Icotrokinra FDA Approval Status

Last updated by Judith Stewart, BPharm on July 21, 2025.

FDA Approved: No
Generic name: icotrokinra
Company: Johnson & Johnson Innovative Medicine
Treatment for: Plaque Psoriasis

Icotrokinra is an oral, selective antagonist of the interleukin-23 receptor in development for the treatment of moderate to severe plaque psoriasis.

Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.
Icotrokinra is a targeted, oral peptide that works in the treatment of plaque psoriasis by selectively blocking the interleukin-23 (IL-23) receptor. IL-23 signaling is a key driver of inflammation in plaque psoriasis, and also other immune-mediated inflammatory diseases such as psoriatic arthritis and inflammatory bowel disease.
A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval for icotrokinra for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis.
The NDA was supported by data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.
Icotrokinra is also being studied for use in the treatment of psoriatic arthritis and ulcerative colitis.

Development timeline for icotrokinra

Date	Article
Jul 21, 2025	Johnson & Johnson Seeks First Icotrokinra U.S. FDA Approval Aiming to Revolutionize Treatment Paradigm for Adults and Adolescents with Plaque Psoriasis
May 9, 2025	Icotrokinra Results Show Significant Skin Clearance in Patients with Difficult-to-Treat Scalp and Genital Psoriasis
Apr 10, 2025	Icotrokinra Results Show 75% of Adolescents with Plaque Psoriasis Achieved Completely Clear Skin and Demonstrate Favorable Safety Profile in a Once Daily Pill
Mar 10, 2025	Icotrokinra Meets Primary Endpoint of Clinical Response in Ulcerative Colitis Study and Shows Potential to Transform the Treatment Paradigm for Patients
Mar 8, 2025	Icotrokinra Results Show Potential to Set a New Standard of Treatment in Plaque Psoriasis
Nov 18, 2024	Icotrokinra Delivered an Industry-Leading Combination of Significant Skin Clearance with Demonstrated Tolerability in a Once Daily Pill in Phase 3 Topline Results

Further information

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