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GSK3511294
GSK3511294 is a TYK2 inhibitor Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Psoriasis, Inflammatory bowel disease. Also known as: Depemokimab.
GSK3511294 is a selective inhibitor of TYK2 (tyrosine kinase 2) that suppresses inflammatory signaling pathways involved in immune-mediated diseases.
GSK3511294, also known as Depemokimab, is an interleukin-5 inhibitor, a type of antibody that targets Interleukin-5. It is being studied in clinical trials for conditions such as asthma, nasal polyps, pulmonary disease, and chronic obstructive pulmonary disease.
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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 | GSK3511294 |
|---|---|
| Also known as | Depemokimab |
| Sponsor | GlaxoSmithKline |
| Drug class | TYK2 inhibitor |
| Target | TYK2 (tyrosine kinase 2) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
TYK2 is a non-receptor tyrosine kinase that plays a critical role in type I and type III interferon signaling and IL-23 signaling. By selectively inhibiting TYK2, GSK3511294 reduces the activation and differentiation of pro-inflammatory T cells and other immune 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
- A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma (PHASE3)
- An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (PHASE3)
- Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (PHASE3)
- A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (PHASE3)
- Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1) (PHASE3)
- Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2) (PHASE3)
- Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2) (PHASE3)
- Study of GSK3511294 in Healthy Chinese Participants (PHASE1)
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:
- GSK3511294 CI brief — competitive landscape report
- GSK3511294 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK3511294
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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
- Also known as: Depemokimab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing