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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

PubMedInternational journal of pharmaceutics: X2026-08-30

Water-triggered in-situ gelling phospholipid oil enema for enhanced budesonide delivery and mucosal healing in ulcerative colitis.

Ouyang Ting T, Chen Yumo Y, Jia Yiying Y, Li Jiarui J et al.

Budesonide (BUD) enema therapy for ulcerative colitis (UC) is limited by poor solubility, inadequate bio-adhesion, and rapid clearance due to intestinal peristalsis. To address the limitations of conventional budesonide enemas, we designed a water-triggered in situ phase-transition phospholipid formulation (termed PG oil). This system comprises soybean phosphatidylcholine (PC-98), glyceryl dioleate (GDO), propylene glycol, and anhydrous ethanol, and achieves markedly enhanced BUD solubilization (35 mg/mL), in contrast to its negligible aqueous solubility (0.021 mg/mL). Upon contact with colonic fluid, PG oil rapidly underwent sol-gel transition, forming a bio-adhesive lamellar liquid crystalline gel that serves as both a physical mucosal barrier and a sustained-release drug depot. In a dextran sulfate sodium (DSS)-induced colitis mouse model, rectal administration of BUD-PG oil (0.3 mg/kg) significantly outperformed free BUD suspension, as evidenced by restored body weight, reduced disease activity index, normalized colon length, and decreased spleen index. Immunohistochemistry revealed marked suppression of pro-inflammatory cytokines (IL-6, TNF-α, IL-1β, MCP-1) in colonic tissue. Histological analysis demonstrated that BUD-PG promoted favorable mucosal repair characterized by reduced collagen deposition (Masson's trichrome: from 48.5% to 16.7%) while restoring gut barrier integrity through replenishment of goblet cells and upregulation of tight junction proteins (ZO-1, Occludin-1, Claudin-5, β-catenin). Collectively, this water-responsive in situ gelling phospholipid oil platform addresses critical limitations of conventional BUD enemas by combining sustained local drug delivery with physical mucosal protection, offering a promising therapeutic strategy for comprehensive mucosal healing in UC.

PMID 42668512
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PubMedJournal of asthma and allergy2026-08-29

Gene Polymorphisms Associated with Treatment Response of Asthma in Chinese Children.

Zhu Lili L, Jiang Xinyi X, Li Changchang C, Zhu Tingting T et al.

To investigate the potential associations between therapeutically relevant single nucleotide polymorphisms (SNPs) with clinical characteristics and medication response of asthma in Chinese children. This prospective observational study was conducted at the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University from August 2021 to July 2022. Patients diagnosed with asthma and age-matched healthy individuals were recruited. Genotyping of 55 SNPs was performed using the Sequenom Mass Array platform. Both the association of 55 SNPs with clinical characteristics of asthma and the efficacy of budesonide/formoterol were analyzed. A total of 412 asthma patients and 262 age-matched healthy were recruited. The Minor Allele Frequency of SNPs differs markedly from that observed in European, American, and African populations but closely in the Asian populations. Comparing genotype and allele frequencies revealed that ORMDL3-rs2872507 (AA) and ZNF432-rs3752120 (TT) were significantly more frequent in the asthma group than in the control group. ZNF432-rs3752120 and ORMDL3-rs2872507 were further analyzed, stratified by clinical features and laboratory indicators. Atopy was significantly more common in ZNF432-rs3752120 TT genotype carriers compared to CC and CT genotypes. Additionally, the demand for inhalation device use was higher in CT carriers compared to those with CC and TT genotypes. However, no significant differences in asthma clinical characteristics were observed among ORMDL3-rs2872507 genotypes. Besides, eight SNPs were confirmed to be associated with the response of inhaling Budesonide/Formoterol dry powder 80/4.5. This study revealed that the ORMDL3-rs2872507 AA genotype and the ZNF432-rs3752120 TT genotype might be susceptible genotypes in Chinese children with asthma. rs1042713, rs2305089, rs2540487, rs2712807, rs28364072, rs320995, rs4980524, and rs730012 were identified as potentially associated with the efficacy of Budesonide/Formoterol (80/4.5) inhalation therapy in a cohort of children with asthma from southern Zhejiang, China.

PMID 42666756
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PubMedWorld journal of otorhinolaryngology - head and neck surgery2026-08-28

Safety, Efficacy, and Mechanism of Action of Budesonide in Rhinitis and Rhinosinusitis: A Systematic Review.

Kennedy David W DW, Cheng Lei L, Wang De-Yun DY

Budesonide is a corticosteroid with unique pharmacokinetic and pharmacodynamic properties that has been a frontline treatment for patients with allergic rhinitis (AR) and chronic rhinosinusitis (CRS) since the 1990s. As research on budesonide continues to produce new insights, our aim was to synthesize recent investigations and provide up-to-date information on safety, clinical, and mechanism of action (MOA) outcomes. Searches were restricted to PubMed from 2014/01/01 to 2025/02/26. Clinical investigations in the primary therapeutic area of rhinitis, sinusitis, or rhinosinusitis with adult patients receiving budesonide were included. Results were screened, and findings from eligible articles were assessed for safety, efficacy, and/or MOA outcomes. Overall, 31 articles were included. CRS was the primary indication in 19 studies and rhinitis in 12 (predominantly AR). Six studies investigated hypothalamic-pituitary-adrenal (HPA) axis suppression, and 2 studies assessed intraocular pressure; budesonide did not adversely affect either outcome, even with long-term, high-dose, high-volume nasal irrigations. Twelve studies of budesonide monotherapy generally showed improved efficacy outcomes. Eight studies of budesonide combination therapies, predominantly in patients with moderate-to-severe AR, generally showed improved efficacy versus budesonide monotherapy. MOA data were reported across seven studies, with anti-inflammatory alterations observed across the nasal mucosa, nasal secretions, nasal polyps, and peripheral blood after budesonide treatment. Safety outcomes were favorable across various budesonide delivery systems, including high-dose, high-volume nasal irrigations, with no evidence of HPA axis suppression after long-term budesonide use. Budesonide demonstrated consistent efficacy that was underpinned by MOA data on its potent anti-inflammatory effects.

PMID 42662515
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PubMedLife (Basel, Switzerland)2026-08-27

Eosinophilic Duodenitis and Jejunitis with Ascites and Peripheral Eosinophilia: A Diagnostic Challenge-Case Report.

Barboi Oana-Bogdana OB, Simiras Constantin C, Vulpoi Radu-Alexandru RA, Floria Diana-Elena DE et al.

Background: Eosinophilic jejuno-duodenitis is a rare inflammatory disorder characterized by eosinophilic infiltration of the gastrointestinal tract, with highly variable clinical presentations. Mucosal eosinophilic duodenitis and jejunitis associated with ascites is uncommon and may mimic inflammatory or neoplastic conditions. Case Presentation: A 26-year-old male presented with persistent left-sided abdominal pain without bowel habit changes. Laboratory investigations revealed only slight inflammatory syndrome and peripheral eosinophilia. Contrast-enhanced abdominopelvic computed tomography demonstrated minimal ascites and circumferential wall thickening with contrast enhancement of duodenal and jejunal loops in the left flank. Given the nonspecific imaging findings, differential diagnoses included Crohn's disease, intestinal lymphoma, and infectious enteritis. Endoscopic evaluation with histopathological analysis confirmed dense eosinophilic infiltration of the duodenal and jejunal mucosa, establishing the diagnosis of eosinophilic jejuno-duodenitis after exclusion of secondary causes. Management and Outcome: The patient was treated with budesonide, with rapid clinical improvement and resolution of inflammatory markers. Follow-up magnetic resonance enterography performed three months after initiation of treatment demonstrated complete resolution of bowel wall thickening and disappearance of the minimal ascites. Conclusions: Eosinophilic jejuno-duodenitis should be considered in young patients presenting with small bowel thickening, ascites, and peripheral eosinophilia. Awareness of this entity is essential to avoid misdiagnosis and unnecessary invasive procedures.

PMID 42652950
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PubMedERJ open research2026-08-25

Airway epithelial transcriptional response to daily high-dose inhaled corticosteroids in asthma.

Menzel Mandy M, Frøssing Laurits L, Sverrild Asger A, Uller Lena L et al.

Inhaled corticosteroids are the cornerstone of asthma treatment, yet the epithelial pathways mediating their anti-inflammatory effects and their relationship to clinical traits remain incompletely understood. The objective of the present study was to investigate airway epithelial transcriptomic changes in steroid-free patients with asthma following treatment with high-dose inhaled corticosteroids. Bronchial brushings from 20 steroid-free patients with asthma were obtained during bronchoscopy before and after 6 weeks of high-dose budesonide treatment, and mRNA-sequencing was performed. Airway epithelial gene expression was analysed by weighted gene co-expression network analysis (WGCNA) to identify gene networks and profiles associated with inhaled corticosteroid treatment response. Four steroid-response clusters were identified; one metabolic cluster related to oxidative phosphorylation, which was upregulated, and three immunological clusters associated with T-cell activation and immune cell and mast cell responses, where gene expression was downregulated following inhaled corticosteroid treatment. In steroid-free patients with asthma, inhaled corticosteroids modulate airway epithelial gene networks by enhancing oxidative phosphorylation and suppressing immune and mast cell pathways. Baseline clinical traits predicted the strength of these responses, suggesting potential biomarkers for stratifying treatment with inhaled corticosteroids in asthma.

PMID 42639399
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PubMedThe journal of allergy and clinical immunology. In practice2026-08-24

Women's Health Considerations in Eosinophilic Esophagitis.

Huang Jenny J, Hsu Blatman Karen S KS, Bauer Maureen M, McGowan Emily C EC

While eosinophilic esophagitis (EoE) is traditionally recognized as a male-predominant disease, its distinct presentation, underlying biology, and management in female patients warrant closer examination. Differing gene profiles between sexes and sex-specific genetic loci associated with disease development have been identified. Estrogen has been shown to have a protective role in EoE development; this may factor into the observed male-predominance. Women tend to have less dysphagia and are more likely to experience the inflammatory symptoms of abdominal pain, nausea, reflux, heartburn, chest pain, and epigastric pain. Females are also less likely to have strictures than males. Data on endoscopic and histologic findings between females and males is variable, with data suggesting that females tend to have less severe disease activity but similar or higher levels of symptoms and quality of life impairment. When it comes to pregnancy, symptoms can improve during pregnancy but may recur after delivery. Data suggests that PPIs, swallowed budesonide, and dupilumab may be safely continued during pregnancy. Elimination diets should be approached cautiously due to the potential for adverse outcomes associated with food restriction but could be considered under the supervision of a knowledgeable dietician. Further research is needed to better understand and treat EoE in women.

PMID 42637005
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