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GSK5764227
GSK5764227 is a TYK2 inhibitor Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Psoriasis, Inflammatory bowel disease.
GSK5764227 is a selective inhibitor of TYK2 (tyrosine kinase 2) that suppresses inflammatory signaling pathways involved in immune-mediated diseases.
GSK5764227 is being studied in a first-time-in-human clinical trial for advanced solid tumors, including conditions such as glioblastoma, brain metastases, and gastrointestinal neoplasms. The study is evaluating the safety and efficacy of GSK5764227, although specific details about its mechanism of action are not provided in the available information.
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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 | GSK5764227 |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | TYK2 inhibitor |
| Target | TYK2 (tyrosine kinase 2) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
TYK2 is a non-receptor tyrosine kinase that plays a critical role in signal transduction downstream of type I and type III interferons and IL-23 signaling. By selectively inhibiting TYK2, GSK5764227 reduces the activation and differentiation of pro-inflammatory immune cells, particularly Th17 cells, thereby dampening pathogenic immune responses in autoimmune and inflammatory conditions.
Approved indications
- Psoriasis
- Inflammatory bowel disease
Common side effects
- Upper respiratory tract infection
- Headache
- Diarrhea
- Nasopharyngitis
Key clinical trials
- First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (PHASE1)
- A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (PHASE3)
- A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) (PHASE3)
- A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases (EARLY_PHASE1)
- A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Resistance in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) (PHASE2)
- A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors (PHASE1)
- A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101) (PHASE1)
- A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (PHASE1, 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:
- GSK5764227 CI brief — competitive landscape report
- GSK5764227 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK5764227
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What does GSK5764227 target?
Related
- Drug class: All TYK2 inhibitor drugs
- Target: All drugs targeting TYK2 (tyrosine kinase 2)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Psoriasis
- Indication: Drugs for Inflammatory bowel disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing