Nipocalimab History and Updates

68 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: August 31, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-01Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Nipocalimab since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (7)

2026

FDA approval (supplemental)Imaavy (nipocalimab) FDA approves supplemental efficacy application· Aug 24, 2026
Label revisionImaavy Label Lists gMG Treatment for Patients Age 12+· Aug 21, 2026

2025

Results postedNipocalimab + Certolizumab for RA: Phase 2 Shows No Significant DAS28-CRP…· Oct 16, 2025
Results postedNipocalimab Phase 2 RA Trial Shows Higher ACR20 Response Than Placebo· Aug 22, 2025
Results postedNipocalimab Shows Greater MG-ADL Score Improvement in Generalized Myasthenia…· Jul 23, 2025
FDA approvalImaavy (nipocalimab) FDA approved as a new molecular entity· Apr 29, 2025

2023

Primary completionNipocalimab Phase 3 for Generalized Myasthenia Gravis Reduces MG-ADL Score· Nov 17, 2023

Upcoming & expected milestones

Primary completionFeb 16, 2027· ClinicalTrials.gov

Phase 1 primary completion: NCT07669077

A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women

Primary completionMay 14, 2027· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT05327114

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Primary completionJun 30, 2027· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT05265273

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Primary completionAug 5, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT05912517

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Primary completionSep 28, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT07217587

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Primary completionDec 15, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06533098

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Primary completionJan 1, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT06741969

Nipocalimab in Moderate to Severe Sjogren's Disease

Primary completionFeb 28, 2028· ClinicalTrials.gov

Phase 2 primary completion: NCT04883619

A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Primary completionDec 6, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT07438496

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Primary completionDec 5, 2029· ClinicalTrials.gov

Phase 3 primary completion: NCT06449651

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Past events

2026

FDA approval (supplemental)Aug 24, 2026· FDA

FDA approved supplemental application for Imaavy (nipocalimab-aahu) — Efficacy (BLA 761430 S-2)

Sponsor: JANSSEN BIOTECH. Class: Efficacy.

Label revisionAug 21, 2026· FDA

Indication and usage updated on IMAAVY label (effective 2026-08-21)

1 INDICATIONS AND USAGE IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of: generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or ant

Primary completionJun 26, 2026· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT05265273

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Trial startedJun 26, 2026· ClinicalTrials.gov

Phase 1 trial started: NCT07669077

A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women

Trial registeredJun 25, 2026· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07669077

A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women

Trial startedMar 5, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07438496

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Trial registeredFeb 27, 2026· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07438496

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Trial startedJan 15, 2026· ClinicalTrials.gov

Phase 2 trial started: NCT04883619

A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Trial startedJan 5, 2026· ClinicalTrials.gov

Phase 3 trial started: NCT07217587

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

2025

Trial registeredOct 16, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07217587

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

Results postedOct 16, 2025· ClinicalTrials.gov

Trial results posted: NCT06028438

A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

Primary completionSep 4, 2025· ClinicalTrials.gov

Phase 2 primary completion: NCT05379634

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Results postedAug 22, 2025· ClinicalTrials.gov

Trial results posted: NCT04991753

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Results postedJul 23, 2025· ClinicalTrials.gov

Trial results posted: NCT04951622

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

FDA approvalApr 29, 2025· FDA

FDA approved Imaavy (nipocalimab-aahu) (BLA 761430)

Sponsor: JANSSEN BIOTECH. Class: Type 1 - New Molecular Entity.

Trial startedFeb 10, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT06533098

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

2024

Trial registeredDec 19, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06741969

Nipocalimab in Moderate to Severe Sjogren's Disease

Trial startedDec 4, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06741969

Nipocalimab in Moderate to Severe Sjogren's Disease

Trial startedNov 11, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06449651

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Primary completionAug 29, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT06028438

A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

Trial registeredAug 1, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06533098

A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Trial registeredJun 10, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06449651

A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Primary completionApr 30, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT04882878

A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

2023

Trial startedDec 20, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05912517

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Primary completionNov 17, 2023· ClinicalTrials.gov

Phase 3 primary completion: NCT04951622

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Primary completionOct 23, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT04968912

A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Primary completionOct 4, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT05827874

A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

Trial registeredSep 8, 2023· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06028438

A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

Trial startedAug 15, 2023· ClinicalTrials.gov

Phase 2 trial started: NCT06028438

A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

Trial registeredJun 22, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05912517

A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Trial registeredApr 25, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05827874

A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

Trial startedApr 12, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05827874

A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants

2022

Trial startedSep 23, 2022· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT05327114

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Primary completionSep 9, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05151692

A Study of JNJ-80202135 in Healthy Chinese Adult Participants

Primary completionAug 10, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT04991753

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Trial startedJul 20, 2022· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT05265273

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Trial startedJul 5, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05379634

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Trial startedMay 30, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05151692

A Study of JNJ-80202135 in Healthy Chinese Adult Participants

Primary completionMay 27, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT04973566

A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants

Primary completionMay 26, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT04848558

A Study of Nipocalimab in Healthy Male and Female Participants

Trial registeredMay 18, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05379634

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

Trial registeredApr 14, 2022· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT05327114

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Trial registeredMar 3, 2022· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT05265273

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

Trial registeredFeb 3, 2022· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05221619

Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

2021

Trial registeredDec 9, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05151692

A Study of JNJ-80202135 in Healthy Chinese Adult Participants

Trial startedOct 14, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04991753

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Trial startedSep 21, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04968912

A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Trial startedAug 31, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04973566

A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants

Trial startedAug 20, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04882878

A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

Trial registeredAug 5, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04991753

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Trial registeredJul 22, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04973566

A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants

Trial registeredJul 20, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04968912

A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

Trial startedJul 15, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT04951622

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Trial registeredJul 7, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT04951622

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Trial startedMay 25, 2021· ClinicalTrials.gov

Phase 1 trial started: NCT04848558

A Study of Nipocalimab in Healthy Male and Female Participants

Trial registeredMay 12, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04883619

A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

Trial registeredMay 12, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04882878

A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

Trial registeredApr 19, 2021· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT04848558

A Study of Nipocalimab in Healthy Male and Female Participants

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.