This intelligence briefing provides a comprehensive overview of significant developments in gastroenterology and endoscopy for the week of June 10-16, 2025. It is intended for advanced medical professionals and focuses on clinical research, technological advancements, guideline updates, policy changes, drug approvals, notable case reports, and upcoming conferences, with a primary emphasis on US-based developments.
Clinical Research & Trials
Advancements in Inflammatory Bowel Disease (IBD) Research and Therapeutics
Recent publications and conference presentations underscore significant progress in understanding and managing Inflammatory Bowel Disease. The June 2025 issue of Gastroenterology (Volume 168, Issue 6) featured studies on ulcerative colitis (UC) and Crohn’s disease (CD), including critical discussions on inclusion criteria for clinical trials involving patients with isolated ulcerative proctitis, reflecting an ongoing effort to refine trial design for more targeted therapeutic evaluation. These discussions aim to ensure that trial populations accurately represent the diverse clinical presentations of IBD, thereby improving the generalizability of study outcomes.
The clinical implications for gastroenterologists involve a more nuanced approach to interpreting and applying clinical trial data, particularly for specific IBD phenotypes like ulcerative proctitis. Understanding refined inclusion criteria will be crucial for assessing the relevance of new therapies to individual patient profiles and for designing future local research initiatives.
Key IBD Clinical Trial Updates from Digestive Disease Week (DDW) 2025
Digestive Disease Week 2025, held in May, showcased several important trials. The Relieve-UCCD Phase 2b study demonstrated the efficacy of Duvakitug in moderate to severe ulcerative colitis, with participants showing improved clinical and endoscopic outcomes. For fibrostenosing Crohn’s disease, the Stenova Trial assessed AGMB-129, a locally acting ALK5 inhibitor, reporting a promising safety profile and pharmacokinetic data, suggesting potential for targeted anti-fibrotic therapy.
These findings suggest that Duvakitug may soon offer a new therapeutic option for UC patients failing existing treatments, while AGMB-129 could address the significant unmet need for effective treatments for fibrostenosis in Crohn’s disease, potentially reducing the need for surgical intervention. Gastroenterologists should monitor the progression of these agents into Phase 3 trials.
Emerging Therapies for Irritable Bowel Syndrome and Eosinophilic Esophagitis
DDW 2025 also brought updates on other GI conditions. The TrIuMPH Trial evaluated EBX-102-02, an oral microbiota product for Irritable Bowel Syndrome with Constipation (IBS-C), indicating good tolerability and potential efficacy signals, highlighting the growing field of microbiome-based therapeutics. For Eosinophilic Esophagitis (EoE), a Phase 2 trial of barzolvolimab demonstrated intraepithelial mast cell depletion, offering a novel mechanistic approach to EoE treatment.
The development of EBX-102-02 could provide a much-needed non-laxative option for IBS-C, targeting the underlying dysbiosis. Barzolvolimab’s mechanism targeting mast cells could be a significant advancement for EoE patients, particularly those refractory to current treatments like PPIs and topical steroids, offering a more targeted immunomodulatory strategy.
Colorectal Cancer Treatment Advances
The American Society of Clinical Oncology (ASCO) 2025 conference featured important updates in colorectal cancer (CRC) management. Notably, discussions included the impact of FDA approvals for targeted therapies, such as the combination of encorafenib with cetuximab for BRAF V600E-mutant metastatic colorectal cancer (mCRC). This highlights the continued trend towards personalized oncology in GI cancers.
For gastroenterologists involved in the multidisciplinary care of CRC patients, awareness of these targeted therapies is crucial for treatment planning and referral to oncology. The approval of encorafenib with cetuximab provides a standard-of-care option for a specific molecular subtype of mCRC, emphasizing the importance of comprehensive genomic profiling in these patients.
Artificial Intelligence in Patient Communication
A thought-provoking presentation at DDW 2025 explored the role of Artificial Intelligence (AI) in patient interaction. A study comparing AI chatbot responses (specifically ChatGPT) to physician responses for patient inquiries found that AI-generated responses were preferred nearly 80% of the time for empathy and quality. This suggests a transformative potential for AI in enhancing patient engagement and possibly alleviating some communication burdens on clinicians.
While AI cannot replace the physician-patient relationship, these findings suggest AI tools could be valuable adjuncts for providing initial information, answering common questions, and potentially improving patient satisfaction. Gastroenterologists may soon see AI integrated into patient portals and communication platforms, requiring adaptation and understanding of its capabilities and limitations.
New Technology & Devices
This section details recent FDA approvals and technological breakthroughs in GI endoscopy and diagnostics.
Olympus EVIS X1™ Endoscopy System with EDOF™ Technology
Olympus received FDA 510(k) clearance for its EZ1500 series endoscopes, including the GIF-EZ1500 gastroscope and CF-EZ1500DL/I colonoscope, which incorporate Extended Depth of Field (EDOF™) technology. As part of the EVIS X1™ system, EDOF uses dual prisms to create a continuously sharp image across a wider depth of field, allowing for closer inspection (3mm vs. 5mm in previous models) without blurring and reducing the need for focal adjustments. The scopes are also 10% lighter and feature ergonomic improvements.
The EDOF technology aims to improve lesion detection and characterization by providing consistently clear images, potentially reducing miss rates for polyps and subtle mucosal changes. The enhanced ergonomics and compatibility with other imaging modalities like TXI™, RDI™, and NBI™ may improve procedural efficiency and physician comfort during long endoscopy lists.
Medtronic PillCam Genius SB Capsule Endoscopy
Medtronic obtained FDA 510(k) clearance for its Next-Generation PillCam Genius SB capsule. This small bowel capsule endoscopy device features a wearable, single-use link device for data storage and provides patient alerts via vibrations, sounds, and lights to indicate procedure progress. It is designed for non-invasive visualization of the small bowel.
The PillCam Genius SB aims to enhance the patient experience and diagnostic workflow for small bowel evaluation. For gastroenterologists, this updated technology may offer more reliable data capture and improved patient compliance, aiding in the diagnosis of conditions like obscure GI bleeding, Crohn’s disease, and small bowel tumors.
AnX Robotica NaviCam ProScan AI for Capsule Endoscopy
FDA clearance was granted for NaviCam ProScan, an AI-assisted reading tool developed by AnX Robotica for capsule endoscopy images. This software is specifically designed to aid in the review of small-bowel bleeding cases, aiming to improve accuracy and speed of interpretation.
The integration of AI like NaviCam ProScan into capsule endoscopy reading can significantly reduce the time burden on clinicians and potentially increase the detection rate of subtle bleeding sources or lesions. This technology supports the trend towards AI-augmented diagnostics in gastroenterology, aiming to improve efficiency and diagnostic yield.
Fujifilm’s EN-840T Double Balloon Enteroscopy (DBE) Scope
Fujifilm’s EN-840T DBE Scope received the 2025 MedTech Breakthrough Award for “Best New Endoscopy Technology Solution.” This scope features HD CMOS imaging, multi-light technology (LCI and BLI), adaptive bending, and a dedicated forward water jet channel. It also allows aspiration while a therapeutic device is inserted, facilitating quicker hemostasis.
The EN-840T DBE scope enhances capabilities for deep small bowel enteroscopy, crucial for diagnosing and treating conditions like Crohn’s disease, small bowel tumors, and obscure GI bleeding. The improved visualization, maneuverability, and therapeutic access can lead to more effective interventions in complex small bowel cases, potentially reducing procedure times and improving patient outcomes.
Updated Guidelines & Policy
ACG Clinical Guideline Update: Ulcerative Colitis in Adults (June 2025)
The American College of Gastroenterology (ACG) published a significant update to its guidelines on the management of ulcerative colitis in adults in the June 2025 issue of The American Journal of Gastroenterology. Authored by Rubin et al., these guidelines emphasize a personalized approach, incorporating new evidence on biologics, small molecules, and treatment strategies. Key recommendations include stool testing for Clostridioides difficile in suspected UC, and strong recommendations against using serologic antibody testing for diagnosis or prognosis. The guidelines also provide detailed key concept statements on diagnosis (requiring colonoscopy with biopsies), assessment of disease extent (proctitis, left-sided, extensive) and severity (using patient-reported outcomes, inflammatory markers, and endoscopic scores like MES or UCEIS), and monitoring (using fecal calprotectin, CRP, and endoscopy).
These comprehensive guidelines provide gastroenterologists with an updated framework for diagnosing, assessing, and managing UC. The emphasis on excluding infections, proper endoscopic evaluation, validated scoring systems, and a treat-to-target approach involving mucosal healing will be central to optimizing patient outcomes. The clear stance against routine serologic antibody testing for diagnosis will also guide appropriate test utilization.
ASGE and ACG Updates on Colonoscopy Quality and Bowel Preparation
Both the ASGE and ACG have reinforced and introduced new quality indicators for colonoscopy. These include a continued emphasis on adenoma detection rate (ADR) and new priority on bowel preparation quality, recommending an adequacy rate of ≥90% for both endoscopy units and individual endoscopists. The 2025 US Multi-Society Task Force (USMSTF) guidelines, supported by these societies, continue to advocate for split-dose bowel preparation regimens as the standard, along with patient education and the use of adjuncts like simethicone to improve visualization.
For practicing gastroenterologists, these updates underscore the critical importance of meticulous bowel preparation and consistent ADR monitoring to ensure high-quality colonoscopy and effective CRC prevention. Implementing strategies to achieve the ≥90% bowel prep adequacy target, such as enhanced patient instructions or tailored prep regimens, will be essential.
ACG and AGA Guidance on Gastric Cancer Screening and Surveillance
The ACG and AGA have provided updated recommendations on gastric cancer screening and surveillance, particularly for high-risk individuals. This includes first-generation immigrants from high-incidence regions, individuals with a family history of gastric cancer, and those with hereditary cancer syndromes. The guidelines advocate for high-definition white light endoscopy with image enhancement and systematic biopsies (e.g., Sydney protocol) for accurate staging and risk stratification. Surveillance intervals are tailored, with recommendations for follow-up every 3 years for patients with severe atrophic gastritis or multifocal gastric intestinal metaplasia. Eradication of Helicobacter pylori is strongly reinforced as a preventive measure.
Gastroenterologists should proactively identify high-risk patients for gastric cancer and implement these screening and surveillance protocols. The emphasis on high-quality endoscopic examination and systematic biopsy sampling is crucial for early detection of pre-malignant conditions and early gastric cancer, which can significantly improve patient prognosis.
ACG Guidelines on Eosinophilic Esophagitis (EoE) Diagnosis and Management
The ACG released updated guidelines for Eosinophilic Esophagitis in June 2025, providing a comprehensive framework for its diagnosis and management. The guidelines reiterate the importance of endoscopic evaluation with scoring systems like EREFS and obtaining multiple biopsies (at least six) from the esophagus. Treatment recommendations cover proton pump inhibitors (PPIs), topical corticosteroids, dietary elimination therapies, and biologics such as dupilumab for refractory cases. A key emphasis is placed on the necessity of maintenance therapy due to the high recurrence rates associated with EoE.
This update provides clinicians with clear, evidence-based pathways for managing EoE. The structured approach to diagnosis, including standardized endoscopic assessment and biopsy protocols, along with a tiered treatment strategy that now firmly includes biologics for appropriate patients, will help optimize care for this increasingly prevalent condition. The focus on maintenance therapy is critical for long-term symptom control and prevention of complications like strictures.
Drug Approvals & Updates
Tremfya (guselkumab) Receives European Commission Approval for Ulcerative Colitis and Crohn’s Disease
Johnson & Johnson Innovative Medicine announced on June 12, 2025, that the European Commission (EC) approved Tremfya (guselkumab) for two new indications: the treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biologic. Guselkumab, an IL-23p19 subunit inhibitor, is now the first dual-acting IL-23 inhibitor approved for both conditions in Europe, offering both intravenous (IV) induction and subcutaneous (SC) maintenance options. The approvals were supported by the GALAXI and GRAVITI programs for CD, and the QUASAR program for UC.
