Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis

Rhea-AI Summary

Johnson & Johnson (NYSE:JNJ) has submitted a New Drug Application (NDA) to the FDA for icotrokinra, a first-in-class targeted oral peptide for treating moderate to severe plaque psoriasis in adults and patients 12+ years old. The submission includes data from four Phase 3 studies (ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 & 2) where icotrokinra met all primary endpoints.

The drug demonstrated superior efficacy to deucravacitinib and showed promising results in difficult-to-treat areas. Safety data revealed similar adverse events between icotrokinra (49.1%) and placebo (51.9%). The company has also initiated ICONIC-ASCEND, the first head-to-head study comparing an oral pill (icotrokinra) to an injectable biologic (ustekinumab).

Positive

• Met all primary endpoints across four Phase 3 clinical trials
• Demonstrated superiority to competitor drug deucravacitinib
• Favorable safety profile with adverse events similar to placebo (49.1% vs 51.9%)
• Effective in difficult-to-treat areas like scalp and genital psoriasis
• Convenient once-daily oral administration versus injectable alternatives

Negative

• Long-term efficacy data (52-week results) not yet presented
• Head-to-head comparison with ustekinumab still ongoing

Insights

Pharmaceutical Industry Analyst

J&J's NDA for icotrokinra represents a potentially transformative oral psoriasis treatment with compelling efficacy and favorable safety profile.

Johnson & Johnson's submission of a New Drug Application for icotrokinra marks a significant milestone in the psoriasis treatment landscape. As a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor, icotrokinra represents a novel approach to treating moderate-to-severe plaque psoriasis.

The data package supporting this application is remarkably robust, spanning four Phase 3 clinical trials that demonstrated not only efficacy versus placebo but also superiority to deucravacitinib, an existing oral treatment. The ICONIC program's trials consistently met all primary endpoints, showing impressive skin clearance rates across different patient populations, including adolescents and those with difficult-to-treat areas like scalp and genital psoriasis.

What makes icotrokinra particularly noteworthy is its unique value proposition - combining the efficacy typically associated with injectable biologics with the convenience of a once-daily oral administration. The ongoing ICONIC-ASCEND study, which directly compares icotrokinra to the injectable biologic ustekinumab, further underscores J&J's confidence in this asset.

From a safety perspective, the pooled data indicating adverse event rates similar to placebo (49.1% vs. 51.9%) is highly encouraging and suggests a favorable risk-benefit profile that could drive strong adoption upon approval.

This submission represents a strategic expansion of J&J's immunology portfolio and positions the company to potentially capture significant market share in the highly competitive psoriasis market, where patient preference for oral options remains strong. If approved, icotrokinra could become the new standard of care for moderate-to-severe plaque psoriasis, providing J&J with a differentiated asset in this therapeutic area.

Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor

Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites

Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout combination of complete skin clearance, a favorable safety profile, and simplicity of a once daily pill

SPRING HOUSE, Pa., July 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO). Icotrokinra is uniquely designed to block the IL-23 receptor, which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases.^1,2,3

The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD^a, ICONIC-TOTAL^b and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2^c. 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.^4,5,6,7,8

"The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," said Liza O'Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Area Lead, Johnson & Johnson Innovative Medicine. "Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease."

Data submitted to the FDA as part of the NDA include:

• Results from the Phase 3 ICONIC-LEAD study, presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, that showed icotrokinra successfully met the co-primary endpoints of Investigator's Global Assessment (IGA)^d score of 0/1 (clear or almost clear skin) and Psoriasis Area and Severity Index (PASI)^e 90 compared to placebo at Week 16.⁴
• A subgroup analysis of ICONIC-LEAD, presented at the 2025 World Congress of Pediatric Dermatology (WCPD), which demonstrated pediatric patients 12 years of age and older treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified.⁵
• Data from the Phase 3 ICONIC-TOTAL study, presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, that highlighted the potential of icotrokinra in patients with difficult-to-treat scalp and genital psoriasis.⁶
• Results from the Phase 3 ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 studies, that further reinforced the overall efficacy profile met co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16. Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO.^7,8 Comprehensive results are being prepared for presentation at a future medical meeting.
• Long-term data from the ICONIC development program, including at least 52-weeks of treatment for ICONIC-LEAD and ICONIC-TOTAL, and results from a randomized withdrawal analysis evaluating the durability of response, are being prepared for presentation at a future medical meeting.

Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCEND^f study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, representing an important step forward in psoriasis research.⁹

Editor's notes:

a.	ICONIC-LEAD is a Phase 3 randomized controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo in 684 participants (icotrokinra=456; placebo=228) 12 years of age or older with moderate-to-severe plaque PsO, with the higher efficacy bar of PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients.
b.	ICONIC-TOTAL is a Phase 3 RCT evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque PsO in 311 participants (icotrokinra=208; placebo=103) with at least moderate severity affecting special areas (e.g., scalp, genital and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.
c.	ICONIC- ADVANCE 1 & 2 are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in participants with moderate-to-severe plaque PsO with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints.
d.	The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.10
e.	The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness.11 PASI 90 corresponds to an improvement of >=90% in PASI score from baseline.11
f.	ICONIC-ASCEND is a Phase 3 RCT and the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab in moderate-to-severe plaque PsO.9

About the ICONIC Clinical Development Program 
The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and adolescent individuals with moderate-to-severe plaque PsO was initiated with two studies in Q4 2023 – ICONIC-LEAD and ICONIC-TOTAL – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johson company.¹²

ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints.¹³

ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.¹⁴

Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.^15,16 ICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis. ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.^17,18

About 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.¹⁹ It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.²⁰ Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.²⁰ Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.²¹ Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.²² Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.^22,23

About Icotrokinra (JNJ-77242113, JNJ-2113) 
Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,¹ which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.^2,3 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells.²⁴ The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.²⁵

Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.^26,27,28

Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, including ICONIC-ASCEND; the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis; and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis. 

About Johnson & Johnson 
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. 

Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. 

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. 

Cautions Concerning Forward-Looking Statements 
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 

 

¹ Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.
² Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.
³ Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
⁴ Bissonnette, R et al. Icotrokinra, a Targeted Oral Peptide That Selectively Blocks the Interleukin-23–Receptor, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results Through Week 24 of the Phase 3, Randomized, Double-blind, Placebo-Controlled ICONIC-LEAD Trial. Late-breaking research presentation (Abstract #66708) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2025.
⁵ Eichenfield, L et al. Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-inhibitor), in Adolescents With Moderate-to- Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD). Presented at the World Congress of Pediatric Dermatology (Abstract #0054). April 2025.
⁶ Gooderham, M.J. et al. Phase 3 results from an innovative trial design of treating plaque psoriasis involving difficult-to-treat, high-impact sites with icotrokinra, a targeted oral peptide that selectively inhibits the IL-23–receptor. Presented at the 2025 Society for Investigative Dermatology (Abstract #LB1142). May 2025.
⁷ Data on file.
⁸ Data on file.
⁹ Clinicaltrials.gov. A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT0693422. https://clinicaltrials.gov/study/NCT06934226?term=iconic-ascend&rank=1. Accessed July 2025.
¹⁰ Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.04.104. Accessed July 2025.
¹¹ Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: https://www.everydayhealth.com/psoriasis/living-with/how-the-pasi-index-works. Accessed July 2025.
¹² Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at: https://www.accesswire.com/791174/protagonist-announces-advancement-of-jnj-2113-across-multiple-indications. Accessed July 2025.
¹³ Clinicaltrials.gov. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. https://classic.clinicaltrials.gov/ct2/show/NCT06095115. Accessed July 2025.
¹⁴ Clinicaltrials.gov. A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. https://classic.clinicaltrials.gov/ct2/show/NCT06095102. Accessed July 2025.
¹⁵ Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. https://clinicaltrials.gov/study/NCT06143878?term=jnj-77242113&rank=10. Accessed July 2025.
¹⁶ Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. https://clinicaltrials.gov/study/NCT06220604. Accessed July 2025.
¹⁷ Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. https://clinicaltrials.gov/study/NCT06878404
¹⁸ A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. https://clinicaltrials.gov/study/NCT06807424
¹⁹ National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed July 2025.
²⁰ National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed July 2025.
²¹ National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/. Accessed July 2025.
²² National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed July 2025.
²³ National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed July 2025.
²⁴ Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.
²⁵ Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: https://www.jnj.com/media-center/press-releases/janssen-enters-into-worldwide-exclusive-license-and-collaboration-agreement-with-protagonist-therapeutics-inc-for-the-oral-interlukin-23-receptor-antagonist-drug-candidate-for-the-treatment-of-inflammatory-bowel-disease. Accessed July 2025.
²⁶ Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html. Accessed July 2025.
²⁷ Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html. Accessed July 2025.
²⁸ Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html. Accessed July 2025.

 

Media contact:  Meg Farina  mfarina@its.jnj.com

Investor contact:  Lauren Johnson investor-relations@its.jnj.com

 

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SOURCE Johnson & Johnson

FAQ

What is icotrokinra and what did Johnson & Johnson (JNJ) submit to the FDA?

Icotrokinra is a first-in-class oral peptide that blocks the IL-23 receptor. JNJ submitted a New Drug Application (NDA) to the FDA for treating moderate to severe plaque psoriasis in adults and patients 12+ years old.

How effective was JNJ's icotrokinra in clinical trials for psoriasis?

Icotrokinra met all primary endpoints across four Phase 3 studies, showing superior efficacy to deucravacitinib and achieving significant skin clearance. The drug demonstrated effectiveness in difficult-to-treat areas like scalp and genital psoriasis.

What are the safety results for JNJ's icotrokinra in psoriasis treatment?

Safety data showed similar adverse events between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified across the clinical trials.

How is JNJ's icotrokinra different from existing psoriasis treatments?

Icotrokinra is unique as it's a once-daily oral pill that selectively blocks the IL-23 receptor, offering a potentially more convenient alternative to injectable biologics while maintaining efficacy.

What age groups can use JNJ's icotrokinra for psoriasis treatment?

The NDA submission covers treatment for both adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis.