FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide

Rhea-AI Impact

(High)

Rhea-AI Sentiment

(Positive)

Rhea-AI Summary

Johnson & Johnson (NYSE: JNJ) announced FDA approval of ICOTYDE (icotrokinra) on March 18, 2026, for moderate-to-severe plaque psoriasis in adults and adolescents 12+ who weigh ≥40 kg.

ICOTYDE is the first oral IL‑23 receptor peptide; Phase 3 data (2,500 patients) showed ~70% IGA 0/1 and 55% PASI 90 at Week 16 with adverse reaction rates within 1.1% of placebo through Week 16 and no new safety signals through Week 52.

Positive

Clinical scale: Phase 3 program enrolled 2,500 patients
Efficacy: ~70% achieved IGA 0/1 and 55% achieved PASI 90 at Week 16
Safety: Adverse reaction rates within 1.1% of placebo through Week 16; no new signals through Week 52

Negative

Label limits: Approval limited to patients ≥12 years old weighing ≥40 kg
Indication scope: Approved for moderate-to-severe plaque psoriasis only, not broader psoriasis types

News Market Reaction – JNJ

-0.35%

1 alert

-0.35% News Effect

On the day this news was published, JNJ declined 0.35%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase 3 patients: 2,500 patients Clear/almost clear skin: ≈70% of patients PASI 90 response: 55% of patients +5 more

8 metrics

Phase 3 patients 2,500 patients Four Phase 3 ICOTYDE studies

Clear/almost clear skin ≈70% of patients IGA 0/1 at Week 16 in head-to-head studies

PASI 90 response 55% of patients PASI 90 at Week 16 in head-to-head studies

Adverse reaction gap Within 1.1% of placebo Adverse reaction rates through Week 16

Phase 3 studies Four Phase 3 trials ICONIC clinical development program

Psoriasis prevalence More than 8 million Americans People affected by psoriasis in the U.S.

Pediatric age threshold 12 years and older Indicated age for ICOTYDE treatment

Pediatric weight threshold At least 40 kg Minimum weight for pediatric ICOTYDE use

Market Reality Check

Price: $244.12 Vol: Volume 7,096,460 is below...

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$244.12 Last Close

Volume Volume 7,096,460 is below the 20-day average of 8,289,015 (relative volume 0.86x). normal

Technical Shares at $238.11 are trading above the 200-day MA of $193.35 and 5.4% below the 52-week high.

Peers on Argus

JNJ fell 2.09% with key peers also down: LLY -4.96%, ABBV -1.01%, AZN -1.38%, NV...

1 Down

JNJ fell 2.09% with key peers also down: LLY -4.96%, ABBV -1.01%, AZN -1.38%, NVS -0.51%, NVO -0.62%, indicating broader weakness across large-cap pharma despite the positive FDA approval.

Previous Fda approval Reports

5 past events · Latest: Mar 12 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 12	Ophthalmology FDA approval	Positive	-0.4%	FDA cleared TECNIS PureSee IOL, expanding JNJ’s TECNIS cataract portfolio.
Feb 24	Hematology sBLA filing	Positive	-0.5%	sBLA submitted for IMAAVY (nipocalimab) as first wAIHA treatment.
Feb 17	NSCLC dosing approval	Positive	-0.1%	FDA approved monthly RYBREVANT FASPRO dosing schedule with oral LAZCLUZE.
Dec 18	Neurovascular FDA expansion	Positive	-1.0%	TRUFILL n‑BCA gained expanded indication for symptomatic chronic subdural hematoma.
Dec 17	NSCLC SC formulation OK	Positive	-1.0%	FDA approved subcutaneous RYBREVANT FASPRO formulation with shorter administration.

Pattern Detected

Recent FDA approval or filing headlines for JNJ have consistently been followed by slightly negative next-day moves despite positive regulatory outcomes.

Recent Company History

Over the past year, Johnson & Johnson has reported multiple regulatory milestones tagged as FDA approval, including TRUFILL n‑BCA for cSDH on Dec 18, 2025, RYBREVANT FASPRO NSCLC approvals in Dec 2025 and Feb 2026, a TECNIS PureSee intraocular lens approval on Mar 12, 2026, and an IMAAVY sBLA submission for wAIHA on Feb 24, 2026. All were clinically or strategically positive, yet 24-hour price reactions ranged from about flat to modestly negative, suggesting a pattern of muted or selling pressure into good regulatory news.

Historical Comparison

-0.6% avg move · In the last five JNJ headlines tagged as FDA approval or related filings, the stock moved on average...

fda approval

-0.6%

Average Historical Move fda approval

In the last five JNJ headlines tagged as FDA approval or related filings, the stock moved on average -0.56% over the next day, pointing to historically muted or slightly negative trading around similar regulatory milestones.

Same-tag history shows a steady stream of FDA-related wins across neurology, oncology, ophthalmology and hematology, reflecting pipeline breadth rather than a single-asset progression path.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2026-02-11

An effective S-3ASR shelf filed on 2026-02-11 allows Johnson & Johnson to issue unsecured debt securities from time to time for general corporate purposes, including working capital, capital expenditures, buybacks, refinancing and acquisitions. No specific capacity amount is disclosed in the provided summary.

Market Pulse Summary

This announcement highlights a major FDA approval for ICOTYDE, an oral IL‑23 receptor antagonist wit...

Analysis

This announcement highlights a major FDA approval for ICOTYDE, an oral IL‑23 receptor antagonist with strong Phase 3 data in about 2,500 patients and meaningful skin clearance metrics (around 70% IGA 0/1, 55% PASI 90 at Week 16). Historically, JNJ’s FDA-related news has produced modestly negative average moves of -0.56%, so investors may focus more on long-term psoriasis market penetration, broader pharma sentiment, and any future use of the effective S‑3ASR debt shelf.

Key Terms

il-23r, interleukin-23 (il-23) receptor antagonist, iga, pasi, +4 more

8 terms

il-23r medical

"first and only IL-23R targeted oral peptide that delivers complete skin clearance"

IL-23R is a protein on certain immune cells that acts like a receptor for a signaling molecule called interleukin‑23 and helps start and sustain inflammatory responses. For investors, it matters because drugs that block or modify this receptor can reduce harmful inflammation in diseases such as psoriasis or inflammatory bowel disease; success or failure in trials and regulatory decisions for IL‑23R‑targeting therapies can materially affect the value of companies developing them—think of the receptor as a light switch that controls an overactive alarm system.

interleukin-23 (il-23) receptor antagonist medical

"ICOTYDE™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment"

A interleukin-23 (IL-23) receptor antagonist is a type of drug, often a biologic, that blocks the cell-surface receptor for IL-23, a chemical messenger that tells the immune system to cause inflammation. By interrupting that signal — like unplugging a loudspeaker that keeps repeating an alarm — these drugs can reduce symptoms in autoimmune conditions, which matters to investors because clinical results, safety and regulatory approvals determine market potential, pricing power and long-term revenue.

iga medical

"approximately 70% of patients achieved clear or almost clear skin (IGA 0/1) and 55%"

IgA (immunoglobulin A) is an antibody that acts like a first-line security guard on the body's surfaces—such as the gut, respiratory tract and eyes—helping block infections and clear harmful substances. For investors, IgA matters because it is a target and a biomarker in diagnostics and drug development for infections, autoimmune conditions and some kidney diseases; changes in IgA levels can influence clinical trial outcomes, regulatory decisions and market demand for treatments and tests.

pasi medical

"55% of patients achieved a Psoriasis Area and Severity Index (PASI) 90 response at Week 16"

PASI is the Psoriasis Area and Severity Index, a single number that combines how much of the body is covered by psoriasis and how severe the lesions are (redness, thickness and scaling). Think of it like measuring both the size and intensity of a stain on clothing — the higher the score, the worse the condition; drug trials report percent reductions in PASI to show effectiveness. Investors watch PASI results because larger, consistent improvements drive regulatory approvals, market uptake and revenue potential for therapies.

psoriasis area and severity index medical

"The PASI score grades the amount of surface area on each body region that is covered"

A psoriasis area and severity index (PASI) is a clinical score that measures how much of the body is affected by psoriasis and how severe the lesions are, combining area and intensity into a single number. Investors care because pharmaceutical trials often use changes in this score to show a drug works; larger, faster improvements can drive regulatory approval, higher sales forecasts and clearer market value — like measuring both the size and heat of a spreading fire when deciding how effective a new extinguisher is.

phototherapy medical

"who weigh at least 40 kg who are candidates for systemic therapy or phototherapy."

Phototherapy is a medical treatment that uses specific wavelengths of light to change biological processes in the body—like easing newborn jaundice, treating skin conditions, or improving mood in seasonal depression. Investors care because demand, regulatory approvals, device makers, and reimbursement rules determine how broadly the therapy is adopted; successful clinical results or new, easier-to-use devices can create business growth similar to a new tool that suddenly makes a common job faster and cheaper.

systemic therapy medical

"are candidates for systemic therapy or phototherapy."

Treatments that travel through the bloodstream or throughout the body to reach disease sites rather than targeting a single spot—think of a citywide water main delivering resources rather than a local hose. They include drugs given orally, by injection, or infusion and are commonly used for cancers, infections, and autoimmune diseases. Investors care because systemic therapies often address large patient populations, drive long-term drug sales, carry regulatory and safety risks, and shape competitive positioning and pricing in healthcare markets.

phase 3 medical

"across four Phase 3 studies including 2,500 patients."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

03/18/2026 - 07:49 AM

Johnson & Johnson introduces the first and only IL-23R targeted oral peptide that delivers complete skin clearance and favorable safety profile in a once-daily pill

ICOTYDE offers an innovative new option for patients with moderate-to-severe plaque psoriasis to address patients cycling on topical therapies in need of systemic treatment

SPRING HOUSE, Pa., March 18, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.¹ ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor.²

"ICOTYDE 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," said Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health.^a "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 ICOTYDE is a potential game–changer for many adult and adolescent patients."

Experience the interactive multimedia news release here: https://www.multivu.com/johnson-johnson/9378651-en-icotyde-icotrokinra-fda-approval-first-line-systemic-treatment-plaque-psoriasis

Clinical evidence summary

ICOTYDE met all primary efficacy endpoints and demonstrated a favorable safety profile across four Phase 3 studies including 2,500 patients. The approval is based on an unprecedented body of evidence from the ICONIC clinical development program, which simultaneously evaluated ICOTYDE in adults and adolescents, high impact sites such as scalp and genital PsO, and in duplicate head-to-head trials versus an active comparator. In the head-to-head superiority studies, approximately 70% of patients achieved clear or almost clear skin (IGA 0/1) and 55% of patients achieved a Psoriasis Area and Severity Index (PASI) 90 response at Week 16.³^,^b,cRates of adverse reactions for ICOTYDE treated patients were within 1.1% of placebo through Week 16 and no new safety signals were identified through Week 52.⁴

"With the FDA approval of ICOTYDE, Johnson & Johnson is setting a new standard for the treatment of moderate-to-severe plaque psoriasis," said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson. "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."

Unmet need in moderate-to-severe plaque psoriasis

Psoriasis affects more than 8 million Americans, impacting physical comfort and quality of life, especially when lesions are on visible or sensitive areas.⁵ For many with moderate-to-severe disease, targeted systemic treatments are key. 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.⁶

"Finding the right treatment can take time, during which people with psoriatic disease should be considering multiple factors from efficacy to safety to how the treatment fits into their everyday life," said Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation.^d "The approval of a novel systemic therapy changes the conversation about treatment options for our community."

"The approval of ICOTYDE represents a pivotal moment for people with plaque psoriasis," said John Reed, M.D., Ph.D., Executive Vice President, R&D, Innovative Medicine, Johnson & Johnson. "At Johnson & Johnson, we are harnessing our scientific expertise to transform cutting-edge science into meaningful solutions for patients. ICOTYDE is a fundamentally different treatment with the potential to redefine what physicians and patients can expect from psoriasis treatment."

Access and support in the U.S.

Johnson & Johnson is committed to helping patients access our treatments. Once a patient and their doctor have decided that ICOTYDE is right for the patient, ICOTYDE withMe provides a simple, comprehensive patient support program offering patients free resources and dedicated support, including cost support options, a dedicated Nurse Guide^e and educational resources, regardless of insurance type.

Editor's notes:

a. Dr. Stein Gold is a paid consultant for Johnson & Johnson. She 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.⁷
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.^⁸d. Leah Howard has not been compensated for any media work.
e. Nurse Guides do not provide medical advice.

About the ICONIC Clinical Development Program
The pivotal Phase 3 ICONIC clinical development program includes five Phase 3 studies of ICOTYDE in patients 12 and older with moderate-to-severe plaque PsO.

ICONIC-LEAD (NCT06095115) is a randomized clinical trial (RCT) to evaluate the efficacy and safety of ICOTYDE 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.⁹
ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of ICOTYDE 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.¹⁰
ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) are RCTs to evaluate the efficacy and safety of ICOTYDE compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.¹¹^,12
ICONIC-ASCEND (NCT06934226) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis.¹³

Additional studies underway in other disease areas include: ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) in active psoriatic arthritis; ICONIC-UC (NCT071196748) in moderately-to-severely active ulcerative colitis; and ICONIC-CD (NCT7196722) in moderately-to-severely active Crohn's disease.¹⁴^,15,16,17

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.¹⁸ It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.¹⁹ Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.¹⁹ 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.²⁰ 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.²¹ 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.¹⁷^,22

About ICOTYDE™ (icotrokinra)
ICOTYDE (icotrokinra) is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO.²^,^23,24 ICOTYDE binds to the IL-23 receptor with high affinity and demonstrated potent, inhibition of IL-23 signaling in human T cells.²⁵ Clinical significance of these findings is unknown.

ICOTYDE is currently approved in the U.S. for the treatment of adults, and pediatric patients 12 years of age and older who weigh at least 40 kg, with moderate-to-severe plaque PsO who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once a day with water upon waking, 30 minutes prior to eating food.¹

ICOTYDE 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 ICOTYDE 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

ICOTYDE is also being studied in active psoriatic arthritis, moderately-to-severely active ulcerative colitis and moderately-to-severely active Crohn's disease.¹⁵^,¹⁶^,¹⁷^,¹⁸

For more information visit: www.icotyde.com.

ICOTYDE™ INDICATION AND IMPORTANT SAFETY INFORMATION

WHAT IS ICOTYDE™ (icotrokinra)?

ICOTYDE 200 mg is a prescription medicine used to treat moderate to severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ICOTYDE?
ICOTYDE may cause serious side effects, including:

Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ICOTYDE.

Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including:

fever, sweat, or chills
cough
shortness of breath
blood in your mucus (phlegm)
muscle aches

warm, red, or painful skin or sores on your body different from your psoriasis
weight loss
diarrhea or stomach pain
burning when you urinate or urinating more often than normal

Before taking ICOTYDE, tell your healthcare provider about all of your medical conditions, including if you:

have an infection that does not go away or that keeps coming back.
have tuberculosis (TB) or have been in close contact with someone with TB.
have recently received or are scheduled to receive an immunization (vaccine). Avoid receiving live vaccines during treatment with ICOTYDE.
have kidney problems.
are pregnant or plan to become pregnant. It is not known if ICOTYDE can harm your unborn baby.
Pregnancy Safety Study. There is a pregnancy safety study for women who take ICOTYDE during pregnancy. The purpose of this study is to collect information about the health of you and your baby. If you are pregnant or become pregnant during treatment with ICOTYDE, you can report your pregnancy by calling 1-800-526-7736 or visiting www.ICOTYDE.com.
are breastfeeding or plan to breastfeed. It is not known if ICOTYDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ICOTYDE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of ICOTYDE?

ICOTYDE may cause serious side effects. See "What is the most important information I should know about ICOTYDE?"

The most common side effects of ICOTYDE include:

headache
nausea
cough

fungal infection
tiredness

These are not all the possible side effects of ICOTYDE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

How should I take ICOTYDE?

Take ICOTYDE exactly as your healthcare provider tells you to take it.
Take ICOTYDE 1 time a day when you wake up on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food.
If you have difficulty swallowing tablets, ICOTYDE can be dispersed in water. For more information, please read the Medication Guide.
If you miss a dose of ICOTYDE, take the dose as soon as you remember and go back to your regular schedule the next day.

Please read the full Prescribing Information, including Medication Guide, for ICOTYDE and discuss any questions that you have with your doctor.

cp-564097v1

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 Biotech, Inc. is a Johnson & Johnson company.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding ICOTYDE™ (icotrokinra). 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 ICOTYDE U.S. Prescribing Information.
² 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.
³ Stein Gold, L et al. Icotrokinra Demonstrated Superior Responses Compared with Placebo and Deucravacitinib in the Treatment of Moderate-to-Severe Plaque Psoriasis : Results Through Week 24 of the Phase 3 ICONIC-ADVANCE 1&2 Studies. Oral presentation (Presentation FC01.1G) at the European Academy of Dermatology and Venereology Congress (EADV). September 2025.
⁴ 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.
⁵ National Psoriasis Foundation. Available at https://www.psoriasis.org/. Accessed January 2026.
⁶ Strober BE et al. Establishing consensus on defining failure of topical therapy in psoriasis: Recommendations from the International Psoriasis Council. Journal of the American Academy of Dermatology, Volume 94, Issue 1, 372 – 375.
⁷ 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 April 2025
⁸ 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 March 2025.
⁹ 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 May 2025.
¹⁰ 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 May 2025.
¹¹ 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 May 2025.
¹² 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 May 2025.
¹³ 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 NCT06934226. https://clinicaltrials.gov/study/NCT06934226. Accessed January 2026.
¹⁴ 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. Accessed January 2026.
¹⁵ 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. Accessed January 2026.
¹⁶ Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately-to-Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748. https://clinicaltrials.gov/study/NCT07196748. Accessed January 2026.
¹⁷ Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately-to-Severely Active Crohn's Disease (ICONIC-CD). Identifier NCT07196722. https://clinicaltrials.gov/study/NCT07196722. Accessed January 2026.
¹⁸ National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed May 2025.
¹⁹ National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed May 2025.
²⁰ National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/.Accessed April 2025.
²¹ National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed June 2025.
²² National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed Sep June 2025.
²³ 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.
²⁴ Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
²⁵ 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.
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 May 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 May 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 May 2025.

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SOURCE Johnson & Johnson

FAQ

When did Johnson & Johnson (JNJ) receive FDA approval for ICOTYDE (icotrokinra)?

The FDA approved ICOTYDE on March 18, 2026, for specified psoriasis patients. According to Johnson & Johnson, approval covers adults and adolescents aged 12 or older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.

What efficacy did ICOTYDE show in Phase 3 trials for JNJ (JNJ)?

ICOTYDE achieved about 70% IGA 0/1 and 55% PASI 90 at Week 16. According to Johnson & Johnson, these results came from the ICONIC Phase 3 program including roughly 2,500 patients and head-to-head superiority studies versus an active comparator.

What is the safety profile for ICOTYDE in Johnson & Johnson's data?

Adverse reaction rates for ICOTYDE were within 1.1% of placebo through Week 16. According to Johnson & Johnson, no new safety signals were identified through Week 52 in the ICONIC trials, indicating a favorable short-term safety profile.

Who is eligible to receive ICOTYDE under the new JNJ (JNJ) FDA approval?

ICOTYDE is indicated for adults and pediatric patients aged 12 years and older who weigh at least 40 kg. According to Johnson & Johnson, eligible patients are those with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

How is ICOTYDE administered according to Johnson & Johnson (JNJ)?

ICOTYDE is delivered as a once-daily oral pill. According to Johnson & Johnson, the targeted oral peptide blocks the IL‑23 receptor and is intended to fit into patients' daily routines as a systemic treatment option.

What access and support does Johnson & Johnson (JNJ) offer for ICOTYDE patients in the U.S.?

Johnson & Johnson offers the ICOTYDE withMe patient support program with cost support and a dedicated Nurse Guide. According to Johnson & Johnson, the program provides resources and assistance regardless of insurance type to help patient access.

FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide