J&J Submits Oral IL-23 Peptide Drug for FDA Approval: Sustained Momentum in Peptide Therapeutics
Time:2025-08-01
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Global pharmaceutical giant Johnson & Johnson (J&J) and Protagonist Therapeutics recently announced the formal submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for icotrokinra (JNJ-2113)—an oral peptide IL-23 receptor antagonist. This drug is indicated for the treatment of moderate-to-severe plaque psoriasis in patients aged 12 years and older. As a peptide-based therapeutic, JNJ-2113 represents the first oral therapy targeting the IL-23 inflammatory pathway, a pivotal mechanism in immune-mediated diseases.
Expanding Frontiers of Peptide Drugs
The peptide drug sector continues to gain significant traction, with several star products demonstrating substantial clinical and commercial success:
Semaglutide (Ozempic®, Wegovy®, Rybelsus®)
Developed by Novo Nordisk, this GLP-1 receptor agonist has revolutionized metabolic disease treatment. Its oral formulation (Rybelsus®) marked a breakthrough in diabetes therapy, while subcutaneous injections (Ozempic®, Wegovy®) ignited global demand for obesity management, establishing a benchmark for GLP-1-targeted peptides .
Tirzepatide (Mounjaro®, Zepbound®)
Eli Lilly‘s dual-target peptide targeting both glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors exhibits comparable efficacy to semaglutide in glycemic control and weight loss. The oral dual agonist Orforglipron is also advancing in clinical development .
Mazdutide
Approved by China‘s NMPA, this first-in-class glucagon (GCG)/GLP-1 dual receptor agonist is indicated for long-term weight management in adults with obesity or overweight .
Bicyclic Peptide Therapeutics
Companies like Bicycle Therapeutics leverage bicyclic structures to enhance stability and targeting, developing peptide-drug conjugates (PDCs) against tumor antigens. Multiple candidates are in Phase I/II trials for solid and hematological malignancies .
Quality Control: The Critical Challenge
Peptide drugs now rank among the fastest-growing segments in global pharmaceuticals. However, ensuring their safety and efficacy hinges on precise control of peptide-related impurities, including:
Structural isomers and stereoisomers
Oxidation/deamidation products
Aggregates and process-related impurities
Rigorous identification, analysis, and removal of these impurities constitute the core technological barrier for successful drug registration and commercialization
Reference Materials Support
SZEB specializes in comprehensive solutions for peptide impurity reference standards. We provide critical analytical support for global pharmaceutical companies and research institutions, including impurities forSemaglutide, Octreotide, Lanreotide,Liraglutide, Leuprorelin, and other therapeutic peptides.
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