Delving into the Latest Updates on Guselkumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Guselkumab (Genetical Recombination), Guselkumab (genetical recombination) (JAN), Guselkumab (USAN)

+ [8]

Target

IL-23p19

Action

inhibitors

Mechanism

IL-23p19 inhibitors(Interleukin-23 subunit p19 inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCongenital Disorders+ [5]

Active Indication

Crohn's disease, active moderateCrohn's disease, active severeUlcerative colitis, active moderate+ [24]

Inactive Indication

Adenomatous Polyposis ColiCeliac DiseaseGeneralized Pustular Psoriasis+ [5]

Originator Organization

Janssen Global Services LLC

Active Organization

Janssen Research & Development LLCJanssen-Cilag Ltd.

Johnson & Johnson (China) Investment Ltd.

+ [11]

Inactive Organization-

License Organization

Janssen Pharmaceuticals, Inc.

Celsius Therapeutics, Inc.

MorphoSys AG

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (13 Jul 2017),

Plaque psoriasis

RegulationPriority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China)

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Structure/Sequence

Sequence Code 9493545H

Source: *****

Sequence Code 9493571L

Source: *****

The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and/or psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are:
* Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?
* What is the safety profile and treatment persistence of IL-23 inhibitors in this population?
* Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA/BASDAI) and adverse-event reporting through a national registry.

Start Date01 May 2026

Sponsor / Collaborator-

NCT07499232

/ Not yet recruitingPhase 3

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Start Date20 Apr 2026

Sponsor / Collaborator

Janssen Research & Development LLC

NCT07444060

/ RecruitingNot ApplicableIIT

Efficacy of Guselkumab Versus Ustekinumab in Stricturing Crohn's Disease: A Multicenter, Prospective, Observational Cohort Study

This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with Guselkumab or Ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.

Start Date01 Mar 2026

Sponsor / Collaborator

The Second Affiliated Hospital Zhejiang University

100 Clinical Results associated with Guselkumab

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100 Translational Medicine associated with Guselkumab

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100 Patents (Medical) associated with Guselkumab

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906

Literatures (Medical) associated with Guselkumab

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

On-label persistence in psoriasis after switching to guselkumab, tumor necrosis factor inhibitors, interleukin-17 inhibitors, or apremilast from other advanced therapies

Article

Author: Zhdanava, Maryia ; Fitzgerald, Timothy ; Feldman, Steven R. ; Boonmak, Porpong ; Schwartzbein, Samuel ; Libchaber, Béatrice ; Pilon, Dominic

OBJECTIVE:

To compare on-label persistence among adults with psoriasis who switched from other advanced therapies to guselkumab versus subcutaneous tumor necrosis factor inhibitors (SC TNFi), subcutaneous interleukin-17 inhibitors (SC IL-17i), or apremilast.

MATERIALS AND METHODS:

This retrospective cohort study used U.S. claims data from the IQVIA PharMetrics® Plus database (2016- 2023). Overlap propensity score weights were used to balance cohorts on baseline characteristics. On-label persistence was defined as the absence of drug discontinuation (event) and any dose change relative to the U.S. label (censoring). Survival analyses were used to assess on-label persistence from the start of the maintenance phase.

RESULTS:

At 12, 18, and 24 months after the start of the maintenance phase, respectively, on-label persistence was 190%, 180%, and 179% more likely on guselkumab versus SC TNFi; 78%, 87%, and 91% more likely on guselkumab versus SC IL-17i; and 187%, 199%, and 193% more likely on guselkumab versus apremilast (all p < 0.001).

CONCLUSIONS:

Patients experiencing suboptimal outcomes with other psoriasis-indicated advanced therapies achieved higher on-label persistence after switching to guselkumab, raising the potential for improved disease control relative to other treatment options.

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Real-world effectiveness and safety of guselkumab in adult patients with facial and/or genital psoriasis: a 52-week analysis from the Italian multicentric GULLIVER study

Article

Author: Pallotta, Sabatino ; Galluzzo, Marco ; Stingeni, Luca ; Megna, Matteo ; Argenziano, Giuseppe ; Corazza, Monica ; Lasagni, Claudia ; Piaserico, Stefano ; Fargnoli, Maria Concetta ; Costanzo, Antonio ; Bardazzi, Federico ; Offidani, Annamaria ; Bonifati, Claudio ; Richetta, Antonio Giovanni ; Potenza, Concetta ; Saibene, Federico ; Atzori, Laura ; Gramiccia, Talia ; Papini, Manuela ; Giofrè, Claudia ; Di Lernia, Vito Giuseppe ; Bongiorno, Maria Rita ; Dapavo, Paolo ; Prignano, Francesca ; Lembo, Serena ; Satolli, Francesca ; Savoia, Paola ; Burlando, Martina ; Guarneri, Claudio ; Zichichi, Leonardo ; Rongioletti, Franco ; Loconsole, Francesco ; Micali, Giuseppe ; Peris, Ketty ; Donini, Massimo ; Romanelli, Marco ; Stinco, Giuseppe ; Carrera, Carlo Giovanni

OBJECTIVES:

Facial and genital plaques are common manifestations of psoriasis, are challenging to treat, and significantly impact patients' quality of life (QoL).

METHODS:

GULLIVER is a prospective, non-interventional study conducted in 2020-2023 in Italy, aimed at examining the effectiveness, safety and QoL impact of guselkumab through 52 weeks of treatment in patients with facial and/or genital psoriasis. The primary endpoint was the percentage of patients achieving a static Physician Global Assessment (sPGA) score of ≤1 and a minimum 2-grade improvement in sPGA score at Week 52.

RESULTS:

Of 351 enrolled patients, 88.6% remained on guselkumab treatment at Week 52. The proportions of patients achieving the sPGA targets in the facial and genital groups, respectively, were 83.3% and 76.5% at week 12, increasing to 93.8% and 97.9% at Week 52. Mean Dermatology Life Quality Index score improved from 12.0 ± 7.5 at baseline to 1.1 ± 2.0 at Week 52 for patients with facial psoriasis (p-value <0.001) and from 12.0 ± 6.9 to 1.6 ± 3.5 for those with genital psoriasis (p-value <0.001). Guselkumab was well-tolerated and no new safety signals were identified.

CONCLUSIONS:

This Italian real-world study demonstrated the high effectiveness and a good safety profile of guselkumab in treating facial and genital psoriasis.

01 Apr 2026·Medicina de Familia-SEMERGEN

Article

Author: Ara-Martín, M ; González Fernández, J ; Ruiz-Cortegoso, A P ; Prieto-Torres, L

OBJECTIVE:

To describe the comorbidity profile in patients with moderate-to-severe psoriasis treated with biologics and their association with clinical phenotype and therapeutic choice.

MATERIAL AND METHODS:

This was an observational, cross-sectional, single-center study conducted at the Lozano Blesa University Clinical Hospital (Zaragoza, Spain). Consecutive patients with moderate-to-severe psoriasis receiving biologic treatment were included. Data were collected during the Dermatology consultation and reviewed from medical records. The variables analyzed included demographic data, clinical phenotype, previous and current treatments, cardiometabolic comorbidities, neoplasia, infections, and lifestyle habits. Statistical analysis employed means and proportions comparison tests, and logistic regression to explore associations between phenotype, comorbidities, and biologic type.

RESULTS:

350 patients were included (median age 54.1years; 57% men; 84% plaque psoriasis). The most prevalent comorbidities were dyslipidemia (55%), hypertension (42%), and obesity (36%). Among patients with liver elastography, 58% met MASLD criteria. Significant associations were observed between clinical phenotype and comorbidities: plaque psoriasis with hypertension and vitaminD deficiency, erythrodermic psoriasis with alcoholism and neoplasia, pustular psoriasis with dyslipidemia and kidney disease, and guttate psoriasis with a lower prevalence of cardiovascular factors. Guselkumab was the most commonly used biologic (15%).

CONCLUSIONS:

Patients with moderate-to-severe psoriasis have a high burden of comorbidities, with differential profiles according to phenotype. These results reinforce the need for a multidisciplinary approach and the role of primary care in screening and managing comorbidities to improve disease control and overall prognosis.

303

News (Medical) associated with Guselkumab

30 Mar 2026

·endpoints.news

Takeda cuts 600+ US jobs; United's stock rises on Tyvaso data

Plus, news about Almirall, Biogen, Aurinia, Day One, Alamar and more: 🏢 Takeda’s workforce cuts: In connection with the company’s extended restructuring that was announced last week, it will cut 634 roles in the US, which includes 247 positions in Massachusetts and 387 more in other states. The move is intended to “further standardize and simplify ways of working” as well as to focus on its late-stage clinical pipeline and prepare for future commercial launches, a Takeda spokesperson said. “As new roles are created, we will prioritize filling them with internal candidates,” the spokesperson said. — Reynald Castaneda 📈 United Therapeutics’ shares pop on IPF data : The company reported that its inhaled drug was successful in a late-stage trial to treat idiopathic pulmonary fibrosis, improving patients’ exhale strength. Tyvaso also achieved statistical significance for reducing clinical worsening, United said. Investors appear impressed, with shares of the biotech $UTHR up about 15% before the market opened. — Max Bayer 🇨🇳 Almirall’s monoclonal antibody pact with Chinese biotech: Almirall said Friday it will kick-start an R&D program with Shanghai Huaota Biopharmaceutical for a monoclonal antibody in a variety of conditions, including skin diseases. The deal is worth up to $340 million, which includes upfront and certain milestone payments from Almirall, plus tiered royalties on net sales. Huaota will drive preclinical work on the asset up to clinical proof of concept and it will take development and commercial rights to the candidate in China, while Almirall will do so everywhere else. — Reynald Castaneda 🟢 FDA approves higher dose of Spinraza : The new regimen of Biogen’s spinal muscular atrophy treatment includes two 50 mg doses delivered two weeks apart, followed by a 28 mg dose given every four months thereafter. The new US nod was based on data that showed the higher dose led to statistically significant improvements in motor function in symptomatic, treatment-naïve infants compared to a prespecified, matched control group. — Max Bayer Kevin Tang returns for Kezar: After overhauling Aurinia Pharmaceuticals’ C-suite, Kevin Tang is forging an M&A deal. Tang, who now leads Aurinia , has inked a $6.95 per share $KZR buyout of Kezar, plus one contingent value right. Kezar began hunting for alternatives in October after it was “unable to align” with the FDA on a registrational trial of its autoimmune hepatitis drug candidate. Tang tried acquiring Kezar for $1.10 per share in October 2024 via Concentra Biosciences, a shell company from his investment shop Tang Capital. — Kyle LaHucik Day One’s path to Servier buyout: Prior to its $2.5 billion exit to Servier, the rare oncology drugmaker had received acquisition offers from two other unnamed companies. Companies “A” and “C” submitted offers during the bidding process, Day One revealed in an SEC filing . Servier went from an $18 per share pitch on Feb. 9 to the final, signed deal of $21.50 per share. — Kyle LaHucik Alamar’s IPO pitch: The precision proteomics company filed for an IPO on Friday afternoon. The company generated $74 million in 2025 revenues. Its antibody engineering platform was licensed out to biologics startup Attovia Therapeutics in 2023. Alamar submitted its Nasdaq pitch the same day as obesity drug developer Kailera Therapeutics. — Kyle LaHucik Idorsia shares Phase 2 data in children with insomnia: As it searches for a CEO , the Swiss biotech’s daridorexant significantly improved total sleep time from baseline on day one of treatment. The drug is a dual orexin receptor antagonist. Idorsia said it will discuss next steps for the pediatric daridorexant program with regulators. — Ayisha Sharma Royalty Pharma supports J&J: The large royalty aggregator is pumping $500 million into Johnson & Johnson’s autoimmune drug candidate JNJ-4804 over the course of this year and 2027. Royalty didn’t disclose what kind of returns it could gain from the co-funding agreement. The medicine — a combination of Tremfya and Simponi — is in Phase 2 trials for ulcerative colitis, psoriatic arthritis and Crohn’s disease. — Kyle LaHucik Neumora delays obesity trial: The biotech has pushed back its clinical foray into obesity to the first quarter of 2027. It’s a long setback for NMRA-215 and Neumora’s entry into the hot NLRP3 inhibitor space. The move came after a 13-week rat toxicology study had “unexpected adverse findings” in five of 142 animals. The biotech had planned to send NMRA-215 into the clinic early this year and have Phase 1 data by the end of 2026. Neumora said the findings were not dose-dependent and the company “believes these findings may be related to a study conduct issue.” The biotech will now run a repeat of the study with a different contract research organization. — Kyle LaHucik Three biotechs win funding from the California Institute for Regenerative Medicine: CIRM awarded over $111 million in its latest grant announcement . That included grants for $8 million or $15 million to fund clinical studies from Mahzi Therapeutics, Cellio Therapeutics and Immusoft. Mahzi is developing a gene therapy for a rare condition called Pitt-Hopkins syndrome, while Cellio is developing a stem cell-derived therapy to restore vision. Immusoft is developing an engineered B cell therapy for the rare lysosomal storage disorder called MPS I, where it previously shared early but promising clinical data. — Lei Lei Wu

AcquisitionDrug Approval

20 Mar 2026

·www.pharmaceutical-technology.com

J&J wins FDA approval for Icotyde to enter psoriasis pill market

Analysis by GlobalData expects 2032 global sales for the drug will reach $4.4bn globally. Credit: PixelBiss/Shutterstock.com. The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (J&J) Icotyde (icotrokinra) for the treatment of plaque psoriasis, marking the first US entry of an oral peptide in the indication. J&J’s treatment is approved for adults and paediatric patients aged 12 and older with moderate-to-severe forms of the disease. Patients who are candidates for systemic therapy or phototherapy will be eligible for Icotyde. Psoriasis is a chronic autoimmune condition causing skin cells to multiply rapidly, resulting in thick, itchy, scaly patches. Icotyde works by inhibiting interleukin-23 (IL-23), a protein that plays a key role in inflammation. Psoriasis affects more than 8 million people in the US. J&J’s pill was approved based on four Phase III studies that included 2,500 patients. Icotyde met all primary efficacy endpoints, helping patients achieve clearer skin and reducing psoriasis severity. The drug also performed well in head-to-head superiority studies against Bristol Myers Squibb’s (BMS) Sotyktu (deucravacitinib). Sotyktu and AbbVie’s Skyrizi (risankizumab) currently dominate the plaque psoriasis market in the US. Sotyktu is an oral small molecule inhibitor that targets tyrosine kinase 2 (TYK2), while Skyrizi is AbbVie’s blockbuster injected monoclonal antibody that inhibits IL-23. The FDA’s approval for Icotyde means it is the only oral peptide that targets IL-23 in the plaque psoriasis US market. GlobalData analyst, Stephanie Ngan, commented: “Its strongest selling point is its biologic-like efficacy delivered in a once-daily oral pill, likely enabled by its macrocyclic design, and contrasts existing oral options. The competitive threat against Sotyktu is especially acute, given that Icotyde has demonstrated superiority over it in head-to-head trials.” “That being said, Icotyde does entail a higher treatment burden and daily commitment than biologics such as Skyrizi, which requires only 4 doses per year,” Ngan added. Icotyde will succeed J&J’s Stelara (ustekinumab), an IL-23 inhibitor approved for plaque psoriasis treatment that lost patent exclusivity in early 2025. J&J also has Tremfya (guselkumab) on the market in this indication, though like Skyrizi, the drug is injected. Leah Howard, CEO of the National Psoriasis Foundation, said: “The approval of a novel systemic therapy changes the conversation about treatment options for our community.” J&J is eying further inflammatory indications for its IL-23 inhibitor. These include active psoriatic arthritis studies ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424); ICONIC-UC (NCT071196748) in moderately-to-severely active ulcerative colitis; and ICONIC-CD (NCT7196722) in moderately-to-severely active Crohn’s disease. Analysis by GlobalData, Pharmaceutical Technology’s parent company, forecasts a blockbuster for J&J’s drug, with 2032 sales expected to reach $4.4bn globally. Ngan stated: “Simultaneous approval of Icotyde for both adults and adolescents, rather than the traditional step-wise path from adults into paediatrics immediately casts a wider net for early uptake across a broader patient population.” J&J acquired global rights to Icotyde from Protagonist Therapeutics via a deal worth up to $990m in 2017. In late 2025, the Wall Street Journal (WSJ) reported the companies were in talks regarding a potential acquisition , though no update has been made public since. It will take some effort to displace Skyrizi’s dominance, however. Armed with a range of immunology indications, along with a strong adoption in inflammatory bowel disease (IBD), the drug has become a major revenue driver for AbbVie. In 2025, the injectable’s global sales reached $17.6bn, exceeding growth forecasts. Skyrizi’s performance has eased AbbVie’s dependency on Humira (adalimumab), which lost exclusivity in 2023 – the product was the world’s best-selling drug between 2012 and 2020.

Drug ApprovalPhase 3AcquisitionClinical ResultBiosimilar

18 Mar 2026

·www.fiercepharma.com

Sandoz expands biosim collab with Samsung Bioepis, sets sights on Takeda's Entyvio

Sandoz has inked a deal with Korean biosimilars specialist Samsung Bioepis to commercialize up to five copycats, including a knockoff of Takeda's Entyvio. Sandoz has struck a deal with Samsung Bioepis to partner on up to five biosimilars, with the first being SB36, a copycat of Takeda’s Entyvio (vedolizumab), which is being developed by the South Korea-based biosimilars specialist. Switzerland-based Sandoz gains the right to commercialize the biosimilars around the world, with Samsung Bioepis retaining commercial rights in China, Hong Kong, Taiwan, Macau and its home country. Samsung Bioepis will continue to develop, manufacture and handle the regulatory submissions for the biosimilars. Financial terms of the partnership were not disclosed. The deal, which builds on the existing partnership of the companies, has the potential to expand Sandoz’s biosimilar portfolio to an “industry-leading” 32 assets, the company said in a release. The growing pipeline of products will allow Sandoz to capture a “significant share” of the $320 billion biosimilar loss-of-exclusivity market opportunity in the next decade, the company added.The companies initially got together in 2023, with Sandoz gaining commercial rights to Samsung’s Pyzchiva (ustekinumab), which is a knockoff of Johnson & Johnson’s Stelara. Sandoz launched it in Europe in July 2024 and in the U.S. in February 2025. Three months ago, the companies also paired up on Epysqli (eculizumab), which is Samsung’s biosimilar version of AstraZeneca’s Soliris.With the most recent agreement, analysts from Jefferies credited Sandoz’s “commercial infrastructure” as key to its ability to attract partners. They also noted that the Samsung Bioepis arrangement provides Sandoz with “improved long-term visibility on both R&D productivity and future launch cadence.” Samsung Bioepis plans to expand its biosimilar portfolio by 20 products by 2030, the company said two months ago at the J.P. Morgan Healthcare Conference. In addition to its Entyvio copycat, the company said it will develop biosimilar versions of Regeneron and Sanofi’s Dupixent, Johnson & Johnson’s Tremfya, Daiichi Sankyo and AZ’s Enhertu, Roche’s Ocrevus and Eli Lilly’s Taltz.As for Samsung and Sandoz’s plan to sell their Entyvio knockoff, Takeda has said its regulatory protection on the ulcerative colitis and Crohn’s disease treatment extends into May 2026. But some patents on the drug expire in 2032, according to the company's most recent annual report (PDF).“Any biosimilar that seeks to launch prior to 2032 would need to address potential infringement and/or the validity of all relevant patents and therefore the exact timing of biosimilar entry is uncertain,” the Japanese company explained in the report.For the last three quarters of 2025, Takeda reported Entyvio worldwide sales were up by 7% at 744.5 billion Japanese yen ($4.98 billion), with U.S. sales accounting for 494.8 billion Japanese yen ($3.03 billion).

License out/inDrug ApprovalBiosimilar

100 Deals associated with Guselkumab

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KEGG	Wiki	ATC	Drug Bank
D10438	Guselkumab	L04AC16	DB11834

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Crohn's disease, active moderate	China	Janssen-Cilag International NV	20 Feb 2025
Crohn's disease, active severe	China	Janssen-Cilag International NV	20 Feb 2025
Ulcerative colitis, active moderate	United States	Janssen Biotech, Inc.	11 Sep 2024
Ulcerative colitis, active severe	United States	Janssen Biotech, Inc.	11 Sep 2024
Pustulosis of Palms and Soles	Japan	Janssen Pharmaceutical KK	21 Nov 2018
Colitis, Ulcerative	South Korea	Janssen Korea Ltd.	12 Apr 2018
Crohn Disease	South Korea	Janssen Korea Ltd.	12 Apr 2018
Keratoderma, Palmoplantar	South Korea	Janssen Korea Ltd.	12 Apr 2018
Erythrodermic psoriasis	Japan	Janssen Pharmaceutical KK	23 Mar 2018
Psoriasis	Japan	Janssen Pharmaceutical KK	23 Mar 2018
Pustular psoriasis	Japan	Janssen Pharmaceutical KK	23 Mar 2018
Arthritis, Psoriatic	European Union	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Iceland	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Liechtenstein	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Norway	Janssen-Cilag International NV	10 Nov 2017
Plaque psoriasis	United States	Janssen Biotech, Inc.	13 Jul 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	NDA/BLA	United States	Johnson & Johnson	02 Dec 2024
Pediatric Crohn's Disease	Phase 3	United States	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Japan	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Australia	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Austria	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Belgium	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Brazil	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Canada	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	France	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Israel	Janssen Research & Development LLC	13 Mar 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05272150 (VISIBLE, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Plaque psoriasis \| Psoriasis of scalp	205	Guselkumab 100 mg	hhyjfanspa(rlatgircat) = rbszqwvxiy dajfdojqny (ywumpkgerx ) View more	Positive	02 Mar 2026
NCT04033445 (QUASAR, Company_Website) Manual	Phase 2/3	Colitis, Ulcerative	-	TREMFYA	tfakledzhm(slyvejtxpk) = vrjnevpnbf tjjyojljde (xzqdrwpmss ) View more	Positive	21 Feb 2026
NCT04882098 (APEX, CTgov)	Phase 3	Arthritis, Psoriatic	1,054	Placebo+Guselkumab	dmvazqapdn = jmiovkqkqq zawrhcmukn (kgxxzhwpnu, jhlnaxixyj - nrpngwbsbv) View more	-	04 Feb 2026
NCT03796858 (COSMOS, Pubmed \| Rheumatol Ther)	Phase 3	Arthritis, Psoriatic	285	Guselkumab	oargwwrgef(gduyzdwkxf): HR = 1.29 (95.0% CI, 0.93 - 1.81) View more	Positive	23 Jan 2026
				Placebo
NCT05528510 (ASTRO, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 3	Colitis, Ulcerative	418	Guselkumab 400/100 mg	xogjclycxv(trdfjspugp) = xalmpswmzv lnyzvrlqyg (ldrsomgzlf ) View more	Positive	01 Jan 2026
				Guselkumab 400/200 mg	xogjclycxv(qvyjtdlxer) = sjddsnvdnd bkojtxhqyu (mmsxgoqzsu ) View more
NCT05528510 (ASTRO, CTgov)	Phase 3	Colitis, Ulcerative	418	placebo+guselkumab (Placebo)	gzctzfqvwo = lnbjctpdtv ofhifkelio (xsdkmvftmd, orrqecmofc - keksctyxwn) View more	-	09 Dec 2025
				Guselkumab (Combined Guselkumab 400 mg)	gzctzfqvwo = cepbcxycmh ofhifkelio (xsdkmvftmd, csrxlxemok - ggzcgwfaln) View more
NCT04936308 (SOLSTICE, CTgov)	Phase 3	Salivary Gland Adenoma, Pleomorphic \| Neoplasms \| Arthritis, Psoriatic	453	Placebo+Guselkumab (Placebo Followed by Guselkumab 100 mg)	dssbwfblwc = lhmkmhnqqe njjxjgihsi (zebnnxszdt, yhounqjeyi - orbtyinuhy) View more	-	08 Dec 2025
				Guselkumab (Guselkumab 100 mg q8w)	dssbwfblwc = xlocgdrbwq njjxjgihsi (zebnnxszdt, xnvzqadyic - ojssfsndkl) View more
NCT03451851 \| NCT03158285 (DISCOVER-1/-2, Pubmed \| Paediatr Drugs)	Phase 3	Psoriasis \| Arthritis, Psoriatic \| Juvenile Idiopathic Arthritis	1,589	Guselkumab (pediatric PsO)	kspwppggav(zolvjrsrmn) = tytaigomxn yhosdwczaa (rtpygzdpey ) View more	Positive	28 Oct 2025
				Guselkumab (adult PsO)	kspwppggav(zolvjrsrmn) = okcfbqxcut yhosdwczaa (rtpygzdpey ) View more
NCT05197049 (GALAXI 3, PRNewswire) Manual	Phase 3	Crohn Disease	-	TREMFYA® 100 mg q8w	hwajtzwiww(zaainhfmjh) = oyrzoeepxi vonkguxgjr (fbwnkfwkdj ) View more	Positive	27 Oct 2025
				TREMFYA® 200 mg q4w	hwajtzwiww(zaainhfmjh) = uviwhlqgqm vonkguxgjr (fbwnkfwkdj ) View more
ACR2025	Not Applicable	Arthritis, Psoriatic	2,754	Guselkumab (biologic-naïve)	pklljurcqs(lrceqgbvwm) = yqfdahpqkw kyncmvitqh (vricpfbwwn ) View more	Positive	24 Oct 2025
				SC Interleukin-17A Inhibitors (biologic-naïve)	pklljurcqs(lrceqgbvwm) = fdevuzgxph kyncmvitqh (vricpfbwwn ) View more

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