Icotrokinra Hydrochloride

Johnson & Johnson introduces the first IL-23R targeted oral peptide that can deliver skin clearance and a favourable safety pro a once-daily pill. 1,2 ICOTYDE™ (icotrokinra) offers an innovative new option for eligible patients with moderate-to-severe plaque psoriasis to address patients cycling on topical therapies in need of systemic treatment. 1,2 BEERSE, BELGIUM (21 Sept 2026) – Johnson & Johnson today announced that the European Commission (EC) has granted approval for the Marketing Authorisation of ICOTYDE™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of adults and adolescent patients (aged ≥12 years and weighing ≥40 kg) with moderate-to-severe plaque psoriasis (Pso) who are candidates for systemic therapy. 1 Icotrokinra is the first targeted oral peptide that precisely blocks the IL-23 receptor. 2,3,4 “For many people living with moderate-to-severe plaque psoriasis, the burden of disease remains substantial, but currently available systemic treatments do not consistently meet patients' treatment needs. There remains an ongoing unmet need for additional treatment options, regardless of route of administration.” said Lluís Puig, Professor of Dermatology, Universitat Autònoma de Barcelona. a “The approval of icotrokinra marks an important evolution in plaque psoriasis treatment. As the first targeted oral peptide designed to precisely block the IL-23 receptor, it combines high levels of skin clearance, a favourable safety profile, and the convenience of once-daily oral administration.” Clinical evidence summary Icotrokinra met all primary efficacy endpoints and demonstrated a favourable safety pro four Phase 3 studies including 2,500 patients. 1,2 The EC decision is supported by an unprecedented breadth of evidence within the Phase 3 ICONIC clinical development programme, which simultaneously evaluated icotrokinra in adults and adolescents aged 12 and older and weighing at least 40 kg with moderate-to-severe plaque Pso. 1 The programme included patients with involvement of high-impact sites such as scalp and genital Pso, and two head-to-head studies versus an active comparator. 1,5 In the head-to-head studies, approximately 70% of patients treated with icotrokinra achieved clear or almost clear skin, as measured by IGA 0/1, and 55% achieved a PASI 90 response at Week 16. 5,b,c Rates of adverse reactions for icotrokinra treated patients were within 1.1% of placebo rates through Week 16 and no new safety signals were observed through Week 52. 1,2,6 “The approval of icotrokinra represents a defining milestone for eligible people living with moderate-to-severe plaque psoriasis,” said Mark Graham, Therapeutic Area Head, Immunology, J&J Innovative Medicine EMEA. “At Johnson & Johnson, we are committed to pushing the boundaries of science to address persistent unmet needs in immunodermatology. As the first targeted oral peptide to block the IL-23 receptor, icotrokinra represents a landmark scientific advance and has the potential to transform the treatment paradigm of plaque psoriasis for patients.” Unmet need in moderate-to-severe plaque psoriasis An estimated 6.4 million people in Europe live with plaque psoriasis, 7 a chronic condition that can significantly impact physical comfort, emotional wellbeing and quality of life, especially when lesions are on visible or sensitive areas. 8 For many with moderate-to-severe disease, targeted systemic treatments are key. 9,10 Most people living with moderate-to-severe plaque psoriasis are eligible for, but are not receiving, systemic treatment. 9,10 An oral therapy that selectively inhibits the IL-23 pathway by directly targeting the IL-23 receptor could help address the unmet needs and preferences of patients. 1,9,10 This aligns with International Psoriasis Council guidance to transition to systemic therapy if two cycles of topical medications applied for four weeks fail to bring meaningful improvement. 11 Johnson & Johnson is committed to helping address the significant unmet need in moderate-to-severe plaque Pso and is working with relevant stakeholders across Europe to support the introduction of icotrokinra and help enable patient access. Editor’s notes: a. Dr. Lluís Puig is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. b. 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. 12 c. 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. PASI 90 corresponds to an improvement of ≥ 90% in PASI score from baseline. 13 About the ICONIC Clinical Development Programme The pivotal Phase 3 ICONIC clinical development programme is ongoing to evaluate the safety and efficacy of icotrokinra in adults and adolescents (12 years of age and older) with moderate-to-severe plaque psoriasis. 14 The following studies are part of this programme: ICONIC-LEAD ( EUCT: 2023-505120-59-00 ; NCT06095115 ) is a Phase 3 randomised 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 psoriasis, with the higher efficacy bar of PASI c 90 and IGA b score of 0/1 with at least a 2-grade improvement vs placebo at week 16 as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients. 2,15 ICONIC-TOTAL ( EUCT: 2023-505122-34 ; NCT06095102 ) is a Phase 3 RCT evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque psoriasis in 311 participants (icotrokinra=208; placebo=103) with at least 1% body surface area involvement, at least mild disease (global IGA of 2 or higher), and at least moderate severity affecting high-impact sites (e.g., scalp, genital, and/or hands and feet). 2,16,17 The primary endpoint was the proportion of patients with overall IGA score of 0 or 1 with at least a 2-grade improvement vs placebo at week 16 as the primary endpoint. 16,17 ICONIC-ADVANCE 1 ( EUCT: 2023-507039-39-00 ; NCT06143878 ) and ICONIC-ADVANCE 2 ( EUCT: 2023-505121-14 ; NCT06220604 ) are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in participants with moderate-to-severe plaque psoriasis with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement versus placebo at week 16 as co-primary endpoints. 18,19 Additional studies underway in other disease areas include: ICONIC-PsA 1 ( EUCT: 2023-509239-19-00 ;NCT06878404) and ICONIC-PsA 2 ( EUCT: 2024-517284-23-00 ; NCT06807424 ) in active psoriatic arthritis;ICONIC-UC ( EUCT: 2025-521381-10-00 ; NCT071196748 ) in moderately-to-severely active ulcerative colitis; and ICONIC-CD ( EUCT: 2025-521382-27-00 ; NCT7196722 ) in moderately-to-severely active Crohn’s disease. 20,21,22,23 About Plaque Psoriasis Plaque psoriasis is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. 8,24 It is estimated that 6.4 million people in Europe 7 and more than 125 million people worldwide live with the disease. 25 Nearly one-quarter of all people with plaque psoriasis have cases that are considered moderate-to-severe. 24 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. 24 Plaques may appear red in lighter skin or more of a purple, grey or dark brown colour in patients with darker skin tones. 24 Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso. 24 Living with plaque psoriasis can be a challenge and impact life beyond a person’s physical health, including emotional health, relationships, and handling the stressors of life. 26 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. 26,27 About icotrokinra (JNJ-77242113, JNJ-2113) Icotrokinra is the first-in-class targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque psoriasis. 2,28,29 Icotrokinra binds to the IL-23 receptor with high affinity and demonstrated potent, selective inhibition of IL-23 signalling in human T cells. 3,4 Clinical significance of these findings is unknown. Icotrokinra has been approved by the European Commission for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents aged 12 years and older and weighing at least 40 kg, who are candidates for systemic therapy. 1 Patients on icotrokinra take one pill, once daily with water upon waking, at least 30 minutes prior to eating food. 1 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. 30 Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialise compounds derived from the research conducted pursuant to the agreement against a broad range of indications. 30,31,32,33 Icotrokinra is also being studied in active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn’s disease. 34,35,36 ▼ In line with EMA regulations for new medicines and those given conditional approval, icotrokinra is subject to additional monitoring. 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 Follow us at . 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 materialise, 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 behaviour 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. CP-598262 September 2026 ### 1. ICOTYDE EU Prescribing Information 2. Lebwohl M, Gooderham M, et al. Safety of Icotrokinra Through 1 Year for the Treatment of Moderate-to-Severe Plaque Psoriasis and Psoriasis Affecting High-Impact Sites: Pooled Results Across the ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 and 2 Phase 3 Trials. Dermatol Ther. 2026; . Accessed September 2026. 3. Bissonnette R, et al. An Oral Interleukin-23-Receptor Antagonist Peptide for Plaque Psoriasis. N Engl J Med. 2024 Feb 8;390(6):510-521. doi: 10.1056/NEJMoa2308713. PMID: 38324484. Accessed August 2026. 4. Fourie A, et al. JNJ-77242113, a highly potent, selective peptide targeting the IL-23 receptor, provides robust IL-23 pathway inhibition upon oral dosing in rats and humans. Sci Rep. 2024; 14(1), 17515. . Accessed August 2026 5. Stein Gold, L 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, randomised, placebo-controlled and active-comparator-controlled trials. Lancet. 2025;406(10510):1363-1374. doi:10.1016/S0140-6736(25)01576-4. Accessed August 2026. 6. Soung, J et al. Maintenance of Response with Icotrokinra, a Targeted Oral Peptide, for the Treatment of Moderate-to-Severe Psoriasis : Randomized Treatment Withdrawal in Adults (weeks 24- 52) and Continuous Treatment in Adolescents (Through Week 52) From the Phase 3, ICONIC-LEAD Trial. Late-breaking research oral presentation (Presentation #D1T01.2B) at the European Academy of Dermatology and Venereology Congress (EADV). September 2025. Accessed August 2026 7. University College Dublin. HPOS: UCD study recruits thousands with aim of predicting cases of psoriatic arthritis. Available at: . Accessed June 2026. 8. National Psoriasis Foundation. About Psoriasis. Available at: . Accessed August 2026. 9. Lebwohl M, Langley RG, Paul C, Puig L, Reich K, van de Kerkhof P, et al. Evolution of patient perceptions of psoriatic disease: results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey. Dermatol Ther (Heidelb). 2022;12(1):61-78. doi:10.1007/s13555-021-00635-4. Accessed August 2026. 10. Data on File. Janssen. Decision Resources & Internal Claims Research. Truven Health Analytics Data. 11. Strober BE, Blauvelt A, van de Kerkhof PCM, et al. Establishing consensus on defining failure of topical therapy in psoriasis: Recommendations from the International Psoriasis Council. J Am Acad Dermatol. 2025. . Accessed August 2026. 12. 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 J Am Acad Dermatol. 2020; doi: 10.1016/j.jaad.2020.04.104. Accessed August 2026. 13. Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: . Accessed August 2026. 14. Protagonist Therapeutics. Press Release. Protagonist Therapeutics Announces Advancement of JNJ-2113 Across Multiple Indications. Available at: . Accessed August 2026. 15. Clinicaltrials.gov. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. . Accessed June 2026. 16. Health Research Authority. A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Plaque Psoriasis involving Special Areas. EUCT number: 2023-505122-34. Available at: . Accessed June 2026. 17. 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. . Accessed August 2026. 18. Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. Accessed June 2026. 19. Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. Available at: . Accessed June 2026. 20. 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. . Accessed August 2026. 21. Clinicaltrials.gov. 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. . Accessed August 2026. 22. Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately-to-Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748. . Accessed August 2026. 23. Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately-to-Severely Active Crohn’s Disease (ICONIC-CD). Identifier NCT07196722. . Accessed January 2026. 24. National Psoriasis Foundation. Plaque Psoriasis. Available at: . Accessed June 2026. 25. National Psoriasis Foundation. Psoriasis Statistics. Available at: . Accessed June 2026. 26. National Psoriasis Foundation. Life with Psoriasis. Available at: . Accessed June 2026 27. National Psoriasis Foundation. High Impact Sites. Available at: . Accessed June 2026. 28. 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. Accessed June 2026. 29. Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. 30. 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: . Accessed June 2026. 31. 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: . Accessed June 2026 32. 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: . Accessed June 2026. 33. 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: . Accessed June 2026. 34. Clinicaltrials.gov. 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. . Accessed August 2026. 35. Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately-to-Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748. . Accessed August 2026. 36. Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease (ICONIC-CD). Identifier NCT07196722. . Accessed August 2026. CONTACT: Media contact: Sophie Daneau SDaneau@ITS.JNJ.com Investor contact: Jessica Margevich investor-relations@its.jnj.com