Budesonide
- Generic Name
- Budesonide
- Brand Names
- Airsupra, Breyna, Breztri, Cortiment, Entocort, Pulmicort, Pulmicort Turbuhaler, Rhinocort, Symbicort, Tarpeyo, Uceris, Jorveza, Kinpeygo
- Drug Type
- Small Molecule
- Chemical Formula
- C25H34O6
- CAS Number
- 51333-22-3
- Unique Ingredient Identifier
- Q3OKS62Q6X
- Background
Budesonide is a glucocorticoid that is a mix of the 22R and 22S epimer used to treat inflammatory conditions of the lungs and intestines such as asthma, COPD, Crohn's disease, and ulcerative colitis.
Budesonide was granted FDA approval on 14 February 1994. It is also available in a combination product with formoterol.
- Indication
Budesonide extended release capsules are indicated for the treatment and maintenance of mild to moderate Crohn’s disease. Various inhaled budesonide products are indicated for prophylactic therapy in asthma and to reduce exacerbations of COPD. A budesonide nasal spray is available over the counter for symptoms of hay fever and upper respiratory allergies. Extended-release capsules are indicated to induce remission of mild to moderate ulcerative colitis and a rectal foam is used for mild to moderate distal ulcerative colitis. In addition, a delayed-release capsule formulation of budesonide is indicated to reduce proteinuria in adults with IgA nephropathy at risk of rapid disease progression. In Europe, budesonide is indicated to treat eosinophilic esophagitis (EoE) in adults.
- Associated Conditions
- Allergic Reaction, Allergic Rhinitis (AR), Asthma, Bronchoconstriction, Chronic Obstructive Pulmonary Disease (COPD), Collagenous Colitis, Crohn's Disease (CD), Eosinophilic Esophagitis, Exacerbation of asthma, Nasal Congestion, Nasal Polyps, Proteinuria, Pruritus, Rhino Sinusitis, Ulcerative Colitis, Vasomotor Rhinitis, Corticosteroid-responsive dermatoses, Mild Crohn’s Disease, Moderate Crohn’s Disease
- Associated Therapies
- Maintenance therapy
BATURA Trial: Airsupra Reduces Severe Asthma Exacerbation Risk by 47% Compared to Albuterol Alone
• AstraZeneca's Airsupra (albuterol/budesonide) demonstrated a 47% reduction in severe asthma exacerbation risk compared to albuterol alone in patients with mild asthma, according to the Phase IIIb BATURA trial.
• The anti-inflammatory rescue therapy reduced total systemic corticosteroid exposure by 63%, potentially decreasing risks associated with cumulative steroid use including diabetes, cardiovascular disease, and other adverse conditions.
• Results were so overwhelmingly positive that the Independent Data Monitoring Committee recommended early termination of the trial, suggesting a potential paradigm shift in asthma rescue treatment after 50 years of albuterol-only standard care.
Breakthrough Therapies Set to Transform Eosinophilic Esophagitis Treatment Landscape
• The eosinophilic esophagitis (EoE) market is projected to grow from $1.8 billion in 2023 to a significantly higher value by 2034, driven by increased disease awareness and healthcare spending.
• Three promising therapies—APT-1011 (Ellodi Pharmaceuticals), tezepelumab (AstraZeneca), and ESO-101 (EsoCap)—are advancing through clinical trials with specialized delivery mechanisms targeting the esophagus.
• Despite recent approvals of DUPIXENT and JORVEZA, the EoE treatment landscape remains limited, with concerns about safety profiles and standardized dosing guidelines hindering widespread clinical adoption.
AstraZeneca to Present Groundbreaking Respiratory Research at ATS 2025 Conference
• AstraZeneca will showcase over 75 abstracts at the American Thoracic Society International Conference, highlighting advancements in asthma and COPD treatments including Airsupra and Breztri.
• The BATURA Phase IIIb trial demonstrates Airsupra's potential to transform asthma rescue treatment by reducing systemic corticosteroid exposure compared to albuterol alone.
• New data shows prompt initiation of Breztri after COPD exacerbations reduces subsequent exacerbations and cardiopulmonary events, addressing COPD as the third leading cause of death globally.
AstraZeneca's Trixeo Aerosphere Becomes First Inhaled Respiratory Medicine with Near-Zero Climate Impact Propellant
• UK regulatory authorities have approved AstraZeneca's Trixeo Aerosphere as the first pressurized metered-dose inhaler using a next-generation propellant with 99.9% lower Global Warming Potential than current options.
• The COPD treatment maintains clinical bioequivalence to the original formulation while achieving a carbon footprint comparable to propellant-free inhalers, addressing both patient needs and environmental concerns.
• This approval marks the first step in AstraZeneca's commitment to transition its entire pressurized metered-dose inhaler portfolio to near-zero climate impact propellants by 2030 as part of its Ambition Zero Carbon strategy.
AstraZeneca's Breztri Shows Significant Improvement in Phase III Asthma Trials
• Breztri Aerosphere met all primary endpoints in KALOS and LOGOS Phase III trials, demonstrating statistically significant improvement in lung function for patients with uncontrolled asthma compared to dual-combination therapies.
• The triple-combination therapy (budesonide/glycopyrronium/formoterol fumarate) could potentially address a critical unmet need, as nearly half of asthma patients on dual therapy remain uncontrolled.
• AstraZeneca plans to share the full trial results with regulatory authorities, potentially expanding Breztri's approved indications beyond its current use in COPD treatment across 80+ countries.
Paradigm Shift in IgA Nephropathy Treatment: Novel Targeted Therapies Address Disease Mechanisms
• Novel targeted therapies for IgA nephropathy are transforming treatment from broad immunosuppression to precision medicine approaches that address specific pathophysiologic mechanisms within the disease's 4-hit cascade.
• Emerging treatments include APRIL inhibitors, targeted enteric release corticosteroids, and selective complement inhibitors, each designed to intervene at different stages of the disease process with potentially improved safety profiles.
• This mechanistic approach enables more precise patient selection, potential combination therapies, reduced reliance on systemic immunosuppression, and promises to modify disease course rather than merely managing symptoms.
FDA Approves Takeda's Exkivity as First Oral Therapy for EGFR Exon20 NSCLC
• Takeda's Exkivity (mobocertinib) receives FDA approval as the first oral therapy specifically designed for NSCLC patients with EGFR exon20 insertion mutations after chemotherapy.
• Clinical trials demonstrated Exkivity's efficacy with 28% tumor shrinkage rate and median progression-free survival of seven months in treated patients.
• The approval strengthens Takeda's Wave1 pipeline portfolio, with the drug projected to reach $600 million in peak sales pending potential first-line treatment approval.
EMA Panel Recommends Sparsentan for IgA Nephropathy, Paving Way for EU Approval
• The EMA's human medicines committee (CHMP) has recommended sparsentan for IgA nephropathy (IgAN) treatment in adults with significant proteinuria.
• Sparsentan, developed by Travere Therapeutics and CSL Vifor, is a dual endothelin type A (ETA) and angiotensin II subtype 1 (AT1) receptor antagonist.
• The positive opinion puts sparsentan on track to potentially become the first-in-class therapy for IgAN in Europe, following accelerated approval in the US as Filspari.
• Clinical data from the PROTECT study supported the recommendation, demonstrating a reduction in proteinuria, though eGFR improvement was not significant.
FDA Approves DUPIXENT for Pediatric Eosinophilic Esophagitis, Expanding Treatment Options
The FDA has granted approval for DUPIXENT (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged 1-11 years weighing at least 15 kg. The approval follows successful Phase III EoE KIDS trial results showing superior histological remission rates compared to placebo. This development represents a significant advancement in treating pediatric EoE, a condition affecting approximately 1 in 2,000 people.
FDA Moves to Remove Oral Phenylephrine as Decongestant Due to Ineffectiveness
• The FDA is moving to phase out oral phenylephrine, a common decongestant in over-the-counter cold medicines, after determining it is no more effective than a placebo.
• This decision follows expert reviews of studies dating back to the 1960s, which revealed flaws and questionable data regarding phenylephrine's efficacy in oral form.
• Consumers may need to switch to alternatives like pseudoephedrine (available behind the counter) or nasal sprays for congestion relief.
• The FDA's decision is expected to take several months to finalize, allowing time for public comment and for drug manufacturers to reformulate or remove affected products.
Ruxoprubart Receives FDA IND Clearance for Phase II Trials in IgAN and Dermatomyositis
• NovelMed's Ruxoprubart, a selective alternative complement pathway inhibitor, has received FDA IND clearance for a Phase II efficacy trial in Immunoglobulin A Nephropathy (IgAN).
• Ruxoprubart also received FDA IND clearance for a Phase II trial for Dermatomyositis (DM), a rare autoimmune disorder affecting the skin and muscles.
• Ruxoprubart uniquely spares the classical complement pathway, potentially offering a safer profile compared to existing complement blockers that may carry Black Box Warnings.
• Clinical data from Phase I and II trials in PNH patients showed promising safety and efficacy, supporting Ruxoprubart's potential across multiple complement-mediated diseases.
Novartis and Apellis Advance C3G Therapies Towards FDA Submission
• Novartis' Fabhalta (iptacopan) demonstrated significant proteinuria reduction in the Phase III APPEAR-C3G trial, meeting its primary endpoint and supporting regulatory submissions.
• Apellis' Empaveli (pegcetacoplan) showed a substantial reduction in proteinuria and C3c deposit clearance in the Phase III VALIANT trial, indicating early efficacy in C3G patients.
• Nephrologists express a strong interest in new C3G therapies that can slow eGFR decline and reduce proteinuria, addressing the urgent need for innovative treatments.
• Spherix data suggests treatment preferences may be influenced by administration route, with Fabhalta's oral administration potentially offering an advantage.
Otsuka's Sibeprenlimab Shows Positive Phase 3 Interim Results for IgA Nephropathy
• Otsuka Pharmaceutical's sibeprenlimab demonstrated a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatinine ratio (uPCR) compared to placebo.
• The Phase 3 VISIONARY trial met its primary endpoint after nine months of treatment in adults with IgA nephropathy.
• Otsuka plans to discuss the interim results with the FDA, potentially leading to an accelerated regulatory submission for sibeprenlimab.
• Sibeprenlimab targets APRIL, a key factor in the immune pathogenic cascade of IgA nephropathy, offering a potential new therapeutic strategy.
FDA Grants Full Approval to Travere's Filspari for IgA Nephropathy
• The FDA granted full approval to Travere Therapeutics' Filspari (sparsentan) for IgA nephropathy, allowing broader use for patients at risk of disease progression.
• The approval was based on the PROTECT study, which demonstrated Filspari significantly slowed kidney function decline over two years compared to irbesartan.
• Filspari is now positioned as a foundational, non-immunosuppressive treatment option, potentially replacing the current standard of care for IgAN patients.
• The label update removes a specific urine protein level requirement, expanding the eligible patient population and increasing Filspari's market potential.
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