Drug Database
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

PubMedAlimentary pharmacology & therapeutics2026-10-15

Corticosteroid Exposure in Autoimmune Hepatitis: Early Toxicity, Cumulative Burden and Associations With Long-Term Patient-Reported Outcomes.

Gentry Elizabeth E, Woods Mackenzie M, Green Kelsey K, Blessing Nadia N et al.

Autoimmune hepatitis (AIH) requires corticosteroid-based induction therapy, but prolonged exposure is common in practice. This study quantified corticosteroid utilization patterns and associations with adverse outcomes from a patient perspective. A cross-sectional patient-reported survey recruited AIHA network members with physician-confirmed AIH (N = 563). Corticosteroid exposure was quantified using annual duration thresholds (≥ 90 days/year at ≥ 5 mg/day prednisone-equivalent). Early side effects (within 6 months; n = 491) and long-term metabolic complications (≥ 2 years disease duration; n = 385) were assessed using multivariable logistic regression adjusting for age, sex and disease duration. Among 563 participants (median age 53 years; 87.4% female), all participants received a corticosteroid at diagnosis (77.6% prednisone; 11.4% budesonide). Side effects within 6 months were near-universal (96.6%; median 5 symptoms) and greater with predniso(lo)ne than budesonide (5.82 vs. 3.55 symptoms; p < 0.001); 51.2% of predniso(lo)ne-initiated patients developed a new metabolic condition within 6 months. Long-term complications affected 75.9% of the chronically exposed cohort, including weight gain > 5% (47.0%), osteoporosis (30.4%) and hypertension (18.1%). Each additional cumulative year of extensive exposure was independently associated with the composite adverse outcome (adjusted OR 1.11, 95% CI 1.02-1.22; p = 0.014), osteoporosis, Type 2 diabetes, weight gain and cataracts, with significant dose-response gradients (p-trend ≤ 0.008). Patients with > 5 cumulative years had 4-fold higher odds of the composite outcome versus patients in the None exposure group (OR 4.21, 95% CI 1.51-11.71). Corticosteroid exposure in AIH is associated with dose-dependent toxicity from the first months of treatment. Reduced induction dosing and budesonide represent potential steroid-minimization strategies in appropriate patients, warranting prospective evaluation.

PMID 42875878
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PubMedFrontiers in pediatrics2026-10-14

Trans-cuff budesonide delivery and its effects on endotracheal intubation-induced subglottic injury.

Zou Yi Y, Hu Qing Q, Yan Xiao X, Lv Zhenli Z et al.

This study aimed to determine whether budesonide inhalation suspension (BIS) diffuses through polyvinyl chloride (PVC) endotracheal tube (ETT) cuffs and whether intracuff budesonide attenuates the acute subglottic injury during endotracheal intubation (ETI) in a rabbit model. in vitro, high-performance liquid chromatography was used to quantify trans-cuff diffusion of budesonide from 2.5-mm-ID PVC ETT cuffs. For the in vivo study, 32 New Zealand White rabbits were allocated to four groups (n=8): control (Con), air-inflated cuff (Air), normal saline-inflated cuff (NS), and BIS-inflated cuff (Bud). Intubated rabbits underwent 12 h of ETI at an intracuff pressure of 22 mmHg. Subglottic tissues were harvested immediately after extubation for histological and immunofluorescence analyses. Budesonide diffusion across PVC ETT cuffs was temperature-dependent during the first 12 h and continued at 37°C for at least 14 days. In vivo, all ETI groups developed acute subglottic histological injury. Compared with the Air and NS groups, the Bud group had lower IL-1β, IL-6, and TNF-α fluorescence intensities (P < 0.05), whereas the measured histological outcomes and CD86/CD206 levels did not differ significantly among the ETI groups. No significant differences were observed between the Air and NS groups. Budesonide diffuses across PVC ETT cuffs, and intracuff BIS was associated with lower subglottic IL-1β, IL-6, and TNF-α fluorescence intensities during a 12-hour acute ETI model. The findings do not establish prevention of histological injury and require confirmation in longer-duration pharmacokinetic and outcome studies.

PMID 42871393
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PubMedFrontiers in pharmacology2026-10-14

Comparative performance of multiple predictive models constructed for budesonide nebulized formulation requirements.

Chen Jian J, Yu Xihui X, Li Ting T, Shen Shanglian S et al.

Developing rational demand forecasting plans for National Centralized Volume-Based Procurement (NCVBP) pharmaceuticals is critical to ensuring patient access while avoiding drug inventory surplus, thereby facilitating refined hospital management and reducing operational costs. This study therefore compared the predictive performance of multiple models to identify an optimal approach for forecasting hospital demand for budesonide nebulized formulation. Using 48 months of actual utilization data (2022-2025) for budesonide nebulized formulation, a fifth-batch NCVBP product, we systematically evaluated the forecasting performance of 10 single models, 3 hybrid models, and 1 weighted ensemble model. On the pediatric hospital dataset, the TBATS-XGB hybrid model achieved the best performance on the test set, yielding the lowest mean absolute percentage error (MAPE) of 12.43%, along with a root mean square error (RMSE) of 5486.0 and a mean absolute error (MAE) of 3659.8. The TBATS-XGB hybrid model can serve as a valuable reference for NCVBP drug quantity forecasting, addressing the limitations of conventional empirical estimation methods that often fail to capture structural changes and seasonal fluctuations in demand. Moreover, because it requires only historical usage data for deployment, this approach may be highly generalizable to hospital settings with limited data infrastructure.

PMID 42871385
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PubMedCureus2026-10-14

Current Evidence, Diagnostic Challenges, and Contemporary Management of Lymphocytic Colitis: A Case Report and Literature Review.

Egbo Oziegbe O, Egbo Ojevwe H OH, Omoregie Faith I FI, Onyeka Favour A FA

Lymphocytic colitis (LC) is a subtype of microscopic colitis characterized by chronic, typically non-bloody, watery diarrhea and increased intraepithelial lymphocytes despite a macroscopically normal or near-normal colon. This clinicopathological discordance creates a major diagnostic challenge because clinically important symptoms may occur without visible mucosal abnormalities, leading to missed diagnoses when colonic biopsies are not obtained. Although recognition of LC has increased, important uncertainties remain regarding its epidemiology, pathogenesis, medication associations, natural history, and optimal management, particularly in recurrent or treatment-dependent disease. This case report of a 39-year-old man and narrative review synthesizes contemporary evidence on LC, emphasizing epidemiology, pathogenesis, clinical presentation, diagnostic approach, histopathological criteria, treatment, and evidence gaps. Recent evidence supports budesonide as the preferred first-line therapy for symptomatic disease, while emerging real-world data suggest potential roles for advanced therapies in selected budesonide-refractory or budesonide-dependent patients. However, these data largely come from mixed microscopic colitis populations. Epidemiological evidence remains concentrated in North America and Europe, and data from Africa, including Nigeria, are sparse. Improved clinical recognition, standardized biopsy practices, consistent histopathological assessment, LC-specific therapeutic research, and geographically diverse epidemiological studies are needed to reduce diagnostic delay and improve long-term management.

PMID 42872171
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PubMedHepatobiliary surgery and nutrition2026-10-14

Combined treatment of budesonide and ursodeoxycholic acid for non-cirrhotic primary biliary cholangitis: a systematic review and meta-analysis.

He Kun K, Song Kai K, Jing Lisha L, Yang Daiyu D et al.

Primary biliary cholangitis (PBC) is a chronic immune-mediated disease that may partially exhibit a poor response to the first-line treatments, such as monotherapy (MU) with ursodeoxycholic acid (UDCA). Budesonide, a widely used and readily available medication, has shown promise in previous studies as an alternative to conventional drugs when combined with UDCA (CBU) for non-cirrhotic PBC. Therefore, this study aimed to confirm the role of CBU in patients with non-cirrhotic PBC. We systematically searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase databases for randomized controlled trials (RCTs) comparing CBU and MU for non-cirrhotic PBC. The certainty of evidence was assessed using the grading of the recommendation assessment, development, and evaluation (GRADE) framework. Trial sequential analysis (TSA) was applied to control for the risk of random errors and to evaluate the conclusion validity. Three high-quality RCTs comprising 170 patients were included. Moderate certainty of evidence revealed that CBU showed a significantly higher percentage improvement over MU in alkaline phosphatase (ALP) [mean difference (MD) =19.97, 95% confidence interval (CI): 6.59 to 33.35, P=0.003, I2=0%], liver histology (MD =27.04, 95% CI: 1.62 to 52.46, P=0.04, I2=46%), total bilirubin (P=0.01) and immunoglobulin G (IgG, P=0.002), with no significant difference in serious adverse drug reactions (ADRs) (P=0.06). There were no significant differences for other biochemical variable outcomes; however, positive trends were observed. TSA confirmed the reliability of the ALP and IgG percentage improvements. CBU might be superior to MU for non-cirrhotic PBC, possibly showing a better biochemical response and liver histology improvement with similar safety. Further large-sample studies are required in this subpopulation.

PMID 42871989
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PubMedACS sensors2026-10-14

Smart Oral Capsule with a Closed-Loop Sense-Decide-Act Strategy for Colitis Therapy.

Pan Wen W, Fu Jie J, Deng Shouzhe S, Lin Lizhi L et al.

Current treatments for inflammatory bowel disease (IBD) lack real-time inflammatory monitoring and lesion-specific drug delivery, resulting in poor efficacy and systemic toxicity. To address this, we present a smart oral capsule that operates a closed-loop "sense-decide-act" strategy entirely autonomously-sensing and drug release are driven by changes in the digestive tract environment without any external intervention. The capsule features a dual-layer shell sequentially responsive to pH and matrix metalloproteinases (MMPs), enabling colon-targeted delivery and inflammation-specific activation. An integrated multimodal sensor wirelessly tracks colonic TNF-α (>5 ng mL-1), pH (>7.0), and Na+ (>100 mM). The encapsulated budesonide nanoparticles (Bud@PEG-SS-NPs) release the drug specifically in reactive oxygen species (ROS)-rich microenvironments and show superior anti-inflammatory efficacy in both lipopolysaccharide (LPS)-induced cellular models and dextran sulfate sodium (DSS)-induced mouse colitis. In live rats, the capsule achieved on-demand drug release in response to elevated local TNF-α levels, and a single intervention significantly alleviated inflammation. This work establishes a new paradigm for personalized, adaptive IBD therapy and provides a versatile platform for closed-loop management of other gastrointestinal diseases.

PMID 42872713
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