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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

PubMedGlomerular diseases2026-08-06

How Late Is Too Late? Successful Use of Targeted-Release Budesonide in IgA Nephropathy with Estimated Glomerular Filtration Rate <30 mL/min/1.73 m2.

Sharma Abhinav A, Fatfat Adnan A, Batish Ishaan I, Amin Md Shahrier MS et al.

IgA nephropathy (IgAN) is a common cause of chronic kidney disease (CKD) worldwide. However, patients with advanced CKD and significant fibrosis on biopsy have limited treatment options, and clinical trials studying targeted-release budesonide have excluded individuals with low estimated glomerular filtration rate (eGFR). We report a case of a 36-year-old male with biopsy-proven crescentic IgAN, initially diagnosed 3 years prior, who presented with progressive renal dysfunction and persistent proteinuria despite prior treatment with immunosuppression, including corticosteroids and rituximab. At evaluation, serum creatinine was 2.86 mg/dL with an eGFR of 28 mL/min/1.73 m2, urine protein-to-creatinine ratio was 1.64 grams/day, and microscopic hematuria was present. Repeat kidney biopsy demonstrated significant chronic changes with severe interstitial fibrosis and tubular atrophy. The Oxford classification score was M1, E1, S1, T2, C1. Targeted-release budesonide was initiated, after which hematuria resolved within 1 month, proteinuria decreased significantly reaching 0.29 g/day, and kidney function improved with a serum creatinine of 2.24 mg/dL and eGFR of 38 mL/min/1.73 m2 at 8 months into treatment. The patient tolerated therapy without major adverse events. This case demonstrates clinically meaningful improvement in both proteinuria and renal function following treatment with targeted-release budesonide, despite advanced chronicity but with disease activity and low eGFR, a population that remains underrepresented in clinical trials and prospective studies. Our findings highlight the importance of repeat biopsy and future studies addressing the potential benefit of targeted-release budesonide in select patients with advanced IgAN, who may retain a therapeutically targetable inflammatory component.

PMID 42559519
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PubMedJournal of nephrology2026-08-06

The outcome of IgAN: a time of reflection in the perspective of new opportunities.

Pozzi Claudio C, Baragetti Ivano I, Barruscotti Alessandro A, Del Vecchio Lucia L

The prognosis of IgA nephropathy (IgAN) has long been uncertain due to its slow progression rate. For this reason, it has been considered a relatively benign disease with limited need for specific treatment. Recent registry data suggest that up to 75% of patients progress to kidney failure within 25 years. Moreover, the average age at the time of kidney biopsy has progressively increased, suggesting that one possible reason for worsening outcomes is the change in patient characteristics. Consequently, delayed kidney biopsies and thus later-stage diagnoses may reduce treatment efficacy and expose more patients to treatment-related adverse events. Traditional therapeutic options, including renin-angiotensin system (RAS) blockers and corticosteroids, have shown limited success in achieving complete remission. Newer agents, such as budesonide, sodium-glucose co-transporter-2 (SGLT2) inhibitors, and sparsentan, have shown improved proteinuria reduction but are still far from achieving remission. The efficacy of corticosteroids appears to depend on the degree of residual kidney function at the time of treatment initiation, with better outcomes observed in patients with higher baseline kidney function. The development of novel therapeutic agents, together with a deeper understanding of IgAN immunopathogenesis and chronic kidney disease (CKD), is reshaping treatment paradigms. As recommended by the new Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, treatment strategies now need to involve a combination approach targeting both immune dysregulation and CKD progression.

PMID 42560657
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PubMedLaryngoscope investigative otolaryngology2026-08-05

Impact of Topical Steroid Nasal Irrigation Adherence on Chronic Rhinosinusitis and Allergic Rhinitis Patient Outcomes.

He Clifford Jiajun CJ, Baker Omer O, LaMonte Olivia O, Verpukhovskiy Philipp P et al.

High volume steroid nasal rinses are often prescribed for chronic rhinosinusitis and allergic rhinitis. Although the general importance of medication adherence is well established, the specific relationship between objectively measured adherence to topical steroid irrigation and patient-reported clinical outcomes has not been previously demonstrated. This study aims to investigate the effect of topical steroid nasal rinse adherence on patient outcomes. This prospective longitudinal study recruited 97 patients with chronic rhinosinusitis or allergic rhinitis. All patients were prescribed twice-daily high-volume budesonide isotonic saline sinus rinses. Objective adherence data through quantified medication usage were collected over 8 weeks. Patient outcomes were assessed via the 22-item Sino-Nasal Outcome Test (SNOT-22), a sinus discomfort visual analog scale (VAS, 0-100), and patient-perceived surgery need. Generalized estimating equations were used to analyze the impact of adherence on symptom outcomes. Higher adherence was significantly associated with improvement in both VAS (β = -0.18, p < 0.001) and SNOT-22 (β = -0.10, p = 0.024) but was not associated with increased surgery desire. Median adherence was overall 47.5%, higher in patients with recent sinus surgery (< 3 months: 55.6%) and higher baseline symptom severity (SNOT-22 ≥ 20: 51.6%), with correspondingly larger improvements in clinical outcomes. Objective adherence to budesonide sinus irrigation significantly associates with improved patient-reported outcomes, with the strongest benefit seen in patients with higher baseline symptoms and in the early postoperative period. Targeting adherence interventions may yield clinically meaningful improvements in sinonasal quality of life. 2.

PMID 42553421
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PubMedFrontiers in allergy2026-08-05

Pediatric eosinophilic esophagitis among children attending a tertiary hospital in Nairobi, Kenya: a case series.

Mwangi Lynnette L, Silim Hassan H, Chebet Faith F, Chowdhury Utpol U et al.

Eosinophilic esophagitis (EoE) is an emerging chronic immune-mediated esophageal disorder characterized by esophageal dysfunction and dense eosinophilic infiltration of the epithelium. Despite increasing global recognition, data from sub-Saharan Africa remain scarce. The aim of this work is to describe the clinical spectrum, endoscopic and histopathologic features, and treatment outcomes of pediatric EoE cases diagnosed at a tertiary private hospital in Nairobi, Kenya. We conducted a retrospective case series of eight children, aged 4-17 years, who were diagnosed with EoE at The Aga Khan University Hospital, Nairobi. Data collected included demographics, presenting symptoms, laboratory findings, endoscopic features, histology, treatment regimens, and follow-up outcomes. Diagnosis was based on the presence of ≥15 eosinophils per high-power field in esophageal biopsies, alongside clinical and endoscopic correlation, and exclusion of other causes of esophageal eosinophilia. Of the eight patients (six boys, two girls), common symptoms included dysphagia (n = 2, 25%), chronic abdominal pain (n = 5, 62%), and globus sensation (n = 1, 12%). Endoscopic findings included edema, furrows, exudates, and white plaques, classified using the Eosinophilic Esophagitis Endoscopic Reference Score (EREFS). Eosinophil counts ranged from 10 to 40 eosinophils per high-power field, demonstrating variability in symptom presentation and endoscopic findings. Two patients with eosinophil counts <15/hpf were classified as suspected EoE and treated empirically. Five patients had a history of atopy, and two had positive food allergy panels for wheat and dairy. Treatment with budesonide slurry and dietary elimination of wheat and dairy achieved clinical remission in six of eight cases. Follow-up endoscopy and histopathological assessment were available for three patients, all of whom achieved histological remission, defined as the resolution of esophageal eosinophilia on repeat biopsy. No severe adverse events were reported. This case series highlights EoE as an important yet often overlooked cause of upper gastrointestinal symptoms in Kenyan children. Its ability to mimic other gastrointestinal disorders warrants heightened clinical suspicion, particularly in cases of refractory gastritis or dysphagia unresponsive to proton pump inhibitors. Effective management includes dietary elimination and topical corticosteroids. Larger multicenter studies are needed to define the epidemiology, diagnostic challenges, and long-term outcomes of pediatric EoE in sub-Saharan Africa and to inform clinical guidelines.

PMID 42553181
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PubMedOxford medical case reports2026-08-04

Protein-losing enteropathy in a child with hypoplastic left heart syndrome after Fontan palliation: a case report.

Saife Sakeena S, Saife Sarah S, Zetawi Momen M

Protein-losing enteropathy (PLE) is a rare but serious complication of the Fontan procedure in patients with single-ventricle physiology. It results from excessive loss of plasma proteins into the gastrointestinal tract, leading to hypoalbuminemia, edema, and ascites. We report the case of a 10-year-old girl with hypoplastic left heart syndrome who underwent staged surgical palliation including the Norwood procedure, bidirectional Glenn shunt, and extracardiac Fontan completion. She presented with progressive abdominal distension, peripheral edema, and severe hypoalbuminemia (albumin 2.3 g/dl). Echocardiography and cardiac catheterization demonstrated a patent Fontan circuit with normal pulmonary artery pressures and no significant obstruction, although the inferior vena cava pressure was mildly elevated at approximately 16 mmHg. The patient was managed with intravenous albumin replacement, diuretics, anticoagulation, sildenafil, and oral budesonide. This case highlights the diagnostic challenges of PLE and emphasizes the importance of early recognition and multidisciplinary management, even in the absence of significant Fontan circuit obstruction, as elevated systemic venous pressure and lymphatic dysfunction may both contribute to disease development. Protein-losing enteropathy is a rare but potentially life-threatening complication of Fontan circulation. It should be suspected in patients with a history of Fontan palliation who present with unexplained hypoalbuminemia, edema, or ascites, even when no significant Fontan circuit obstruction is identified, as elevated systemic venous pressure and lymphatic abnormalities may contribute to disease development. Early recognition and multidisciplinary management are essential to improve clinical outcomes and guide further evaluation of underlying lymphatic abnormalities.

PMID 42549227
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PubMedEuropean journal of internal medicine2026-08-02

Particle engineering, aerosol physics, and pulmonary deposition of single-inhaler triple ICS/LABA/LAMA therapies in obstructive airway diseases.

Sorino Claudio C, Virchow Johann Christian JC, Spanevello Antonio A, Buscemi Agata A et al.

Single-inhaler triple therapy (SITT) combining an inhaled corticosteroid, long-acting β2-agonist, and long-acting muscarinic antagonist (ICS/LABA/LAMA) represents the current ceiling of inhaled pharmacotherapy for moderate-to-very-severe chronic obstructive pulmonary disease and severe uncontrolled asthma. Five device platforms are currently approved: two extrafine formulations delivering beclomethasone dipropionate/formoterol/glycopyrronium (the Modulite solution pressurised metered-dose inhaler [pMDI] and the NEXThaler breath-actuated dry powder inhaler [DPI]); the co-suspension pMDI Aerosphere platform (budesonide/glycopyrrolate/formoterol); the standard-particle Ellipta DPI (fluticasone furoate/umeclidinium/vilanterol); and the low-resistance, single-dose capsule-based DPI Breezhaler (mometasone furoate/indacaterol/glycopyrronium). Despite a shared pharmacological class, these systems differ in aerosol physics, particle engineering, intrapulmonary deposition patterns, and device-patient interaction. Furthermore, some of them are authorized only for COPD or asthma. This narrative review examines the technology and in vivo deposition evidence for each SITT platform, discusses real-world performance determinants (particle size, flow dependency, technique robustness), and proposes an expert-informed framework for patient-level device selection. Methodological limitations include reliance on in silico Functional Respiratory Imaging data when in vivo scintigraphy is unavailable, and inconsistent dose denominators across studies (emitted vs. metered dose). Cross-platform comparisons are limited by heterogeneous methodologies, and no SITT platform has demonstrated universal superiority. In platform-specific studies, NEXThaler shows relatively high lung deposition (∼55% of emitted dose) though flow-dependent; Aerosphere is robust to inhalation technique variations; Modulite provides extrafine, peripheral delivery; Ellipta and Breezhaler offer once-daily convenience with moderate deposition. Rational device selection requires structured assessment of patient inspiratory capacity, disease phenotype, coordination, and adherence. Head-to-head scintigraphy and prospective imaging-outcome studies represent major evidence gaps.

PMID 42542404
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