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Placebo to budesonide inhaler
Placebo to budesonide inhaler is a Inhaled corticosteroid Small molecule drug developed by Organon and Co. It is currently FDA-approved for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).
Budesonide is a corticosteroid that reduces airway inflammation by binding to glucocorticoid receptors and suppressing inflammatory cytokine production.
Budesonide is a corticosteroid that reduces airway inflammation by binding to glucocorticoid receptors and suppressing inflammatory cytokine production. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | Placebo to budesonide inhaler |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Inhaled corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Budesonide acts as a topical corticosteroid in the lungs, binding to intracellular glucocorticoid receptors and modulating gene transcription to decrease production of inflammatory mediators such as cytokines and adhesion molecules. This reduces airway edema, mucus production, and eosinophil infiltration, thereby improving airflow and reducing asthma symptoms. The inhaled route delivers the drug directly to the site of inflammation while minimizing systemic exposure.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Oral candidiasis
- Dysphonia/hoarseness
- Tremor
- Headache
- Throat irritation
Key clinical trials
- A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation (PHASE4)
- A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD). (PHASE3)
- Cardiovascular Consequences of Inhaled Short-acting Beta-agonist Use (PHASE1)
- A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma (PHASE3)
- A Combination of an Inhaled Budesonide and Ipratropium in Patients at Risk of Developing ARDS (PHASE1, PHASE2)
- Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254) (PHASE4)
- U-LABA/ICS Effects on Exercise Performance, Formoterol (NA)
- Diesel Exhaust Induces Glucocorticoid Resistance (PHASE4)
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:
- Placebo to budesonide inhaler CI brief — competitive landscape report
- Placebo to budesonide inhaler updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about Placebo to budesonide inhaler
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Related
- Drug class: All Inhaled corticosteroid 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 therapy
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
- Compare: Placebo to budesonide inhaler vs similar drugs
- Pricing: Placebo to budesonide inhaler cost, discount & access