While this is a European approval, it signals a significant advancement in IBD therapeutics that will likely influence practice globally, including in the US pending FDA decisions. The availability of a new MOA with flexible induction options provides another valuable tool for managing complex IBD cases, particularly for patients who have failed other biologics. Gastroenterologists should anticipate its potential future availability and familiarize themselves with its efficacy and safety profile.
FDA Approves Xifyrm (meloxicam) Injection for Pain Management
On June 10, 2025, the FDA approved Xifyrm (meloxicam) injection for the management of moderate-to-severe pain. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID). While not specific to GI, this formulation may be used in postoperative settings or for acute pain episodes relevant to GI patients.
Gastroenterologists should be aware of this new formulation, particularly when managing pain in patients where oral NSAIDs may be contraindicated or less appropriate, such as post-procedurally. However, the usual GI-related NSAID precautions regarding mucosal injury and bleeding risk remain pertinent.
FDA Review of Sebetralstat for Hereditary Angioedema (HAE) Attacks
KalVista Pharmaceuticals is awaiting an FDA decision for sebetralstat, an oral plasma kallikrein inhibitor for the on-demand treatment of HAE attacks in patients aged 12 and older. The PDUFA date is set for June 17, 2025. Phase 3 KONFIDENT trial data showed rapid symptom relief (median ~1.3-1.8 hours) and a favorable safety profile.
While HAE is not primarily a GI disorder, GI manifestations such as severe abdominal pain, nausea, and vomiting are common during attacks. An effective oral on-demand treatment like sebetralstat could significantly improve the management of these debilitating symptoms, and gastroenterologists may be consulted for such GI presentations.
Expansion of Biosimilars for Inflammatory Bowel Disease
Throughout 2025, the landscape of IBD treatment continues to be shaped by the increasing availability of biosimilars. Several biosimilars for ustekinumab (Stelara), including Selarsdi, Yesintek, Imuldosa, and Otulfi, have been approved or are expected to launch, indicated for both Crohn’s disease and ulcerative colitis. Similarly, adalimumab (Humira) biosimilars, such as Simlandi (a high-concentration, citrate-free formulation), are becoming more widespread.
The proliferation of biosimilars is anticipated to reduce treatment costs and improve access to biologic therapies for IBD patients. Gastroenterologists will need to stay informed about the specific approved biosimilars, their interchangeability status, and engage in discussions with patients about these options, balancing efficacy, safety, and cost considerations.
Notable Case Reports
Jejunal Cancer Arising from Ectopic Pancreas
A recent case report published in June 2025 described a rare instance of jejunal adenocarcinoma originating from ectopic pancreatic tissue. Ectopic pancreas is a relatively uncommon congenital anomaly, and malignant transformation within it is exceedingly rare. The case highlighted the diagnostic challenges, often requiring advanced imaging and endoscopic techniques for identification and definitive histopathological confirmation.
This case serves as a reminder for gastroenterologists to consider rare etiologies for small bowel tumors, especially when encountering unusual lesions. It underscores the importance of thorough histopathological examination of resected ectopic pancreatic tissue, even if incidentally found, due to its malignant potential, albeit low.
Fatal Vanishing Bile Duct Syndrome Following Cord Blood Transplantation
Another significant case reported in June 2025 detailed a patient who developed fatal vanishing bile duct syndrome (VBDS) after undergoing cord blood transplantation. VBDS in this context is a severe form of graft-versus-host disease (GVHD) affecting the liver, characterized by progressive destruction of intrahepatic bile ducts, leading to cholestasis and liver failure. The report emphasized the diagnostic complexity and limited treatment options for this devastating complication.
This report is pertinent for gastroenterologists and hepatologists managing post-transplant patients. Early recognition of progressive cholestasis and liver dysfunction in this population should prompt consideration of VBDS, necessitating liver biopsy for confirmation and aggressive immunosuppressive therapy, although prognosis often remains poor.
Crohn’s Disease Remission Achieved via Fecal Microbiota Transplantation (FMT)
A case study highlighted the successful induction of remission in a patient with Crohn’s disease using fecal microbiota transplantation. While FMT is established for recurrent Clostridioides difficile infection, its role in IBD is still investigational. This report adds to the growing body of anecdotal and small-study evidence suggesting potential efficacy in select IBD patients, likely through modulation of the gut microbiome and immune responses.
While FMT is not yet a standard therapy for Crohn’s disease, such cases fuel further research into its mechanisms and potential as a therapeutic modality. Gastroenterologists should be aware of the ongoing clinical trials and the investigational nature of FMT for IBD, counseling patients appropriately about its current status.
Upcoming Conferences
This section lists key upcoming conferences and educational events in gastroenterology.
Harvard CME | Gastroenterology 2025
This comprehensive online update, organized by Harvard Medical School, was held from June 9–12, 2025. The program covered recent advances, guidelines, and clinical practices in gastroenterology, including topics such as biologics in IBD, management of GI complications of immunotherapy, advances in liver disease, and endoscopic techniques. Recorded content is available for 90 days post-event.
For those who attended or access the recordings, this event offers practical, results-driven education with CME credits, valuable for staying current with the rapidly evolving field of gastroenterology from a leading academic institution.
Clinical and Medical Case Reports Summit
This summit is scheduled for June 16-17, 2025, in Rome, Italy. It emphasizes global healthcare lessons through case reports across multiple specialties, including gastroenterology. The conference provides a platform for presenting unique cases, fostering discussion on diagnostic and therapeutic challenges.
This event offers an international perspective on clinical problem-solving and is a valuable venue for clinicians interested in sharing and learning from unique or challenging gastroenterology cases.
Gastroenterology Conference in Zurich, Switzerland
Organized by Frigate Conferences, this in-person international conference will take place from June 23–24, 2025, in Zurich. The theme is “Late progressions and remedial procedures in the field of Gastroenterology,” covering topics such as gastrointestinal carcinogenesis, IBD, GI bleeding, pancreatic diseases, liver fibrosis, and endoscopic advancements.
This conference provides an opportunity for in-depth discussion on advanced topics and research in gastroenterology, facilitating networking with international experts and exploring new therapeutic strategies and surgical innovations.
World Gastroenterology Organisation (WGO) Meeting in Rabat, Morocco
The WGO hosted a meeting in Rabat, Morocco, from June 13–15, 2025. This event is part of WGO’s global initiative to promote knowledge exchange and capacity building in digestive health, particularly relevant for understanding gastroenterology practice and challenges in different regions.
Participation in WGO events offers insights into global gastroenterology trends, educational initiatives, and collaborative opportunities, contributing to a broader understanding of digestive health worldwide.
References
The Lancet Gastroenterology & Hepatology, June 2025 Medpace Highlights from Digestive Disease Week 2025 Cancer Therapy Advisor – ASCO 2025: Advances in Colorectal Cancer Olympus America – FDA Clearance of EZ1500 Series Endoscopes Gastroendonews – FDA Clearance Next-Gen PillCam Medtronic Becker’s GI & Endoscopy – 10 AI algorithms FDA-cleared for gastroenterology Fujifilm Healthcare Americas Corporation – EN-840T DBE Scope Wins 2025 MedTech Breakthrough Award ACG Clinical Guideline Update: Ulcerative Colitis in Adults – AJG June 2025ASGE Guidelines and Practice Standards 2025 USMSTF Bowel Preparation Guidelines – GuidelineCentral Gastric Cancer Prevention Guidelines – The Hospitalist EoE Diagnosis and Management Guidelines – ASGE Learn IMT Ireland – Two new indications of Tremfya approved Drugs.com – New Drug Approvals Clinical Pain Advisor – FDA Drug Approval Decisions Expected in June 2025 Healio – Biosimilar boom set to expand treatment landscape for IBD in 2025Springer – Clinical Journal of Gastroenterology JAMA Network Gastroenterology Collection Harvard CME | Gastroenterology 2025 CRG Conferences – Clinical and Medical Case Reports Summit Frigate Conferences | Gastroenterology 2025 World Gastroenterology Organisation Meetings Calendar