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Last update 06 May 2025
Icotrokinra
Last update 06 May 2025
Overview
Basic Info
Drug Type Synthetic peptide |
Synonyms JNJ 67864238, JNJ-2113, JNJ-4238 + [7] |
Target |
Action inhibitors |
Mechanism IL-23R inhibitors(Interleukin 23 Receptor inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Sequence Code 1311911322
Source: *****
Related
31
Clinical Trials associated with IcotrokinraCTRI/2025/04/084956
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced Participants with Active Psoriatic Arthritis - ICONIC-PsA 2
Start Date16 May 2025 |
Sponsor / Collaborator- |
ISRCTN56487896
A phase III multicenter, randomized, double-blind, placebo-controlled and ustekinumab active comparator-controlled study to evaluate the efficacy and safety of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis
Start Date09 May 2025 |
Sponsor / Collaborator |
CTRI/2025/04/084370
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-na ve Participants with Active Psoriatic Arthritis - ICONIC-PsA 1
Start Date08 May 2025 |
Sponsor / Collaborator- |
100 Clinical Results associated with Icotrokinra
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100 Translational Medicine associated with Icotrokinra
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100 Patents (Medical) associated with Icotrokinra
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4
Literatures (Medical) associated with Icotrokinra01 Mar 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
FRONTIER-2: A phase 2b, long-term extension, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis
Article
Author: Ferris, Laura K ; Tyring, Stephen K ; Iaconangelo, Charles ; Ota, Takayuki ; Huang, Yu-Huei ; Shen, Yaung-Kaung ; Bissonnette, Robert ; Pink, Andrew E ; Bagel, Jerry ; Kokolakis, Georgios ; Li, Shu ; DeLozier, Amy M
BACKGROUND:
More patients with moderate-to-severe plaque psoriasis achieved responses with JNJ-77242113, a targeted oral peptide inhibiting interleukin-23 receptor signaling, versus placebo (PBO) at week (W)16 of the phase 2 FRONTIER-1 study.
OBJECTIVE:
FRONTIER-2, a long-term extension of FRONTIER-1, evaluated JNJ-77242113 through 1 year.
METHODS:
FRONTIER-1 participants received JNJ-77242113 at doses from 25 mg daily to 100 mg twice daily or PBO through W16. Patients completing FRONTIER-1 could enroll in FRONTIER-2 and continue JNJ-77242113 at the same dose through W52. Those on PBO crossed over to JNJ-77242113 100 mg daily for W16-52. Safety follow-up continued through W56.
RESULTS:
Most (89%) FRONTIER-1 patients continued to FRONTIER-2. Across outcomes, response rates were maintained from W16-52. The highest response rates generally occurred with JNJ-77242113 100 mg twice daily. At W52, 76% of patients achieved up to 75% improvement in Psoriasis Area and Severity Index (PASI75) with 100 mg twice daily; rates of clear or almost clear skin were 64% (PASI90), 74% (Investigator's Global Assessment 0/1), 40% (PASI100), and 43% (Investigator's Global Assessment 0). From W16-56, 59% of JNJ-77242113-treated patients had ≥1 adverse events. Serious adverse events, considered unrelated to treatment by investigators, occurred in 4% of patients.
LIMITATIONS:
The study was limited by the small number of patients in each treatment group and the descriptive nature of the longer-term data.
CONCLUSION:
Rates of skin clearance with JNJ-77242113 were durable to 1 year and no safety signals were identified.
01 Feb 2025·The Journal of clinical and aesthetic dermatology
From the Masterclasses in Dermatology 2024 Meeting: Updates in Psoriasis Treatments.
Review
Author: Merola, Joseph F ; Gottlieb, Alice B ; Childs, Beth ; Romanelli, Sarah
Psoriasis (PsO) is an immune-mediated, chronic inflammatory skin disease that significantly impairs quality of life. Its treatment landscape is rapidly evolving, providing better disease control. Here, we highlight updates in biologics, obtaining coverage for biologics under Medicare, the PsO-to-psoriatic arthritis (PsA) transition, and orally administered drugs, as presented at the 2024 Masterclass in Dermatology in Puerto Rico. We provide a concise overview of the evolving therapeutic landscape and its impact on personalized care for patients with PsO. The toolkit of biologics is expanding, with agents that target interleukin (IL)-17 and IL-23 pathways addressing symptoms across multiple disease domains. Interchangeable biosimilars reduce financial barriers to access, particularly for tumor necrosis factor (TNF) inhibitors. An IL-36 receptor antibody, spesolimab, demonstrates efficacy in generalized pustular psoriasis. Further, Medicare has expanded coverage of certain biologics, addressing challenges to treating patients of this population. PsA is an important comorbidity that can significantly reduce quality of life. Recent studies suggest that biologic therapies-including TNF inhibitors, as well as anti-IL-17, anti-IL-23, and anti-IL-12/23 agents-protect against arthritis onset in PsO patients. In addition to traditional modes of delivery, novel formulations address widespread preference for orally administered therapies. Deucravacitinib, a tyrosine kinase (TYK) 2 inhibitor, is highly selective, effective, and safe. Additionally, JNJ-77242113, an investigational IL-23 receptor antagonist, constitutes an orally administered, targeted biologic therapy. Together, these developments are shaping the future for patients with PsO. It is our goal to simplify the complexities of emerging treatment options, offering clinicians a concise and useful guide for patient management.
08 Feb 2024·The New England journal of medicineQ1 · MEDICINE
An Oral Interleukin-23–Receptor Antagonist Peptide for Plaque Psoriasis
Q1 · MEDICINE
Article
Author: Ferris, Laura K ; Li, Shu ; Papp, Kim ; Bissonnette, Robert ; Kannan, Arun ; Shen, Yaung-Kaung ; Pinter, Andreas ; Miller, Megan ; Vender, Ronald ; Gerdes, Sascha ; Rich, Phoebe ; DeKlotz, Cynthia
BACKGROUND:
The use of monoclonal antibodies has changed the treatment of several immune-mediated inflammatory diseases, including psoriasis. However, these large proteins must be administered by injection. JNJ-77242113 is a novel, orally administered interleukin-23-receptor antagonist peptide that selectively blocks interleukin-23 signaling and downstream cytokine production.
METHODS:
In this phase 2 dose-finding trial, we randomly assigned patients with moderate-to-severe plaque psoriasis to receive JNJ-77242113 at a dose of 25 mg once daily, 25 mg twice daily, 50 mg once daily, 100 mg once daily, or 100 mg twice daily or placebo for 16 weeks. The primary end point was a reduction from baseline of at least 75% in the Psoriasis Area and Severity Index (PASI) score (PASI 75 response; PASI scores range from 0 to 72, with higher scores indicating greater extent or severity of psoriasis) at week 16.
RESULTS:
A total of 255 patients underwent randomization. The mean PASI score at baseline was 19.1. The mean duration of psoriasis was 18.2 years, and 78% of the patients across all the trial groups had previously received systemic treatments. At week 16, the percentages of patients with a PASI 75 response were higher among those in the JNJ-77242113 groups (37%, 51%, 58%, 65%, and 79% in the 25-mg once-daily, 25-mg twice-daily, 50-mg once-daily, 100-mg once-daily, and 100-mg twice-daily groups, respectively) than among those in the placebo group (9%), a finding that showed a significant dose-response relationship (P<0.001). The most common adverse events included coronavirus disease 2019 (in 12% of the patients in the placebo group and in 11% of those across the JNJ-77242113 dose groups) and nasopharyngitis (in 5% and 7%, respectively). The percentages of patients who had at least one adverse event were similar in the combined JNJ-77242113 dose group (52%) and the placebo group (51%). There was no evidence of a dose-related increase in adverse events across the JNJ-77242113 dose groups.
CONCLUSIONS:
After 16 weeks of once- or twice-daily oral administration, treatment with the interleukin-23-receptor antagonist peptide JNJ-77242113 showed greater efficacy than placebo in patients with moderate-to-severe plaque psoriasis. (Funded by Janssen Research and Development; FRONTIER 1 ClinicalTrials.gov number, NCT05223868.).
123
News (Medical) associated with Icotrokinra15 Apr 2025
2025 First-Quarter reported sales growth of 2.4% to $21.9 Billion with operational growth of 4.2%* and adjusted operational growth of 3.3%* 2025 First-Quarter earnings per share (EPS) increased to $4.54 which includes the reversal of special charges and adjusted EPS increased to $2.77 or 2.2%* Significant new product pipeline progress including approval of TREMFYA in Crohn’s disease, data for RYBREVANT/LAZCLUZE overall survival in non-small cell lung cancer and icotrokinra in plaque psoriasis, and initiation of the clinical trial for a general surgery robotic system, OTTAVA Company increases Full-Year 2025 operational sales2,5 guidance to reflect the addition of CAPLYTA following the completion of the Intra-Cellular Therapies acquisition Including tariff costs, dilution from the Intra-Cellular Therapies acquisition, and updated foreign exchange, Company maintains Full-Year 2025 adjusted reported EPS4 outlook of 6.2%* growth at the mid-point
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2025. “The power of Johnson & Johnson’s uniquely diversified portfolio was on full display this quarter, with strong operational sales growth reinforcing our confidence in 2025 guidance,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “During the quarter, we fortified our position as an innovation powerhouse with major advancements across our pipeline, including TREMFYA in IBD, RYBREVANT plus LAZCLUZE in non-small-cell lung cancer, and OTTAVA, our soft tissue surgical robotic system, and further enhanced our leading neuroscience portfolio with the completion of the Intra-Cellular Therapies acquisition.”
Overall financial results
Q1
($ in Millions, expect EPS)
2025
2024
% Change
Reported Sales
$21,893
$ 21,383
2.4%
Net Earnings
$10,999
$3,255
237.9%
EPS (diluted)
$4.54
$1.34
238.8%
Q1
Non-GAAP* ($ in Millions, except EPS)
2025
2024
% Change
Operational Sales1,2
4.2%
Adjusted Operational Sales1,3
3.3%
Adjusted Net Earnings1,4
$6,706
$6,580
1.9%
Adjusted EPS (diluted)1,4
$2.77
$2.71
2.2%
Free Cash Flow6,7
~$3,400
$2,850
1
Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2
Excludes the impact of translational currency
3
Excludes the net impact of acquisitions and divestitures and translational currency
4
Excludes intangible amortization expense and special items
5
Excludes COVID-19 Vaccine
6
Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings.
7
First-quarter 2025 is estimated as of April 15, 2025
Regional sales results
Q1
% Change
($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$12,305
$11,620
5.9%
5.9
-
4.4
International
9,588
9,763
(1.8)
2.1
(3.9)
1.9
Worldwide
$21,893
$21,383
2.4%
4.2
(1.8)
3.3
1
Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2
Excludes the impact of translational currency
3
Excludes the net impact of acquisitions and divestitures and translational currency
Segment sales results
Q1
% Change
($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$13,873
$13,562
2.3%
4.2
(1.9)
4.4
MedTech
8,020
7,821
2.5
4.1
(1.6)
1.3
Worldwide
$21,893
$21,383
2.4%
4.2
(1.8)
3.3
1
Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2
Excludes the impact of translational currency
3
Excludes the net impact of acquisitions and divestitures and translational currency
First-Quarter 2025 segment commentary:
Operational sales* reflected below excludes the impact of translational currency.
Innovative Medicine
Innovative Medicine worldwide operational sales grew 4.2%* driven primarily by DARZALEX, CARVYKTI, ERLEADA, and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, SPRAVATO in Neuroscience, and XARELTO in Cardiovascular/Metabolism/Other. Growth was partially offset by an approximate (810) basis points impact from STELARA in Immunology.
MedTech
MedTech worldwide operational sales grew 4.1%*, with net acquisitions and divestitures positively impacting growth by 2.8%. Growth was driven primarily by Abiomed in Cardiovascular and wound closure products in General Surgery. Growth was partially offset by Spine, Sports & Other in Orthopaedics.
Full-year 2025 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP.
($ in Billions, except EPS)
April 2025
January 2025
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
2.0% – 3.0% / 2.5%
2.0% – 3.0% / 2.5%
Operational Sales2,5 / Mid-point
Change vs. Prior Year / Mid-point
$91.6B – $92.4B / $92.0B
3.3% – 4.3% / 3.8%
$90.9B – $91.7B / $91.3B
2.5% – 3.5% / 3.0%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$91.0B – $91.8B / $91.4B
2.6% – 3.6% / 3.1%
$89.2B – $90.0B / $89.6B
0.5% – 1.5% / 1.0%
Adjusted Operational EPS (Diluted)2,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
$10.75 – $10.95 / $10.85
7.7% – 9.7% / 8.7%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
1
Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2
Non-GAAP financial measure; excludes the impact of translational currency
3
Calculated using Euro Average Rate: April 2025 = $1.10 and January 2025 = $1.04 (Illustrative purposes only)
4
Non-GAAP financial measure; excludes intangible amortization expense and special items
5
Excludes COVID-19 Vaccine
Other modeling considerations will be provided on the webcast.
Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com.
Regulatory
European Commission approves subcutaneous RYBREVANT (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer1
Press Release
European Commission approves Johnson & Johnson’s subcutaneous DARZALEX (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility1
Press Release
U.S. FDA approves TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease
Press Release
Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren's disease, has now received Fast Track designation
Press Release
Data Releases
Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA Robotic Surgical System1
Press Release
Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill1
Press Release
Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG)1
Press Release
TREMFYA (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis1
Press Release
Johnson & Johnson MedTech to Highlight Latest Advancements in Heart Disease Treatment with Impella at ACC.25
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer
Press Release
New nipocalimab data and real-world research at AAN 2025 highlight positive Phase 3 results and commitment to people living with generalized myasthenia gravis (gMG)
Press Release
RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025
Press Release
Johnson & Johnson MedTech Showcases New Era of Digital Orthopaedics at AAOS 2025
Press Release
Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients
Press Release
Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis
Press Release
TREMFYA (guselkumab) subcutaneous (SC) induction data support potential to be the first and only in its class to offer the option of both intravenous and SC induction therapy in ulcerative colitis
Press Release
New nipocalimab data published in mAbs journal details differentiated molecular design, clinical profile and potential of nipocalimab to treat IgG-driven alloantibody and autoantibody diseases
Press Release
Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalized myasthenia gravis (gMG) published in The Lancet Neurology
Press Release
Product Launch
Shockwave Medical Launches Novel Forward Intravascular Lithotripsy Platform in U.S. to Transform Treatment of Difficult-to-Cross Calcified Lesions
Press Release
Other
Johnson & Johnson Closes Landmark Intra-Cellular Therapies, Inc. Acquisition to Solidify Neuroscience Leadership1
Press Release
Johnson & Johnson to Return to Tort System to Defeat Meritless Talc Claims1
Press Release
Johnson & Johnson Increases U.S. Investment to More than $55 Billion Over the Next Four Years
Press Release
Johnson & Johnson Announces Darren Snellgrove as Vice President, Investor Relations
Press Release
Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations.
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 www.jnj.com.
Non-GAAP financial measures:
* “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results.
Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results.
Note to investors concerning forward-looking statements:
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. 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: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; and increased scrutiny of the health care industry by government agencies. 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. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
Percent Change
2025
2024
Total
Operations
Currency
$
8,092
7,612
6.3
%
6.3
-
5,781
5,950
(2.9
)
1.5
(4.4
)
13,873
13,562
2.3
4.2
(1.9
)
4,213
4,008
5.1
5.1
-
3,807
3,813
(0.2
)
3.0
(3.2
)
8,020
7,821
2.5
4.1
(1.6
)
12,305
11,620
5.9
5.9
-
9,588
9,763
(1.8
)
2.1
(3.9
)
$
21,893
21,383
2.4
%
4.2
(1.8
)
Percent Change
2025
2024
Total
Operations
Currency
$
12,305
11,620
5.9
%
5.9
-
5,110
5,163
(1.0
)
2.2
(3.2
)
1,167
1,194
(2.3
)
9.2
(11.5
)
3,311
3,406
(2.8
)
(0.6
)
(2.2
)
9,588
9,763
(1.8
)
2.1
(3.9
)
$
21,893
21,383
2.4
%
4.2
(1.8
)
2025
2024
Percent
Percent
Percent
Increase
Amount
to Sales
Amount
to Sales
(Decrease)
$
21,893
100.0
$
21,383
100.0
2.4
7,357
33.6
6,511
30.4
13.0
14,536
66.4
14,872
69.6
(2.3
)
5,112
23.3
5,257
24.6
(2.8
)
3,225
14.7
3,542
16.6
(8.9
)
(128
)
(0.6
)
(209
)
(1.0
)
(7,321
)
(33.4
)
2,404
11.2
17
0.1
164
0.8
13,631
62.3
3,714
17.4
267.0
2,632
12.1
459
2.2
473.4
$
10,999
50.2
$
3,255
15.2
237.9
$
4.54
$
1.34
238.8
2,423.8
2,430.1
19.3
%
12.4
%
$
8,011
36.6
$
7,877
36.8
1.7
$
6,706
30.6
$
6,580
30.8
1.9
$
2.77
$
2.71
2.2
16.3
%
16.5
%
2025
2024
$10,999
$3,255
(6,966)
2,726
1,120
1,078
55
171
132
148
39
(20)
-
51
-
9
1,315
(856)
12
18
$6,706
$6,580
2,423.8
2,430.1
$2.77
$2.71
$2.81
1
2
2.3%
2.5%
2.4%
6.3%
5.1%
5.9%
(2.9)%
(0.2)%
(1.8)%
(1.9)
(1.6)
(1.8)
-
-
-
(4.4)
(3.2)
(3.9)
4.2%
4.1%
4.2%
6.3%
5.1%
5.9%
1.5%
3.0%
2.1%
(3.3)
(1.2)
(5.1)
(1.8)
(1.4)
(0.5)
0.2
0.5
0.3
0.0
0.9
0.3
0.4
0.2
0.3
4.4%
1.3%
3.3%
6.3%
0.9%
4.4%
1.9%
1.8%
1.9%
REPORTED SALES vs. PRIOR PERIOD ($MM)
2025
2024
Reported
Operational (1)
Currency
$ 3,013
2,383
26.4
%
26.4
%
-
2,664
2,430
9.6
%
14.4
%
-4.8
%
5,678
4,814
17.9
%
20.4
%
-2.5
%
318
140
*
*
-
51
16
*
*
*
369
157
*
*
*
1,829
1,464
24.9
%
24.9
%
-
1,409
1,228
14.7
%
19.8
%
-5.1
%
3,237
2,692
20.3
%
22.5
%
-2.2
%
292
285
2.5
%
2.5
%
-
479
404
18.5
%
23.1
%
-4.6
%
771
689
11.9
%
14.6
%
-2.7
%
235
265
-11.5
%
-11.5
%
-
474
518
-8.5
%
-4.2
%
-4.3
%
709
784
-9.5
%
-6.7
%
-2.8
%
113
36
*
*
-
28
11
*
*
*
141
47
*
*
*
68
50
35.2
%
35.2
%
-
18
8
*
*
*
86
58
48.4
%
50.2
%
-1.8
%
105
101
4.9
%
4.9
%
-
46
33
38.8
%
45.9
%
-7.1
%
151
133
13.3
%
15.0
%
-1.7
%
7
9
-24.3
%
-24.3
%
-
118
172
-31.3
%
-28.5
%
-2.8
%
125
181
-30.9
%
-28.3
%
-2.6
%
47
33
42.9
%
42.9
%
-
42
41
4.6
%
10.1
%
-5.5
%
89
73
21.7
%
24.7
%
-3.0
%
REPORTED SALES vs. PRIOR PERIOD ($MM)
2025
2024
Reported
Operational (1)
Currency
2,196
2,453
-10.5
%
-10.5
%
-
1,510
1,794
-15.8
%
-11.5
%
-4.3
%
3,707
4,247
-12.7
%
-10.9
%
-1.8
%
314
266
18.1
%
18.1
%
-
10
27
-64.2
%
-64.2
%
-
143
141
1.3
%
6.8
%
-5.5
%
467
434
7.5
%
9.3
%
-1.8
%
292
254
14.8
%
14.8
%
-
366
299
22.4
%
29.7
%
-7.3
%
659
554
18.9
%
22.9
%
-4.0
%
981
1,396
-29.8
%
-29.8
%
-
644
1,055
-38.9
%
-35.8
%
-3.1
%
1,625
2,451
-33.7
%
-32.3
%
-1.4
%
599
509
17.6
%
17.6
%
-
356
299
19.2
%
24.4
%
-5.2
%
956
808
18.2
%
20.1
%
-1.9
%
1
0
*
*
-
0
0
-
-
-
1
0
*
*
-
968
1,054
-8.1
%
-8.1
%
-
679
749
-9.3
%
-5.5
%
-3.8
%
1,647
1,803
-8.6
%
-7.0
%
-1.6
%
38
41
-7.4
%
-7.4
%
-
110
136
-18.9
%
-15.2
%
-3.7
%
148
177
-16.3
%
-13.4
%
-2.9
%
625
765
-18.2
%
-18.2
%
-
277
292
-4.9
%
-1.1
%
-3.8
%
903
1,056
-14.5
%
-13.5
%
-1.0
%
276
191
45.0
%
45.0
%
-
43
34
25.0
%
31.7
%
-6.7
%
320
225
41.9
%
42.9
%
-1.0
%
28
58
-50.6
%
-50.6
%
-
248
287
-13.4
%
-9.8
%
-3.6
%
277
345
-19.6
%
-16.7
%
-2.9
%
REPORTED SALES vs. PRIOR PERIOD ($MM)
2025
2024
Reported
Operational (1)
Currency
744
766
-2.9
%
-2.9
%
-
281
283
-0.6
%
3.2
%
-3.8
%
1,025
1,049
-2.3
%
-1.2
%
-1.1
%
363
356
2.1
%
2.1
%
-
159
169
-6.0
%
-2.5
%
-3.5
%
522
524
-0.5
%
0.6
%
-1.1
%
365
392
-6.9
%
-6.9
%
-
86
76
13.4
%
17.5
%
-4.1
%
451
468
-3.6
%
-2.9
%
-0.7
%
15
18
-12.7
%
-12.7
%
-
37
39
-4.6
%
-0.3
%
-4.3
%
52
56
-7.2
%
-4.3
%
-2.9
%
315
324
-2.8
%
-2.8
%
-
487
497
-1.9
%
1.9
%
-3.8
%
802
821
-2.2
%
0.1
%
-2.3
%
8
8
-1.3
%
-1.3
%
-
350
315
11.0
%
14.7
%
-3.7
%
358
323
10.7
%
14.3
%
-3.6
%
305
314
-2.9
%
-2.9
%
-
98
104
-6.2
%
-0.6
%
-5.6
%
403
418
-3.7
%
-2.3
%
-1.4
%
2
2
7.7
%
7.7
%
-
39
77
-48.8
%
-47.0
%
-1.8
%
41
78
-47.6
%
-45.9
%
-1.7
%
855
631
35.4
%
35.4
%
-
158
197
-19.7
%
-15.3
%
-4.4
%
1,013
829
22.3
%
23.4
%
-1.1
%
690
518
33.3
%
33.3
%
-
-
-
-
-
-
690
518
33.3
%
33.3
%
-
165
114
45.0
%
45.0
%
-
158
197
-19.7
%
-15.3
%
-4.4
%
323
311
3.9
%
6.7
%
-2.8
%
8,092
7,612
6.3
%
6.3
%
-
5,781
5,950
-2.9
%
1.5
%
-4.4
%
$ 13,873
13,562
2.3
%
4.2
%
-1.9
%
REPORTED SALES vs. PRIOR PERIOD ($MM)
FIRST QUARTER
% Change
2025
2024
Reported
Operational (1)
Currency
$ 1,261
1,025
23.0
%
23.0
%
-
842
781
7.8
%
10.7
%
-2.9
%
2,103
1,806
16.4
%
17.7
%
-1.3
%
684
692
-1.1
%
-1.1
%
-
638
652
-2.0
%
0.7
%
-2.7
%
1,323
1,344
-1.6
%
-0.2
%
-1.4
%
339
303
11.9
%
11.9
%
-
81
67
19.7
%
23.6
%
-3.9
%
420
371
13.3
%
14.0
%
-0.7
%
206
-
*
*
-
52
-
*
*
-
258
-
*
*
-
32
30
7.1
%
7.1
%
-
72
62
15.1
%
17.4
%
-2.3
%
103
92
12.5
%
14.1
%
-1.6
%
1,384
1,448
-4.4
%
-4.4
%
-
857
892
-3.9
%
-0.9
%
-3.0
%
2,241
2,340
-4.2
%
-3.1
%
-1.1
%
263
270
-2.5
%
-2.5
%
-
146
152
-4.0
%
-0.8
%
-3.2
%
409
422
-3.1
%
-1.9
%
-1.2
%
231
242
-4.3
%
-4.3
%
-
158
160
-1.0
%
2.1
%
-3.1
%
389
401
-3.0
%
-1.7
%
-1.3
%
502
504
-0.5
%
-0.5
%
-
270
261
3.7
%
7.2
%
-3.5
%
772
765
0.9
%
2.1
%
-1.2
%
388
432
-10.2
%
-10.2
%
-
283
320
-11.6
%
-8.9
%
-2.7
%
671
752
-10.8
%
-9.7
%
-1.1
%
REPORTED SALES vs. PRIOR PERIOD ($MM)
FIRST QUARTER
% Change
2025
2024
Reported
Operational (1)
Currency
1,002
987
1.5
%
1.5
%
-
1,394
1,429
-2.5
%
0.8
%
-3.3
%
2,396
2,416
-0.8
%
1.1
%
-1.9
%
457
446
2.7
%
2.7
%
-
616
641
-4.0
%
-1.0
%
-3.0
%
1,073
1,087
-1.2
%
0.5
%
-1.7
%
544
542
0.5
%
0.5
%
-
778
788
-1.2
%
2.3
%
-3.5
%
1,323
1,330
-0.5
%
1.6
%
-2.1
%
566
547
3.4
%
3.4
%
-
713
710
0.4
%
3.9
%
-3.5
%
1,279
1,258
1.7
%
3.7
%
-2.0
%
452
438
3.1
%
3.1
%
-
467
472
-1.1
%
2.4
%
-3.5
%
919
910
1.0
%
2.7
%
-1.7
%
114
110
4.3
%
4.3
%
-
246
238
3.4
%
7.1
%
-3.7
%
361
348
3.7
%
6.2
%
-2.5
%
4,213
4,008
5.1
%
5.1
%
-
3,807
3,813
-0.2
%
3.0
%
-3.2
%
$ 8,020
7,821
2.5
%
4.1
%
-1.6
%
2023
2024
2024
Full Year
Q1
Q2
Q3
Q4
Full Year
66
36
52
68
101
257
27
11
17
21
21
70
93
47
69
89
122
327
56
50
59
64
68
241
7
8
9
12
17
46
63
58
69
75
85
287
93
33
37
36
39
145
235
41
45
50
36
172
328
73
83
86
75
317
1,292
356
376
417
408
1,557
681
169
171
166
162
668
1,973
524
548
583
570
2,225
79
18
17
21
19
75
182
39
49
39
38
165
260
56
67
60
57
240
19
2
5
3
1
11
1,395
77
227
54
43
401
1,414
78
233
56
45
412
First Quarter March 30, 2025 GAAP
Intangible asset amortization
Litigation related
Restructuring related
Acquisition, integration and divestiture related
(Loss)/gain on securities
Tax legislation and other tax related
First Quarter March 30, 2025 Non-GAAP
$
4,020
(649
)
3,371
2,261
2,261
2,548
2,548
(166
)
-
-
-
(20
)
(18
)
-
(204
)
5,210
649
-
-
20
18
-
5,897
First Quarter March 30, 2025 GAAP
Intangible asset amortization
Litigation related
Restructuring related
Acquisition, integration and divestiture related
(Loss)/gain on securities
Tax legislation and other tax related
First Quarter March 30, 2025 Non-GAAP
$
3,326
(471
)
(8
)
(52
)
2,795
2,656
2,656
677
(6
)
671
(60
)
-
-
(47
)
(54
)
(21
)
-
(182
)
1,421
471
-
55
112
21
-
2,080
First Quarter March 30, 2025 GAAP
Intangible asset amortization
Litigation related
Restructuring related
Acquisition, integration and divestiture related
(Loss)/gain on securities
Tax legislation and other tax related
First Quarter March 30, 2025 Non-GAAP
$
11
11
195
195
-
(7,206
)
-
6,966
-
-
-
-
(240
)
7,000
-
(6,966
)
-
-
-
-
34
First Quarter March 30, 2025 GAAP
Intangible asset amortization
Litigation related
Restructuring related
Acquisition, integration and divestiture related
(Loss)/gain on securities
Tax legislation and other tax related
First Quarter March 30, 2025 Non-GAAP
$
7,357
(1,120
)
(8
)
(52
)
-
6,177
5,112
5,112
3,225
(6
)
3,219
(7,321
)
-
6,966
(30
)
(74
)
(39
)
(498
)
-
-
(128
)
(128
)
17
(17
)
-
13,631
1,120
(6,966
)
55
132
39
-
8,011
2,632
188
(1,553
)
11
30
9
(12
)
1,305
10,999
932
(5,413
)
44
102
30
12
6,706
$
3,370
(698
)
(2
)
2,670
2,438
2,438
2,896
(7
)
2,889
(111
)
(144
)
(47
)
55
(247
)
4,969
698
-
144
47
(55
)
-
9
-
5,812
$
3,120
(380
)
(7
)
(20
)
2,713
2,582
(4
)
2,578
646
(18
)
(27
)
601
(47
)
(20
)
(43
)
(22
)
(132
)
1,520
380
-
27
61
22
51
-
-
2,061
$
21
21
237
237
-
-
2,517
(2,726
)
(40
)
(13
)
(262
)
(2,775
)
-
2,726
-
40
13
-
-
-
4
$
6,511
(1,078
)
(7
)
(20
)
(2
)
5,404
5,257
(4
)
5,253
3,542
(18
)
(27
)
(7
)
3,490
2,404
(2,726
)
(130
)
20
(432
)
-
-
(209
)
(209
)
164
(164
)
-
3,714
1,078
2,726
171
148
(20
)
51
9
-
7,877
459
148
627
39
38
(7
)
9
2
(18
)
1,297
3,255
930
2,099
132
110
(13
)
42
7
18
6,580
Media contact: media-relations@its.jnj.com
Investor contact: investor-relations@its.jnj.com
Clinical ResultPhase 3Breakthrough TherapyDrug ApprovalFinancial Statement
11 Apr 2025
Today, a brief rundown of news involving Amgen and the Parker Institute, as well as updates from J&J, Alzheon and Amylyx Pharmaceuticals that you may have missed.Amgens bispecific cancer antibody Imdelltra helped people with previously treated small cell lung cancer live longer than those who received chemotherapy, the company said Friday. The conclusion was made at an interim analysis of the Phase 3 DeLLphi-304 trial, which enrolled 500 people around the world and randomized half to receive Imdelltra and half to receive standard-of-care chemotherapy. Amgen didnt disclose specific data, but said treatment with Imdelltra led to a statistically significant and clinically meaningful improvement in survival. The data, if confirmed, could help it convert Imdelltras conditional U.S. approval into a full clearance. Jonathan GardnerThe Parker Institute for Cancer Immunotherapy has appointed two well-known researchers to its leadership in recent weeks. In March, the institute announced its new CEO would be Karen Knudsen, who recently served as the CEO of the American Cancer Society and its Cancer Action Network. And on Thursday the Parker Institute appointed Ira Mellman as its president of research. A Genentech veteran, Mellman played a major role in the development of new cancer medicines such as anti-TIGIT antibodies, patient-specific neo-antigen mRNA and DNA vaccines and the immunotherapy Tecentriq, which has been on the market for years. Delilah AlvaradoJohnson & Johnsons experimental autoimmune drug icotrokinra helped 84% of adolescents with psoriasis achieve clear or nearly clear skin after 16 weeks, compared with 27% of those receiving a placebo, the company said Thursday. The data came from an analysis presented at the World Congress of Pediatric Dermatology of the ICONIC-LEAD trial, which enrolled adolescents aged 12 and older along with adults to test the oral peptide drug. Icotrokinra targets IL-23, and if approved, would offer an oral alternative to injectable drugs like AbbVies Skyrizi and J&Js own Tremfya in the skin condition. J&J is developing the drug as part of a collaboration with Protagonist Therapeutics. Jonathan GardnerAlzehons experimental Alzheimers disease drug valiltramiprosate failed to delay cognitive decline in a trial of people with genetic mutations that lead to early onset of the disease, the company said Thursday. The Phase 3 trial enrolled 325 early Alzheimers patients with two copies of the 4 allele of the apolipoprotein E gene and randomized them to take valiltramiprosate or placebo. Researchers found no difference between people given the drug versus those on placebo when examining a measure called ADAS-Cog13, nor on any of the studys secondary endpoints. Trial investigators identified a nominal benefit on ADAS-Cog13 and two other measures among participants who were categorized as having mild cognitive impairment. That difference didnt meet pre-specified statistical analysis goals, however, and would likely need to be confirmed by additional trials before regulators would review valiltramiprosate. Jonathan GardnerAmylyx Pharmaceuticals on Wednesday said it dosed the first participant in a Phase 1 trial of a new treatment for ALS. The company, which previously pulled the ALS drug Relyvrio from market and switched its R&D focus, is looking again to target the neurodegenerative condition. Known as Lumina, the trial will evaluate the tolerability, safety, pharmacokinetics, and pharmacodynamics of Amylyxs new experimental drug, an antisense oligonucleotide targeting the protease calpain-2. The trial will enroll 48 individuals with ALS in the U.S. who will be randomized 3-to-1 to receive either placebo or Amylyxs drug. Early data from the trial is expected this year. Delilah Alvarado '
Phase 3Clinical ResultExecutive ChangeOligonucleotidePhase 1
10 Apr 2025
ICONIC-LEAD is the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis to assess safety and efficacy of a systemic therapy in adolescents and adults simultaneously
84% of adolescents with moderate-to-severe plaque psoriasis treated with investigational icotrokinra achieved clear or almost clear skin (IGA 0/1) at Week 16
SPRING HOUSE, PA, USA I April 10, 2025 I
Johnson & Johnson (NYSE:
JNJ
) today announced new icotrokinra (JNJ-2113) data from a subgroup analysis of ICONIC-LEAD
a
, the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis (PsO) to assess efficacy and safety of a systemic therapy in adolescents and adults simultaneously. These data, presented at the 2025 World Congress of Pediatric Dermatology (WCPD) Annual Meeting, show adolescents 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.
1
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor and is being studied in adults and adolescents 12 years of age and older with moderate-to-severe plaque PsO.
In the study, 84.1% of adolescent patients treated with once daily icotrokinra achieved an Investigator’s Global Assessment (IGA)
b
score of 0/1 (clear or almost clear skin) and 70.5% achieved a Psoriasis Area and Severity Index (PASI)
c
90 response, compared to 27.3% and 13.6% receiving placebo, respectively, at Week 16.
1
Response rates continued to improve through Week 24 where 86.4% of adolescents achieved IGA 0/1 (clear or almost clear skin) and 88.6% achieved PASI 90.
1
Further, at Week 24, 75% of adolescents achieved IGA 0 (completely clear skin) and 63.6% achieved PASI 100.
1
“Data from the Phase 3 ICONIC LEAD subgroup analysis demonstrate impressive efficacy rates, showing the promise of this novel therapeutic option in the treatment of adolescents with moderate-to-severe plaque psoriasis who’ve often not yet received an advanced therapy,” said Lawrence Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital-San Diego, and Professor of Pediatrics and Medicine (Dermatology), at the University of California, San Diego (UCSD) School of Medicine, ICONIC-LEAD presenter.
d
“Young patients with plaque psoriasis face unique challenges due to the visible and uncomfortable nature of the disease, making effective treatment options that align with their needs and preferences all the more important.”
Icotrokinra demonstrated a favorable safety profile. At Week 16, 50% of adolescents treated with icotrokinra experienced ≥1 adverse event (AE), compared to 73% of adolescents receiving placebo, with no new safety signals identified.
1
“Adolescents living with moderate to severe plaque psoriasis shouldn’t have to wait for effective treatments options that have the potential to deliver completely clear skin, which is the driving force for studying this younger population as part of the pivotal ICONIC program,” said Liza O’Dowd, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine. “These data underscore the promise of next-generation therapies and the potential for icotrokinra to offer adolescents with moderate-to-severe plaque psoriasis the unique combination of a favorable safety profile and complete skin clearance in a once-daily pill.”
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. 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.
2
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.
3
PASI 90 corresponds to an improvement of >=90% in PASI score from baseline.
3
d. Dr. Lawrence Eichenfield is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.
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.
4
ICONIC-LEAD (
NCT06095115
) is a randomized controlled trial (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.
5
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.
6
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.
7,8
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. will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.
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.
9
It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.
10
Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.
11
On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale.
11
On skin of color, the plaques may appear darker and thicker and more of a purple, gray or dark brown color.
12
Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.
12
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.
12
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.
12,13
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,
14
which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.
15,16
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.
17
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.
18
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.
19,20,21
Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis and 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.
1 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.
2 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.
3 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 April 2025.
4 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 April 2025.
5 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 April 2025
6 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 April 2025.
7 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 April 2025.
8 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 April 2025.
9 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed April 2025.
10 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed April 2025.
11 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/.Accessed April 2025.
12 National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed April 2025.
13 National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed April 2025.
14 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.
15 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.
16 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
17 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.
18 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 April 2025.
19 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 April 2025.
20 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 April 2025.
21 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 April 2025
.
SOURCE:
Johnson & Johnson
Clinical ResultPhase 3Phase 2License out/inPhase 1
100 Deals associated with Icotrokinra
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Arthritis, Psoriatic | Phase 3 | United States | 09 Jan 2025 | |
| Arthritis, Psoriatic | Phase 3 | China | 09 Jan 2025 | |
| Arthritis, Psoriatic | Phase 3 | Japan | 09 Jan 2025 | |
| Arthritis, Psoriatic | Phase 3 | Argentina | 09 Jan 2025 | |
| Arthritis, Psoriatic | Phase 3 | Australia | 09 Jan 2025 | |
| Arthritis, Psoriatic | Phase 3 | Brazil | 09 Jan 2025 | |
| Arthritis, Psoriatic | Phase 3 | Bulgaria | 09 Jan 2025 | |
| Arthritis, Psoriatic | Phase 3 | Canada | 09 Jan 2025 | |
| Arthritis, Psoriatic | Phase 3 | Czechia | 09 Jan 2025 | |
| Arthritis, Psoriatic | Phase 3 | Denmark | 09 Jan 2025 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 3 | - | votjxpgawi(kixaoyacxd) = psforpcdgq jtvdrwfonu (sgiulnaekb ) View more | Positive | 10 Apr 2025 | |||
Placebo | votjxpgawi(kixaoyacxd) = nleqckscay jtvdrwfonu (sgiulnaekb ) View more | ||||||
Phase 2 | 252 | mccsvqdhnj(iimkldbtlz) = ttkcwqeduy rlluooxyxq (kiknzthwch ) Met View more | Positive | 10 Mar 2025 | |||
Placebo | mccsvqdhnj(iimkldbtlz) = xjxzqyaunv rlluooxyxq (kiknzthwch ) Met View more | ||||||
Phase 3 | - | vibsxdlbbf(astmxhekxa) = positive topline results from the Phase 3 ICONIC-TOTAL study showed once-daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo. sdufzinymd (qmvvabwsgw ) Met | Positive | 18 Nov 2024 | |||
Placebo | |||||||
Phase 3 | - | akvuorofim(rcfchqljfs) = jsjmxqyvjk xjuncxjvaa (xbqvulglrj ) Met View more | Positive | 18 Nov 2024 | |||
Placebo | akvuorofim(rcfchqljfs) = ipqivdhgvp xjuncxjvaa (xbqvulglrj ) Met View more | ||||||
Phase 2 | 227 | ydpadovqlz(fryjhpvrfg) = unogjqciof lzybiqnqyy (sichebgkfo ) View more | Positive | 09 Mar 2024 | |||
Phase 2 | 255 | JNJ-77242113 25 mg once daily | ebwkubopte(oflhsaybhf) = jnrwupycxf ixzltyjfhi (frpubjzwcg ) Met | Positive | 08 Feb 2024 | ||
JNJ-77242113 25 mg twice daily | ebwkubopte(oflhsaybhf) = lfrhajjnrd ixzltyjfhi (frpubjzwcg ) Met | ||||||
Phase 2 | 255 | xnbtvaugzi(lxvzqbzadl) = hltdefkpcz tbdwlazqpc (fafgkfkqbg ) Met View more | Positive | 04 Jul 2023 | |||
xnbtvaugzi(lxvzqbzadl) = mevkhuliyo tbdwlazqpc (fafgkfkqbg ) Met View more | |||||||
Phase 2 | 48 | Placebo (Placebo) | osddbujkvp(xiibfehszy) = dmatisoqls lrvmiocjvz (sfnvythkbk, 94.71) View more | - | 09 Dec 2022 | ||
(JNJ-67864238) | osddbujkvp(xiibfehszy) = wvpiwqpurs lrvmiocjvz (sfnvythkbk, 124.94) View more | ||||||
Not Applicable | - | - | owlfyfhuxf(yosfzbcqqk) = latejbmwca kqaelauiuj (knowewtqcl, 0.81) View more | - | 01 Oct 2019 | ||
owlfyfhuxf(yosfzbcqqk) = bjyithdbnl kqaelauiuj (knowewtqcl, 1.23) View more |
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