budesonide ER / Generic mfg. - LARVOL DELTA

Medical Management of UC: From 5-ASA to Corticosteroids (IASGO 2026) - "Those patients with suboptimal response or intolerance to rectal mesalaminemay opt to use rectal corticosteroids enemas or foams. Patients with inadequate response to optimized5-ASA require escalation of therapy to oral prednisone or budesonide MMX."

Inflammatory Bowel Disease • Ulcerative Colitis

EFFICACY AND SAFETY OF BUDESONIDE MMX AND CONTROLLED RELEASE FOR INDUCTION OF CLINICAL REMISSION IN MICROSCOPIC COLITIS: A PROSPECTIVE RANDOMIZED ACTIVE COMPARATOR TRIAL (UEGW 2026) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology

Efficacy and Safety of Oral Prednisolone and Budesonide MMX for Outpatient Induction Therapy in Active Ulcerative Colitis: A Multicenter Retrospective Cohort Study. (PubMed, J Clin Med) - " Treatment selection between PSL and BUD-MMX appeared to reflect baseline disease activity, with a partial overlap in the moderate clinical range. BUD-MMX may be a reasonable initial option for selected patients."

Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

NATIONWIDE VARIABILITY IN STEROID TAPERING AND ADRENAL INSUFFICIENCY MANAGEMENT IN PAEDIATRIC INFLAMMATORY BOWEL DISEASES: RESULTS FROM AN ITALIAN SURVEY (ESPGHAN 2026) - "Regarding prednisone/prednisolone, 5/31 (16%) and 4/31 (13%) routinely maintain full-dose therapy for 3 and 4 weeks, respectively, while 3/31 (10%) extend full-dose therapy beyond 4 weeks in 10–25% of cases...Second-generation steroids are routinely tapered in 19/30 (budesonide), 14/30 (budesonide-MMX) and 13/30 (beclomethasone) centers (Figure 1B)...These findings underscore the need for disease-specific, evidence-based guidelines to harmonise practice and improve patient management. Contact e-mail address [email protected]"

Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Nephrology • Pediatrics • Renal Disease

Belatacept-Induced Colitis: a diagnostic challenge in a kidney transplant patient (ERA 2026) - "Initial immunosuppression included induction with antithymocyte globulin and corticosteroids, followed by maintenance with tacrolimus and mycophenolate sodium (MPA)...At nine months, tacrolimus was dose-reduced due to impaired renal function and replaced with everolimus and prednisone...Due to 75% interstitial fibrosis on protocol biopsy, cyclosporine was replaced with belatacept at 3.5 years post-transplant...Azithromycin was started empirically...Similar cases have been described with abatacept—a related CTLA-4Ig agent—in rheumatoid arthritis patients, showing ulcerative colitis–like presentations...Budesonide MMX® may offer a safe and effective adjunctive therapy. As belatacept becomes more widely used, recognizing this rare but reversible complication is crucial for avoiding misdiagnosis and ensuring prompt, targeted treatment. Image"

Clinical • Cardiovascular • Cytomegalovirus Infection • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Hematological Disorders • Herpes Simplex • IgA Nephropathy • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Nephrology • Pneumonia • Respiratory Diseases • Rheumatoid Arthritis • Transplantation • Ulcerative Colitis

Increased failure of budesonide MMX for ulcerative colitis during the COVID-19 pandemic: a population-based study. (PubMed, Ther Adv Gastroenterol) - "Budesonide MMX dispensing declined during the pandemic wherein, the hazard of prednisone rescue increased (HR 1.64; 95% CI: 1.01-2.67). Budesonide MMX was prescribed less frequently during the COVID-19 pandemic, with increased treatment failure, underscoring pandemic-related disruptions in UC management."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Novel Coronavirus Disease • Ulcerative Colitis

Nationwide variability in steroid tapering and adrenal insufficiency management in paediatric Inflammatory Bowel Diseases: results from an Italian survey (ECCO-IBD 2026) - "Regarding prednisone/prednisolone, 5/31 (16%) and 4/31 (13%) reported routinely maintaining full-dose therapy for 3 and 4 weeks, respectively; 3/31 (10%) extended full-dose treatment beyond 4 weeks in 10–25% of cases...Second-generation steroids were routinely tapered in 19/30 (budesonide), 14/30 (budesonide-MMX) and 13/30 (beclomethasone) centers (Figure 2)...Notably, the evaluation and management of AI risk remains inconsistent and often overlooked. These findings underscore the urgent need for disease-specific, evidence-based guidelines to harmonise practice and improve patient safety."

Immunology • Inflammation • Inflammatory Bowel Disease

Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

Trial completion • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Cytomegalovirus Colitis during Budesonide Therapy for Ulcerative Colitis. (PubMed, Intern Med) - "We report the case of a 69-year-old woman with left-sided UC who developed worsening diarrhea and hematochezia while receiving budesonide rectal foam and MMX...Oral valganciclovir was initiated, leading to rapid improvement, with antigenemia converting to negative; follow-up endoscopy showed shallower ulcers. This case illustrates that locally acting budesonide MMX does not eliminate the risk of CMV colitis, and viral reactivation can occur even during its use. Accordingly, when clinical worsening occurs during budesonide MMX therapy, early CMV testing should be considered to avoid unnecessary escalation to systemic corticosteroids or advanced agents."

Journal • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P4 | N=70 | Recruiting | Sponsor: Bausch Health Americas, Inc. | Trial completion date: Dec 2024 ➔ Jun 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pediatrics • Ulcerative Colitis

A real-world, observational study comparing the side effects of budesonide MMX with prednisolone and the resolution of symptoms in patients with mild to moderate ulcerative colitis (ECCO-IBD 2025) - "Some prednisolone-related side effects were not reported following treatment with budesonide MMX. Of those that were, only 1 patient reported that they affected daily life, indicating that budesonide MMX may have a lower impact on patients’ daily activities.Either rectal bleeding or stool frequency was resolved in over three quarters of patients by week 4 of flare therapy with budesonide MMX."

Adverse events • Clinical • Observational data • Real-world • Real-world evidence • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CMV infection in IBD patients with disease flare in the era of advanced therapies and outpatient setting (ECCO-IBD 2025) - "Median CRP was 27,5 mg/L (range 3-240), all patients had normal leucocytes and thrombocytes count and no liver tests abnormalities.None of the patients had systemic corticosteroids at the time of CMV diagnosis, one patient was using topical budesonide and one budesonide-MMX; three patients were treated with infliximab for several years; two had vedolizumab; one ustekinumab and two patients had no treatment and were about to start their first line biologic.All patients were treated with virostatic treatment with valganciclovir or ganciclovir.All patients had their biologic treatment interrupted for the time of antivirotic treatment. Conclusion CMV infection in IBD patients with active colonic disease is rare but when present, it can lead to systemic manifestation of the infection. In contrast to the thus far reported typical picture of infection complicating severe ulcerative colitis, it can occurs in both, Crohn’s disease and ulcerative colitis patients with moderate..."

Clinical • Metastases • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

Insights from the Polish Registry of Microscopic Colitis. The Overlapping Symptoms of Microscopic Colitis and Irritable Bowel Syndrome. (ECCO-IBD 2025) - "The most effective treatment was budesonide MMX, with a 93.2% improvement rate. 54% of patients using rifaximin and almost 40% of patients using probiotics reported improvement in intestinal symptoms, although these are not recommended therapies in MC...Five patients with severe MC were successfully treated with biologics (three with adalimumab and two with vedolizumab)...The overlap in symptoms, necessitate a comprehensive clinical evaluation to select appropriate treatment and avoid unnecessary escalation of immunosuppressive therapy. The much more frequent diagnosis of the lymphocytic subtype than the collagenous subtype indicates the need for discussion with pathologists about the potential underdiagnosis of collagenous colitis in Poland."

Immunology • Inflammatory Bowel Disease

Budesonide MMX for prevention of colonic stricture after subcircumferential endoscopic submucosal dissection. (PubMed, Gastrointest Endosc) - No abstract available

Journal

CORTICOSTEROID-SPARING EFFECT OF MIRIKIZUMAB FOR THE TREATMENT OF MODERATELY-TO-SEVERELY ACTIVE ULCERATIVE COLITIS: EXTENDED INDUCTION SUBGROUP ANALYSIS FROM PHASE 3 TRIAL (UEGW 2024) - P3 | "Patients receiving mirikizumab on CS at baseline (n=351) remained on their stable baseline dose (prednisone ≤20 mg/day or equivalent, budesonide MMX 9 mg/day, or beclomethasone 5 mg/day) during induction (W0 to W12). Nearly 70% of extended induction responders discontinued CS by W52. CS-sparing effect of mirikizumab in patients with moderately-to-severely active UC is clinically meaningful and aligns with the treatment goal of CS discontinuation."

P3 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

INSIGHTS FROM THE POLISH REGISTRY OF MICROSCOPIC COLITIS: ANALYSIS OF THE FIRST 165 PATIENTS ACROSS NINE ACADEMIC GASTROENTEROLOGY REFERENCE CENTERS IN POLAND (UEGW 2024) - "Three patients with severe MC were successfully treated with adalimumab.Number of patients using treatmentNumber of patients reporting improvement after treatmentNumber of patients reporting no improvement after treatmentImprovement after treatment (in percentage)Budesonide MMX9285792.4%Budesonide2321291.3%Loperamide34151944.1%Mesalazine1851327.8%Rifaximine40202050.0%Probiotics45153033.3%Table 1. The Polish Registry of Microscopic Colitis provides comprehensive insights into the clinical features and treatment outcomes of MC in Poland. Budesonide MMX emerged as an effective treatment option, while biologic therapy showed promise in refractory cases. Our findings suggest a potential overlap of symptoms between MC and IBS, highlighting the importance of thorough clinical assessment."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Novel Coronavirus Disease • Pain

Practical management of mild-to-moderate ulcerative colitis: an international expert consensus. (PubMed, Expert Rev Gastroenterol Hepatol) - "Furthermore, noninvasive tools for patient monitoring such as fecal calprotectin and intestinal ultrasound are now available. Their implementation in clinical practice will allow clinicians to tightly monitor disease activity and promptly adapt treatment, avoiding complications and disease progression and targeting better disease control."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Bausch Health, Canada Inc. Announces Additional Public Drug Plan Listings for PrUCERIS(R) (Budesonide) Aerosol Foam To Treat Mild to Moderate Distal Ulcerative Colitis in Adults (Yahoo Finance) - "Bausch Health, Canada Inc...today announced additional Canadian public drug plan listings for Pr UCERIS (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults. UCERIS has most recently become available for patients through the public drug plans of Alberta, Prince Edward Island and Newfoundland and Labrador, as well as to beneficiaries of the federal drug plans for Indigenous people through the Non-Insured Health Benefit (NIHB) and Veterans Affairs Canada."

Reimbursement • Inflammatory Bowel Disease • Ulcerative Colitis

Drug Optimization in Patients with Mild-to-Moderate Ulcerative Colitis: A Global Survey. (PubMed, J Clin Med) - "Budesonide MMX (41.8%) and systemic steroids (39.9%) were preferred in patients who failed 5-ASA...Endoscopic remission remains the main therapeutic target, followed by clinical remission. Fecal calprotectin and intestinal ultrasound still elicit complaints from physicians."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

WARNING TO DELAY IN DIAGNOSING MICROSCOPIC COLITIS IN OLDER ADULTS. A SERIES OF CASES. (PubMed, Arq Gastroenterol) - "Older females using high-risk medications are suggestive of MC. Preventing delay in the diagnosis of MC is crucial to improvement in patients´ quality of life. Budesonide MMX appears to be effective, safe and well-tolerated."

Journal • Celiac Disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Corticosteroid-sparing effect of mirikizumab for the treatment of moderately-to-severely active Ulcerative Colitis: Extended induction subgroup analysis from Phase 3 trial (ECCO-IBD 2024) - P3 | "Patients receiving mirikizumab on CS at baseline (n=351) remained on their stable baseline dose (prednisone ≤20 mg/day or equivalent, budesonide MMX 9 mg/day, or beclomethasone 5 mg/day) during induction (W0 to W12). Conclusion Nearly 70% of extended induction responders discontinued CS by W52. CS-sparing effect of mirikizumab in patients with moderately-to-severely active UC is clinically meaningful and aligns with the treatment goal of CS discontinuation."

P3 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Management and treatment optimization of patients with mild to moderate ulcerative colitis. (PubMed, Expert Rev Clin Immunol) - "Realizing individualized plans through informed shared-decision making between health-care providers and fully engaged patients holds promise to maximize quality of life outcomes. Continuous improvement relies on innovation bridging different domains to overcome current limitations and push the field toward more predictive and tailored care."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: University of Calgary | Initiation date: Sep 2023 ➔ Jan 2024

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology

Treatment of Patients with Mild to Moderate Ulcerative Colitis: A Middle East Expert Consensus. (PubMed, J Clin Med) - "We conducted an expert consensus to standardize the management of patients with mild to moderate UC. Sixteen experts in inflammatory bowel diseases, through a well-established and accepted Delphi methodology, voted and approved eight statements in order to provide practical guidance to clinicians in the Middle East."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Corticosteroid Use Among Patients With Crohn’s Disease and Ulcerative Colitis on Advanced Therapy From the CorEvitas Inflammatory Bowel Disease Registry (ACG 2023) - "bSystemic steroids include budesonide/Entocort EC, budesonide extended release/Uceris MMX, prednisone, other... A total of 1351 pts with CD (active disease: 370, remission: 981) and 894 pts with UC (active disease: 333, remission: 561) were evaluated ( Table ). For CD and UC, 28.9% and 36.6% of pts with active disease and 18.1% and 21.8% of pts in remission had systemic CS use, respectively. Demographic and other patient characteristics were generally similar, as >50% of the study population were white females."

Clinical • Metastases • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis