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GSK1562902A
GSK1562902A is a PDE4 inhibitor Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD).
GSK1562902A is a selective inhibitor of phosphodiesterase 4 (PDE4) that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells.
GSK1562902A is a selective inhibitor of phosphodiesterase 4 (PDE4) that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells. Used for Chronic obstructive pulmonary disease (COPD).
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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). -
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 | 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 | GSK1562902A |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | PDE4 inhibitor |
| Target | PDE4 |
| Modality | Biologic |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
PDE4 inhibition leads to accumulation of cyclic adenosine monophosphate (cAMP) in inflammatory cells, which suppresses the release of pro-inflammatory cytokines and chemokines. This mechanism reduces airway inflammation and mucus production, making it potentially beneficial for chronic inflammatory airway diseases. The drug was developed to provide anti-inflammatory effects with improved tolerability compared to earlier PDE4 inhibitors.
Approved indications
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Nausea
- Diarrhea
- Headache
- Tremor
Key clinical trials
- Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults (PHASE3)
- Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A) (PHASE2)
- Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age (PHASE2)
- Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children (PHASE2)
- Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children (PHASE2)
- A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children (PHASE3)
- A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine. (PHASE3)
- Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules (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:
- GSK1562902A CI brief — competitive landscape report
- GSK1562902A updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK1562902A
What is GSK1562902A?
How does GSK1562902A work?
What is GSK1562902A used for?
Who makes GSK1562902A?
What drug class is GSK1562902A in?
What development phase is GSK1562902A in?
What are the side effects of GSK1562902A?
What does GSK1562902A target?
Related
- Drug class: All PDE4 inhibitor drugs
- Target: All drugs targeting PDE4
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Respiratory/Pulmonology
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing