Delving into the Latest Updates on Icotrokinra with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide, Cyclic Peptide

Synonyms

伊科托金拉, 依可替金拉, 艾克罗金特罗

+ [11]

Target

IL-23R

Action

inhibitors

Mechanism

IL-23R inhibitors(Interleukin 23 Receptor inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesOther Diseases+ [2]

Active Indication

Plaque psoriasisCrohn DiseaseColitis, Ulcerative+ [5]

Inactive Indication-

Originator Organization

Janssen Biotech, Inc.

Active Organization

Janssen Research & Development LLC

Johnson & Johnson (China) Investment Ltd.

Janssen Pharmaceutica NV

+ [7]

Inactive Organization

Protagonist Therapeutics, Inc.

License Organization

Protagonist Therapeutics, Inc.

Janssen Biotech, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (17 Mar 2026),

Plaque psoriasis

RegulationPriority Review (China)

Login to view timeline

Structure/Sequence

Sequence Code 1311911322

Source: *****

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).

Start Date01 Oct 2025

Sponsor / Collaborator

Janssen Research & Development LLC

CTIS2025-521005-41-00

/ Active, not recruitingPhase 1

A three-part trial in healthy volunteers to find out how long icotrokinra stays in and acts on the body when administered as different tablet formulations and under different food conditions

Start Date30 Jun 2025

Sponsor / Collaborator-

100 Clinical Results associated with Icotrokinra

Login to view more data

100 Translational Medicine associated with Icotrokinra

Login to view more data

100 Patents (Medical) associated with Icotrokinra

Login to view more data

23

Literatures (Medical) associated with Icotrokinra

01 Jun 2026·INTERNATIONAL JOURNAL OF DERMATOLOGY

Editor's Highlights—June 2026

Article

Author: Kemény, Lajos

ABSTRACT:

Major advances have broadened the therapeutic landscape of inflammatory skin diseases. In psoriasis, alongside the tyrosine kinase 2 (TYK2) inhibitor deucravacitinib, the United States Food and Drug Administration (FDA) has approved the first oral interleukin‐23 (IL‐23) receptor antagonist peptide, icotrokinra. In atopic dermatitis, new data have emerged on stapokibart, an interleukin‐4 receptor alpha subunit (IL‐4Rα) inhibitor introduced in China. In hidradenitis suppurativa, glucagon‐like peptide‐1 receptor agonists (GLP‐1 RA) are also gaining increasing attention as adjunctive therapy.

01 Jun 2026·INFLAMMOPHARMACOLOGY

A novel oral interleukin-23 receptor antagonist peptide, icotrokinra, for moderate-to- severe plaque psoriasis: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Fonseca, Lorena Oliveira ; Tyring, Stephen K ; Ghanem, Laura ; Onejeme, Chinenye ; Cevallos-Cueva, Martin

BACKGROUND:

Icotrokinra represents a novel therapeutic approach that may address limitations associated with current injectable biologic therapies, including storage requirements and self-administration complexity, and may benefit patients who have needle aversion.

METHODS:

We included five randomized controlled trials (RCTs) comparing icotrokinra with placebo. PubMed, Embase, and Cochrane CENTRAL were systematically searched from inception to November 2025. Primary outcomes included the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear skin) or 1 (minimal disease) and an IGA score of 0 at weeks 4, 8 and 16; a scalp-specific IGA (ss-IGA) score of 0 or 1 at weeks 8 and 16; and at least 75%, 90%, and 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75, PASI 90, and PASI 100) at weeks 4, 8 and 16. Patient-reported outcomes included the Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0 at weeks 8 and 16. Safety outcomes were also assessed. Secondary analyses involved subgroup evaluations of icotrokinra 200 mg once daily.

RESULTS:

Across five included RCTs, 1509 (54.77%) patients received icotrokinra. Icotrokinra significantly increased the likelihood of achieving an IGA score of 0 or1 at week 4 (OR 7.08; 95% CI 4.33 to 11.55; P < 0.001), week 8 (OR 13.29; 95% CI 9.19 to 19.21; P < 0.001), and week 16 (OR 18.76; 95% CI 13.88 to 25.36; P < 0.001). Consistent findings were observed for PASI 90 at week 4 (OR 10.30; 95% CI 2.54 to 41.81; P = 0.003), week 8 (OR 28.65; 95% CI 11.60 to 70.75; P < 0.001),and week 16 (OR 27.14; 95% CI 16.66 to 44.22; P < 0.001). For high-impact, difficult-to-treat sites, icotrokinra significantly increased the likelihood of achieving a ss-IGA score of 0 or 1 at week 8 (OR 7.56; 95% CI 5.73 to 9.96; P < 0.001) and week 16 (OR 9.61; 95% CI 7.00 to 13.20; P < 0.001). Neither the incidence of serious adverse events (OR 0.63; 95% CI 0.29 to 1.34; P = 0.23) nor malignancy (OR 2.61; 95% CI 0.30 to 22.56; P = 0.82) was significantly different between groups.

CONCLUSIONS:

Icotrokinra demonstrated a favorable short-term efficacy and an acceptable safety profile compared to placebo in patients with moderate-to-severe plaque psoriasis, including meaningful responses in high-impact sites, supporting its potential as a promising oral therapeutic option. Long-term studies and comparative trials against current injectable biologic therapies are warranted to better define its place in the therapeutic armamentarium.

01 Jun 2026·INTERNATIONAL JOURNAL OF DERMATOLOGY

Efficacy and Safety of Oral Icotrokinra in Moderate‐to‐Severe Plaque Psoriasis: A Systematic Review, Meta‐Analysis, and Trial Sequential Analysis

Review

Author: Alfeetouri, Mohamed Yaseen ; Lateiresh, Munder ; Zouaoui, Yassine ; Marwan, Lutfiyah ; Elhadi, Muhammed ; Altayf, Alhasan

ABSTRACT:

Oral therapies for moderate‐to‐severe plaque psoriasis are limited by modest efficacy or safety concerns. Icotrokinra is a novel oral interleukin‐23 receptor antagonist peptide that has shown promising efficacy in randomized trials. This study aimed to systematically evaluate the efficacy and safety of icotrokinra in patients with moderate‐to‐severe plaque psoriasis. A systematic review and meta‐analysis of randomized controlled trials (RCTs) comparing icotrokinra 200 mg once daily with placebo was conducted in accordance with PRISMA 2020 guidelines. The primary outcome was achievement of a ≥ 75% reduction in Psoriasis Area and Severity Index (PASI 75) at Week 16. Random‐effects models were used to calculate odds ratios (ORs) with 95% confidence intervals (CIs), and trial sequential analysis was performed. Five RCTs, including 1951 participants, were analyzed. Icotrokinra 200 mg once daily significantly increased PASI 75 response rates compared with placebo at Week 4 (15% vs. 2%; OR = 6.57, 95% CI 3.66–11.81; p < 0.0001) and Week 16 (73% vs. 11%; OR = 22.03, 95% CI 16.13–30.10; p < 0.0001). Higher clearance thresholds also favored icotrokinra, including PASI 90 (54% vs. 4%; OR = 28.24) and PASI 100 (30% vs. 1%; OR = 45.86). The incidence of adverse events, serious adverse events, and infections did not differ significantly between groups. Icotrokinra is an effective and well‐tolerated oral treatment for moderate‐to‐severe plaque psoriasis, offering rapid and sustained clinical benefit with a safety profile comparable to placebo. It represents a promising oral option bridging the gap between existing oral therapies and biologics. image

226

News (Medical) associated with Icotrokinra

17 Jul 2026

·www.biospace.com

Protagonist Therapeutics Reports Granting of Inducement Awards - July 16, 2026

NEWARK, CA / ACCESS Newswire / July 16, 2026 / Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today reported that on July 15, 2026, it granted inducement awards to three recently hired employees in accordance with the terms of their employment offer letters. The awards were granted under the Protagonist Therapeutics Amended and Restated Inducement Plan, which was adopted May 29, 2018, and amended February 18, 2020 and February 15, 2022. The new employees received, in the aggregate, options to purchase 12,600 shares of Protagonist Therapeutics common stock and restricted stock units (RSUs) to acquire 3,330 shares of Protagonist Therapeutics common stock. The exercise price of the options is $135.46, which is equal to the per-share closing price of Protagonist Therapeutics common stock on the Nasdaq Global Market on July 15, 2026. The shares subject to each option vest over a four-year period, with 25 percent of the shares subject to the option vesting on the first anniversary of each employee's date of hire and the remainder vesting in equal monthly installments over three years thereafter. One-fourth of the shares underlying the RSUs will vest annually over a four-year period. The awards were approved by the compensation committee of the Company's board of directors and were granted as a material inducement to each employee entering into employment with the Company in accordance with Nasdaq Marketplace Rule 5635(c)(4). About Protagonist Protagonist Therapeutics is a discovery-through-late-stage development biopharmaceutical company with a proprietary technology platform that enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026, is approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further development and commercialization. Protagonist also discovered and led development through Phase 3 of rusfertide, a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceuticals. An NDA for rusfertide for the treatment of polycythemia vera is under priority review with the FDA. The Company also has a number of clinical and preclinical programs addressing clinically and commercially validated targets, including an oral IL-17 antagonist peptide, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at . Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com +1 212 915 2577 Media Relations Contact Virginia Amann ENTENTE Network of Companies virginiaamann@ententeinc.com +1 833 500 0061 ext 1 View the original press release on ACCESS Newswire SOURCE: Protagonist Therapeutics View the original press release on ACCESS Newswire

Phase 3NDADrug ApprovalPriority Review

15 Jul 2026

·www.fiercepharma.com

No patent protection for Stelara? No problem for J&J as Tremfya fills the void

After a 7% increase in revenue for the second quarter, which came on the heels of a 10% gain in Q1, Johnson & Johnson has bumped up its annual sales guidance. The company now projects 2026 revenue at the midpoint to land at $101.1 billion, versus a prior midpoint estimate of $100.8 billion. Much of the credit for J&J’s recent performance can be attributed to the resilience of its immunology portfolio, which took a massive hit with the loss of patent protection in the United States for Stelara, its top-selling drug in 2024 at $10.4 billion. Stelara saw its sales decline to $6.7 billion last year. Despite this, J&J has now pieced together five straight quarters of at least 6% revenue growth. In Q2, there was more evidence of the slide of Stelara, with worldwide sales falling (PDF) 55% to $740 million. But compensating for nearly all of that decline was J&J’s new immunology juggernaut Tremfya, which pulled off a 72% sales increase for the period. While Stelara’s worldwide sales dropped by $913 million year over year, those for Tremfya increased by $862 million to $2.05 billion. “The major driver here is our performance in ulcerative colitis and in Crohn’s disease,” Jennifer Taubert, J&J’s innovative medicines chief, said during a conference call, pointing out that Tremfya is attracting more than half of the new patients in both inflammatory bowel disease (IBD) indications as it battles AbbVie’s rival IL-23 med Skyrizi. “We have got an awful lot of growth potential ahead for Tremfya in IBD,” Taubert added. “And as a reminder, back when we had Stelara here, over 75% of Stelara sales were in IBD. There is absolutely no reason why Tremfya can’t do that or even more.” Also in the immunology arena, J&J touted the launch of its newest Il-23 inhibitor, Icotyde, which was approved by the FDA four months ago for plaque psoriasis as a daily pill option in a market flooded with injected biologics. With the launch so new, the company did not specify sales but did say that Icotyde has attracted more than 18,000 prescriptions for 11,000 patients across 6,000 unique prescribers. “That tells us that there’s really good confidence in the product in both the efficacy and safety profile as well as the simplicity of the once-daily pill,” Taubert said. Icotyde and Tremfya give J&J "differentiated oral and biologic approaches across dermatology and potentially IBD," Citi analyst Geoffrey Meacham wrote in a note to clients. "Icotyde momentum and a traditionally stronger second half also contributed to the guidance raise." For the quarter, J&J’s sales came to $25.3 billion, which puts the company on track to top the $100 billion mark for the first time in its 140-year history, CEO Joaquin Duato pointed out on the conference call. He also highlighted the company’s 28 “platforms” that deliver at least $1 billion in sales. Doing much of the remaining heavy lifting for J&J in the second quarter were its oncology drugs, with the portfolio achieving a 17% year-over-year sales increase. Multiple myeloma powerhouse Darzalex was up 19% in the period to $4.2 billion. Meanwhile, J&J’s newer multiple myeloma treatments are also making major gains, with Talvey up 63% to $174 million, Tecvayli up 56% to $260 million and Carvykti up 49% to $657 million. For the quarter, J&J’s oncology drugs amassed sales of $7.4 billion altogether. “We’re on track to become the No. 1 oncology company by 2030 with sales projected to exceed $50 billion,” Duato said.

Drug ApprovalBiosimilar

15 Jul 2026

·firstwordpharma.com

Tremfya surges, Icotyde gains ground as J&J raises bar for 2026

Johnson & Johnson on Wednesday lifted its sales guidance for the year as psoriasis treatments Tremfya and oral newcomer Icotyde are doing heavy work to help offset steep biosimilar erosion for Stelara.Tremfya, an IL-23 inhibitor, beat analyst projections with $2 billion in second-quarter sales, a gain of 72.5% year-over-year, while the company said early uptake of Icotyde, which was approved by the FDA in March, has surpassed expectations. On the flip side, Stelara's second-quarter sales fell 55.2% to $740 million."We're extremely thrilled with the launch of Icotyde for the first 90 days," Chief Financial Officer Joe Wolk told Barron's. "It's exceeding almost any product launch that we've seen in recent memory."Speaking on the earnings call, Jennifer Taubert, J&J's worldwide chairman of Innovative Medicine, said the launch of Icotyde hasn't come at Tremfya's expense either.Over 18,000 prescriptions"We've got this great uptick in Icotyde. This has not slowed down Tremfya in psoriatic disease at all," she said. "In terms of really co-positioning, Icotyde is the first-choice systemic treatment... For Tremfya, we think it's the first-choice biologic, particularly for patients that have potential for or have any psoriatic arthritis involvement…[These are] really distinct and unique positions for both."According to Taubert, over 18,000 prescriptions for Icotyde have been written to date for a total of 11,000 patients (see – Vital Signs: J&J maps megablockbuster trajectory for oral peptide). "That's an update from the 10,000 just shortly," she said. "There are 6000 unique prescribers, and if you take a look at those, over 50% are actually advanced practice providers."Pharma unit milestoneQuarterly sales for J&J's oncology portfolio grew 17.3% to $7.4 billion driven by products like Darzalex ($4.2 billion, +18.9%), Carvykti ($657 million. +49.4%) and Tecvayli ($260 million, +56.5%). Neuroscience therapies such as Spravato ($584 million, +40.8%) and Caplyta ($361 million, +70.9%) also saw significant growth."I think the second quarter was just an affirmation of the first quarter," Wolk said. "Our pharmaceutical unit continues to thrive, surpassing $16 billion in sales for the first time ever in the company's history."More to follow.

Drug ApprovalBiosimilar

100 Deals associated with Icotrokinra

Login to view more data

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Plaque psoriasis	United States	Janssen Biotech, Inc.	17 Mar 2026

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	NDA/BLA	Canada	Janssen, Inc.	01 Dec 2025
Colitis, Ulcerative	Phase 3	United States	Janssen Research & Development LLC	01 Oct 2025
Colitis, Ulcerative	Phase 3	United States	Janssen Pharmaceutica NV	01 Oct 2025
Colitis, Ulcerative	Phase 3	China	Janssen Research & Development LLC	01 Oct 2025
Colitis, Ulcerative	Phase 3	Japan	Janssen Research & Development LLC	01 Oct 2025
Colitis, Ulcerative	Phase 3	Japan	Janssen Pharmaceutica NV	01 Oct 2025
Colitis, Ulcerative	Phase 3	Argentina	Janssen Research & Development LLC	01 Oct 2025
Colitis, Ulcerative	Phase 3	Argentina	Janssen Pharmaceutica NV	01 Oct 2025
Colitis, Ulcerative	Phase 3	Australia	Janssen Research & Development LLC	01 Oct 2025
Colitis, Ulcerative	Phase 3	Australia	Janssen Pharmaceutica NV	01 Oct 2025

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06220604 (ICONIC-ADVANCE 2 \| PSO-2, CTgov)	Phase 3	Plaque psoriasis	731	Placebo+JNJ-77242113 (Arm 1: Placebo Followed by JNJ-77242113 200 mg)	aqfcvhvhnd = cgzxjmocfr lcrpykhpxq (oawqumxhzw, bqkfxqabbr - nmbiryfnul) View more	-	25 Jun 2026
				JNJ-77242113 (Arm 2: JNJ-77242113 200 mg)	aqfcvhvhnd = sjvhtsnjtw lcrpykhpxq (oawqumxhzw, kierrubeux - vdcmuoxliy) View more
NCT06095102 (ICONIC-TOTAL \| PSO-4, CTgov)	Phase 3	Plaque psoriasis	311	placebo+JNJ-77242113 (Arm 1: Placebo)	bmpuvusjms = ccynsnktvi hgeslfkivu (xbnqpzjpvl, lsxlgjimwb - wqpksvusnv) View more	-	25 Jun 2026
				JNJ-77242113 (Arm 2: JNJ-77242113 200 mg)	bmpuvusjms = comynnduxf hgeslfkivu (xbnqpzjpvl, pzekijqozf - pegsvsvqaw) View more
NCT06143878 (ICONIC-ADVANCE 1 \| PSO-1, CTgov)	Phase 3	Plaque psoriasis	774	Placebo+JNJ-77242113 (Arm 1: Placebo Followed by JNJ-77242113 200 mg)	ccckegnoen = midaagtohb tcfgeajwqy (vixnyygasa, wgdnhcqcln - mgxjeycxmr) View more	-	25 Jun 2026
				JNJ-77242113 (Arm 2: JNJ-77242113 200 mg)	ccckegnoen = ppwygylswg tcfgeajwqy (vixnyygasa, uehogyegpq - sirandhkli) View more
ICONIC-LEAD (EULAR2026)	Phase 3	Plaque psoriasis	1,343	Icotrokinra 200 mg	gbtyecvbdv(ujhbafzprd) = cpbzztlzvg dndlnysrjn (gxvfojcxae ) View more	Positive	11 Jun 2026
				Placebo	gbtyecvbdv(ujhbafzprd) = sdbhvjxyss dndlnysrjn (gxvfojcxae ) View more
NCT06095115 (ICONIC-LEAD, EULAR2026)	Phase 3	Plaque psoriasis \| Arthritis, Psoriatic IL-23 receptor	216	Icotrokinra 200 mg	qppehjlxca(iddqvpljtr) = ymgyywvost fcugblrmrl (uekoujoafn ) View more	Positive	11 Jun 2026
				Placebo	qppehjlxca(iddqvpljtr) = zkelojbgta fcugblrmrl (uekoujoafn ) View more
NCT06095115 (ICONIC-LEAD \| PSO-3, CTgov)	Phase 3	Plaque psoriasis	684	Placebo+JNJ-77242113 (Placebo to JNJ-77242113 200 mg)	fwnqgumsxm = ptewnirnmq gobzibntsg (ychesunbih, svmgewarzo - evqxujvcab) View more	-	01 Jun 2026
				JNJ-77242113 (JNJ-77242113 200 mg)	fwnqgumsxm = dwdgoqetsz gobzibntsg (ychesunbih, ketkhfdyyj - pgyobyyssj) View more
NCT05364554 (FRONTIER 2, CTgov)	Phase 2	Plaque psoriasis	227	Placebo+JNJ-77242113 (Placebo Then JNJ-77242113 100 mg QD)	ftoqyjojop = riuonhwmco kaqvuetduw (yziblbaqgl, ctmsdmfrvf - xqjudxtuvh) View more	-	01 Jun 2026
				JNJ-77242113 (JNJ-77242113 25 mg QD)	ftoqyjojop = mghojlgksm kaqvuetduw (yziblbaqgl, rengzjifpj - kukghecvke) View more
NCT05357755 (SUMMIT, CTgov)	Phase 2	Plaque psoriasis	90	placebo+JNJ-77242113 (Placebo)	pbbvtyemcz = lipwnbhcym pkjrppwbin (zfwhelrmrx, zekynpjiaf - mczpdusraw) View more	-	05 May 2026
				JNJ-77242113 (JNJ-77242113 10 mg QD)	pbbvtyemcz = pzycyndphg pkjrppwbin (zfwhelrmrx, oufkrspyyx - jeaaawihig) View more
NCT06095115 (ICONIC-LEAD, AAD2026)	Phase 3	Plaque psoriasis	1,343	Icotrokinra 200mg	nwgxzgciim(rsouctfnci) = augsrfnrnw apceihnawl (hcfokhabtr ) View more	Positive	27 Mar 2026
				Placebo	nwgxzgciim(rsouctfnci) = mjotbgdakx apceihnawl (hcfokhabtr ) View more
NCT06095115 (ICONIC-LEAD, AAD2026)	Phase 3	Plaque psoriasis	66	Icotrokinra 200mg	qcbolzdcpx(yhgemtikii): LSM difference = 2.8 (95.0% CI, 1.4 - 4.1) View more	Positive	27 Mar 2026
				Placebo

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data