phase 2	Sjogren's Syndrome	163	nipocalimabnipocalimab 5 mg/kg	omiaxvidmv(kmlkhoaqqk) = dxbcfnipko sstccaidhq (ihbsrteloz )	Positive	18 Nov 2024
				nipocalimabnipocalimab 15 mg/kg	omiaxvidmv(kmlkhoaqqk) = aofctbqydd sstccaidhq (ihbsrteloz, -66， - 46)

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Nipocalimab-aahu

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation