Drugs / Guselkumab
Regulatory milestones approvals, filings & regulatory actions · 18 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Crohn jejunoileitis 2 milestones | |||||
| Filed | EU (EMA) | TREMFYA | Crohn jejunoileitis | 2024-07-17 | “Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA (guselkumab) for treatment of patients with ulcerative colitis and Crohn's disease” jnj.com ↗ “Applications seeking approval of TREMFYA®for both UC and Crohn’s disease (CD) have been submitted in Europe.” jnj.com ↗ |
| Filed | US (FDA) | TREMFYA | Crohn jejunoileitis | 2024-06-21 | “Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA® (guselkumab) for the treatment of moderately to severely active Crohn’s disease” jnj.com ↗ “An application seeking approval of TREMFYA®for the treatment of adults with moderately to severely active CD has been submitted in the U.S.” jnj.com ↗ “In June 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of TREMFYA®” jnj.com ↗ |
| Filed psoriasis 2 milestones | |||||
| Filed | US (FDA) | — | psoriasis | 2016-11-17 | “Regulatory applications for approval were submitted to the FDA and European Medicines Agency (EMA) for guselkumab” jnj.com ↗ “Janssen Submits Application To FDA Seeking Approval Of Anti-Interleukin-23 Monoclonal Antibody Guselkumab” jnj.com ↗ |
| Filed | EU (EMA) | — | psoriasis | — | “Regulatory applications for approval were submitted to the FDA and European Medicines Agency (EMA) for guselkumab” jnj.com ↗ |
| Filed psoriatic arthritis 3 milestones | |||||
| Filed | US (FDA) | TREMFYA | psoriatic arthritis | 2025-07-29 | “Johnson & Johnson files with U.S. FDA to include new evidence in TREMFYA® (guselkumab) label” jnj.com ↗ |
| Filed | EU (EMA) | TREMFYA | psoriatic arthritis | 2019-10-11 | “Variation Application to the European Medicines Agency (EMA) seeking first-in-class approval of TREMFYA®▼(guselkumab) for the treatment of adult patients with active psoriatic...” jnj.com ↗ “validated filing on October 11, 2019 to the European Medicines Agency (EMA) for approval of TREMFYA in the European Union for adult patients with active psoriatic arthritis.” jnj.com ↗ |
| Filed | US (FDA) | TREMFYA | psoriatic arthritis | 2019-09-13 | “September 13, 2019 supplemental Biologics License Application submission to the U.S. Food and Drug Administration (FDA) for approval of TREMFYA” jnj.com ↗ |
| Filed ulcerative colitis 2 milestones | |||||
| Filed | EU (EMA) | TREMFYA | ulcerative colitis | 2024-07-17 | “Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA (guselkumab) for treatment of patients with ulcerative colitis and Crohn's disease” jnj.com ↗ “previously announced the submission of applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA®” jnj.com ↗ “Applications seeking approval of TREMFYA®for both UC and Crohn’s disease (CD) have been submitted in Europe.” jnj.com ↗ |
| Filed | US (FDA) | TREMFYA | ulcerative colitis | — | “This marks the second submission to the FDA for TREMFYA® in inflammatory bowel disease this year following an application in March for” jnj.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (7) | US (FDA) | TREMFYA | — | 2019-01-29 – 2026-05-28 | fda.gov ↗ |
| Approved | EU (EMA) | Tremfya | — | 2017-11-10 | europa.eu ↗ |
| Approved | US (FDA) | TREMFYA | — | 2017-07-13 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04084665 | Jun → Jul 2020 | hidradenitis suppurativa | Rockefeller University | Withdrawn | No outcome recorded |
| Phase 113 trials | ||||||
| Phase 1 | NCT05083078 | Nov 2021 → Jul 2022 | psoriatic arthritis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT04704843 | Jun → Sep 2021 | celiac disease | Janssen Research & Development, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT04736966 | Mar 2021 → Mar 2024 | alcoholic liver disease | University of California, San Diego | Completed | No outcome recorded |
| Phase 1 | NCT04617691 | Nov 2020 → Jul 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04030533 | Nov 2019 → Dec 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04147338 | Oct 2019 → Sep 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03649971 | Nov 2018 → Sep 2021 | classic or attenuated familial adenomatous polyposis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03536325 | May → Oct 2018 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT02570373 | Sep 2015 → Jan 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02397382 | Jun 2015 → Aug 2016 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01866007 | May → Sep 2013 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01484587 | Aug 2011 → Apr 2013 | psoriasis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT00925574 | Jun 2009 → Oct 2010 | psoriasis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 217 trials · 4 met primary · 4 missed | ||||||
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06651489 | Mar 2025 → Dec 2026 expected | Hailey-Hailey disease | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT06563323 | Feb 2025 → Aug 2027 expected | pyoderma gangrenosum, ulcer disease | Oregon Health and Science University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05242484 | Sep 2022 → May 2025 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05242471 | Jul 2022 → May 2025 overdue | Crohn disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05071664 | Oct 2021 → May 2024 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04683029 | Feb 2021 → May 2023 | systemic sclerosis | Janssen Pharmaceutical K.K. | Completed | Met primary |
| Phase 2 | NCT04633447 | Dec 2020 → May 2024 | temporal arteritis | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 2 | NCT04376827 | Sep 2020 → Feb 2023 | lupus nephritis | Janssen Research & Development, LLC | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT03975153 | Oct 2019 → Aug 2022 | pityriasis rubra pilaris | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT04061395 | Oct 2019 → Dec 2021 | hidradenitis suppurativa | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 2 | NCT03662542 | Nov 2018 → Dec 2020 | ulcerative colitis | Janssen Research & Development, LLC | Completed | Mixed |
| Phase 2 | NCT03628924 | Sep 2018 → May 2020 | hidradenitis suppurativa | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT02319759 | Mar 2015 → May 2016 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT01845987 | Jun 2013 → Sep 2014 | palmoplantar pustulosis | Janssen Pharmaceutical K.K. | Completed | Met primary |
| Phase 2 | NCT01645280 | Aug 2012 → Dec 2013 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 2 | NCT01483599 | Nov 2011 → Nov 2012 | psoriasis | Janssen, LP | Completed | Met primary |
| Phase 2/33 trials · 2 met primary | ||||||
| Phase 2/3 | NCT05535738 | Nov 2022 → Jan 2027 expected | allergic contact dermatitis | Wei-Che Ko | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04033445 | Sep 2019 → Sep 2023 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 2/3 | NCT03466411 | Apr 2018 → Oct 2023 overdue | Crohn disease | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 330 trials · 19 met primary | ||||||
| Phase 3 | NCT07499232 | Apr 2026 → Nov 2028 expected | Crohn disease | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06663332 | Oct 2024 → Dec 2031 expected | Crohn disease, psoriatic arthritis, ulcerative colitis | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06408935 | Apr 2024 → Jun 2027 expected | Crohn disease | Janssen-Cilag Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05923073 | Mar 2024 → Oct 2027 expected | Crohn disease | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06260163 | Jan 2024 → Feb 2027 expected | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06039189 | Aug 2023 → Apr 2025 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT05669833 | Jul 2023 → Oct 2026 expected | psoriatic arthritis | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 3 | NCT05347095 | Sep 2022 → Mar 2027 expected | perianal Crohn disease | Janssen-Cilag Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT05528510 | Sep 2022 → Apr 2024 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT05083182 | Aug 2022 → Jan 2026 overdue | arthritic joint disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05272150 | Jul 2022 → May 2025 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT05197049 | Jan 2022 → Jul 2023 overdue | Crohn disease | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT04936308 | Sep 2021 → Oct 2024 overdue | psoriatic arthritis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04882098 | Jun 2021 → Dec 2024 overdue | psoriatic arthritis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT04397263 | Jun 2020 → Feb 2024 | Crohn disease | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT03998683 | Sep 2019 → Mar 2021 | psoriasis | Janssen-Cilag Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03796858 | Mar 2019 → Nov 2020 | psoriatic arthritis | Janssen Pharmaceutica N.V., Belgium | Completed | Met primary |
| Phase 3 | NCT03818035 | Feb 2019 → Mar 2022 | psoriasis | Janssen-Cilag International NV | Completed | Met primary |
| Phase 3 | NCT03451851 | Jul 2018 → Jul 2023 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT03162796 | Aug 2017 → Mar 2019 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03158285 | Jul 2017 → Feb 2019 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT03090100 | Apr 2017 → Aug 2018 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02905331 | Feb 2017 → Feb 2018 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02951533 | Dec 2016 → Sep 2017 | psoriasis | Janssen-Cilag GmbH | Completed | Met primary |
| Phase 3 | NCT02641730 | Dec 2015 → Mar 2017 | palmoplantar pustulosis | Janssen Pharmaceutical K.K. | Completed | Met primary |
| Phase 3 | NCT02343744 | Jan → Dec 2015 | pustular psoriasis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT02325219 | Dec 2014 → Mar 2016 | psoriasis | Janssen Pharmaceutical K.K. | Completed | Met primary |
| Phase 3 | NCT02207231 | Nov 2014 → Sep 2015 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02207244 | Nov 2014 → Oct 2015 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02203032 | Oct 2014 → Dec 2015 | psoriasis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 417 trials · 1 met primary | ||||||
| Phase 4 | NCT07654751 | Aug 2026 → Aug 2027 expected | Crohn disease, psoriasis, psoriatic arthritis, ulcerative colitis | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07616687 | Jun 2026 → Mar 2029 expected | Crohn disease | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Recruiting | No outcome recorded |
| Phase 4 | NCT07310095 | Dec 2025 → Sep 2027 expected | Crohn disease | Xian-Janssen Pharmaceutical Ltd. | Recruiting | No outcome recorded |
| Phase 4 | NCT07141004 | Aug 2025 → Jun 2027 expected | psoriatic arthritis | Johnson & Johnson Private Limited | Recruiting | No outcome recorded |
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06398106 | Dec 2024 → Mar 2028 expected | psoriasis | University Hospital, Ghent | Recruiting | No outcome recorded |
| Phase 4 | NCT06974474 | Jun 2024 → Nov 2025 overdue | psoriatic arthritis | Fondazione Policlinico Universitario Campus Bio-Medico | Recruiting | No outcome recorded |
| Phase 4 | NCT05858632 | Jul 2023 → Jun 2028 expected | psoriasis | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT05270733 | Nov 2022 → Dec 2026 expected | psoriasis | University Hospitals Cleveland Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05004727 | Feb 2022 → Dec 2026 expected | psoriasis | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 4 | NCT05125679 | Nov 2021 → Jul 2023 | psoriasis | Janssen-Cilag Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT04929210 | Aug 2021 → Apr 2027 expected | psoriatic arthritis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04914429 | Aug 2021 → Sep 2023 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 4 | NCT04645355 | Mar 2021 → Apr 2025 | guttate psoriasis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT04340076 | Aug 2020 → Jan 2025 | psoriasis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03573323 | Nov 2018 → Jul 2019 | psoriasis | Eli Lilly and Company | Completed | Met primary |
| Phase not applicable3 trials | ||||||
| — | NCT06586281 | Jun 2025 → Sep 2027 expected | psoriatic arthritis | University of California, San Diego | Recruiting | No outcome recorded |
| — | NCT05503875 | Jan 2023 → Dec 2027 expected | psoriasis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| — | NCT04394936 | Sep 2020 → Feb 2023 | psoriasis | Centre for Human Drug Research, Netherlands | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy9 trials | ||||||
| Phase 3 | NCT07511647 Comparator | Jun 2026 → Dec 2027 expected | psoriasis | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07577856 Comparator | May 2026 → Aug 2028 expected | ulcerative colitis | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07577843 Comparator | May 2026 → Jun 2028 expected | Crohn disease | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06274554 Background | Oct 2024 → Dec 2028 expected | Crohn disease | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 3 | NCT05784129 Comparator | Feb → Sep 2023 | Crohn disease | Janssen Research & Development, LLC | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT06916390 Comparator | Apr 2026 → May 2028 expected | pouchitis | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT04533737 Comparator | Dec 2020 → Sep 2022 | psoriasis | LEO Pharma | Terminated | Missed primary Stop: Enrollment |
| — | NCT07532486 Comparator | Jul 2024 → Jul 2027 expected | psoriasis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| — | NCT04948398 Background | — | classic or attenuated familial adenomatous polyposis | Janssen Research & Development, LLC | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 131
| Date | Issuer | Release |
|---|---|---|
| 2026-09-25 | Janssen Research & Development, LLC | Results Johnson & Johnson announces TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to show significant improvement in spinal pain and stiffness in landmark axial psoriatic arthritis (PsA) study jnj.com ↗
TREMFYA also met major secondary endpoints demonstrating a significant reduction in both axial symptoms, as measured by ASDAS-CRPb, and objective (MRI) inflammation of the sacroiliac joints. |
| 2026-09-25 | Janssen Research & Development, LLC | Results Johnson & Johnson announces TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to show significant improvement in spinal pain and stiffness in landmark axial psoriatic arthritis (PsA) study jnj.com ↗ |
| 2026-05-28 | Janssen Research & Development, LLC | Regulatory FDA approves label expansion, cementing TREMFYA® as the only IL‑23 inhibitor proven to help stop further joint damage jnj.com ↗ |
| 2026-05-28 | Janssen Research & Development, LLC | Regulatory FDA approves label expansion, cementing TREMFYA® as the only IL‑23 inhibitor proven to help stop further joint damage jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include evidence in the TREMFYA (guselkumab) label for the inhibition of progression of structural joint damage in adults with active psoriatic arthritis (PsA). |
| 2026-05-05 | Janssen Research & Development, LLC | Results Johnson & Johnson study shows TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn’s disease jnj.com ↗
At Week 24, TREMFYA demonstrated significantly higher rates of combined fistula remission, a highly stringent endpoint defined as complete external closure of draining fistulas and absence of fluid collection on MRI, compared to placebo. |
| 2026-05-05 | Janssen Research & Development, LLC | Results Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel disease jnj.com ↗
The JNJ-4804 rates were also numerically higher than the rates achieved with guselkumab (42.5% for clinical remission and 33.9% for endoscopic response). |
| 2026-05-05 | Janssen Research & Development, LLC | Results Johnson & Johnson study shows TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn's disease jnj.com ↗ |
| 2026-02-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new long-term data from the QUASAR long-term extension (LTE) study showing that TREMFYA®(guselkumab) sustained clinical, endoscopic, and histologic outcomes through Week 140 in adults with moderately to severely active ulcerative colitis (UC). |
| 2026-02-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years jnj.com ↗
At Week 140, 80.8% of patients taking TREMFYA were in clinical remission. |
| 2025-12-22 | Janssen Research & Development, LLC | Regulatory European Commission approves TREMFYA® (guselkumab) for the treatment of children with plaque psoriasis, marking the first paediatric indication for an IL-23 inhibitor jnj.com ↗
This milestone makes guselkumab the first IL-23 inhibitor approved for any paediatric indication, building on EC approval in adults living with moderate to severe plaque Pso in 2017. |
| 2025-11-17 | Janssen Research & Development, LLC | Results New long-term data reinforces TREMFYA® (guselkumab) as the only IL-23 inhibitor proven to substantially inhibit structural joint damage in active psoriatic arthritis jnj.com ↗
Johnson & Johnson today announced new data from the Phase 3b APEX study showing that TREMFYA®continued to reduce both signs and symptoms of active psoriatic arthritis (PsA) and inhibit progression of structural damage at 48 weeks. |
| 2025-11-17 | Janssen Research & Development, LLC | Results New long-term data reinforces TREMFYA® (guselkumab) as the only IL-23 inhibitor proven to substantially inhibit structural joint damage in active psoriatic arthritis jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3b APEX study showing that TREMFYAcontinued to reduce both signs and symptoms of active psoriatic arthritis (PsA) and inhibit progression of structural damage at 48 weeks. |
| 2025-10-27 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab), the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen, demonstrates durable remission in Crohn’s disease at two years jnj.com ↗
These results show that guselkumab can provide endoscopic remission through either SC or IV induction, allowing people with moderate to severely active Crohn’s disease to manage their condition with greater independence and confidence. |
| 2025-10-27 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab), the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen, demonstrates durable remission in Crohn's disease at two years jnj.com ↗
Clinical remission rates were over 85% for both TREMFYA maintenance doses at 96 weeks in both the Phase 3 GRAVITI and GALAXI studies |
| 2025-10-07 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new 48-week data from the Phase 3 ASTRO study evaluating TREMFYA®(guselkumab) subcutaneous (SC) induction and maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). |
| 2025-10-07 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new 48-week data from the Phase 3 ASTRO study evaluating TREMFYA (guselkumab) subcutaneous (SC) induction and maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). |
| 2025-09-29 | Janssen Research & Development, LLC | Regulatory U.S. FDA approves TREMFYA® (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor jnj.com ↗
This milestone makes TREMFYA®the first and only IL-23 inhibitor approved for these pediatric indications and builds on the initial FDA approvals in adults living with moderate to severe plaque PsO in 2017 and active PsA in 2020. |
| 2025-09-29 | Janssen Research & Development, LLC | Regulatory U.S. FDA approves TREMFYA® (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor jnj.com ↗ |
| 2025-09-19 | Janssen Research & Development, LLC | Regulatory TREMFYA® (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen of TREMFYA®(guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). |
| 2025-09-19 | Janssen Research & Development, LLC | Regulatory TREMFYA® (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous (SC) induction regimen of TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). |
| 2025-07-29 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson files with U.S. FDA to include new evidence in TREMFYA® (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to include new evidence in the TREMFYA®(guselkumab) label for the inhibition of progression of structural damage in adults with active psoriatic arthritis (PsA). |
| 2025-07-29 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson files with U.S. FDA to include new evidence in TREMFYA® (guselkumab) label as the only IL-23 inhibitor to demonstrate significant inhibition of joint structural damage in active psoriatic arthritis jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to include new evidence in the TREMFYA (guselkumab) label for the inhibition of progression of structural damage in adults with active psoriatic arthritis (PsA). |
| 2025-06-11 | Janssen Research & Development, LLC | Results New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 3b APEX study showing that TREMFYA®(guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at 24 weeks compared to placebo. |
| 2025-06-11 | Janssen Research & Development, LLC | Results New data show TREMFYA® (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis jnj.com ↗ |
| 2025-05-05 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3 ASTRO study evaluating TREMFYA®(guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC). |
| 2025-05-05 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new data from the TREMFYA®(guselkumab) Phase 3 QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis (UC). |
| 2025-05-05 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks jnj.com ↗ |
| 2025-05-05 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced new data from the TREMFYA (guselkumab) Phase 3 QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis (UC). |
| 2025-04-04 | Janssen Research & Development, LLC | Results 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 arthritis jnj.com ↗
Data were consistent with the well-established safety profile of TREMFYA®with no new safety signals identified. |
| 2025-04-04 | Janssen Research & Development, LLC | Results 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 arthritis jnj.com ↗ |
| 2025-03-20 | Janssen Research & Development, LLC | Regulatory 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 jnj.com ↗ |
| 2025-03-20 | Janssen Research & Development, LLC | Regulatory 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 jnj.com ↗ |
| 2025-02-21 | Janssen Research & Development, LLC | Results 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 jnj.com ↗
Study findings through Week 12 showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures consistent with the U.S. Food and Drug Administration (FDA)-approved intravenous (IV) induction regimen in this population. |
| 2025-02-21 | Janssen Research & Development, LLC | Results 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 jnj.com ↗ |
| 2024-12-02 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for TREMFYA® (guselkumab) jnj.com ↗
Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA®(guselkumab) for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis (PsO) and children 5 years of age and older with active juvenile psoriatic arthritis (jPsA). |
| 2024-12-02 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for TREMFYA® (guselkumab) jnj.com ↗ |
| 2024-11-22 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA® (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor jnj.com ↗ |
| 2024-11-22 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA® (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor jnj.com ↗ |
| 2024-11-07 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024 jnj.com ↗
Guselkumab and IL-17 Inhibitors Improve Patient-perceived Impact of Psoriatic Arthritis Similarly: 6-month Interim Results of the PsABIOnd Observational Cohort Study |
| 2024-11-07 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024 jnj.com ↗
Results from the PsABIOnd observational study highlight the patient-reported impact in psoriatic arthritis (PsA) disease burden following treatment with TREMFYA, presented as an oral presentation |
| 2024-10-28 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced results from the Phase 3 GRAVITI study of TREMFYA®(guselkumab), the first and only IL-23 inhibitor, demonstrating robust results in subcutaneous (SC) induction and maintenance therapy. |
| 2024-10-28 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn's disease jnj.com ↗ |
| 2024-10-25 | Janssen Research & Development, LLC | Results New SPECTREM study findings reveal TREMFYA® (guselkumab) effectively clears overlooked and undertreated plaque psoriasis jnj.com ↗
Las Vegas, Nevada (October 25, 2024– Johnson & Johnson (NYSE: JNJ) announced today that treatment with TREMFYA®(guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis (PsO) with special site involvement who had failed topical treatment. |
| 2024-10-25 | Janssen Research & Development, LLC | Results New SPECTREM study findings reveal TREMFYA® (guselkumab) effectively clears overlooked and undertreated plaque psoriasis jnj.com ↗ |
| 2024-10-10 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn’s disease and ulcerative colitis jnj.com ↗
Data from GALAXI 2 & 3 showed guselkumab was superior to ustekinumab in all pooled endoscopic endpoints. |
| 2024-10-10 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn's disease and ulcerative colitis jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced TREMFYA (guselkumab) data in both Crohn's disease (CD) and ulcerative colitis (UC) showing high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients (including UC patients refractory to JAK inhibitors), indicating a normal appearance of intestinal mucosa. |
| 2024-09-11 | Janssen Research & Development, LLC | Regulatory TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease jnj.com ↗
Today’s approval of TREMFYA builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease. |
| 2024-09-11 | Janssen Research & Development, LLC | Regulatory TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson's leadership in inflammatory bowel disease jnj.com ↗ |
| 2024-06-20 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA®(guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn’s disease. |
| 2024-06-20 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA® (guselkumab) for the treatment of moderately to severely active Crohn’s disease jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA®(guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease. |
| 2024-06-20 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn’s disease. |
| 2024-06-20 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA® (guselkumab) for the treatment of moderately to severely active Crohn’s disease jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease. |
| 2024-05-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) demonstrates superiority versus STELARA® (ustekinumab) in Phase 3 Crohn’s disease program jnj.com ↗
In results versus ustekinumab, both doses of TREMFYA®demonstrated statistically significant and clinically meaningful differences on all prespecified pooled endoscopic endpoints. |
| 2024-05-21 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) demonstrates superiority versus STELARA® (ustekinumab) in Phase 3 Crohn’s disease program jnj.com ↗
Johnson & Johnson today announced the first Phase 3 results for TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), which demonstrated superiority of both subcutaneous (SC) maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8 weeks [q8w]) versus placebo and ustekinumab. |
| 2024-05-20 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) QUASAR Maintenance Study in UC met its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission jnj.com ↗
Both TREMFYA® treatment groups also met all nine major secondary endpoints with high statistical significance and clinically meaningful improvements versus placebo. |
| 2024-05-20 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) QUASAR Maintenance Study in UC met its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission jnj.com ↗
TREMFYA® (guselkumab) QUASAR Maintenance Study in UC met its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission |
| 2024-05-01 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA® (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced it has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA®(guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease. |
| 2024-05-01 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA® (guselkumab) for treatment of patients with ulcerative colitis and Crohn's disease jnj.com ↗
Janssen-Cilag International NV, a Johnson & Johnson company, today announced it has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease. |
| 2024-03-11 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of TREMFYA®(guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis jnj.com ↗
Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for treatment of adults with moderately to severely active ulcerative colitis (UC). |
| 2024-03-11 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis jnj.com ↗
Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for treatment of adults with moderately to severely active ulcerative colitis (UC). |
| 2024-01-22 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Demonstrates Significant and Rapid Scalp Psoriasis Clearance in People of Color in New Large Phase 3b Study jnj.com ↗
TREMFYA demonstrated significant and rapid scalp PsO clearance and improvement in scalp itch as well as patient-reported health-related quality of life (HRQoL) outcomes. |
| 2023-11-08 | Janssen Research & Development, LLC | Results New Real-World Data Show TREMFYA® (guselkumab) Was Associated With Clinically Meaningful Improvements in Patient-Reported Outcomes for Adults Living With Active Psoriatic Arthritis jnj.com ↗ |
| 2023-11-08 | Janssen Research & Development, LLC | Results New Real-World Data Show TREMFYA® (guselkumab) Was Associated With Clinically Meaningful Improvements in Patient-Reported Outcomes for Adults Living With Active Psoriatic Arthritis jnj.com ↗
People living with treatment-resistant active psoriatic arthritis reported meaningful improvements in pain, physical function and fatigue on TREMFYA through six months |
| 2023-10-23 | Janssen Research & Development, LLC | Results New Phase 3 TREMFYA® (guselkumab) Results in Ulcerative Colitis Show a 77 Percent Overall Clinical Response Rate and Early Symptom Improvement jnj.com ↗
Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, today announced new data from the QUASAR Phase 3 Induction Study demonstrating the efficacy and safety profile of TREMFYA®(guselkumab), a selective IL-23 p19 inhibitor, in patients with moderately to severely active ulcerative colitis (UC) through 24 weeks. |
| 2023-10-23 | Janssen Research & Development, LLC | Results New Phase 3 TREMFYA® (guselkumab) Results in Ulcerative Colitis Show a 77 Percent Overall Clinical Response Rate and Early Symptom Improvement jnj.com ↗
High rates of clinical responsea were observed at Weeks 12 or 24, with no new safety signals observed compared to the safety profile of TREMFYA in its approved indications. |
| 2023-10-20 | Janssen Research & Development, LLC | Results Janssen Announces TREMFYA® (guselkumab) Demonstrates Significant Skin Clearance in First-of-its-Kind Prospective, Large-Scale Study Dedicated to People of Color Living with Moderate to Severe Plaque Psoriasis jnj.com ↗
In the study, TREMFYA demonstrated significant skin clearance, rapid scalp psoriasis clearance and improvement in health-related quality of life outcomes. |
| 2023-10-16 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Maintains Key Efficacy Endpoints Through Three Years for Adults with Moderately to Severely Active Crohn’s Disease in a Phase 2 Study jnj.com ↗
Rates of clinical remission and endoscopic response were maintained through three years. |
| 2023-10-16 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Maintains Key Efficacy Endpoints Through Three Years for Adults with Moderately to Severely Active Crohn's Disease in a Phase 2 Study jnj.com ↗
Rates of clinical remission and endoscopic response were maintained through three years. |
| 2023-10-09 | Janssen Research & Development, LLC | Results Janssen Highlights Latest Research for TREMFYA® (guselkumab) and Investigational Targeted Oral Peptide JNJ-2113 in Moderate to Severe Plaque Psoriasis at the European Academy of Dermatology and Venereology (EADV) Congress jnj.com ↗
In the GUIDE trial, the results experienced by super respondersbwith short disease duration of PsO who were treated with TREMFYA extended beyond high levels of Psoriasis Area and Severity Index (PASI) responses. |
| 2023-10-09 | Janssen Research & Development, LLC | Results Janssen Highlights Latest Research for TREMFYA® (guselkumab) and Investigational Targeted Oral Peptide JNJ-2113 in Moderate to Severe Plaque Psoriasis at the European Academy of Dermatology and Venereology (EADV) Congress jnj.com ↗ |
| 2023-05-31 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Provides Sustained Improvements Across All Minimal Disease Activity Domains for Adults Living with Active Psoriatic Arthritis in Phase 3b Trial jnj.com ↗
In a separate post-hoc analysis of the Phase 3 DISCOVER-1 and DISCOVER-2bclinical trial findings, TREMFYA was shown to be associated with prompt and sustained improvements in all identified determinants. |
| 2023-05-09 | Janssen Research & Development, LLC | Results First Phase 3 TREMFYA® (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis jnj.com ↗
The data show statistically significant and clinically meaningful improvements across symptomatic and histo-endoscopic outcome measures. |
| 2023-05-09 | Janssen Research & Development, LLC | Results First Phase 3 TREMFYA® (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis jnj.com ↗ |
| 2023-03-17 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis jnj.com ↗
Analysis of real-world data from the IBM MarketScan Research Databases from July 13, 2017, to May 1, 2021, showed TREMFYA was associated with greater persistence (i.e., longer median time to index treatment discontinuation) compared to secukinumab and ixekizumab among bio-naïve patients:[1] |
| 2023-03-17 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis jnj.com ↗
Additionally, in a post-hoc analysis of Phase 3 VOYAGE 2 clinical trial results, TREMFYA demonstrated durable clinical efficacy, itch relief and quality-of-life improvements in patients living with scalp PsO. |
| 2023-03-03 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Demonstrates a Differentiated Binding Mechanism from Risankizumab in In Vitro Studies jnj.com ↗
Findings show that guselkumab is able to dose-dependently bind to CD64+amyeloid cells,1the predominant source of IL-23-driven inflammation in the gut.2,b |
| 2022-11-11 | Janssen Research & Development, LLC | Results New TREMFYA® (guselkumab) Post-Hoc Analysis Reveals Early Efficacy Predicted Longer-Term Efficacy And Sustained Achievement Among A Diverse Active Psoriatic Arthritis Patient Population jnj.com ↗
The data derived from TREMFYA-treated patients in the DISCOVER program give us more tools to evaluate treatment plan options that may help facilitate long-term relief as we work toward the ultimate goal of disease remission. |
| 2022-11-11 | Janssen Research & Development, LLC | Results New TREMFYA® (guselkumab) Post-Hoc Analysis Reveals Early Efficacy Predicted Longer-Term Efficacy And Sustained Achievement Among A Diverse Active Psoriatic Arthritis Patient Population jnj.com ↗
New TREMFYA® (guselkumab) Post-Hoc Analysis Reveals Early Efficacy Predicted Longer-Term Efficacy And Sustained Achievement Among A Diverse Active Psoriatic Arthritis Patient Population |
| 2022-11-10 | Janssen Research & Development, LLC | Results New TREMFYA® (guselkumab) Post-Hoc Analysis Reveals Active Psoriatic Arthritis Patients With Early Efficacy Had Meaningful Long-Term Improvement in Health-Related Quality of Life jnj.com ↗
In a separate post-hoc analysis of DISCOVER-2, clinically meaningful improvements in fatigue (measured by Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F])cobserved at one year in TREMFYA-treated patients were enhanced through two years, resulting in greater proportions of patients achieving normative FACIT-F levels. |
| 2022-11-10 | Janssen Research & Development, LLC | Results New TREMFYA® (guselkumab) Post-Hoc Analysis Reveals Active Psoriatic Arthritis Patients With Early Efficacy Had Meaningful LongTerm Improvement in Health-Related Quality of Life jnj.com ↗
Post-hoc analysis of DISCOVER-2 Phase 3 data suggest active psoriatic arthritis patients with week 8 response to TREMFYA showed meaningful improvements in health-related quality of life at week 100, compared to patients without early response |
| 2022-10-24 | Janssen Research & Development, LLC | Results New TREMFYA® (guselkumab) Data Show an Overall Clinical Response Rate of Approximately 80 Percent in a Phase 2b Induction Study of Adults with Moderately to Severely Active Ulcerative Colitis jnj.com ↗
The data presented at the 2022 American College of Gastroenterology (ACG) Annual Scientific Meeting show an overall clinical response rate of approximately 80 percent in patients who were randomized to TREMFYA®(guselkumab). |
| 2022-10-24 | Janssen Research & Development, LLC | Results New TREMFYA® (guselkumab) Data Show an Overall Clinical Response Rate of Approximately 80 Percent in a Phase 2b Induction Study of Adults with Moderately to Severely Active Ulcerative Colitis jnj.com ↗ |
| 2022-10-10 | Janssen Research & Development, LLC | Results Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic, and Endoscopic Remission at Week 38 jnj.com ↗ |
| 2022-10-10 | Janssen Research & Development, LLC | Results Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic, and Endoscopic Remission at Week 38 jnj.com ↗
The rate of clinical remission was 47.9 percent in patients who received combination induction therapy with guselkumab and golimumab compared with either treatment alone (31.0 percent and 20.8 percent, respectively) at 38 weeks1 |
| 2022-09-08 | Janssen Research & Development, LLC | Results TREMFYA®▼ (guselkumab) Demonstrates Higher Rates of Complete Skin Clearance with Earlier Treatment in Adults with Moderate to Severe Plaque Psoriasis in Phase 3b GUIDE Study jnj.com ↗ |
| 2022-09-08 | Janssen Research & Development, LLC | Results TREMFYA®▼ (guselkumab) Demonstrates Higher Rates of Complete Skin Clearance with Earlier Treatment in Adults with Moderate to Severe Plaque Psoriasis in Phase 3b GUIDE Study jnj.com ↗ |
| 2022-06-01 | Janssen Research & Development, LLC | Results New Data Show Patients Treated with First-in-Class TREMFYA® (guselkumab) Achieve Durable Efficacy Across Joint and Axial Symptoms of Active Psoriatic Arthritis Through Two Years jnj.com ↗
Further analyses showed TREMFYA also provided patients with sustained improvements in measures of health-related quality of life (HRQoL), including fatigue, pain and work productivity. |
| 2022-06-01 | Janssen Research & Development, LLC | Results New Data Show Patients Treated with First-in-Class TREMFYA® (guselkumab) Achieve Durable Efficacy Across Joint and Axial Symptoms of Active Psoriatic Arthritis Through Two Years jnj.com ↗
New Data Show Patients Treated with First-in-Class TREMFYA® (guselkumab) Achieve Durable Efficacy Across Joint and Axial Symptoms of Active Psoriatic Arthritis Through Two Years |
| 2022-05-24 | Janssen Research & Development, LLC | Results Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022 jnj.com ↗
The GALAXI 1 data showed study participants with an inadequate response or intolerance to conventional therapies and/or biologics treated with TREMFYA achieved high levels of clinical-biomarker responsea(47.5-66.7 percent), endoscopic responseb(44.3-46 percent), and clinical remissioncwith C-reactive protein (CRP) ≤3 mg/L or fecal calprotectin ≤250 μg/g (39.3-66.7 percent) at 48 weeks across dose groups. |
| 2022-05-24 | Janssen Research & Development, LLC | Results Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA® (guselkumab) and Long-Term Safety for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022 jnj.com ↗
New data show proportions of patients treated with TREMFYA who achieved clinical-biomarker response ranged from 47.5-66.7 percent across dose groups in the Phase 2 GALAXI 1 study |
| 2022-05-18 | Janssen Research & Development, LLC | Results New Data Show TREMFYA® (guselkumab) Binds to Both Inflammatory Cells and Interleukin (IL)-23, Supporting a Hypothesis for a Differentiated Mechanism from Risankizumab jnj.com ↗
The initial results of these studies show the potential differentiating mechanism of TREMFYA |
| 2022-03-25 | Janssen Research & Development, LLC | Results New Data Show Majority of Adults with Moderate to Severe Plaque Psoriasis Treated with First-in-Class TREMFYA® (guselkumab) Experienced Durable Skin Clearance Through Five Years Regardless of Metabolic Syndrome Status, Baseline Disease Severity, or Treatment History jnj.com ↗
A separate post hoc analysis of the VOYAGE studies showed TREMFYA provided high rates of efficacy and durability through five years and similar safety outcomes among patients with and without metabolic syndrome status at baseline. |
| 2022-02-19 | Janssen Research & Development, LLC | Results Results of Novel Clinical Study Show Adults with Moderately to Severely Active Ulcerative Colitis Achieved Higher Rates of Clinical Response, Clinical Remission, and Endoscopic Improvement at 12 Weeks with Guselkumab and Golimumab Combination Therapy Versus Either Monotherapy Alone jnj.com ↗
The VEGA Phase 2a proof-of-concept study shows 83.1 percent of patients who received combination therapy achieved the primary endpoint of clinical response and 36.6 percent of patients achieved clinical remission at week 12 |
| 2022-02-18 | Janssen Research & Development, LLC | Results The Majority of Adults with Moderately to Severely Active Crohn’s Disease in a Phase 2 Study Achieved Clinical Remission and Corticosteroid-Free Remission Through 48 Weeks with TREMFYA® (guselkumab) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new results from the Phase 2 GALAXI 1 clinical trial showing the majority (57.4-73 percent) of adults with moderately to severely active Crohn’s disease (CD) who were treated with TREMFYA® (guselkumab) achieved clinical remission (Crohn’s Disease Activity Index [CDAI]<150)a at week 48. |
| 2022-01-26 | Janssen Research & Development, LLC | Results A Newly Published Network Meta-Analysis (NMA) Found TREMFYA® (guselkumab) Ranked Highest for Overall Level of Skin Clearance and Provided Positive Joint Efficacy Among Active Psoriatic Arthritis (PsA) Therapies jnj.com ↗
The NMA concluded TREMFYA ranked highestbfor skin clearance based on Psoriasis (PsO) Area Severity Index (PASI)c90 response among 23 treatment regimens |
| 2022-01-24 | Janssen Research & Development, LLC | Results A Newly Published Network Meta-Analysis (NMA) Found TREMFYA® (guselkumab) Ranked Highest for Overall Level of Skin Clearance and Provided Positive Joint Efficacy Among Active Psoriatic Arthritis (PsA) Therapies jnj.com ↗
TREMFYA ranked highest among 23 active PsA treatment regimens on skin clearance (PASI 90 response) and showed positive joint efficacy (ACR20), including inhibition of structural damage (vdH-S) |
| 2021-12-03 | Janssen Research & Development, LLC | Results Latest Phase 3 Data for First-in-Class TREMFYA® (guselkumab) Demonstrates Significant and Durable Improvement in Signs and Symptoms of Active Psoriatic Arthritis while Maintaining its Safety Profile in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR) jnj.com ↗
Results showed significantly higher proportions of patients treated with TREMFYA had improvement in joint signs and symptoms and complete skin clearance versus placebo at week 24 in this documented TNFi-IRapatient population, which is often more difficult to treat. |
| 2021-11-17 | Janssen Research & Development, LLC | Results Janssen Reports Positive Topline Week 48 Phase 2 Results for TREMFYA® (guselkumab) in Adults With Moderately to Severely Active Crohn’s Disease jnj.com ↗
At week 48, 65 percent of patients receiving TREMFYA achieved clinical remission. |
| 2021-11-01 | Janssen Research & Development, LLC | Results New Comprehensive Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Provided Durable Improvements in Measures of Psoriatic Arthritis (PsA) Disease Activity Through Two Years jnj.com ↗ |
| 2021-11-01 | Janssen Research & Development, LLC | Results New Phase 3 First-in-Class TREMFYA® (guselkumab) Data Show Durability of Joint Efficacy, Including Low Rates of Structural Damage Progression, and a Demonstrated Safety Profile in Adults with Active Psoriatic Arthritis (PsA) jnj.com ↗
TREMFYA inhibited radiographic progression versus placebo and maintained low rates of progression through two years in biologic-naïve active PsA patients |
| 2021-11-01 | Janssen Research & Development, LLC | Results New Comprehensive Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Provided Durable Improvements in Measures of Psoriatic Arthritis (PsA) Disease Activity Through Two Years jnj.com ↗
New Comprehensive Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Provided Durable Improvements in Measures of Psoriatic Arthritis (PsA) Disease Activity Through Two Years |
| 2021-06-02 | Janssen Research & Development, LLC | Results New Phase 3b Psoriatic Arthritis (PsA) Data Show First-in-Class TREMFYA® (guselkumab) Achieved Robust Joint Symptom Improvement and Complete Skin Clearance in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR) jnj.com ↗
In the COSMOS Phase 3b study, significantly higher proportions of patients treated with TREMFYA showed joint symptom improvement and complete skin clearance versus placebo at week 24 in this true TNFi-IRapatient population, which is often more difficult to treat. |
| 2021-06-02 | Janssen Research & Development, LLC | Results New Phase 3b Psoriatic Arthritis (PsA) Data Show First-in-Class TREMFYA® (guselkumab) Achieved Robust Joint Symptom Improvement and Complete Skin Clearance in Patients with Inadequate Response to Tumor Necrosis Factor Inhibition (TNFi-IR) jnj.com ↗
In the COSMOS Phase 3b study, significantly higher proportions of patients treated with TREMFYA showed joint symptom improvement and complete skin clearance versus placebo at week 24 in this true TNFi-IRa patient population, which is often more difficult to treat. |
| 2021-04-23 | Janssen Research & Development, LLC | Results New Phase 3 Data Showed First-in-Class TREMFYA® (guselkumab) Provided Durable Complete Skin Clearance Through Five Years in Moderate to Severe Plaque Psoriasis (PsO) and Robust Joint Symptom Improvement Through 52 Weeks in Active Psoriatic Arthritis (PsA) jnj.com ↗
sustained durable, complete skin clearance rates in a majority of adults with moderate to severe plaque psoriasis (PsO) through five years (252 weeks) |
| 2021-04-23 | Janssen Research & Development, LLC | Results New Phase 3 Data Showed First-in-Class TREMFYA® (guselkumab) Provided Durable Complete Skin Clearance Through Five Years in Moderate to Severe Plaque Psoriasis (PsO) and Robust Joint Symptom Improvement Through 52 Weeks in Active Psoriatic Arthritis (PsA) jnj.com ↗
Skin clearance rates were maintained at five years with 55.5 percent of patients achieving an Investigator’s Global Assessment score of 0 and 53 percent achieving Psoriasis Area Severity Index 100 response in VOYAGE 2 |
| 2021-04-23 | Eli Lilly and Company | Results Taltz® Delivers More Cumulative Days with Completely Clear Skin for Adults with Psoriasis Compared to Seven Other Biologics in Novel Network Meta-Analysis lilly.com ↗
Taltz offered patients with psoriasis the greatest number of cumulative days of completely clear skin compared to adalimumab, brodalumab, etanercept, guselkumab, risankizumab, secukinumab and ustekinumab. |
| 2021-03-16 | Janssen Research & Development, LLC | Results New Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Achieved Complete Skin Clearance and Favorable Joint Efficacy in Adult Patients with Active Psoriatic Arthritis (PsA) Through Two Years jnj.com ↗
These findings also confirmed that the robust efficacy TREMFYA demonstrated in patients at Week 24 on physical function, physical aspects of health-related quality of life, and resolution of enthesitisb and dactylitisc was also seen through Week 100. |
| 2021-03-16 | Janssen Research & Development, LLC | Results New Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Achieved Complete Skin Clearance and Favorable Joint Efficacy in Adult Patients with Active Psoriatic Arthritis (PsA) Through Two Years jnj.com ↗
These findings also confirmed that the robust efficacy TREMFYA demonstrated in patients at Week 24 on physical function, physical aspects of health-related quality of life, and resolution of enthesitisb and dactylitisc was also seen through Week 100. |
| 2020-11-25 | Janssen Research & Development, LLC | Regulatory European Commission Approves Janssen’s TREMFYA®▼ (guselkumab), a First-in-Class Treatment for Active Psoriatic Arthritis (PsA) jnj.com ↗ |
| 2020-10-16 | Janssen Research & Development, LLC | Regulatory Janssen Receives CHMP Positive Opinion for Expanded Use of TREMFYA®▼ (guselkumab) in the Treatment of Active Psoriatic Arthritis (PsA) in the European Union (EU) jnj.com ↗ |
| 2020-10-15 | Janssen Research & Development, LLC | Results New First-in-Class Phase 3 Data Demonstrate TREMFYA® (guselkumab) Maintained Skin Clearance Rates Through Nearly 5 Years of Continuous Use in Adult Patients with Moderate to Severe Plaque Psoriasis jnj.com ↗
New First-in-Class Phase 3 Data Demonstrate TREMFYA® (guselkumab) Maintained Skin Clearance Rates Through Nearly 5 Years of Continuous Use in Adult Patients with Moderate to Severe Plaque Psoriasis |
| 2020-10-12 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab) Induces Clinical and Endoscopic Improvements in Patients with Moderately to Severely Active Crohn’s Disease based on Interim Results from Phase 2 Study jnj.com ↗
At 12 weeks, TREMFYA induced significantly greater improvements compared to placebo across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications. |
| 2020-09-10 | Janssen Research & Development, LLC | Regulatory Health Canada Approves TREMFYA®* (guselkumab injection), a First-In-Class Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Health Canada has approved TREMFYA ® (guselkumab injection) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation. |
| 2020-07-14 | Janssen Research & Development, LLC | Regulatory TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA®(guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation. |
| 2020-07-14 | Janssen Research & Development, LLC | Regulatory TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis jnj.com ↗
TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA. |
| 2020-06-15 | Janssen Research & Development, LLC | Results New Phase 3 Data for TREMFYA®▼ (guselkumab), a First-in-Class IL-23 p19 Subunit Inhibitor, Show Consistent, High Levels of Skin Clearance Through Four Years in Adult Patients with Moderate to Severe Plaque Psoriasis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new long-term plaque psoriasis data for TREMFYA®▼ (guselkumab), a first-in-class treatment showing consistent, high levels of skin clearance at week 100 and week 204 (four years). |
| 2020-04-06 | Janssen Research & Development, LLC | Results The Lancet Simultaneously Publishes Two Phase 3 Studies Detailing Comprehensive Efficacy and Safety of TREMFYA® (guselkumab), a First-in-Class IL-23 p19 Subunit Inhibitor, in Psoriatic Arthritis jnj.com ↗
These are the first publications from a Phase 3 program reporting safety and efficacy results in active PsA for an antibody with this mechanism of action. |
| 2019-11-11 | Janssen Research & Development, LLC | Results TREMFYA® (guselkumab), a First-in-Class IL-23 p19 Subunit Inhibitor, Meets Primary Endpoints of Superior ACR20 Responses versus Placebo at Week 24 in Phase 3 Psoriatic Arthritis Studies jnj.com ↗
These findings represent the primary endpoints of the DISCOVER-1 and DISCOVER-2 Phase 3 studies, which were designed to evaluate the efficacy and safety of investigational use of TREMFYA for the treatment of adult patients with active PsA. |
| 2019-10-23 | Janssen Research & Development, LLC | Regulatory Janssen Seeks to Expand Use of TREMFYA®▼ (guselkumab) in the Treatment of Adults with Active Psoriatic Arthritis jnj.com ↗ |
| 2019-10-03 | Eli Lilly and Company | Results New Head-to-Head Data Show Taltz® (ixekizumab) Superiority versus TREMFYA® (guselkumab) in People with Moderate to Severe Plaque Psoriasis lilly.com ↗
Taltz met the primary endpoint of superiority vs. TREMFYA in the proportion of patients with moderate to severe plaque psoriasis achieving complete skin clearance as measured by PASI 100 at Week 12, as well as key secondary endpoints. |
| 2019-09-16 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA Seeking First-in-Class Approval of TREMFYA® (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis jnj.com ↗
Janssen Submits Application to U.S. FDA Seeking First-in-Class Approval of TREMFYA® (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis |
| 2019-08-13 | Eli Lilly and Company | Results Lilly Announces Superiority of Taltz® (ixekizumab) versus TREMFYA® (guselkumab) in Delivering Total Skin Clearance at Week 12 in Topline Results from Head-to-Head (IXORA-R) Trial in People Living with Moderate to Severe Plaque Psoriasis lilly.com ↗
At 12 weeks, Taltz met the primary endpoint by demonstrating superiority in the proportion of patients achieving complete skin clearance compared to TREMFYA as measured by PASI 100. |
| 2019-06-14 | Janssen Research & Development, LLC | Results Janssen reports top-line Phase 3 results for TREMFYA® (guselkumab) in adults with active psoriatic arthritis jnj.com ↗
Both studies met their primary endpoints of American College of Rheumatology 20 percent improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER program were consistent with previous studies of guselkumab and TREMFYA®current prescribing information. |
| 2019-06-14 | Janssen Research & Development, LLC | Results Janssen reports top-line Phase 3 results for TREMFYA® (guselkumab) in adults with active psoriatic arthritis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). |
| 2019-02-27 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of Novel TREMFYA® (guselkumab) One-Press Patient-controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis jnj.com ↗ |
| 2018-12-12 | Janssen Research & Development, LLC | Results New Phase 3 data demonstrate superiority of TREMFYA® (guselkumab) vs Cosentyx® (secukinumab) in delivering PASI 90 responses in the treatment of moderate to severe plaque psoriasis at week 48 jnj.com ↗
New Phase 3 data demonstrate superiority of TREMFYA® (guselkumab) vs Cosentyx® (secukinumab) in delivering PASI 90 responses in the treatment of moderate to severe plaque psoriasis at week 48 |
| 2018-10-19 | Janssen Research & Development, LLC | Results Janssen Announces New Three-Year TREMFYA® (Guselkumab) Data Demonstrates Stably Maintained Rates of Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis jnj.com ↗
At the three-year mark, patients receiving TREMFYA® in clinical studies continue to show stably maintained PASI 90 and IGA 0/1 responses |
| 2017-09-15 | Janssen Research & Development, LLC | Regulatory JANSSEN RECEIVES CHMP POSITIVE OPINION FOR GUSELKUMAB RECOMMENDING APPROVAL FOR THE TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS IN THE EUROPEAN UNION jnj.com ↗
Following this positive opinion, a final decision from the European Commission (EC) is expected later this year. |
| 2016-11-17 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application To FDA Seeking Approval Of Anti-Interleukin-23 Monoclonal Antibody Guselkumab For The Treatment Of Moderate To Severe Plaque Psoriasis jnj.com ↗
Janssen Biotech, Inc. (Janssen) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. |
| 2015-07-08 | Janssen Research & Development, LLC | Results Phase 2b Findings Published In The New England Journal Of Medicine Demonstrate Significant Efficacy Of Guselkumab In Treatment Of Moderate To Severe Plaque Psoriasis jnj.com ↗ |
| 2014-03-24 | Janssen Research & Development, LLC | Results Anti-Interleukin-23 Monoclonal Antibody Guselkumab Shows Significant Efficacy in Treatment of Moderate to Severe Plaque Psoriasis jnj.com ↗
The Phase 2b Janssen Research & Development, LLC (Janssen) -sponsored X-PLORE study demonstrated significantly higher levels of efficacy at all doses of guselkumab studied at week 16 when compared with the placebo group. |
All press releases naming this drug 136 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 136 releases opens the full record — a long page | ||
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 97 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | guselkumab | “Patients will be treated with ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks followed by treatment with guselkumab (100mg at week 0 and week 4 by...” NCT05270733 ↗86“we compared guselkumab (CNTO 1959), an anti-interleukin-23 monoclonal antibody, with adalimumab in patients with moderate-to-severe plaque psoriasis.” PMID 26154787 ↗ Jul 2015 “IL-23 therapy may include ustekinumab (anti-interleukin-12/23), risankizumab (anti-interleukin-23), or guselkumab (anti-interleukin-23).” NCT06274554 ↗ “S. pyogenes + guselkumab (1.2 μg/mL)” NCT07149792 ↗ |
| Known as | CNTO 1959 | “Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis” NCT02397382 ↗8“A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis” NCT03090100 ↗ “guselkumab (CNTO 1959) in the treatment of participants” NCT02203032 ↗ |
| Known as | GUS | “guselkumab (GUS), an interleukin-23p19 inhibitor” PMID 38332436 ↗ Feb 2024 |
| Known as | Tremfya | “Guselkumab (Tremfya®), an IL-23 inhibitor approved for the treatment of moderate-to-severe plaque psoriasis.” NCT04645355 ↗ |
| Action | Inhibit | “guselkumab, one such selective IL-23 inhibitor” PMID 37071038 ↗ Apr 2023 |
| Modality | Monoclonal antibody | “we compared guselkumab (CNTO 1959), an anti-interleukin-23 monoclonal antibody, with adalimumab in patients with moderate-to-severe plaque psoriasis.” PMID 26154787 ↗ Jul 2015 |
| Route | Intravenous | “intravenous (IV) infusion” NCT00925574 ↗ |
| Target | IL23A | “ECLIPSE is the first comparator study of an IL-23p19 inhibitor, guselkumab” PMID 31402114 ↗ Aug 2019 |