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Budesonide DPI
Budesonide DPI is a Inhaled corticosteroid (ICS) Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Asthma (maintenance and reliever therapy), Chronic obstructive pulmonary disease (COPD). Also known as: Pulmicort.
Budesonide is a corticosteroid that reduces inflammation by binding to glucocorticoid receptors and suppressing immune and inflammatory responses in the lungs.
Budesonide is a small molecule glucocorticoid receptor agonist used to treat conditions such as asthma and chronic obstructive pulmonary disease (COPD). It is administered via a dry powder inhaler (DPI) or other forms, often in combination with other medications like formoterol.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Budesonide DPI |
|---|---|
| Also known as | Pulmicort |
| Sponsor | Organon and Co |
| Drug class | Inhaled corticosteroid (ICS) |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Budesonide is an inhaled corticosteroid (ICS) that acts as a glucocorticoid receptor agonist. When inhaled as a dry powder, it deposits directly in the airways where it binds intracellular glucocorticoid receptors, leading to suppression of inflammatory mediator production, reduction of airway edema, and decreased mucus secretion. This localized delivery minimizes systemic exposure while maximizing anti-inflammatory effects in the respiratory tract.
Approved indications
- Asthma (maintenance and reliever therapy)
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Oral candidiasis (thrush)
- Hoarseness
- Tremor
- Headache
- Nervousness
Key clinical trials
- Pressurized Meter Dose Inhaler V/S Dry Powder Inhaler (NA)
- Anti-Inflammatory Reliever South Africa (PHASE3)
- CIVETTA: Correlating Inflammatory Values of FEno, SympToms, SpuTum and Lung Function in Asthma (PHASE2)
- A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880) (PHASE3)
- Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER® (PHASE3)
- Optimal Type of Inhaler in Cough Variant- or Cough Predominant Asthma (NA)
- Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing. (PHASE3)
- Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Budesonide DPI CI brief — competitive landscape report
- Budesonide DPI updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about Budesonide DPI
What is Budesonide DPI?
How does Budesonide DPI work?
What is Budesonide DPI used for?
Who makes Budesonide DPI?
Is Budesonide DPI also known as anything else?
What drug class is Budesonide DPI in?
What development phase is Budesonide DPI in?
What are the side effects of Budesonide DPI?
What does Budesonide DPI target?
Related
- Drug class: All Inhaled corticosteroid (ICS) drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonology
- Indication: Drugs for Asthma (maintenance and reliever therapy)
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
- Also known as: Pulmicort
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing