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

PubMedHealthcare (Basel, Switzerland)2026-07-15

Effectiveness and Safety of Budesonide/Formoterol in Asthma: A Systematic Review.

Vo Nam Xuan NX, Pham Huong Lai HL, Ho Han Tue HT, Chung Khoi Quoc KQ et al.

Background/Objectives: Asthma's preventable burden is heavily driven by severe exacerbations (SE). Replacing standalone short-acting β2-agonists (SABAs), which risk reducing patient tolerance, with inhaled corticosteroid/long-acting β2-agonist combinations optimizes care through maintenance, reliever, and maintenance-and-reliever therapy (MART). This systematic review and meta-analysis evaluated the efficacy, effectiveness, and safety of Budesonide/Formoterol (B/F). Methods: PubMed, Cochrane, and Embase were searched for randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) through May 15, 2026. Bias was assessed via the Cochrane Risk of Bias tool version 2 (RoB 2) and the Risk ff Bias in Non-randomized Studies of Interventions (ROBINS-I) version 2.0. Primary outcomes (time to first SE, annual SE rate) were pooled using a random-effects meta-analysis, yielding hazard ratios (HRs) and rate ratios (RRs). Results: We included 19 studies (15 RCTs, 4 non-RCTs) comprising 104,600 patients (primarily aged ≥12 years with mild-to-severe asthma). Most RCTs had a low risk of bias, whereas the non-RCTs had a high risk of bias. B/F MART significantly delayed the first SE and reduced annual rates versus Budesonide + SABA (HR = 0.57; RR = 0.55), B/F + SABA (HR = 0.62; RR = 0.58), and Fluticasone/Salmeterol + SABA (HR = 0.75; RR = 0.72). As-needed B/F reduced first SE hazard and annual rates versus SABA alone (HR = 0.43; RR = 0.42). Compared with Budesonide + SABA, it delayed the first SE (HR = 0.85) but showed non-significant rate reductions (RR = 0.90). Adverse events were balanced between groups over 12-52 weeks. Conclusions: B/F MART demonstrates high efficacy in mitigating the risk of the first SE. However, limited trial data leave the evidence for maintenance or reliever regimens controversial. Across all regimens, B/F is well-tolerated within 6 to 12 months.

PMID 42450874
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PubMedJournal of clinical medicine2026-07-15

Efficacy and Safety of Oral Prednisolone and Budesonide MMX for Outpatient Induction Therapy in Active Ulcerative Colitis: A Multicenter Retrospective Cohort Study.

Kojima Kentaro K, Takada Jun J, Iwata Keisuke K, Otani Kiichi K et al.

Background/Objectives: Oral prednisolone (PSL) and budesonide multi-matrix (BUD-MMX) are used to induce remission in ulcerative colitis (UC); however, their therapeutic positioning remains unclear. Comparative data from real-world practices are limited. This study assessed the efficacy and safety of PSL and BUD-MMX in patients with active UC. Methods: Consecutive outpatients with UC initiated on oral PSL or BUD-MMX at two tertiary referral centers were included. The primary outcome was clinical remission at week 8, defined as a partial Mayo score (PMS) ≤ 1 with a rectal bleeding subscore of 0. Secondary outcomes included clinical response and safety. Pre-specified subgroup analyses were performed according to baseline disease activity. Results: Sixty PSL-treated and 40 BUD-MMX-treated patients were evaluated at week 8. Clinical remission was achieved in 65.0% and 55.0% of the PSL and BUD-MMX groups, respectively, whereas a clinical response was observed in 75.0% and 62.5%, respectively. No patient with a baseline PMS of 2-3 was initiated on PSL. Among patients with a baseline PMS of 4-5, the remission and response rates at week 8 were similar between the groups. In contrast, remission in patients with a baseline PMS ≥ 6 was numerically lower in the BUD-MMX group. Treatment escalation rates were comparable in the overall cohort, whereas adverse events were more frequent in the PSL group (23.3% vs. 2.4%). Conclusions: Treatment selection between PSL and BUD-MMX appeared to reflect baseline disease activity, with a partial overlap in the moderate clinical range. BUD-MMX may be a reasonable initial option for selected patients.

PMID 42452575
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PubMedPakistan journal of pharmaceutical sciences2026-07-12

Clinical pharmacist-led intervention improves anxiety, depression and inhaler technique in budesonide/glycopyrronium/formoterol-using patients: A single-center prospective randomized cohort study.

Lin Meiying M, Wang Zhiyong Z, Chen Zhibin Z, Chen Youwei Y et al.

Chronic respiratory disease (CRD) patients using budesonide/glycopyrronium/formoterol (BGF) inhalers often face anxiety, depression and incorrect inhaler technique, which impair treatment outcomes. This study aimed to evaluate the effects of clinical pharmacist-led intervention on anxiety, depression, inhaler technique, adverse drug reactions (ADR) and body mass index (BMI) in BGF users. A prospective randomized cohort study enrolled 100 BGF users from July 2023 to December 2023 at a public tertiary hospital and randomized them 1:1 to either the experimental or control group. Among these, 48 experimental patients and 45 control patients completed this study, which comprised an initial and three follow-up visits. The control group received routine care, whereas the experimental group received supplementary care led by a clinical pharmacist alongside conventional treatment. Outcomes included Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Inhaler technique scores, Adverse drug reaction (ADR) and Body mass index (BMI) were assessed at 1-, 3- and 6-months post-intervention. The experimental group had lower SAS scores at 3/6 months (p<0.05), lower moderate-to-severe anxiety rate at 6 months (68.75% vs. 93.33%, p<0.05) and lower SDS scores at 3/6 months (p<0.05). Inhaler technique scores were higher in the experimental group at all follow-ups (p<0.05). ADR incidence was lower (2 vs. 5 cases) and BMI slightly increased (p=0.312). Pharmacist-led intervention alleviates anxiety/depression, improves inhaler technique and reduces ADR in BGF users. These findings support the adoption of pharmacist-led integration into comprehensive BGF management.

PMID 42434819
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PubMedActa gastro-enterologica Belgica2026-07-08

High relapse rates after budesonide in microscopic colitis: a large retrospective analysis revealing the need for advanced therapies.

Taelman T T, Lenfant M M, Vermeire S S, Ferrante M M et al.

Microscopic colitis (MC) is a chronic inflammatory bowel disorder causing watery diarrhea despite normal endoscopic findings. Budesonide is the only approved therapy, yet long-term durability and the need for alternatives in steroid-dependent or -refractory cases remain unclear. We performed a retrospective single-center cohort study of all patients with histologically confirmed MC between 2013 and 2022, with ≥3 months of follow-up. Demographics, clinical features, treatments, and outcomes were collected. Clinical remission followed Hjortswang criteria: fewer than three stools per day or fewer than one watery stool per day on average. A total of 239 idiopathic MC patients met inclusion criteria. Spontaneous remission occurred in 19.2%, more often in males (OR 2.39, p=0.02). Corticosteroids, predominantly budesonide, were prescribed in 78.7% and induced remission in 75.5% within three months. Relapse affected 54.8% of responders, typically during tapering (44.6%) or shortly after cessation (55.3%). Younger age predicted relapse (OR 0.97, p=0.003). Conventional alternatives, including 5-ASA, cholestyramine, methotrexate, and azathioprine, were largely ineffective after corticosteroid failure or dependency. Advanced therapies (anti-TNF agents, vedolizumab, JAK inhibitors) were initiated in 12.6%, more often in younger patients (OR 0.95, p=0.001) and those with a family history of IBD (OR 4.11, p=0.03). These therapies achieved post-induction remission in 70% of refractory cases. Two patients required colectomy. In this large cohort with long-term follow-up, budesonide remained the primary treatment, yet over half of responders relapsed during tapering or after discontinuation. Conventional alternatives showed limited benefit. Advanced therapies demonstrated meaningful effectiveness in steroid-refractory or steroid-dependent MC, underscoring the need for broader therapeutic options.

PMID 42417633
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PubMedScience translational medicine2026-07-08

Phage intervention improves colitis and response to corticosteroids by attenuating virulence of Crohn's disease-associated bacteria.

Jackson Kyle K, Galipeau Heather J HJ, Hann Amber A, Constante Marco M et al.

Adherent-invasive Escherichia coli (AIEC) exhibits proinflammatory properties and has been implicated in the pathogenesis of Crohn's disease (CD), a form of inflammatory bowel disease (IBD). Antibiotic use in CD lacks specificity and may worsen microbiome disruption, prompting interest in bacteriophages (phages) for targeted microbiome editing. Here, we identified HER259, a phage active against clinical AIEC isolates. HER259 ameliorated colitis in gnotobiotic models and attenuated the virulence of AIEC strain NRG857c, including suppression of the FimH adhesin through inversion of the fimS promoter to its "off" orientation. The effects were confirmed in CD-microbiota colitis models. Withdrawal of HER259 treatment led to reversion of the fimS promoter and reactivated colitis. The HER259 phage also enhanced the therapeutic effect of subtherapeutic budesonide independent of microbial drug metabolism. These findings support targeted phage therapy as an adjunct treatment approach in IBD, demonstrating modulation of bacterial virulence and improved response to conventional treatments that may reduce drug-related side effects.

PMID 42418560
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PubMedCase reports in gastroenterology2026-07-08

Case Report: Olmesartan-Induced Enteropathy Mimicking Amyloidosis in the Setting of New Multiple Myeloma Diagnosis.

Osman Mohamad Mahdi MM, Salgado-de la Mora Moises M, Sharma Rishaan R, Ahmed Abdelwahab A et al.

Olmesartan-induced enteropathy is an uncommon but important cause of severe chronic diarrhea and weight loss that can mimic celiac disease and infiltrative gastrointestinal disorders. We report a 71-year-old man on long-term olmesartan who presented with months of diarrhea, nausea/vomiting, profound weakness, and ∼100 pounds of unintentional weight loss. Esophagogastroduodenoscopy demonstrated duodenal villous blunting with lamina propria lymphoplasmacytic inflammation and rare periodic acid-Schiff-positive macrophages. An empiric 3-week gluten-free diet trial was ineffective. Celiac serologies, infectious stool studies, and HIV testing were negative. Laboratory evaluation revealed anemia, elevated creatinine, hypercalcemia, and a gamma gap; serum and urine protein electrophoresis showed an M-protein, and bone marrow biopsy confirmed multiple myeloma. Repeat duodenal biopsies again showed villous blunting, while Congo red staining was negative, arguing against gastrointestinal amyloidosis. Olmesartan-induced enteropathy was favored; olmesartan was discontinued and budesonide was started. Within 1 month, gastrointestinal symptoms resolved and the patient gained 20 pounds. Recognition of this drug effect is critical, particularly when concurrent hematologic disease raises concern for infiltrative etiologies.

PMID 42416503
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