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GSK1325760A
GSK1325760A is a OX40 agonist monoclonal antibody Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Advanced solid tumors (in combination with checkpoint inhibitors). Also known as: Ambrisentan.
GSK1325760A is a monoclonal antibody that blocks OX40, a co-stimulatory immune checkpoint receptor, to enhance T-cell activation and anti-tumor immunity.
GSK1325760A is a monoclonal antibody that blocks OX40, a co-stimulatory immune checkpoint receptor, to enhance T-cell activation and anti-tumor immunity. Used for Advanced solid tumors (in combination with checkpoint inhibitors).
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
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 | GSK1325760A |
|---|---|
| Also known as | Ambrisentan |
| Sponsor | GlaxoSmithKline |
| Drug class | OX40 agonist monoclonal antibody |
| Target | OX40 (TNFRSF4) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
OX40 is an inducible T-cell co-stimulatory molecule that, when engaged by its ligand OX40L, amplifies T-cell proliferation, survival, and effector function. By antagonizing OX40, GSK1325760A removes a negative regulatory signal and promotes robust anti-tumor immune responses. This approach is designed to work synergistically with other immunotherapies, particularly PD-1/PD-L1 inhibitors, to overcome immune tolerance in cancer.
Approved indications
- Advanced solid tumors (in combination with checkpoint inhibitors)
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Diarrhea
- Rash
Key clinical trials
- Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants (PHASE1)
- A Study of GSK1325760A in Healthy Japanese Subjects (PHASE1)
- A Study to Evaluate GSK1325760A - a Long-Term Extension Study (PHASE3)
- Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (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:
- GSK1325760A CI brief — competitive landscape report
- GSK1325760A updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK1325760A
What is GSK1325760A?
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What is GSK1325760A used for?
Who makes GSK1325760A?
Is GSK1325760A also known as anything else?
What drug class is GSK1325760A in?
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What does GSK1325760A target?
Related
- Drug class: All OX40 agonist monoclonal antibody drugs
- Target: All drugs targeting OX40 (TNFRSF4)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced solid tumors (in combination with checkpoint inhibitors)
- Also known as: Ambrisentan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing