Drug Information
| Drug General Information | Top | |||
|---|---|---|---|---|
| Drug ID |
DR5V8I
|
|||
| Drug Name |
Nipocalimab?
|
|||
| Drug Type |
Monoclonal antibody
|
|||
| Indication | Chronic inflammatory demyelinating polyneuropathy [ICD-11: 8C01.3] | Phase 3 | [1] | |
| Generalized myasthenia gravis [ICD-11: 8C60] | Phase 3 | [2] | ||
| Warm autoimmune hemolytic anemia [ICD-11: 3A20.0] | Phase 3 | [3] | ||
| Autoimmune haemolytic anaemia [ICD-11: 3A20] | Phase 2/3 | [3] | ||
| Idiopathic inflammatory myopathy [ICD-11: 4A41] | Phase 2 | [4] | ||
| Rheumatoid arthritis [ICD-11: FA20; ICD-9: 729] | Phase 2 | [5] | ||
| Sjogren syndrome [ICD-11: 4A43.20; ICD-10: M35, M35.0; ICD-9: 710.2] | Phase 2 | [6] | ||
| Systemic lupus erythematosus [ICD-11: 4A40.0; ICD-9: 710] | Phase 2 | [7] | ||
| Company |
JOHNSON & JOHNSON
|
|||
| Target and Pathway | Top | |||
|---|---|---|---|---|
| Target(s) | Neonatal Fc receptor (FCGRT) | Target Info | . | [8] |
| NetPath Pathway | TCR Signaling Pathway | |||
| References | Top | |||
|---|---|---|---|---|
| REF 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. | |||
| REF 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. | |||
| REF 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. | |||
| REF 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. | |||
| REF 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. | |||
| REF 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. | |||
| REF 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. | |||
| REF 8 | New Therapies for the Treatment of Warm Autoimmune Hemolytic Anemia. Transfus Med Rev. 2022 Oct;36(4):175-180. | |||
If You Find Any Error in Data or Bug in Web Service, Please Kindly Report It to Dr. Zhou and Dr. Zhang.