Details of the Drug

General Information of Drug (ID: DM0DYAX)

Drug Name
Nipocalimab?
Indication
Disease Entry ICD 11 Status REF
Chronic inflammatory demyelinating polyneuropathy 8C01.3 Phase 3 [1]
Generalized myasthenia gravis 8C60 Phase 3 [2]
Warm autoimmune hemolytic anemia 3A20.0 Phase 3 [3]
Autoimmune haemolytic anaemia 3A20 Phase 2/3 [3]
Idiopathic inflammatory myopathy 4A41 Phase 2 [4]
Rheumatoid arthritis FA20 Phase 2 [5]
Sjogren syndrome 4A43.20 Phase 2 [6]
Systemic lupus erythematosus 4A40.0 Phase 2 [7]
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Drug Type
Monoclonal antibody
Cross-matching ID
TTD ID
DR5V8I
Repurposed Drugs (RPD) Click to Jump to the Detailed RPD Information of This Drug

Molecular Interaction Atlas of This Drug


Drug Therapeutic Target (DTT)
DTT Name DTT ID UniProt ID MOA REF
Neonatal Fc receptor (FCGRT) TTKLPHO FCGRN_HUMAN Not Available [8]
Molecular Interaction Atlas (MIA) Jump to Detail Molecular Interaction Atlas of This Drug

References

1 ClinicalTrials.gov (NCT05327114) Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). U.S.National Institutes of Health.
2 ClinicalTrials.gov (NCT05265273) An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis. U.S.National Institutes of Health.
3 ClinicalTrials.gov (NCT04119050) Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension. U.S.National Institutes of Health.
4 ClinicalTrials.gov (NCT05379634) A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies. U.S.National Institutes of Health.
5 ClinicalTrials.gov (NCT04991753) A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy. U.S.National Institutes of Health.
6 ClinicalTrials.gov (NCT04968912) A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS). U.S.National Institutes of Health.
7 ClinicalTrials.gov (NCT04882878) A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus. U.S.National Institutes of Health.
8 New Therapies for the Treatment of Warm Autoimmune Hemolytic Anemia. Transfus Med Rev. 2022 Oct;36(4):175-180.