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Johnson & Johnson (Protagonist TherapeuticsIt was announced today that a New Drug Application (NDA) has been submitted to the U.S. FDA.Seeking approval for its investigational, once-dailyOralPeptide Therapy Icotrokinra (JNJ-2113) Launched for Treatment of Moderate to Severe Plaque Psoriasis (PsO) in Adults and Pediatric Patients Aged 12 Years and AboveIt is worth mentioning that it was rated as one of the drugs of the year 2024 in April this year by the well-known industry media Drug Hunter.Top Ten Star MoleculesOne of.

This application includes data from four pivotal Phase 3 clinical studies, all part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2.Icotrokinra Successfully Achieved All Primary and Co-Primary Endpoints in the Above Phase 3 Study, showing significant skin symptom clearance and good safety in adults and pediatric patients aged 12 years and older with moderate to severe plaque psoriasis.

The topline positive results of the pivotal Phase 3 ICONIC-LEAD study, announced in April this year, showed that once-daily icotrokinra significantly improved moderate to severe plaque.StatusSkin condition of psoriasis patients, with good safety.At week 16, 65% of patients in the icotrokinra group achieved an Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear skin symptoms), and 50% of patients achieved at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90)., while the values for these two indicators in the placebo group were only 8% and 4%, respectively. By the 24th week, the patient remission rate further improved,74% of patients achieved an IGA score of 0/1, with 46% achieving IGA 0; 65% of patients achieved PASI 90, and 40% achieved PASI 100.

In addition, the results of the ICONIC-ADVANCE 1 and 2 studies showed,Icotrokinra in Moderate to Severe PlaqueStatusAchieved Co-primary Endpoints in Psoriasis with Efficacy Superior to Existing Approved Therapies.In all studies, the integrated safety data showed that the incidence of adverse events in the icotrokinra group (49.1%) was similar to that in the placebo group (51.9%), and no new safety signals have been identified to date.

Icotrokinra is a potential "first-in-class" targeted oral peptide that can selectively block the IL-23 receptor (IL-23R).IL-23 plays a key role in the pathogenic T-cell activation in moderate to severe plaque PsO and is fundamental to the inflammatory response in PsO and other dermatologic, rheumatologic, and IL-23-mediated gastrointestinal diseases. Icotrokinra binds to IL-23R with single-digit picomolar affinity and potently and selectively inhibits IL-23 signaling in human T cells.

References:

[1] Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis. Retrieved July 21, 2025 from https://www.prnewswire.com/news-releases/johnson--johnson-seeks-first-icotrokinra-us-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis-302509221.html

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