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Higher-dose inhaled corticosteroids
Higher-dose inhaled corticosteroids is a Inhaled corticosteroid Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 2 development for Asthma (maintenance and control), Chronic obstructive pulmonary disease (COPD). Also known as: Flovent® is a registered trademark of GlaxoSmithKline.
Higher-dose inhaled corticosteroids reduce airway inflammation by binding to glucocorticoid receptors in lung tissue, suppressing inflammatory cytokine production and immune cell activation.
Higher-dose inhaled corticosteroids reduce airway inflammation by binding to glucocorticoid receptors in lung tissue, suppressing inflammatory cytokine production and immune cell activation. Used for Asthma (maintenance and control), Chronic obstructive pulmonary disease (COPD).
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Higher-dose inhaled corticosteroids |
|---|---|
| Also known as | Flovent® is a registered trademark of GlaxoSmithKline |
| Sponsor | GlaxoSmithKline |
| Drug class | Inhaled corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 2 |
Mechanism of action
Inhaled corticosteroids are potent anti-inflammatory agents that work locally in the airways to decrease recruitment and activation of inflammatory cells, reduce mucus production, and restore airway function. By delivering the drug directly to the lungs via inhalation, higher doses can be achieved at the site of disease while minimizing systemic exposure and side effects compared to oral corticosteroids.
Approved indications
- Asthma (maintenance and control)
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Oropharyngeal candidiasis
- Dysphonia / hoarseness
- Tremor
- Headache
- Throat irritation
Key clinical trials
- Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment (PHASE3)
- Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients (PHASE3)
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population
- Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids (PHASE2)
- Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy
- Platform of Randomized Adaptive Clinical Trials in Critical Illness (NA)
- Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2) (PHASE3)
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:
- Higher-dose inhaled corticosteroids CI brief — competitive landscape report
- Higher-dose inhaled corticosteroids updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Higher-dose inhaled corticosteroids
What is Higher-dose inhaled corticosteroids?
How does Higher-dose inhaled corticosteroids work?
What is Higher-dose inhaled corticosteroids used for?
Who makes Higher-dose inhaled corticosteroids?
Is Higher-dose inhaled corticosteroids also known as anything else?
What drug class is Higher-dose inhaled corticosteroids in?
What development phase is Higher-dose inhaled corticosteroids in?
What are the side effects of Higher-dose inhaled corticosteroids?
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Related
- Drug class: All Inhaled corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonology
- Indication: Drugs for Asthma (maintenance and control)
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
- Also known as: Flovent® is a registered trademark of GlaxoSmithKline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing