FDA Approves Icotrokinra as First Targeted Oral Peptide for Moderate-to-Severe Plaque Psoriasis

The FDA has approved icotrokinra (Icotyde; Johnson & Johnson) for the treatment of moderate-to-severe plaque psoriasis (PsO) in adults and pediatric patients 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. The approval marks a notable shift in the treatment paradigm for PsO, introducing the first and only targeted oral peptide designed to precisely block the IL-23 receptor.¹

“[Icotrokinra] delivers something unique in psoriasis treatment—combining skin clearance with a favorable safety profile in a once-daily pill, making it an easy addition to a patient's routine,” Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health, said in a news release. “With new guidance from the International Psoriasis Council that clarifies when to move beyond cycling on topical treatments to systemic therapy, an innovative option like [icotrokinra] is a potential game changer for many adult and adolescent patients.”¹

What Is Plaque PsO?

Plaque PsO is a chronic, immune-mediated inflammatory skin disease that affects more than 8 million US adults, with nearly one-fourth experiencing moderate-to-severe disease. The condition is driven by dysregulation of the IL-23/type 17 T-cell axis, which underpins the inflammatory cascade responsible for the characteristic skin plaques. Beyond physical symptoms, which may involve the scalp, knees, elbows, genitals, and torso, plaque PsO carries a substantial psychological and quality-of-life burden, particularly when lesions affect visible or sensitive areas of the body. Despite the availability of injectable biologics targeting IL-23, many patients with moderate-to-severe disease continue to cycle through topical therapies before transitioning to systemic treatment, often due to needle aversion, convenience barriers, or cost concerns.^1-3

Understanding Icotrokinra for PsO

Icotrokinra addresses this gap as a once-daily oral pill that binds to the IL-23 receptor with high affinity, potently inhibiting IL-23 signaling in human T cells. Unlike small molecule agents such as deucravacitinib (Sotyktu; Bristol Myers Squibb), a tyrosine kinase 2 inhibitor, icotrokinra employs a peptide-based mechanism that mimics the receptor-blocking activity of injectable IL-23 biologics while offering the convenience of oral administration.¹

A network meta-analysis presented at the Maui Derm Hawaii 2026 meeting found that icotrokinra achieved rates of completely clear skin comparable to injectable IL-23 inhibitors and superior to other advanced oral treatments across both Psoriasis Area and Severity Index (PASI) 100 and Investigator's Global Assessment (IGA) 0 end points.^1,3

Clinical Trial Data Supporting Approval

The FDA approval is supported by an extensive body of evidence from the multicenter, randomized, double-blind, placebo-controlled ICONIC clinical development program (NCT06143878), which enrolled approximately 2500 patients across 4 phase 3 studies. The program simultaneously evaluated icotrokinra in adults and adolescents at high-impact sites, including scalp and genital PsO, and in 2 duplicate head-to-head superiority trials vs an active comparator.^1,4

In the head-to-head ICONIC-ADVANCE 1 and 2 studies, approximately 70% of patients achieved clear or almost clear skin (IGA 0/1), and 55% achieved a PASI 90 response at week 16, outcomes that exceeded those observed with deucravacitinib.¹

These data were published in The Lancet in 2025 and noted a favorable safety profile. Adverse reaction rates in icotrokinra-treated patients were within 1.1% of placebo through week 16, and no new safety signals were identified through week 52 of the ICONIC trials.^1,5

Dosing and Administration

Icotrokinra is taken once daily with water upon waking and 30 minutes prior to eating. Johnson & Johnson is also investigating icotrokinra in active psoriatic arthritis, moderately-to-severely active ulcerative colitis, and moderately-to-severely active Crohn disease.¹

Icotrokinra was jointly discovered by Protagonist Therapeutics and Johnson & Johnson scientists, and will be commercialized by Johnson & Johnson under a 2017 license and collaboration agreement. To support patient access, Johnson & Johnson offers the ICOTYDE withMe program, which provides cost support options, a dedicated nurse guide, and educational resources regardless of insurance type.^1,2

“With the FDA approval of [icotrokinra], Johnson & Johnson is setting a new standard for the treatment of moderate-to-severe plaque psoriasis,” Jennifer Taubert, executive vice president, worldwide chairman, innovative medicine for Johnson & Johnson, said in the news release. “We’re proud to bring this game-changing innovation to the market, marking a transformative shift in plaque psoriasis management that empowers patients and clinicians to reach their treatment goals.”¹

REFERENCES

1. FDA approval of Icotyde (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. News release. Johnson & Johnson. March 18, 2026. Accessed March 18, 2026. https://www.investor.jnj.com/investor-news/news-details/2026/FDA-approval-of-ICOTYDE-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide/default.aspx

2. Abdeldayem MR, Elsherbeeny A. Safety and efficacy of the oral IL-23 receptor antagonist icotrokinra for plaque psoriasis: a systematic review and meta-analysis of randomized controlled trials. J Cutan Med Surg. Published online February 12, 2026. doi:10.1177/12034754261419058

3. Aggarwal P, Fleischer AB Jr. IL-17 and IL-23 inhibitors have the fastest time to meaningful clinical response for plaque psoriasis: a network meta-analysis. J Clin Med. 2024;13(17):5139. doi:10.3390/jcm13175139

4. A study of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis. ClinicalTrials.gov. Updated March 12, 2026. Accessed March 18, 2026. https://clinicaltrials.gov/study/NCT06143878

5. Stein Gold L, Armstrong AW, Bissonnette R, et al. Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomized, placebo-controlled and active-comparator-controlled trials. Lancet. 2025;406(10510):1363-1374. doi:10.1016/S0140-6736(25)01576-4