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GSK1358820
GSK1358820 is a IL-13 inhibitor monoclonal antibody Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Asthma (type 2 inflammation), Atopic dermatitis. Also known as: Botulinum Toxin Type A.
GSK1358820 is a monoclonal antibody that targets and inhibits IL-13, a key cytokine involved in type 2 inflammatory responses.
GSK1358820 is a monoclonal antibody that targets and inhibits IL-13, a key cytokine involved in type 2 inflammatory responses. Used for Asthma (type 2 inflammation), Atopic dermatitis.
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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 | GSK1358820 |
|---|---|
| Also known as | Botulinum Toxin Type A |
| Sponsor | GlaxoSmithKline |
| Drug class | IL-13 inhibitor monoclonal antibody |
| Target | IL-13 |
| Modality | Small molecule |
| Therapeutic area | Immunology / Respiratory |
| Phase | Phase 3 |
Mechanism of action
IL-13 is a critical mediator of type 2 inflammation implicated in conditions such as asthma and atopic dermatitis. By neutralizing IL-13, GSK1358820 reduces downstream inflammatory signaling and tissue remodeling associated with type 2 immune responses. This mechanism aims to reduce airway inflammation, mucus production, and other pathological features of allergic and eosinophilic diseases.
Approved indications
- Asthma (type 2 inflammation)
- Atopic dermatitis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
Key clinical trials
- Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity (PHASE3)
- Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder (PHASE3)
- A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity (PHASE3)
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity (PHASE3)
- Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity (PHASE3)
- A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity (PHASE3)
- Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus (PHASE3)
- GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis (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:
- GSK1358820 CI brief — competitive landscape report
- GSK1358820 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK1358820
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Related
- Drug class: All IL-13 inhibitor monoclonal antibody drugs
- Target: All drugs targeting IL-13
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Respiratory
- Indication: Drugs for Asthma (type 2 inflammation)
- Indication: Drugs for Atopic dermatitis
- Also known as: Botulinum Toxin Type A
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing