Home›Allergy & Immunology› Ulcerative Colitis Trials Shift Toward Biologics and Small Molecules Since 2019
Ulcerative Colitis Trials Shift Toward Biologics and Small Molecules Since 2019Biologics and Targeted Drugs Show Growth in Ulcerative Colitis Trials
Frontiers in MedicinePublished October 19, 2026DOI ↗Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease
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Key Takeaway
Recognize that UC trial activity has shifted toward biologics and small molecules since 2019.
This scoping review characterizes the landscape of clinical trials for active ulcerative colitis, focusing on trial volume, intervention types, and outcome measures. It does not report pooled clinical efficacy or safety data for specific agents.
The authors report a rapid increase in the number of clinical trials since 2019. Biologics and small-molecule targeted drugs are identified as the core interventions under study, while traditional therapies constitute a smaller proportion of all treatments evaluated.
Regarding outcome measurement, the review notes heavy reliance on the Mayo score, with underutilization of patient-reported outcomes and novel endoscopic scoring tools. The authors also cite small sample sizes and short follow-up periods as limitations across the trial landscape.
No adverse event, discontinuation, or tolerability data are reported in this review. Funding sources and conflicts of interest are not reported.
The review suggests that future trials should prioritize large-scale, long-term studies with comprehensive and patient-centered outcome measures. It identifies trends in trial design and outcomes rather than clinical outcomes of specific drugs, so its findings should be interpreted as descriptive of the research landscape rather than as evidence of comparative efficacy.
How this fits prior evidence
This scoping review extends prior coverage of ulcerative colitis therapeutic evidence by documenting a shift in trial activity toward biologics and small-molecule targeted drugs since 2019. Prior coverage highlighted favorable efficacy and tolerability for upadacitinib and IL-23 inhibitors in moderate-to-severe disease, and noted short-term efficacy signals but limited clinical evidence for traditional Chinese medicine components. The current review's observation that traditional therapies now represent a smaller proportion of trials is consistent with the established evidence base for targeted agents. It does not provide new comparative efficacy data.
A scoping review looked at clinical trials for people with active ulcerative colitis. The review found a rapid increase in the number of trials involving biologics and small-molecule targeted drugs since 2019. Meanwhile, traditional therapies now make up a smaller portion of the total treatments being tested.
While these newer treatments are being studied more often, the review noted some limitations in the current research. Many studies had small sample sizes or short follow-up periods. There was also an imbalance in how success was measured, as many trials relied heavily on the Mayo score while using fewer patient-reported outcomes or new endoscopic tools.
Because this was a scoping review, it identifies trends in how trials are designed rather than the specific success of one drug over another. The findings suggest that future research should focus on larger, longer studies that include more patient-centered measures. Patients should talk to their doctor to understand which treatment options are best for their specific needs.
What this means for you:
Newer targeted drugs are appearing more often in clinical trials for ulcerative colitis since 2019.
Common questions
What types of drugs are being tested for ulcerative colitis?
The review found that biologics and small-molecule targeted drugs are the core interventions being studied in clinical trials. These types of treatments have seen a rapid increase in trial numbers since 2019, while traditional therapies now make up a smaller proportion of the total treatments being tested.
Are these new treatments proven to be better than old ones?
The review does not provide data on which specific drug is better. Instead, it identifies a trend where newer treatments are being studied more frequently. Because the study was a scoping review, it looks at trial designs rather than the specific clinical outcomes of individual drugs.
What are the limitations of the current research on these drugs?
The current research has some limitations, including small sample sizes and short follow-up periods. Additionally, many trials rely heavily on the Mayo score, while there is less use of patient-reported outcomes and newer endoscopic scoring tools to measure how patients feel.
BackgroundUlcerative colitis (UC) reduces the quality of life for patients and creates a significant economic burden on global healthcare systems. Although there have been advances in UC clinical trials recently, most existing reviews have primarily focused on pathogenesis or pharmacological treatments. This review analyzed the characteristics of current clinical trials for active ulcerative colitis and assessed research methods. This review focused on refining trial design and providing evidence-based methods for improving treatment outcomes and prognosis.MethodThis scoping review was conducted in accordance with the PRISMA extension for Scoping Reviews (PRISMA-ScR). The study searched clinical trials registered in ClinicalTrials.gov and the Chinese Clinical Trial Registry (ChiCTR) from April 1, 2016, to April 1, 2026. In addition, the study searched PubMed for clinical trials published between April 1, 2016, and April 1, 2026. Data were charted and presented in tables.ResultThe study revealed a rapid increase in the number of clinical trials focusing on active ulcerative colitis since 2019. Biologics and small-molecule targeted drugs have become the core interventions, while traditional therapies constitute a smaller proportion of all treatments. However, these studies face limitations, such as small sample sizes, short follow-up periods, and an imbalance in outcome measures, which heavily rely on the Mayo score while underutilizing patient-reported outcomes and novel endoscopic scoring tools.ConclusionThe number of clinical trials for active ulcerative colitis has increased, and intervention strategies have become more varied. However, there is significant variation in study populations, trial design, and the evaluation of their effectiveness. Future trials should prioritize large-scale, long-term studies with comprehensive and patient-centered outcome measures.
