Drugs / Nipocalimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed generalized myasthenia gravis 1 milestone | |||||
| Filed | EU (EMA) | — | generalized myasthenia gravis | 2024-09-11 | “submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of nipocalimab in gMG on September 11, 2024.” jnj.com ↗ “submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA)seeking approvalof nipocalimab in gMG in September 2024.” jnj.com ↗ “and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of nipocalimab in gMG” jnj.com ↗ “MAA submitted to the European Medicines Agency (EMA) for nipocalimab in gMG in September 2024.” jnj.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Imaavy | — | 2025-11-28 | europa.eu ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 1 missed | ||||||
| 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 | Missed primary |
| 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 · 4 met primary · 2 missed | ||||||
| Phase 2 | NCT04883619 | Jan 2026 → Feb 2028 | lupus nephritis | Janssen Research & Development, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06028438 | Aug 2023 → Aug 2024 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | Missed primary |
| 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 | Missed primary |
| Phase 2 | NCT04968912 | Sep 2021 → Oct 2023 | Sjogren syndrome | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT04882878 | Aug 2021 → Apr 2024 | systemic lupus erythematosus | Janssen Research & Development, LLC | Completed | Met primary |
| 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 | Met primary |
| Phase 2 | NCT03842189 | Apr 2018 → Aug 2024 | fetal erythroblastosis | Janssen Research & Development, LLC | Completed | Met primary |
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT05221619 | — | autoimmune hemolytic anemia, warm type | Janssen Research & Development, LLC | Temporarily not available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT06449651 Comparator | Nov 2024 → Dec 2029 expected | fetal and neonatal alloimmune thrombocytopenia | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 78
| Date | Issuer | Release |
|---|---|---|
| 2026-09-29 | Janssen Research & Development, LLC | Results Johnson & Johnson presents new data reinforcing sustained disease control and improved daily function achieved with IMAAVY® (nipocalimab-aahu) in generalized myasthenia gravis (gMG) jnj.com ↗
These data include two-year results from the Phase 2/3 study in adolescents which demonstrated sustained disease control while on IMAAVY, with patients maintaining improvements in daily function and muscle strength alongside reductions in corticosteroid use. |
| 2026-09-29 | Janssen Research & Development, LLC | Results Johnson & Johnson presents new data reinforcing sustained disease control and improved daily function achieved with IMAAVY® (nipocalimab-aahu) in generalized myasthenia gravis (gMG) jnj.com ↗
These data include two-year results from the Phase 2/3 study in adolescents which demonstrated sustained disease control while on IMAAVY, with patients maintaining improvements in daily function and muscle strength alongside reductions in corticosteroid use. |
| 2026-08-24 | Janssen Research & Development, LLC | Regulatory FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced the U.S. Food and Drug Administration (FDA) approval of IMAAVY®(nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) – a rare, life-threatening autoantibody disease – in adults and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. |
| 2026-08-24 | Janssen Research & Development, LLC | Regulatory FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients jnj.com ↗ |
| 2026-06-26 | Janssen Research & Development, LLC | Results Johnson & Johnson presents new IMAAVY® (nipocalimab-aahu) data at European Academy of Neurology (EAN) 2026 Congress reinforcing sustained disease control in generalized myasthenia gravis jnj.com ↗ |
| 2026-06-26 | Janssen Research & Development, LLC | Results Johnson & Johnson presents new IMAAVY® (nipocalimab-aahu) data at European Academy of Neurology (EAN) 2026 Congress reinforcing sustained disease control in generalized myasthenia gravis jnj.com ↗ |
| 2026-06-11 | Janssen Research & Development, LLC | Results IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies jnj.com ↗
The randomized, placebo-controlled trial demonstrated approximately three times as many patients achieved durable Hgb levels versus placebo by 24 weeks. |
| 2026-06-11 | Janssen Research & Development, LLC | Results IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wAIHA), an autoantibody-driven disease with no FDA-approved therapies jnj.com ↗
The randomized, placebo-controlled trial demonstrated approximately three times as many patients achieved durable Hgb levels versus placebo by 24 weeks. |
| 2026-06-03 | Janssen Research & Development, LLC | Results Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren’s disease jnj.com ↗
Clinical improvements were observed across all patients, with the greatest responses observed in participants with elevated known disease-driving autoantibodies and IgG levels – factors associated with more severe SjD activity and outcomes. |
| 2026-06-03 | Janssen Research & Development, LLC | Results Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study jnj.com ↗ |
| 2026-06-03 | Janssen Research & Development, LLC | Results Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren's disease jnj.com ↗
New exploratory analysis of Phase 2 study data shows a strong correlation between autoantibody levels and even greater clinical response rates of participants in the nipocalimab treatment group |
| 2026-06-03 | Janssen Research & Development, LLC | Results Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study jnj.com ↗ |
| 2026-04-27 | Janssen Research & Development, LLC | Regulatory FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA) jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY®(nipocalimab-aahu),cconfirming the urgent need for treatment options in warm autoimmune hemolytic anemia (wAIHA). |
| 2026-04-27 | Janssen Research & Development, LLC | Regulatory FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA) jnj.com ↗ |
| 2026-04-22 | Janssen Research & Development, LLC | Results IMAAVY® (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG) jnj.com ↗ |
| 2026-04-22 | Janssen Research & Development, LLC | Results IMAAVY® (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG) jnj.com ↗
IMAAVY® (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG) |
| 2026-03-03 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE) jnj.com ↗
nipocalimabawas granted U.S. Food and Drug Administration (FDA) Fast Track designation as a potential treatment for adults with systemic lupus erythematosus (SLE) |
| 2026-03-03 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE) jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced that nipocalimaba was granted U.S. Food and Drug Administration (FDA) Fast Track designation as a potential treatment for adults with systemic lupus erythematosus (SLE), a debilitating autoantibody-driven disease that impacts approximately 3 to 5 million people worldwide. |
| 2026-02-24 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA) jnj.com ↗
The submission of this sBLA represents an important milestone for the wAIHA community and underscores our commitment to advancing targeted, immunoselective therapies that can deliver meaningful, rapid improvement for these patients. |
| 2026-02-24 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA) jnj.com ↗ |
| 2026-01-06 | Janssen Research & Development, LLC | Results Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the Phase 2b JASMINE (NCT04882878) study of adults living with systemic lupus erythematosus (SLE) and the initiation of a Phase 3 program. |
| 2026-01-06 | Janssen Research & Development, LLC | Results Johnson & Johnson unveils new data showing nipocalimab is the first and only investigational FcRn blocker with potential to reduce systemic lupus erythematosus (SLE) activity in a Phase 2 study jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the Phase 2b JASMINE (NCT04882878) study of adults living with systemic lupus erythematosus (SLE) and the initiation of a Phase 3 program. |
| 2025-12-02 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives European Commission approval of IMAAVY®▼ (nipocalimab), a new FcRn blocker offering sustained disease control in a broad population of people living with generalised myasthenia gravis (gMG) jnj.com ↗
Johnson & Johnson today announced that the European Commission has approved a Marketing Authorisation for IMAAVY®▼(nipocalimab), a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG). |
| 2025-10-24 | Janssen Research & Development, LLC | Results Published in The Lancet: Nipocalimab significantly decreased Sjögren’s disease (SjD) activity and severity through substantial reduction in Sjögren’s-related autoantibodies jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 2 DAHLIAS study published inThe Lancetshowing that nipocalimab, an investigational FcRn treatment for Sjögren’s disease (SjD), significantly decreased disease activity and severity in patients with moderate-to-severe disease. |
| 2025-10-24 | Janssen Research & Development, LLC | Results Published in The Lancet: Nipocalimab significantly decreased Sjögren's disease (SjD) activity and severity through substantial reduction in Sjögren's-related autoantibodies jnj.com ↗ |
| 2025-09-19 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives positive CHMP opinion of nipocalimab to treat a broad population of antibody-positive patients living with generalised myasthenia gravis (gMG) jnj.com ↗
Today’s positive CHMP opinion is a vital step forward in our unwavering commitment to improve the treatment landscape for people living with generalised myasthenia gravis across Europe. |
| 2025-09-19 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives positive CHMP opinion of nipocalimab to treat a broad population of antibody-positive patients living with generalised myasthenia gravis (gMG) jnj.com ↗
Johnson & Johnson receives positive CHMP opinion of nipocalimab to treat a broad population of antibody-positive patients living with generalised myasthenia gravis (gMG) |
| 2025-08-28 | Janssen Research & Development, LLC | Results Phase 2a DAISY proof-of-concept combination study update jnj.com ↗
At 12 weeks, study results did not show sufficient evidence that the combination therapy provided significant added benefit over anti-TNFα therapy alone. |
| 2025-06-23 | Janssen Research & Development, LLC | Results IMAAVYTM (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC) jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new data from an indirect treatment comparison (ITC) that showed consistent and sustained disease control with IMAAVY™ (nipocalimab-aahu) versus other approved FcRn blockers in adults with generalized myasthenia gravis (gMG). |
| 2025-06-23 | Janssen Research & Development, LLC | Results IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC) jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new data from an indirect treatment comparison (ITC) that showed consistent and sustained disease control with IMAAVY™ (nipocalimab-aahu) versus other approved FcRn blockers in adults with generalized myasthenia gravis (gMG). |
| 2025-04-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives FDA approval for IMAAVYTM (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG) jnj.com ↗
SPRING HOUSE, Pa., (April 30, 2025)– Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). |
| 2025-04-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG) jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). |
| 2025-04-08 | Janssen Research & Development, LLC | Results Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG) jnj.com ↗
Patients treated with nipocalimab plus standard of care (SOC) maintained improvements in their MG-ADLcand QMGbscores over 84 weeks with sustained reductions in total immunoglobulin G (IgG). |
| 2025-04-08 | Janssen Research & Development, LLC | Results Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG) jnj.com ↗ |
| 2025-03-26 | Janssen Research & Development, LLC | Results New nipocalimab data and real-world research at AAN 2025 highlight positive Phase 3 results and commitment to people living with generalized myasthenia gravis (gMG) jnj.com ↗
Results from the ongoing open-label extension (OLE)study evaluating long-term efficacy and safety of nipocalimab show sustained disease control with nipocalimab in a broad population of antibody-positive gMG adult patients. |
| 2025-03-26 | Janssen Research & Development, LLC | Results New nipocalimab data and real-world research at AAN 2025 highlight positive Phase 3 results and commitment to people living with generalized myasthenia gravis (gMG) jnj.com ↗
Nipocalimab data demonstrate longer-term sustained disease control as measured by MG-ADL and QMG scores from the ongoing open-label extension (OLE) of the Vivacity-MG3 study |
| 2025-03-18 | Janssen Research & Development, LLC | Regulatory Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren’s disease, has now received Fast Track designation jnj.com ↗
SPRING HOUSE, Pa.,(March 18, 2025)– Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sjögren’s disease (SjD), having previously been grantedBreakthroughTherapy designation (BTD) for the investigational therapy late last year. |
| 2025-03-18 | Janssen Research & Development, LLC | Regulatory Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren's disease, has now received Fast Track designation jnj.com ↗ |
| 2025-02-13 | Janssen Research & Development, LLC | Results New nipocalimab data published in mAbs journal details differentiated molecular design, clinical profile and potential of nipocalimab to treat IgG-driven alloantibody and autoantibody diseases jnj.com ↗
The studies established that nipocalimab binds both specifically and with high, pH-independent affinity to FcRn. |
| 2025-02-13 | Janssen Research & Development, LLC | Results New nipocalimab data published in mAbs journal details differentiated molecular design, clinical profile and potential of nipocalimab to treat IgG-driven alloantibody and autoantibody diseases jnj.com ↗ |
| 2025-01-23 | Janssen Research & Development, LLC | Results Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalized myasthenia gravis (gMG) published in The Lancet Neurology jnj.com ↗
The Vivacity-MG3 study met its primary endpoint demonstrating statistically significant and clinically meaningful improvement over 24 weeks in the MG-ADLascore. |
| 2025-01-23 | Janssen Research & Development, LLC | Results Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalized myasthenia gravis (gMG) published in The Lancet Neurology jnj.com ↗ |
| 2025-01-09 | Janssen Research & Development, LLC | Regulatory Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced the nipocalimab Biologics License Application (BLA) received Priority Review designation from the U.S. Food and Drug Administration (FDA) for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalized myasthenia gravis (gMG), as supported by findings from the Phase 3 Vivacity-MG3 study. |
| 2025-01-09 | Janssen Research & Development, LLC | Regulatory Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis jnj.com ↗
Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis |
| 2024-11-14 | Janssen Research & Development, LLC | Results Nipocalimab demonstrates significant clinical improvement in disease activity and IgG reduction in Phase 2 Sjögren’s disease study jnj.com ↗
Patients receiving nipocalimab, an investigational FcRn blocker, showed a significant improvement in the ClinESSDAIascore at 24 weeks, achieving the primary endpoint. |
| 2024-11-14 | Janssen Research & Development, LLC | Results Nipocalimab demonstrates significant clinical improvement in disease activity and IgG reduction in Phase 2 Sjögren's disease study jnj.com ↗
Patients receiving nipocalimab, an investigational FcRn blocker, showed a signi cant improvement in the ClinESSDAI score at 24 weeks, achieving the primary endpoint. |
| 2024-11-11 | Janssen Research & Development, LLC | Regulatory Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren’s disease jnj.com ↗ |
| 2024-11-11 | Janssen Research & Development, LLC | Regulatory Nipocalimab is the first and only investigational therapy granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease jnj.com ↗ |
| 2024-11-07 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024 jnj.com ↗
The data showed that adult patients who received nipocalimab 15 mg/kg every two weeks demonstrated a greater than 70% relative average improvement on the primary endpoint compared to patients who received placebo. |
| 2024-11-07 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024 jnj.com ↗
Results from the Phase 2 DAHLIAS study of nipocalimab in SjD show nipocalimab met the primary endpoint with a reduction in ClinESSDAI score from baseline and other key e cacy endpoints at Week 24 compared with placebo, presented in a plenary session |
| 2024-10-15 | Janssen Research & Development, LLC | Results Nipocalimab demonstrates sustained disease control in adolescents living with generalized myasthenia gravis in Phase 2/3 study jnj.com ↗
Johnson & Johnson today announced positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChRapositive adolescents (aged 12 – 17 years) living with generalized myasthenia gravis (gMG). |
| 2024-10-15 | Janssen Research & Development, LLC | Results Nipocalimab demonstrates sustained disease control in adolescents living with generalized myasthenia gravis in Phase 2/3 study jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in anti-AChR positive adolescents (aged 12 – 17 years) living with generalized myasthenia gravis (gMG). |
| 2024-10-03 | Janssen Research & Development, LLC | Results Johnson & Johnson showcases innovation and commitment to people living with gMG, presenting 25 abstracts at AANEM Annual Meeting and MGFA Scientific Session jnj.com ↗
Positive results from the Phase 2/3 Vibrance-MGstudy of nipocalimab in adolescents living with gMG. |
| 2024-09-12 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks first EU approval of nipocalimab to treat a broad population of patients living with antibody-positive generalised myasthenia gravis jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking first approval of nipocalimab for the treatment of people living with generalised myasthenia gravis (gMG). |
| 2024-08-29 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalized myasthenia gravis jnj.com ↗ |
| 2024-08-29 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks first approval of nipocalimab to treat broadest population living with antibody positive generalized myasthenia gravis jnj.com ↗ |
| 2024-08-07 | Janssen Research & Development, LLC | Results Groundbreaking nipocalimab study of pregnant individuals at high risk for early onset severe hemolytic disease of the fetus and newborn published in The New England Journal of Medicine jnj.com ↗
The UNITY study met its primary endpoint with 54 percent of individuals receiving nipocalimab achieving a live birth at or after 32 weeks gestational age (GA) without the need for IUT. |
| 2024-08-07 | Janssen Research & Development, LLC | Results Groundbreaking nipocalimab study of pregnant individuals at high risk for early onset severe hemolytic disease of the fetus and newborn published in The New England Journal of Medicine jnj.com ↗
The UNITY study met its primary endpoint with 54 percent of individuals receiving nipocalimab achieving a live birth at or after 32 weeks gestational age (GA) without the need for IUT. |
| 2024-06-28 | Janssen Research & Development, LLC | Results Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced positive results from the nipocalimab Phase 3 Vivacity-MG3 study in patients with generalized myasthenia gravis (gMG). |
| 2024-06-28 | Janssen Research & Development, LLC | Results Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class for broadest population of myasthenia gravis patients jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced positive results from the nipocalimab Phase 3 Vivacity-MG3 study in patients with generalized myasthenia gravis (gMG). |
| 2024-06-15 | Janssen Research & Development, LLC | Results Late-breaking results show nipocalimab significantly improves Sjögren’s disease activity in a Phase 2 study jnj.com ↗
These data represent the first positive results in SjD for nipocalimab. |
| 2024-06-15 | Janssen Research & Development, LLC | Results Late-breaking results show nipocalimab significantly improves Sjögren’s disease activity in a Phase 2 study jnj.com ↗
These data represent the first positive results in SjD for nipocalimab. |
| 2024-06-04 | Janssen Research & Development, LLC | Results Johnson & Johnson showcases innovation and leadership in rheumatology at EULAR 2024 Congress jnj.com ↗
Among the accepted data, 21 abstracts and presentations will feature TREMFYA®(guselkumab) and nine will feature nipocalimab, including a late-breaking abstract on new positive Phase 2 data in Sjögren’s disease. |
| 2024-06-04 | Janssen Research & Development, LLC | Results Johnson & Johnson showcases innovation and leadership in rheumatology at EULAR 2024 Congress jnj.com ↗
Features positive results from a Phase 2 study of nipocalimab in Sjögren’s disease as a late-breaking oral presentation |
| 2024-04-11 | Janssen Research & Development, LLC | Results Unique molecular properties of nipocalimab enabling differentiated potential in treating generalized myasthenia gravis to be presented at American Academy of Neurology’s 2024 Annual Meeting jnj.com ↗
These data showcase the promise of nipocalimab as a potential best-in-class FcRn blocker and unique characteristics including its high binding affinity and specificity to the immunoglobulin G (IgG) binding site of FcRn. |
| 2024-03-26 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s nipocalimab granted U.S. FDA Fast Track designation to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults jnj.com ↗
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for nipocalimab to reduce the risk of FNAIT in alloimmunizedapregnant adults during their current pregnancy. |
| 2024-03-26 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s nipocalimab granted U.S. FDA Fast Track designation to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults jnj.com ↗
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for nipocalimab to reduce the risk of FNAIT in alloimmunizeda pregnant adults during their current pregnancy. |
| 2024-02-09 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN) jnj.com ↗
Spring House, Pa. (February 9, 2024)– Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nipocalimab for the treatment of alloimmunizedapregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN). |
| 2024-02-09 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN) jnj.com ↗ |
| 2024-02-05 | Janssen Research & Development, LLC | Results Johnson & Johnson reports positive topline results for nipocalimab from a Phase 3 pivotal study in generalized myasthenia gravis (gMG) and a Phase 2 study in Sjögren’s Disease (SjD) jnj.com ↗
Johnson & Johnson today announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG) as well as the Phase 2 DAHLIAS study of nipocalimab in adults with Sjögren’s disease (SjD). |
| 2024-02-05 | Janssen Research & Development, LLC | Results Johnson & Johnson reports positive topline results for Nipocalimab from a Phase 3 pivotal study in generalized myasthenia gravis (gMG) and a Phase 2 study in Sjögren’s Disease (SjD) jnj.com ↗
Johnson & Johnson today announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG) as well as the Phase 2 DAHLIAS study of nipocalimab in adults with Sjögren’s disease (SjD). |
| 2023-11-07 | Janssen Research & Development, LLC | Results Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study jnj.com ↗
The data from this study establish proof of mechanism for nipocalimab in RA and support its progression into a combination study. |
| 2023-11-07 | Janssen Research & Development, LLC | Results Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study jnj.com ↗ |
| 2023-06-26 | Janssen Research & Development, LLC | Results New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) jnj.com ↗
Among the seven participants who achieved the primary endpoint, the median gestational age at delivery was 37 and 1/7 weeks.6 |
| 2023-06-26 | Janssen Research & Development, LLC | Results New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) jnj.com ↗
New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) |
| 2023-02-08 | Janssen Research & Development, LLC | Results Janssen Reports Positive Topline Phase 2 Results for Nipocalimab in Pregnant Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) jnj.com ↗
During the treatment period of approximately 20 weeks, nipocalimab demonstrated a safety profile that supports further development of the treatment in HDFN. |
| 2023-02-06 | Janssen Research & Development, LLC | Results Janssen Reports Positive Topline Phase 2 Results for Nipocalimab in Pregnant Individuals at High Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) jnj.com ↗
During the treatment period of approximately 20 weeks, nipocalimab demonstrated a safety profile that supports further development of the treatment in HDFN. |
| 2021-04-16 | Janssen Research & Development, LLC | Results Janssen Showcases Phase 2 Nipocalimab (M281) Data in Adults with Generalized Myasthenia Gravis (gMG) at the 2021 American Academy of Neurology Virtual Meeting jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the full results from the Phase 2 Vivacity-MG study of the investigational compound, nipocalimab (M281), in generalized myasthenia gravis (gMG)–a chronic, autoimmune neuromuscular disease. |
All press releases naming this drug 82 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited 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 |
| 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 NCT04119050 ↗ |
| Action | Inhibit | “IgG receptor FcRn large subunit p51 antagonist” CHEMBL4594310 ↗1“bind, saturate, and block the IgG binding site” NCT04882878 ↗ |
| Modality | Monoclonal antibody | “a fully human, antineonatal Fc receptor monoclonal antibody” PMID 38165333 ↗ Dec 2023 |
| Route | Intravenous | “once weekly intravenous (IV) infusions of M281” NCT03842189 ↗ |
| Target | FCGRT | “IgG receptor FcRn large subunit p51 antagonist” CHEMBL4594310 ↗ |