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GSK2340269A
GSK2340269A is a PI3K-delta inhibitor Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Chronic lymphocytic leukemia (CLL), Follicular lymphoma.
GSK2340269A is a selective inhibitor of phosphoinositide 3-kinase delta (PI3K-delta) that reduces proliferation and survival of B cells and T cells in lymphoid tissues.
GSK2340269A is a selective inhibitor of phosphoinositide 3-kinase delta (PI3K-delta) that reduces proliferation and survival of B cells and T cells in lymphoid tissues. Used for Chronic lymphocytic leukemia (CLL), Follicular lymphoma.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
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 | GSK2340269A |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | PI3K-delta inhibitor |
| Target | PI3K-delta (phosphoinositide 3-kinase delta) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PI3K-delta is a lipid kinase predominantly expressed in leukocytes that plays a critical role in B and T cell activation and proliferation. By selectively inhibiting PI3K-delta, GSK2340269A suppresses aberrant lymphocyte activation and proliferation, reducing pathogenic immune responses. This mechanism is particularly relevant in B-cell malignancies and certain autoimmune conditions where PI3K-delta signaling drives disease pathology.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- Follicular lymphoma
Common side effects
- Diarrhea
- Pneumonia
- Transaminitis
- Fatigue
Key clinical trials
- Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults (PHASE3)
- Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults (PHASE3)
- Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults (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:
- GSK2340269A CI brief — competitive landscape report
- GSK2340269A updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK2340269A
What is GSK2340269A?
How does GSK2340269A work?
What is GSK2340269A used for?
Who makes GSK2340269A?
What drug class is GSK2340269A in?
What development phase is GSK2340269A in?
What are the side effects of GSK2340269A?
What does GSK2340269A target?
Related
- Drug class: All PI3K-delta inhibitor drugs
- Target: All drugs targeting PI3K-delta (phosphoinositide 3-kinase delta)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic lymphocytic leukemia (CLL)
- Indication: Drugs for Follicular lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing