Last reviewed · How we verify

GSK2269557

GlaxoSmithKline · Phase 2 active Small molecule

GSK2269557 is a HDAC6 inhibitor Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 2 development for Advanced solid tumors.

GSK2269557 is a selective inhibitor of the histone deacetylase 6 (HDAC6).

GSK2269557 is a selective inhibitor of the histone deacetylase 6 (HDAC6). Used for Advanced solid tumors.

Likelihood of approval
16.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
  • Oncology Phase 2 attrition -2.0pp
    Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameGSK2269557
SponsorGlaxoSmithKline
Drug classHDAC6 inhibitor
TargetHDAC6
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

Mechanism of action

By inhibiting HDAC6, GSK2269557 modulates protein acetylation levels, which can affect cellular processes such as protein degradation and cytoskeletal dynamics.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about GSK2269557

What is GSK2269557?

GSK2269557 is a HDAC6 inhibitor drug developed by GlaxoSmithKline, indicated for Advanced solid tumors.

How does GSK2269557 work?

GSK2269557 is a selective inhibitor of the histone deacetylase 6 (HDAC6).

What is GSK2269557 used for?

GSK2269557 is indicated for Advanced solid tumors.

Who makes GSK2269557?

GSK2269557 is developed by GlaxoSmithKline (see full GlaxoSmithKline pipeline at /company/gsk).

What drug class is GSK2269557 in?

GSK2269557 belongs to the HDAC6 inhibitor class. See all HDAC6 inhibitor drugs at /class/hdac6-inhibitor.

What development phase is GSK2269557 in?

GSK2269557 is in Phase 2.

What are the side effects of GSK2269557?

Common side effects of GSK2269557 include Fatigue, Nausea.

What does GSK2269557 target?

GSK2269557 targets HDAC6 and is a HDAC6 inhibitor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing