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GSK576428
GSK576428 is a PDE4 inhibitor Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Inflammatory bowel disease, Psoriasis. Also known as: Fondaparinux sodium.
GSK576428 is a selective inhibitor of phosphodiesterase 4 (PDE4) that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells.
GSK576428 is a selective inhibitor of phosphodiesterase 4 (PDE4) that reduces inflammatory mediator production by increasing intracellular cAMP levels in immune cells. Used for Inflammatory bowel disease, Psoriasis.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
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 | GSK576428 |
|---|---|
| Also known as | Fondaparinux sodium |
| Sponsor | GlaxoSmithKline |
| Drug class | PDE4 inhibitor |
| Target | PDE4 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| 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 is intended to reduce excessive inflammatory responses in autoimmune and inflammatory conditions. The drug's selectivity for PDE4 aims to provide anti-inflammatory effects while minimizing off-target effects associated with broader PDE inhibition.
Approved indications
- Inflammatory bowel disease
- Psoriasis
Common side effects
- Nausea
- Diarrhea
- Headache
- Vomiting
Key clinical trials
- Hip Fracture Study of GSK576428 (Fondaparinux Sodium) (PHASE3)
- Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium) (PHASE3)
- The Treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese Patients (PHASE3)
- The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients (PHASE3)
- Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients (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:
- GSK576428 CI brief — competitive landscape report
- GSK576428 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK576428
What is GSK576428?
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What is GSK576428 used for?
Who makes GSK576428?
Is GSK576428 also known as anything else?
What drug class is GSK576428 in?
What development phase is GSK576428 in?
What are the side effects of GSK576428?
What does GSK576428 target?
Related
- Drug class: All PDE4 inhibitor drugs
- Target: All drugs targeting PDE4
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Inflammatory bowel disease
- Indication: Drugs for Psoriasis
- Also known as: Fondaparinux sodium
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing