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GSK256066
GSK256066 is a Ryanodine receptor 2 inhibitor Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 2 development for Atrial fibrillation for stroke prevention.
GSK256066 is a selective and potent inhibitor of the cardiac ryanodine receptor 2.
GSK256066 is a selective and potent inhibitor of the cardiac ryanodine receptor 2. Used for Atrial fibrillation for stroke prevention.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care. -
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 | 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 name | GSK256066 |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Ryanodine receptor 2 inhibitor |
| Target | RyR2 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Mechanism of action
By blocking the ryanodine receptor 2, GSK256066 reduces the intracellular calcium release from the sarcoplasmic reticulum, leading to a decrease in cardiac contractility and a reduction in heart rate. This mechanism is thought to be beneficial in the treatment of atrial fibrillation.
Approved indications
- Atrial fibrillation for stroke prevention
Common side effects
- Hypotension
- Bradycardia
- Dizziness
Key clinical trials
- A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis (PHASE2)
- Endotoxin Challenge Study For Healthy Men and Women (PHASE1)
- Study To Evaluate Safety And Tolerability Of GSK256066 In Chronic Obstructive Pulmonary Disease (COPD) Patients (PHASE2)
- Clinical Endpoint Trial Investigating Once Daily and Bronchodilator Dosing (PHASE2)
- A Phase II Study Evaluating Intranasal GSK256066 and Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis (SAR) (PHASE2)
- Trial With Rhinitic Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber (PHASE2)
- A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis (PHASE2)
- Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma (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:
- GSK256066 CI brief — competitive landscape report
- GSK256066 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK256066
What is GSK256066?
How does GSK256066 work?
What is GSK256066 used for?
Who makes GSK256066?
What drug class is GSK256066 in?
What development phase is GSK256066 in?
What are the side effects of GSK256066?
What does GSK256066 target?
Related
- Drug class: All Ryanodine receptor 2 inhibitor drugs
- Target: All drugs targeting RyR2
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Atrial fibrillation for stroke prevention
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing