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GSK5733584
GSK5733584 is a PDE4 inhibitor Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
GSK5733584 is a selective inhibitor of phosphodiesterase 4 (PDE4) that reduces inflammatory signaling by increasing intracellular cAMP levels.
GSK5733584 is a selective inhibitor of phosphodiesterase 4 (PDE4) that reduces inflammatory signaling by increasing intracellular cAMP levels. Used for Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
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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 | GSK5733584 |
|---|---|
| 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 immune and inflammatory cells, suppressing the production of pro-inflammatory cytokines and chemokines. This mechanism is intended to reduce excessive inflammatory responses in autoimmune and inflammatory diseases. The selective PDE4 inhibition aims to provide anti-inflammatory benefits while potentially minimizing off-target effects associated with broader phosphodiesterase inhibition.
Approved indications
- Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Common side effects
- Nausea
- Diarrhea
- Headache
- Vomiting
Key clinical trials
- A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01) (PHASE3)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
- A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-Endometrial01) (PHASE3)
- A Study of GSK5733584 in Combination With Anti-cancer Therapies for Advanced Solid Tumors (PHASE1, PHASE2)
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors (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:
- GSK5733584 CI brief — competitive landscape report
- GSK5733584 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK5733584
What is GSK5733584?
How does GSK5733584 work?
What is GSK5733584 used for?
Who makes GSK5733584?
What drug class is GSK5733584 in?
What development phase is GSK5733584 in?
What are the side effects of GSK5733584?
What does GSK5733584 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 (Crohn's disease or ulcerative colitis)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing