{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T11:58:43Z","timestamp":1790683123235,"version":"4.1.0"},"reference-count":46,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T00:00:00Z","timestamp":1786579200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T00:00:00Z","timestamp":1786579200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pediatr Drugs"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Despite considerable advancements in the therapeutic landscape of inflammatory bowel disease (IBD) for adults, long delays exist for paediatric IBD (pIBD) approval, with a median delay of &gt;7 years following adult approval. Our aim is to summarise the landscape of pIBD clinical trials through a review of trial registries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a cross-sectional review of ClinicalTrials.gov and ClinicalTrialsRegister.eu to identify investigational and approved therapeutic agents for the treatment of pIBD. All interventional studies involving pIBD (aged &lt;18 years) from database inception to July 2, 2026, were considered for inclusion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 3941 records screened, 123 completed trials (77 randomised controlled trials [RCTs] and 46 non-RCTs) and 90 active trials (55 RCTs and 35 non-RCTs) met the inclusion criteria. A majority of completed trials (71%) recruited mixed adult and paediatric populations, whereas nearly half of the active trials recruited exclusively paediatric patients, with most studies enrolling participants aged 2\u201317 years. Biologics were assessed in 81 trials (42 completed and 39 active), including the approved agents (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a039), infliximab, adalimumab, golimumab, and ustekinumab, and investigational therapies (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a042) such as vedolizumab, guselkumab, mirikizumab, risankizumab, duvakitug, afimkibart, and tulisokibart. Nine completed and 11 active trials assess small molecule therapies, including tofacitinib, upadacitinib, filgotinib, etrasimod, ozanimod, and obefazimod.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Efforts to expedite approval of new agents in pIBD are warranted to ensure timely access to effective medications. Consideration for novel trial designs alongside continued engagement with regulatory bodies, sponsors, and the academic pIBD community is essential to advance drug approvals for pIBD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s40272-026-00766-1","type":"journal-article","created":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T16:01:25Z","timestamp":1786636885000},"page":"547-561","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries"],"prefix":"10.1007","volume":"28","author":[{"given":"Dhruv","family":"Gupte","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nidhi Rashmikant","family":"Suthar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John K.","family":"MacDonald","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Le","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruben J.","family":"Colman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian G.","family":"Feagan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Camilyn","family":"Cheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jurij","family":"Hanzel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Ma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9545-4384","authenticated-orcid":false,"given":"Eileen","family":"Crowley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,8,13]]},"reference":[{"issue":"2","key":"766_CR1","doi-asserted-by":"publisher","first-page":"265","DOI":"10.1038\/ajg.2017.228","volume":"113","author":"S Ghione","year":"2018","unstructured":"Ghione S, Sarter H, Fumery M, Armengol-Debeir L, Savoye G, Ley D, et al. 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NRS: no conflicts to declare. JKM: is a former employee of Alimentiv Inc. JL: is an employee of Alimentiv Inc. RJC: has received consulting fees from Alimentiv Inc. BGF: has received consulting fees from AbbVie, Abivax, Adiso, AgomAB Therapeutics, Akros, Alira Health, Ally Bridge Group, AnaptysBio, Apini Therapeutics, Argenx, Avoro Capital Advisors, Belmore Law, BioFactura, BioJamp, Biora Therapeutics, Blackbird Laboratories, Boehringer-Ingelheim, Boxer Capital, Celsius Therapeutics, Celgene\/BMS, Celltrion, Clarivate, Connect BioPharma, Disc Medicine, Duality, EcoR1, Eli Lilly, Ensho Therapeutics, Evida, Enveda, Faes Farma, First Wave, Forbion, Galapagos, Galen Atlantica, Genentech\/Roche, General Atlantic, Genesis Therapeutics, Gilead, Gossamer Pharma, GSK, Imhotex, ImmiDomics, Immunic Therapeutics, Intercept, Janssen, Japan Tobacco Inc., Klick Health, LifeMine Therapeutics, Mage Biologics, Merck, Mestag, Mirador Therapeutics, Mobius, Monte Rosa Tx, Morphic Therapeutics, Nexys Therapeutics, Nighthawk Therapeutics, Nimbus Therapeutics, Novartis, OncoC4, OrbiMed, Orphagen, Pendopharm, Pfizer, Protagonist, 32 Bio, REDX, Roche, Roivant\/Televant, Sanofi, Sobi, Sorriso, Spyre Therapeutics, Surrozen Inc., Sun Pharma, Synedgen, Takeda, Teva, Triastek, Trex Bio, TR1X Inc. TVM Lifesciences, Ventyx Biosciences, Versant Ventures, Vida Ventures, and Zagbio; lecture fees from AbbVie, Takeda, Janssen, Pfizer, and Eli Lilly; payment for expert testimony from Belmore Law; participated in advisory boards for AbbVie, AnaptysBio, Boehringer-Ingelheim, Celgene\/BMS Eli Lilly, Genentech\/Roche, Janssen, Merck, MiroBio, Origo BioPharma, Pfizer, REDX Pharma, Sanofi, Takeda, Teva, Ecor1Capital, Morphic, and GSK; and has received stock or stock options from Connect BioPharma and EnGene. CC: no conflicts to declare. JH: has received speaker\u2019s fees from AbbVie, Janssen, and Takeda; consulting fees from Alimentiv Inc. CM: has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Pendopharm, Pfizer, Prometheus Biosciences Inc., Roche, Sanofi, Takeda, Tillotts Pharma; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, Organon, Pendopharm, Pfizer, Takeda; royalties from Springer Publishing; research support from Ferring, Pfizer. VJ: has received consulting\/advisory board fees from AbbVie, Alimentiv, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris, AstraZeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Metacrine, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus, Reistone Biopharma, Roche, Sandoz, Second Genome, Sorriso Pharmaceuticals, Takeda, Teva, TopiVert, Ventyx, and Vividion; and speaker\u2019s fees from AbbVie, Ferring, Bristol Myers Squibb, Galapagos, Janssen, Pfizer, Shire, Takeda, and Fresenius Kabi. EC: has received an educational grant and speaker fees from AbbVie, Pfizer, and consulting fees from AbbVie, Pfizer, Sanofi and Alimentiv Inc.","order":2,"name":"Ethics","label":"Conflicts of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All relevant data are included within the article and its supplementary material.","order":3,"name":"Ethics","label":"Availability of Data and Materials","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":5,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":6,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Guarantors of the article: EC. Development of study concept and design: EC, RJC, VJ. Acquisition, analysis, and interpretation of the data: DG, NRS, CC, JKM, JL. Drafting of the manuscript: DG, NRS, CC, JKM, JL, EC. Critical revision of the manuscript for important intellectual content: EC, DG, NRS, JKM, JL, RJC, BGF, CC, JH, CM, VJ. All authors approved the final version of the manuscript. We respectfully acknowledge the contributions of Dr Brian Feagan, who passed away during the submission of this finalised manuscript. This manuscript, including related data, figures and tables has not been previously published and is not under consideration elsewhere.","order":7,"name":"Ethics","label":"Authors\u2019 Contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}