Details of the Drug-Related molecule(s) Interaction Atlas

General Information of Drug (ID: DM0DYAX)

• Drug Name: Nipocalimab? Drug Info

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]

• Cross-matching ID: TTD Drug ID: DM0DYAX

Molecule-Related Drug Atlas

Drug(s) Targeting Neonatal Fc receptor (FCGRT)

Drug Name	Drug ID	Indication	ICD 11	Highest Status	REF
Efgartigimod alfa	DM2M93X	Myasthenia gravis	8C6Y	Approved	[9]
ARGX-113	DM180DM	Myasthenia gravis	8C6Y	Phase 3	[10]
Batoclimab	DMYPMR8	Myasthenia gravis	8C6Y	Phase 3	[11]
SYN-1327	DMFNR75	Discovery agent	N.A.	Investigative	[12]

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]

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.
• [9] FDA Approved Drug Products from FDA Official Website. 2021. Application Number: 761195.
• [10] Randomized phase 2 study of FcRn antagonist efgartigimod in generalized myasthenia gravis. Neurology. 2019 Jun 4;92(23):e2661-e2673.
• [11] Batoclimab as an add-on therapy in neuromyelitis optica spectrum disorder patients with acute attacks. Eur J Neurol. 2023 Jan;30(1):195-203.
• [12] Structure-activity relationships of a peptide inhibitor of the human FcRn:human IgG interaction. Bioorg Med Chem. 2008 Jun 15;16(12):6394-405.