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BU

budesonide (Xavin / Pulairmax / Aerosial)

✓ Approved

Teva Pharmaceutical Industries Ltd. · NR3C1 · Small Molecule

What is budesonide?

budesonide is a small molecule developed by Teva Pharmaceutical Industries Ltd.. It is approved for therapeutic indications via inhaled.

Drug Profile

Brand NamesXavin, Pulairmax, Aerosial
CompanyTeva Pharmaceutical Industries Ltd.
Drug ClassSmall Molecule
Molecular TargetNR3C1
RouteInhaled
StatusApproved
Sources: ClinicalTrials.gov, Teva Pharmaceutical Industries Ltd.

Mechanism of Action

Molecular Targets

budesonide acts on 1 molecular target:

NR3C1nuclear receptor subfamily 3 group C member 1 (GR, GCCR)
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Therapeutic Indications

budesonide is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Respiratory, thoracic and mediastinal disordersAsthma✓ Approved

Related Research Articles

PubMedJournal of pediatric gastroenterology and nutrition2026-11-11

Low-risk paediatric Crohn's disease: A narrative review of current evidence and unmet research needs.

Pochesci Saverio S, Scarallo Luca L, Gianolio Laura L, Russell Richard K RK

While current paediatric management increasingly favours early intensive treatment for children and adolescents with Crohn's disease (CD) at high risk of disease progression, a smaller subset of patients presents with a potentially 'low-risk' disease phenotype. Identifying these children is clinically challenging, as overtreatment may expose them to unnecessary risks and costs, whereas undertreatment may allow irreversible bowel damage and complications to develop. This narrative review summarises the current evidence on the definition, assessment, treatment, and monitoring of low-risk paediatric CD, highlighting existing knowledge gaps and future research priorities. At present, no consensus definition of low-risk paediatric CD exists, and disease classification relies largely on the absence of recognised high-risk features rather than validated criteria. Similarly, unlike adult practice, no paediatric prognostic model is available to identify children likely to follow a persistently mild disease course. Current assessment requires integration of clinical indices, inflammatory biomarkers, endoscopy, cross-sectional imaging, and evaluation of growth and nutritional status. Dietary treatment (Exclusive Enteral Nutrition and emerging dietary strategies, including the CD Exclusion Diet [CDED] and the Tasty & Healthy [T&H]] remains the commonest induction therapy. Budesonide or antibiotics (azithromycin and metronidazole) represent an appropriate alternative for selected children. CDED and the T&H diet may also represent attractive medium term treatment options, although robust maintenance data are still awaited. Prospective studies are needed to establish a consensus definition, develop paediatric-specific prediction models, optimise risk stratification, and determine the most effective long-term therapeutic and monitoring approaches for the 'low-risk' population.

PMID 43010643
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PubMedCureus2026-11-09

Celiac Crisis: An Unusual Case of Severe Diarrhea.

Chen Ellie E, Cusumano Vivy V

Celiac disease is an immune-mediated enteropathy triggered by dietary gluten. Celiac crisis is a severe manifestation characterized by profuse diarrhea, dehydration, hypotension, and severe metabolic derangements. We describe the case of an elderly patient with a remote childhood diagnosis of celiac disease who presented in celiac crisis. A 79-year-old man with hypertension managed on olmesartan presented with two weeks of severe watery diarrhea, weight loss, and edema that progressed to hypotension, acute kidney injury, and profound electrolyte abnormalities, necessitating multiple hospitalizations. Celiac serologies were markedly elevated, and he subsequently disclosed a childhood diagnosis of celiac disease that he had believed resolved. Duodenal biopsies demonstrated duodenitis with intraepithelial lymphocytosis and villous blunting. His symptoms persisted despite a gluten-free diet, withholding olmesartan, and supportive care but improved rapidly after initiation of budesonide. He was diagnosed with celiac crisis, with a possible contribution from olmesartan-associated enteropathy. Repeat endoscopy eight months later showed histologic remission. Celiac crisis should be considered in any patient presenting with severe diarrhea, dehydration, and metabolic abnormalities, especially when there is evidence of underlying celiac disease. In this patient, concurrent olmesartan use raised the possibility of a superimposed drug-induced enteropathy; although olmesartan was discontinued five days before budesonide was started, its contribution cannot be excluded and remains a confounding factor. Even so, this case highlights the importance of promptly recognizing celiac crisis and suggests a potential role for budesonide in patients whose symptoms persist despite gluten withdrawal and supportive care.

PMID 43001292
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PubMedAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2026-11-09

Combined Rituximab and Daratumumab Induces Remission in Refractory Post-Transplant Crescentic IgA Nephropathy.

Zhang Xuchao X, Wei Chunchun C, Zheng Gui G, Yao Dicui D et al.

Recurrent crescentic IgA nephropathy (IgAN) after kidney transplantation is rare, aggressive, and often refractory to standard immunosuppression. We report a 17-year-old recipient with biopsy-confirmed recurrent crescentic IgAN two years after transplantation despite corticosteroids and targeted-release budesonide. Rescue therapy comprised one rituximab infusion with daratumumab, followed by four daratumumab infusions. Proteinuria decreased from 5.21 to 0.06 g/g, serum albumin normalized, and allograft function remained stable through day 482 after the first rescue infusion. Longitudinal CyTOF and flow cytometry showed sustained peripheral B-cell depletion and transient NK-cell reductions. One mild upper respiratory infection occurred. Sequential biopsies showed resolution of the active cellular crescent, although mesangial IgA staining and electron-dense deposits persisted. These clinical, histologic, and immune changes were temporally associated with combined CD20- and CD38-targeted therapy. This single case cannot establish efficacy, distinguish the contributions of rituximab and daratumumab, or exclude effects of preceding and supportive treatments, but supports further study of this rescue approach.

PMID 43003186
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PubMedJornal brasileiro de nefrologia2026-11-09

IgA nephropathy: evolving treatment strategies.

Mastroianni-Kirsztajn Gianna G, Siliano Juliana Mansur JM, Luciano Eduardo de Paiva EP

IgA nephropathy (IgAN) is the most common primary glomerular disease and is characterized by marked clinical, laboratory, and histopathological heterogeneity, with a variable risk of progression to advanced stages of chronic kidney disease depending on several underlying factors. A better understanding of its pathogenesis, which involves at least a four-hit pathogenic sequence, has enabled the development of novel therapeutic strategies targeting different stages of disease development, including agents directed at specific molecular pathways. Supportive kidney-protective therapy is now well established as the cornerstone of IgAN management and involves lifestyle modifications such as a healthy diet, regular physical activity, weight control, smoking cessation, sodium restriction, optimal blood pressure control, and interventions to reduce cardiovascular risk. Pharmacological measures include renin-angiotensin-aldosterone system and sodium-glucose cotransporter 2 (SGLT2) inhibitors, as well as mineralocorticoid receptor and endothelin A receptor antagonists. Historically, immunosuppressive treatment relied primarily on systemic corticosteroids, with cyclophosphamide or azathioprine reserved for selected clinical situations. More recently, targeted-release budesonide has emerged as a therapeutic option, followed by the development of agents directed at specific molecular pathways, particularly complement inhibitors and therapies targeting BAFF and/or APRIL signaling, among others. Although this expanding therapeutic armamentarium provides new opportunities to improve patient outcomes, it also introduces uncertainty and complexity into clinical decision-making. Therefore, defining evidence-based parameters to guide the selection and combination of available therapies according to the distinct endotypes of IgAN has become increasingly important.

PMID 43002663
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PubMedBioorganic chemistry2026-11-09

Glucocorticoid-based immunology antibody-drug conjugates: linker, warhead, and targeting strategies for anti-inflammatory drug development.

Kang Bomi B, Park Jieon J, Baek Sumin S, Jeon Heonjoo H et al.

Glucocorticoids (GCs) are effective anti-inflammatory agents, but systemic glucocorticoid receptor (GR) activation limits prolonged treatment. Immunology antibody-drug conjugates (iADCs) seek to concentrate GR agonist activity in selected cell populations while limiting systemic payload exposure. This review examines GC- and glucocorticoid receptor modulator (GRM)-based iADCs from a medicinal chemistry perspective, emphasizing the evolution of steroidal payloads and their integration with linker chemistry and antibody targeting. Dexamethasone-, budesonide-, and fluticasone propionate-derived conjugates illustrate how payload potency, hydrophobicity, metabolic stability, and available attachment sites shape linker selection and release strategies. Engineered GRM payloads introduce amine handles, phosphate prodrugs, or metabolically labile groups to address specific constraints in conjugation, solubility, formulation, or systemic exposure. We compare reported phosphate, pyrophosphate, peptide, and self-immolative linker systems, distinguishing proposed release mechanisms from those supported by experimental evidence. We also consider how target expression, antibody internalization, conjugation chemistry, and drug-to-antibody ratio influence delivery and developability. The progression from ABBV-3373 to ABBV-154 highlights the importance of controlling aggregation and conjugate stability for subcutaneous administration. Their clinical development, including the discontinuation of ABBV-154, underscores the need to establish differentiated benefit-risk profiles in patients. Emerging programs further motivate coordinated optimization of payload pharmacology, linker behavior, formulation, and translational biomarkers. GC/GRM-based iADCs remain investigational, and improved targeting or molecular properties alone do not establish clinical superiority.

PMID 43003049
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PubMedJournal of Crohn's & colitis2026-11-08

ECCO Topical Review: Inflammatory Bowel Disease-Like Patterns of Drug Colitis with Practical Guidance and a Focus on Immune Checkpoint Inhibitor-Induced Enterocolitis.

Verstockt Bram B, Dragoni Gabriele G, van Schaik Fiona F, Nunes Paula Borralho PB et al.

Drug-induced enterocolitis (DIC) consists of a heterogeneous group of gastrointestinal inflammatory disorders with clinical, endoscopic, and histological features that often overlap with inflammatory bowel disease (IBD). Given the increasing recognition of immune checkpoint inhibitor (ICI)-induced enterocolitis and the lack of standardized management algorithms, the European Crohn's and Colitis Organisation (ECCO) convened a multidisciplinary panel to review DIC, with a particular focus on ICI-induced disease. Gastroenterologists, histopathologists, and oncologists systematically reviewed the literature using Medline, PubMed, EMBASE, and Scopus. Evidence was synthesized into ECCO Current Practice Positions addressing diagnostic principles, histopathological patterns, therapeutic strategies, and ICI-specific considerations. Statements were refined and approved through structured consensus. Twenty-three practice positions were agreed upon. DIC may present with diverse histological patterns, including IBD-like/chronic enterocolitis, acute enterocolitis, microscopic colitis, ischemic-type injury, and mixed features, none of which are pathognomonic. Close clinicopathological collaboration is therefore essential. In suspected ICI-induced enterocolitis, assessment should include Common Terminology Criteria for Adverse Events-based grading, stool testing for pathogens, fecal calprotectin, endoscopy with biopsies, and imaging when indicated. Corticosteroids remain first-line therapy, while mild or microscopic disease may respond to budesonide or beclomethasone. Corticosteroid-refractory or corticosteroid-dependent disease should prompt early escalation to infliximab or vedolizumab. Surgery is reserved for refractory or complicated cases. Rechallenge with ICIs may be considered following multidisciplinary evaluation. DIC represents a diagnostically complex spectrum of disorders that require integrated multidisciplinary evaluation. These ECCO Current Practice Positions provide a practical framework for diagnostic work-up and treatment, particularly for ICI-induced enterocolitis.

PMID 42998365
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