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
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