Drugs / Nipocalimab

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Imaavy 2025-11-28 europa.eu

Trials 25 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT07669077 Jun 2026 → Feb 2027 expected Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 1 NCT05827874 Apr → Oct 2023 Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT05151692 May → Sep 2022 Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT04973566 Aug 2021 → May 2022 Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT04848558 May 2021 → May 2022 Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT02828046 May 2016 → Aug 2017 Momenta Pharmaceuticals, Inc. Completed No outcome recorded
Phase 29 trials
Phase 2 NCT04883619 Jan 2026 → Feb 2028 lupus nephritis Janssen Research & Development, LLC Withdrawn No outcome recorded
Phase 2 NCT06028438 Aug 2023 → Aug 2024 rheumatoid arthritis Janssen Research & Development, LLC Completed No outcome recorded
Phase 2 NCT05379634 Jul 2022 → Sep 2025 overdue idiopathic inflammatory myopathy Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 2 NCT04991753 Oct 2021 → Aug 2022 rheumatoid arthritis Janssen Research & Development, LLC Completed No outcome recorded
Phase 2 NCT04968912 Sep 2021 → Oct 2023 Sjogren syndrome Janssen Research & Development, LLC Completed No outcome recorded
Phase 2 NCT04882878 Aug 2021 → Apr 2024 systemic lupus erythematosus Janssen Research & Development, LLC Completed No outcome recorded
Phase 2 NCT03896295 Aug 2019 → Dec 2020 generalized myasthenia gravis Momenta Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 2 NCT03772587 Apr 2019 → Jun 2020 generalized myasthenia gravis Momenta Pharmaceuticals, Inc. Completed No outcome recorded
Phase 2 NCT03842189 Apr 2018 → Aug 2024 fetal erythroblastosis Janssen Research & Development, LLC Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT05327114 Sep 2022 → May 2027 expected chronic inflammatory demyelinating polyradiculoneuropathy Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 2/3 NCT05265273 Jul 2022 → Jun 2026 overdue myasthenia gravis Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 2/3 NCT04119050 Aug 2019 → Feb 2025 overdue autoimmune hemolytic anemia, warm type Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 36 trials
Phase 3 NCT07438496 Mar 2026 → Dec 2028 expected systemic lupus erythematosus Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT07217587 Jan 2026 → Sep 2027 expected generalized myasthenia gravis Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT06533098 Feb 2025 → Dec 2027 expected fetal and neonatal alloimmune thrombocytopenia Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT06741969 Dec 2024 → Jan 2028 expected Sjogren syndrome Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 3 NCT05912517 Dec 2023 → Aug 2027 expected fetal erythroblastosis Janssen Research & Development, LLC Recruiting No outcome recorded
Phase 3 NCT04951622 Jul 2021 → Nov 2023 overdue myasthenia gravis Janssen Research & Development, LLC Recruiting No outcome recorded
Phase not stated1 trial
NCT05221619 autoimmune hemolytic anemia, warm type Janssen Research & Development, LLC Temporarily not available No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT06449651 Comparator Nov 2024 → Dec 2029 expected fetal and neonatal alloimmune thrombocytopenia Janssen Research & Development, LLC Recruiting No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 27 sources stand behind the page.

FieldValueCited text
Known as Nipocalimab “BACKGROUND AND OBJECTIVES: To evaluate in a phase 2 study the safety and efficacy of IV nipocalimab, a fully human, antineonatal Fc receptor monoclonal antibody, in patients...” PMID 38165333 Dec 2023
21

NCT07217587

NCT05827874

NCT06449651

NCT04991753

NCT04883619

NCT05327114

NCT04848558

NCT06533098

NCT05221619

NCT04973566

NCT06741969

NCT07438496

NCT04882878

NCT04951622

NCT05379634

NCT05151692

NCT05265273

NCT07669077

NCT06028438

NCT05912517

NCT04968912

Known as JNJ-80202135 ChEMBL registry synonym — accepted as the source's own label CHEMBL4594310
Known as M281 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03896295
3

NCT03842189

NCT04119050

NCT02828046

Action Inhibit “bind, saturate, and block the IgG binding site” NCT04882878
1

“IgG receptor FcRn large subunit p51 antagonist” CHEMBL4594310

Modality Monoclonal antibody “a fully human, antineonatal Fc receptor monoclonal antibodyPMID 38165333 Dec 2023
Route Intravenous “once weekly intravenous (IV) infusions of M281” NCT03842189
Target FCGRT “IgG receptor FcRn large subunit p51 antagonist” CHEMBL4594310