# Icotrokinra and the ANTHEM-UC trial Canonical: https://europeanpeptideshop.com/blog/icotrokinra-icotyde-ulcerative-colitis-anthem-uc/ Explore the catalogue and research library. Ordering and shipping have not opened yet. Research news · 8 November 2026 · 3 min read · By [European Peptide Shop](https://europeanpeptideshop.com/about/) ### On this page Icotrokinra (Icotyde) has US approval for a specified psoriasis population. ANTHEM-UC evaluates this oral IL-23 receptor antagonist in ulcerative colitis; that remains a separate research indication. [1](https://pubmed.ncbi.nlm.nih.gov/42874103/) [2](https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-icotyde) ## What is already approved, and what is still being studied? FDA’s Icotyde snapshot records an original approval date of March 17, 2026. The indication covers moderate-to-severe plaque psoriasis in adults and patients aged 12 or older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. That is the approved population described by the snapshot. [2](https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-icotyde) For a reader following oral-peptide research, the distinction is useful: one medicine can have an established indication while trials examine another. Neither the shared brand name nor a successful endpoint expands the approved indication automatically. The condition and evidence stage belong beside every headline. Question | Current evidence Plaque psoriasis | An FDA-approved indication for the specified population Ulcerative colitis | Phase 2b ANTHEM-UC evidence Does oral delivery establish equal safety to other drugs? | No head-to-head conclusion follows from this placebo comparison [1](https://pubmed.ncbi.nlm.nih.gov/42874103/) [2](https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-icotyde) [3](https://clinicaltrials.gov/study/NCT06049017) ## How was ANTHEM-UC designed? The registry identifies a randomized study in adults with moderately to severely active ulcerative colitis. Actual enrollment was 252. The primary endpoint was clinical response at week 12, based on changes in the modified Mayo score and rectal-bleeding component. This is a defined scoring outcome, not a general statement that symptoms disappeared. [3](https://clinicaltrials.gov/study/NCT06049017) The registry’s completed status describes the study record checked here. It does not indicate a regulatory decision. Trial identifiers are useful for following a molecule whose development code, generic name and brand name may all appear in different documents. [3](https://clinicaltrials.gov/study/NCT06049017) ## What did the published abstract report? The abstract reports week-12 clinical response in 63%, 58% and 55% of participants across the three icotrokinra groups, versus 27% with placebo. For the highest-dose group, clinical remission was 30% versus 11%. Those are separate endpoints and should remain separate in summaries. [1](https://pubmed.ncbi.nlm.nih.gov/42874103/) One lower-dose remission comparison did not reach the prespecified significance threshold, and the fixed-sequence analysis stopped further formal secondary-endpoint testing. The primary-response success therefore should not be extended to every secondary endpoint or every study group. [1](https://pubmed.ncbi.nlm.nih.gov/42874103/) ## What about safety and longer-term interpretation? Through week 28, the abstract reports adverse events in 60%–66% of icotrokinra participants versus 62% with placebo; serious adverse events occurred in 0%–5% versus 10%. Small-group percentages do not establish that the medicine is safer than placebo or another treatment. [1](https://pubmed.ncbi.nlm.nih.gov/42874103/) The US prescribing information separately describes infection and tuberculosis precautions and advice about live vaccines. These label warnings remain relevant when discussing the medicine’s established use; oral administration is not a reason to omit them from an evidence summary. [4](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aee3c963-edc0-4252-8769-cdf6c7cdc21a) For future updates, the useful questions are whether the response persists, which endpoints are prespecified, how missing observations are handled and whether additional studies change the benefit: risk assessment. This article explains published research; it does not turn the study regimens into instructions for individual use. ## Scope for European readers This is a dated account of the research or policy described in the linked sources. The stated jurisdiction, study product and population matter. A US or UK announcement does not establish authorisation or availability across Europe. Nothing in this report establishes results for an EPS catalogue material. Read the [research-use statement](https://europeanpeptideshop.com/research-use/) for the storefront's scope. ## Laboratory research only Materials listed on this site are supplied for in-vitro laboratory research and are not for use in or on humans or animals. They are not medicines. This article summarises published work and gives no dosing, administration, treatment or in-vivo guidance. Findings from a study apply to the material and conditions of that study, and they say nothing about any product listed here. ## References - [ANTHEM-UC published trial abstract: PMID 42874103](https://pubmed.ncbi.nlm.nih.gov/42874103/) - [FDA: Drug Trials Snapshot for Icotyde](https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-icotyde) - [ClinicalTrials.gov: ANTHEM-UC, NCT06049017](https://clinicaltrials.gov/study/NCT06049017) - [DailyMed: Icotyde prescribing information](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aee3c963-edc0-4252-8769-cdf6c7cdc21a) ## More articles Research news · 3 min read ## [Avexitide and the LUCIDITY trial](https://europeanpeptideshop.com/blog/avexitide-glp-1-antagonist-lucidity/) Why does avexitide block GLP-1? Explore post-bariatric hypoglycemia, LUCIDITY results and Amylyx’s November 2026 FDA-filing and conference plans. 8 November 2026 Research news · 3 min read ## [Eloralintide and the EloraTZP trial](https://europeanpeptideshop.com/blog/eloralintide-tirzepatide-eloratzp-trial/) Understand Lilly's eloralintide and tirzepatide EloraTZP Phase 2b study, the population tested, combination results, tolerability and development stage. 8 November 2026 Research news · 3 min read ## [MariTide's MARITIME trial programme](https://europeanpeptideshop.com/blog/maritide-monthly-weight-loss-maritime-phase-3/) Read the November 2026 MariTide update: antibody-peptide design, MARITIME-SWITCH, earlier Phase 2 results and the limits of monthly weight-loss claims. 8 November 2026