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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

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

PubMedFrontiers in immunology2026-09-18

Clinical remission trajectories and histopathological associations in patients with IgA nephropathy treated with targeted-release budesonide: a real-world cohort study.

He Dafeng D, Xu Jun J, Gao Bo B, Jiang Mingzhu M et al.

Targeted-release (TR) budesonide provides upstream mucosal immunomodulation in IgA nephropathy (IgAN) by targeting the gut-associated lymphoid tissue. However, the extent to which distinct downstream immune-inflammatory phenotypes and established structural chronicity shape real-world remission trajectories remains insufficiently characterized. We retrospectively analyzed 57 adults with biopsy-proven primary IgAN treated with TR-budesonide. Prespecified milestones were Very Early Response (VER) at 3 months, Early Response (ER) at 6 months, and composite clinical remission (complete or partial remission, CR/PR) over 12 months. We constructed a time-dependent prognostic nomogram using multivariable Cox modeling integrating the full Oxford MEST-C spectrum and concurrent therapies, strictly applying optimism-corrected bootstrapping (1,000 iterations) to ensure robust internal validation. Relative proteinuria reductions were broadly comparable across MEST-C strata, even among patients with substantial baseline chronicity (S1, 91.2%; T1/T2, 63.2%). Concomitant sodium-glucose cotransporter 2 inhibitor (SGLT2i) therapy independently predicted VER (OR 9.40, 95% CI 1.36-64.92; P = 0.023), consistent with an early complementary kinetic profile. Over 12 months, endocapillary hypercellularity (E1) was the only independent histopathological factor associated with composite remission (OR 2.20; P = 0.022) and was associated with a shorter time to remission (log-rank P = 0.031). The resulting optimized 3-variable nomogram demonstrated good discrimination (time-dependent AUC 0.79 at 6 months and 0.83 at 12 months) with favorable internal calibration. In routine practice, the antiproteinuric effect of TR-budesonide appears largely preserved even in patients with advanced tubulointerstitial fibrosis. Early response is strongly associated with concomitant SGLT2i therapy, while the E1 lesions was associated with a faster trajectory toward composite clinical remission within this treated cohort, identifying a potentially reversible inflammatory phenotype that warrants further validation. These findings highlight the translational value of integrating histopathological phenotyping to characterize real-world remission trajectories.

PubMedNaunyn-Schmiedeberg's archives of pharmacology2026-09-18

Myrtenol inhalation ameliorates lung injury induced by cigarette smoke in rats: the role of inflammation and oxidative stress.

Pardakhty Soheil S, Najafipour Hamid H, Jafari Elham E, Akbari Mohammad Mahdi MM et al.

Cigarette smoke is a major contributor to chronic lung injury through oxidative stress, inflammation, and structural damage. Myrtenol, a natural monoterpene, exhibits anti-inflammatory and antioxidant properties. This study evaluated the protective effects of inhaled myrtenol against cigarette smoke-induced lung injury in rats. Twenty male Wistar rats were divided into four groups: control, cigarette smoke (CS), CS + myrtenol (50 mg/kg via inhalation), and CS + budesonide. Rats were exposed to cigarette smoke for 4 weeks. Inflammatory markers (tumor necrosis factor alpha [TNF-α] and interleukin-10 [IL-10]) and oxidative stress parameters (malondialdehyde [MDA], total antioxidant capacity [TAC], and superoxide dismutase [SOD]) in lung tissue and bronchoalveolar lavage fluid (BALF) were measured by ELISA. Gene expression of MUC5AC and matrix metalloproteinase 21 (MMP-21) in lung tissue was assessed by real-time PCR. Serum cotinine levels were measured, and histopathology was performed using H&E staining. Myrtenol significantly mitigated CS-induced lung injury. Treatment reduced TNF-α, MDA, MUC5AC, MMP-21, and serum cotinine levels, while increasing IL-10, TAC, and SOD compared with the CS group. Histological analysis showed decreased inflammatory infiltration and improved tissue structure. Effects were comparable to those of budesonide. Inhaled myrtenol exerts potent anti-inflammatory and antioxidant effects, reduces oxidative and inflammatory markers, and protects lung structure against chronic cigarette smoke exposure. These findings suggest myrtenol as a promising therapeutic agent for smoke-related pulmonary disorders.

PubMedMaterials today. Bio2026-09-17

Octopus-inspired suction-cup microneedle patch enables intralesional SMAD7/Budesonide co-delivery to disrupt TGF-β-driven fibrotic remodeling.

Qin Xiaoyu X, Wie Wei W, Song Chuanhui C, Xu Jiale J et al.

Gastrointestinal stenosis following endoscopic intervention remains a major clinical challenge, largely driven by excessive fibrotic remodeling rather than persistent inflammation alone. Although glucocorticoids are widely used to suppress acute inflammatory responses, their therapeutic benefit is limited since the core profibrotic circuitry governed by the TGF-β/Smad signaling pathway. In fibrotic lesions throughout the gastrointestinal tract, activated myofibroblasts and dense extracellular matrix deposition increase tissue stiffness, reinforce mechanotransduction-dependent TGF-β activation, and restrict effective intralesional drug retention, thereby establishing a self-sustaining profibrotic microenvironment. To address this mechanistic barrier, we developed an octopus-inspired suction-cup microneedle patch with a mechanically decoupled architecture composed of rigid PLGA microneedles (MN) and a flexible pectin-based substrate. This design enables efficient penetration into stiffened mucosa and stable adhesion within the moist, dynamic luminal environment. The system achieves localized co-delivery of Budesonide (BUD) and SMAD7, an endogenous intracellular antagonist of TGF-β/Smad signaling. Comprehensive in vitro mechanistic studies and in vivo wound-healing models demonstrate effective intralesional retention, significant suppression of fibrotic remodeling, and promotion of mucosal regeneration. By simultaneously targeting inflammation and the core fibrotic signaling cascade, this bioinspired microneedle platform offers a mechanistically informed and clinically translatable strategy for the prevention and treatment of post-endoscopic gastrointestinal stenosis.

PubMedInternational forum of allergy & rhinology2026-09-15

Comment on "Effect of Budesonide Nasal Irrigation in Patients With Chronic Rhinosinusitis With Nasal Polyps Without Prior Sinus Surgery: A Randomized, Double-Blind, Placebo-Controlled Study".

Malik Maajid Mohi Ud Din MMUD, Saraf Abhay A

PubMedERJ open research2026-09-15

Budesonide/formoterol fumarate dihydrate versus budesonide with a novel suspension technology for uncontrolled asthma: phase 3 VATHOS study.

Jackson David J DJ, Wise Robert A RA, Papi Alberto A, Lugogo Njira N et al.

Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy is important in asthma. The phase 3 VATHOS study (ClinicalTrials.gov: NCT05202262) assessed the efficacy and safety of budesonide/formoterol fumarate dihydrate (BFF) via metered-dose inhaler (MDI) using Aerosphere co-suspension technology (BFFA) versus either budesonide (BD) via MDI using Aerosphere or BFF via dry-powder inhaler (BFFDPI). Participants (age 12-80 years; n=645) with inadequately controlled asthma on medium-dose ICS or ICS/LABA were randomised 1:2:2:2 to twice-daily BFF 160/10 μg (BFFA 160), BFF 320/10 μg (BFFA 320), BD 320 μg (BD 320) or open-label BFFDPI 320/9 μg, respectively. End-points included change from baseline in forced expiratory volume in 1 s area under the curve from 0 to 3 h (FEV1 AUC0-3) at 24 weeks (primary), and morning pre-dose trough FEV1 at 24 weeks, onset of action (day 1 change in FEV1, 5 min post-dose) and severe exacerbation rates (secondary). Adverse events (AEs) were recorded. BFFA 320 demonstrated superior lung function versus BD 320 at week 24 (mean change from baseline in FEV1 AUC0-3: 173 (95% CI 112-233) mL (p<0.0001); trough FEV1: 61 (95% CI 1-120) mL (p=0.0447); onset of action: 144 (95% CI 110-177) mL (p<0.0001)). Severe exacerbation rates were similar between BFFA 320 and BD 320 (rate ratio 1.02 (95% CI 0.61-1.70); p=0.9473). AEs were similar across treatments (BFFA 320, 50.3%; BFFA 160, 50.0%; BD 320, 38.1%; BFFDPI, 45.7%). BFFA 320 showed non-inferiority to BFFDPI in lung function. These findings support the use of BFFA 320 with co-suspension delivery technology in people with inadequately controlled asthma on medium-dose ICS or ICS/LABA.

PubMedERJ open research2026-09-15

Budesonide/formoterol fumarate dihydrate versus budesonide with a novel suspension technology for uncontrolled asthma: phase 3 LITHOS study.

Papi Alberto A, Wise Robert A RA, Jackson David J DJ, Lugogo Njira N et al.

Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy is a mainstay asthma treatment. LITHOS (clinicaltrials.gov identifier NCT05755906), a randomised phase 3 study, assessed efficacy and safety of low-dose budesonide/formoterol fumarate dihydrate (BFF) via a metered-dose inhaler (MDI) using Aerosphere co-suspension delivery technology (BFFA) versus low-dose budesonide via MDI using Aerosphere (BD). Participants (aged 12-80 years; N=374) with inadequately controlled asthma (seven-item Asthma Control Questionnaire score ≥1.5) despite low-dose ICS or ICS/LABA were randomised to 12 weeks of twice-daily BFF 160/10 μg (BFFA 160) or BD 160 μg (BD 160). End-points included change from baseline in forced expiratory volume in 1 s (FEV1) area under the curve from 0-3 h (AUC0-3) (primary) and morning pre-dose trough FEV1 (key secondary) at week 12, onset of action, severe exacerbation rates and safety/tolerability. Least-square mean differences (95% CI) demonstrated that BFFA 160 provided superior lung function improvement versus BD 160 at week 12 for change from baseline in FEV1 AUC0-3 (200 (134-267) mL; p<0.0001) and morning pre-dose FEV1 (82 (20-144) mL; p=0.0096). Severe exacerbation rates were nominally reduced with BFFA 160 versus BD 160 (rate ratio (95% CI) 0.48 (0.23-0.97); unadjusted p=0.0419). No new or unexpected safety findings were observed; on-treatment adverse effects were comparable between treatments (BFFA 160, 18.4%; BD 160, 19.5%). These findings support the use of BFFA 160 twice daily with novel Aerosphere technology for the treatment of people aged 12-80 years with asthma inadequately controlled by low-dose ICS or ICS/LABA.

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