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SKP-Fluticasone
SKP-Fluticasone is a Inhaled corticosteroid Small molecule drug developed by SkyePharma AG. It is currently in Phase 3 development for Asthma (likely maintenance therapy), Chronic obstructive pulmonary disease (COPD) (likely).
SKP-Fluticasone is a corticosteroid that reduces inflammation by binding to glucocorticoid receptors and suppressing immune and inflammatory responses.
SKP-Fluticasone is a glucocorticoid receptor agonist, classified as an AGONIST, and is used to treat Asthma and Mild to Moderate Asthma. It is a small molecule that acts as a glucocorticoid receptor agonist, similar to other drugs such as Fluticasone propionate.
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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 | SKP-Fluticasone |
|---|---|
| Sponsor | SkyePharma AG |
| Drug class | Inhaled corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Fluticasone is a potent inhaled corticosteroid that works by activating glucocorticoid receptors in immune cells, leading to decreased production of inflammatory mediators and reduced airway inflammation. SKP-Fluticasone represents a formulation or delivery optimization of the established fluticasone molecule by SkyePharma AG, likely designed to improve bioavailability, lung deposition, or patient convenience.
Approved indications
- Asthma (likely maintenance therapy)
- Chronic obstructive pulmonary disease (COPD) (likely)
Common side effects
- Oropharyngeal candidiasis
- Dysphonia / hoarseness
- Tremor
- Headache
- Throat irritation
Key clinical trials
- Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma (PHASE3)
- Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma (PHASE3)
- A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005 (PHASE3)
- New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma (PHASE3)
- A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults (PHASE3)
- Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma (PHASE2)
- A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands (PHASE1)
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:
- SKP-Fluticasone CI brief — competitive landscape report
- SKP-Fluticasone updates RSS · CI watch RSS
- SkyePharma AG portfolio CI
Frequently asked questions about SKP-Fluticasone
What is SKP-Fluticasone?
How does SKP-Fluticasone work?
What is SKP-Fluticasone used for?
Who makes SKP-Fluticasone?
What drug class is SKP-Fluticasone in?
What development phase is SKP-Fluticasone in?
What are the side effects of SKP-Fluticasone?
What does SKP-Fluticasone target?
Related
- Drug class: All Inhaled corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: SkyePharma AG — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonology
- Indication: Drugs for Asthma (likely maintenance therapy)
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) (likely)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing