Nipocalimab

Summary

Nipocalimab (CHEMBL4594310) is a phase-3 clinical-stage antibody targeting FCGRT; indicated across 9 conditions including myasthenia gravis and fetal erythroblastosis.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Targets: 1 (FCGRT)
• Indications: 9 conditions
• Clinical trials: 25

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4594310
Name	Nipocalimab
Type	Antibody
Max phase	3

Also known as: JNJ-80202135, M-281, M281, Nipocalimab, NIPOCALIMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
FCGRT	Fc fragment of IgG receptor and transporter	Binding	10.36	0%	P55899

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): FCGRT.

Dominant GO biological processes

GO term	Targets
IgG immunoglobulin transcytosis in epithelial cells mediated by FcRn immunoglobulin receptor	1
immune response	1

Indications & clinical

Indications

9 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
myasthenia gravis	3	MONDO:0009688	EFO:0004991
fetal erythroblastosis	3	MONDO:0006760	EFO:1000937
thrombocytopenia	3	MONDO:0002049	HP:0001873
autoimmune hemolytic anemia	2	MONDO:0020108	EFO:1001264
Sjogren syndrome	2	MONDO:0010030	EFO:0000699
lupus nephritis	2	MONDO:0005556	EFO:0005761
rheumatoid arthritis	2	MONDO:0008383	EFO:0000685
myositis disease	2	MONDO:0021167	EFO:0000783
chronic inflammatory demyelinating polyradiculoneuropathy	2	MONDO:0006702	EFO:1000868

Clinical trials

Total trials: 25.

Phase distribution

Phase	Trials
PHASE2	9
PHASE3	7
PHASE1	5
PHASE2/PHASE3	3
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04119050	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
NCT04951622	PHASE3	RECRUITING	A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
NCT05265273	PHASE2/PHASE3	RECRUITING	A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis
NCT05327114	PHASE2/PHASE3	RECRUITING	Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT05912517	PHASE3	RECRUITING	A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
NCT06449651	PHASE3	RECRUITING	A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT06533098	PHASE3	RECRUITING	A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
NCT06741969	PHASE3	ACTIVE_NOT_RECRUITING	Nipocalimab in Moderate to Severe Sjogren’s Disease
NCT07217587	PHASE3	RECRUITING	Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis
NCT07438496	PHASE3	RECRUITING	A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
NCT05379634	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
NCT03772587	PHASE2	COMPLETED	A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
NCT03842189	PHASE2	COMPLETED	A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
NCT03896295	PHASE2	TERMINATED	An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis
NCT04882878	PHASE2	COMPLETED	A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
NCT04883619	PHASE2	WITHDRAWN	A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
NCT04968912	PHASE2	COMPLETED	A Study of Nipocalimab in Adults With Primary Sjogren’s Syndrome (pSS)
NCT04991753	PHASE2	COMPLETED	A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
NCT06028438	PHASE2	COMPLETED	A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
NCT02828046	PHASE1	COMPLETED	An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)
NCT04848558	PHASE1	COMPLETED	A Study of Nipocalimab in Healthy Male and Female Participants
NCT04973566	PHASE1	COMPLETED	A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants
NCT05151692	PHASE1	COMPLETED	A Study of JNJ-80202135 in Healthy Chinese Adult Participants
NCT05827874	PHASE1	COMPLETED	A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants
NCT05221619	Not specified	TEMPORARILY_NOT_AVAILABLE	Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).