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

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

PubMedActa anaesthesiologica Scandinavica2026-07-24

Impact of Regional Hepatic Immunosuppression With Budesonide on Bacterial Elimination in Porcine Abdominal Sepsis.

Hanslin Katja K, Skorup Paul P, Wilske Frida F, Larsson Anders A et al.

The liver is essential for bacterial elimination, preventing intestinal bacteria from entering the systemic circulation, and for producing inflammatory cytokines. Glucocorticoids have been reported to exert heterogeneous effects on bacterial clearance in sepsis. Using a porcine model of gram-negative abdominal sepsis, we investigated how portal venous administration of budesonide, a glucocorticoid with extensive hepatic first-pass metabolism, affects hepatic bacterial and endotoxin elimination as well as the systemic inflammatory response, in comparison with systemic administration and no treatment. The Portal Steroid-Sepsis (Sep-Port, n = 8) and Systemic Steroid-Sepsis (Sep-Syst, n = 8) groups were administered budesonide in the portal vein or systemically, followed by an E. coli infusion for 3 h in the portal vein. The Septic Controls (Sep-Ctrl, n = 8) received saline instead of budesonide. Non-septic Controls (NSep-Port, n = 3) were treated only with portal budesonide. Portal, arterial, and hepatic venous bacterial counts were analyzed hourly during the bacterial infusion. The levels of endotoxin and inflammatory cytokines were measured. There was no difference in hepatic/portal venous bacterial count ratios. However, the arterial and hepatic venous bacterial counts were higher in the Sep-Syst compared to Sep-Port group (p < 0.001 and p < 0.01, respectively), while microbiological findings were similar in the Sep-Port and Sep-Ctrl groups. Hepatic endotoxin elimination did not differ between the groups. IL-10 levels were higher in the Sep-Port compared to the Sep-Syst group at 1 h (p < 0.01), and IL-6 levels were lower in the Sep-Port compared to the Sep-Ctrl after the bacterial infusion (p < 0.05). In this experimental sepsis model, hepatic bacterial elimination was unaffected by portal or systemic budesonide, whereas systemic administration was associated with increased systemic bacterial levels. Endotoxin clearance was unaffected by budesonide. Portal budesonide elicited a more pronounced anti-inflammatory response compared to systemic administration. These findings suggest that hepatic exposure to budesonide may modulate the inflammatory response while limiting adverse effects on systemic bacterial clearance. Glucocorticoids are widely used in sepsis management, yet their effects on bacterial clearance is incompletely understood. In this porcine model of gram-negative abdominal sepsis, portal venous delivery of budesonide (which has ~90% hepatic first-pass metabolism) preserved bacterial elimination and enhanced the early anti-inflammatory response, without the increase in systemic bacterial levels seen with systemic administration. These results demonstrate that route of delivery as a potentially important determinant of the risk-benefit balance of glucocorticoid therapy in sepsis, and support further investigation of hepatic-targeting strategies.

PubMedJournal of pharmaceutical sciences2026-07-24

Salbutamol sulfate and budesonide inhalation suspension for inhalation therapy: In vivo and in vitro evaluation.

Zhang Chao C, Bi Yunqi Y, Wang Zengming Z, Tang Zhiqiang Z et al.

Nebulized inhalation therapy is widely used for the treatment of acute exacerbations of asthma and COPD, in which budesonide (BUD) and salbutamol sulfate (SA) are commonly combined for synergistic anti-inflammatory and bronchodilatory effects. However, the in vitro and in vivo performance of such combination formulations remains insufficiently characterized. This study systematically evaluated the aerodynamic behavior, dissolution profiles, and pharmacokinetics/pharmacodynamics of BUD and SA inhalation suspensions. Suspensions with different volume median diameters (VMDs) were prepared by high-pressure homogenization, and their nebulization performance was assessed. Aerosol particle size distribution and pulmonary deposition were analyzed using a next-generation impactor (NGI) and a CT-based human nasal-throat airway model. The combination formulation showed a slightly higher fine particle fraction but a marginally lower total delivered dose than the single-drug formulations, with comparable droplet size and surface tension, suggesting possible aerosol interactions between the two drugs. Similar upper airway deposition was observed for both formulations, whereas pulmonary deposition was slightly reduced for the combination. In vitro dissolution studies demonstrated rapid release of SA and sustained release of BUD. In an acute lung injury model, the combination significantly improved lung histopathology and reduced TNF-α and IL-6 levels, showing superior anti-inflammatory efficacy compared with monotherapy. Pharmacokinetic analysis revealed comparable SA exposure and increased BUD Cmax and AUC in the combination formulation. Overall, the combination formulation exhibited stable aerosolization characteristics, coordinated drug release behavior, and improved pharmacodynamic performance, while increasing the systemic exposure of budesonide without significantly affecting the pharmacokinetics of salbutamol.

PubMedAdvances in respiratory medicine2026-07-24

Utilization Patterns of Nebulized Glycopyrronium in Patients Hospitalized for Acute Exacerbations of Obstructive Airway Disease (AEOAD)-Indian Expert Perspectives.

Khanna Arjun A, Waghray Pradyut P, Singh Ashok Kr AK, Mehta Jinay J et al.

Background: Acute exacerbation of obstructive airway disease (AEOAD) is a major cause of hospitalization, morbidity, and premature mortality in India. Hospitalized patients for the same are predominantly treated with short-acting bronchodilators, which require frequent administration and are associated with systemic adverse effects. Despite the availability of nebulized long-acting muscarinic antagonists (LAMAs) with quick onset of action, such as glycopyrronium, their role in acute care remains unclear in India. Methods: A pan-India expert opinion-building initiative was conducted among 220 pulmonologists across Tier I-II cities through 13 structured advisory meetings between April 2025 and July 2025. The final expert perspectives were then categorized into recurrent insights, raised in 75% or more meetings, and variable insights, raised in <75% of all meetings. Results: Experts reported that AEOAD management commonly involved initial stabilization with SABA/SAMA followed by transition to triple therapy with nebulized glycopyrronium, formoterol, and budesonide. Nebulized glycopyrronium was perceived to provide rapid and sustained bronchodilation with fewer cardiovascular side effects compared to short-acting agents. Benefits were reported in patients with frequent exacerbations, high sputum burden, and bronchiectasis. Operational advantages included reduced dosing frequency and nursing workload. Experts also noted potential improvements in hospital stay and readmissions; however, these observations were based on clinical experience rather than controlled data. Conclusions: Indian pulmonologists agreed that early initiation of nebulized glycopyrronium (with formoterol and budesonide) in hospitalized AEOAD may improve symptom control, lower exacerbation burden, reduce reliance on short-acting bronchodilators and corticosteroids, and shorten hospital stays.

PubMedJPGN reports2026-07-24

Effects of post-hepatic portoenterostomy adjuvant therapy on liver transplantation in children with biliary atresia: A systematic review.

de Almeida Silva Bianca Ferraz BF, Nascimento Cerqueira Alice Palmeira AP, Marques Breno Oliveira BO, de Carvalho Laguna Gabriela Garcia GG et al.

Biliary atresia (BA) is a cholangiopathy characterized by obstruction of the intrahepatic and extrahepatic bile ducts. Hepatic portoenterostomy (HPE) is the primary palliative treatment and there is still an urgent need to improve post-HPE management. This study aims to identify post-HPE adjuvant therapies associated with reducing or delaying the need for liver transplantation in children with BA. This systematic review was registered on the PROSPERO platform (ID: CRD42024553671). Studies were extracted from the following databases: PubMed, Web of Science, Lilacs, and Scielo. Original articles published between 2003 and 2025 in English, Portuguese, and Spanish were included, while studies involving adults, animals, or unrelated topics were excluded. A total of 870 studies were identified, and after applying eligibility criteria, 16 articles were selected. The studies indicated that corticosteroids alone as adjuvant therapy were not associated with improved native liver survival. However, observational studies indicated that corticosteroid therapy combined with antibiotics, anticholestatics, and immunoglobulin may be associated with improvements in jaundice, although only two studies reported increased liver survival. Rectal budesonide demonstrated promising short and long-term results in children with nonsyndromic BA. The use of adjuvant therapy after HPE was associated with improvements in jaundice and cholangitis and, in some studies, with increased liver survival. However, the findings are conflicting and heterogeneous. Further research is needed, with standardized therapeutic approaches to enable more comprehensive analyses.

PubMedAmerican journal of translational research2026-07-23

Short-term efficacy of nebulized budesonide for allergic airway inflammation in young children and dynamic changes in fractional exhaled nitric oxide (FeNO): a retrospective cohort study.

Chen Xia X, Xiao Qiang Q

Allergic airway inflammation in young children with recurrent wheezing may precede asthma. Fractional exhaled nitric oxide (FeNO) may reflect type 2 airway inflammation. To evaluate the short-term effectiveness and safety of nebulized budesonide and dynamic FeNO changes in children aged 6 to 36 months. We retrospectively analyzed 548 children treated between January 2023 and February 2025, with follow-up through June 2025. Children receiving standard care plus nebulized budesonide (n = 286) were compared to those on standard care alone (n = 262). Outcomes included clinical response, symptom-resolution time, serial FeNO, inflammatory biomarkers, three-month recurrence and adverse events. Overall response at day 7 was higher with budesonide than in the control group (92.7% vs. 80.9%; χ2 = 16.71, P < 0.001), and systemic corticosteroid rescue was less frequent (1.05% vs. 4.20%; Fisher exact P = 0.028). Wheeze resolution time was shorter (3.2 ± 1.1 vs. 5.1 ± 1.6 days; P < 0.001). FeNO decreased more in the budesonide group from baseline to day 28 (22.6 ± 6.4 to 9.8 ± 3.2 ppb) than in controls (22.4 ± 6.7 to 14.5 ± 4.6 ppb; P < 0.001 for change). Three-month recurrence was lower with budesonide (14.7% vs. 27.5%; χ2 = 13.59, P < 0.001), with no increase in adverse events. Nebulized budesonide added to standard care was associated with improved short-term clinical outcome, greater FeNO reduction, and lower three-month recurrence in young children with allergic airway inflammation.

PubMedFrontiers in immunology2026-07-23

Effect of budesonide oral suspension on dysphagia and esophageal inflammation in eosinophilic esophagitis: a systematic review and meta-analysis.

López Delgado Darío S DS, Narváez Carlos A CA, Chapues-Andrade Gloria L GL, Matus-Hernández María A MA et al.

Eosinophilic esophagitis (EoE) is a chronic, immune-mediated esophageal disease defined by the combination of clinical symptoms of esophageal dysfunction and histological evidence of eosinophilic infiltration (≥15 eosinophils per high-power field [eos/hpf]) once secondary causes have been excluded. Tissue remodelling and impaired motility cause dysphagia and food impaction. Budesonide oral suspension (BOS) is a topical corticosteroid formulated to enhance mucosal contact and reduce inflammation. This systematic review and meta-analysis evaluated the efficacy and safety of BOS in improving dysphagia and achieving histological remission in EoE. Following the PRISMA 2020 statement, PubMed, Scopus, Web of Science, and EMBASE were searched from inception to October 14, 2024, with an update verified up to the date of submission. Randomized controlled trials (RCTs) comparing BOS (1-2 mg twice daily) versus placebo in pediatric or adult EoE patients treated for ≥12 weeks were included. The primary outcome was histologic remission (<15 eos/hpf). Secondary outcomes included endoscopic findings (Eosinophilic Esophagitis Endoscopic Reference Score, EREFS), patient-reported symptom severity (assessed with validated symptom instruments, including the Dysphagia Symptom Questionnaire, DSQ), and treatment-emergent adverse events. Random-effects meta-analyses were performed using the Paule-Mandel estimator, and certainty of evidence was graded with GRADE. Mean difference (MD; the average between-group difference in the unit of the outcome) and odds ratio (OR) were reported with 95% confidence intervals (CI). Four RCTs (n = 523) met the inclusion criteria. BOS significantly improved histologic outcomes versus placebo (MD = -54.62 eos/hpf; 95% CI -68.19 to -41.05; I2 = 34.3%). Endoscopic severity improved (MD = -1.68; 95% CI -3.09 to -0.26). Patient-reported symptom severity also improved (pooled MD = -3.29 points; 95% CI -6.17 to -0.40), although the contributing trials used different validated symptom instruments, so this estimate reflects a composite symptom-severity effect. Treatment-emergent adverse events, mainly oropharyngeal/esophageal candidiasis, did not differ meaningfully between groups; serious adverse events were rare. BOS effectively reduces esophageal inflammation and alleviates dysphagia in EoE, supporting its use as a first-line topical therapy. The novel contribution of this synthesis is a strictly homogenous BOS-versus-placebo evidence base in which formulation, dose range, and follow-up are aligned across the four RCTs, complementing-rather than duplicating-broader meta-analyses that pooled heterogeneous budesonide preparations. https://www.crd.york.ac.uk/PROSPERO/view/CRD42025631228, identifier CRD4202525631228.

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